*
|
http://www.vitaminlawyer.com/ -
www.vitaminlawyernews.com
|
Private, privileged and confidential...
Vitamin Lawyer Update eMemo Archives -
Index
| Memo from: Ralph Fucetola JD - The Vitamin Lawyer For the past several years, I’ve provided update memoranda to my regular clients. I’ve now created an Online Archives that will include excerpts from some of the memos, with a hypertext Index. The Tiny URL for the Archive Index page is: http://tinyurl.com/rkneb |
Online Seminar compilation of briefs and white papers:
http://tinyurl.com/ua9lq For an outline of a typical SOP: http://tinyurl.com/2eu6yj For the latest on Adverse Event Reporting: www.aer-consultants.com Vitamin Lawyer Health Freedom Blog http://vitaminlawyerhealthfreedom.blogspot.com |
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential... 10/05/07 - 7 Marketing Mistakes to
Avoid; Oversight Seal |
VLUeM Standard Disclaimers: You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… ;) And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj For the latest on Adverse Event Reporting: www.aer-consultants.com Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com For Health Freedom Issues: www.globalhealthfreedom.org Ralph
Fucetola, JD |
… VLUeM – 10.05.07 - VITAMIN LAWYER UPDATE
e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Update / Factoid
2. DHEA threatened again…
3. Do you sell in Europe?
4. Vitamin Lawyer Oversight Seal
5. 7 Marketing Mistakes to Avoid when Promoting your Business
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog –
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: "There are currently more than 194 million people with diabetes
worldwide, set to exceed 333 million by 2025."
The price of Chinese produced Vitamin C has gone from $3.5 to nearly $20 since
July.
--------------------------------------------------------
2. DHEA Threatened Again
“ ------ Original Message ------
From: news@naturesbotanicals.com
Subject: Action Alert--Stop Congress from Restricting Access to DHEA
Action Alert--Stop Congress from Restricting Access to DHEA
Your access to DHEA is in jeopardy! The Senate is considering a bill, S. 762, to
classify DHEA as an anabolic steroid, adding it to the list of controlled
substances and removing it from the market. H.R. 1249 is the companion bill in
the U.S. House of Representatives. Your immediate help is needed to keep this
safe and effective dietary supplement legal and accessible.
DHEA is not an anabolic steroid. It is a naturally occurring hormone that has a
wide range of benefits, including maintaining muscle strength and strong bones,
boosting immunity, and improving mood and sleep patterns. Further
studies suggest that DHEA may be helpful for such conditions as obesity, cancer
and Alzheimers disease. DHEA dietary supplements, which have been on the market
for over 20 years, are derived from a plant in the wild yam family; for more
information. – http://www.capwiz.com/nnfa/issues/bills/?bill=9492216 ”
We need your help to keep DHEA legal. Send a message to Congress asking your
Senators and Representative to oppose S. 762 and H.R. 1249 and any amendment to
restrict access to DHEA to minors. Congress should not restrict access to a
dietary supplement that has given health to millions of Americans. Take action
now!
If you want some background see my article on how I kept DHEA legal in 1995.
http://www.lifespirit.org/dhealegal.html
--------------------------------------------------------
3. Do you sell to Europe?
If people in Europe buy through your web site, you do. “The scope of the changes
will not just affect food packaging, but any content including websites
associated with the food.”
Innocent found guilty over antioxidant health claim
www.nutraingredients.com/news/ng.asp?n=80271&m=1NIEO03&c=jegwylrviswtnqa
By Alex McNally
10/03/2007 - UK's Innocent has been rapped on the knuckles for making a health
claim about its smoothie having a high antioxidant content and detoxifying
effect. The Advertising Standards Authority (ASA) said an advert by the firm,
which claimed its fruit juice contained more antioxidants than the "five-a-day"
portion, was not truthful or substantiated.
The verdict will come as a blow to Innocent and could set a precedent for other
companies looking to make claims about antioxidant ability of fruit. It also
adds the pressure on speeding up EU rules, which will require all health claims
to meet a Commission-improved list. Although no official wording or accepted
health claims have been approved, it seems that advertising regulators are
already tightening up on health claims in preparation, and food companies should
think carefully before making a health claim.
This is the second time in a week a company has come under fire for making a
statement about a products' health or nutritional benefit. Last week the UK Tea
Council was criticised for exaggerating the benefits of tea, and banned from
making further claims about the drinks' antioxidant potential after running a
series of adverts...
Under regulation (EC) No 1924/2006, which came into force in the UK from 1 July
2007, any food product claiming to have a health benefit must meet a list of
European Commission-approved wording and be supported by scientific evidence.
Although the regulation came into force this month in the UK, the European
Commission is not expected to agree a list of approved literature until the end
of the year. The scope of the changes will not just affect food packaging, but
any content including websites associated with the food.
--------------------------------------------------------
4. Vitamin Lawyer Oversight Seal
"The trademark Vitamin Lawyer Oversight Seal may only be displayed on a website
if the owner of the website meets or exceeds specific standards. Displaying the
Seal indicates:
1. The Website content has been reviewed for FDA and FTC regulation compliance
by The Vitamin Lawyer.*
2. The Company’s cGMP (Current Good Manufacturing Practices) have been reviewed
for government and industry standards.
3. The Company’s product labels are formatted and printed in conformity with FDA
regulations.
4. The Company’s Internet advertisements comply with FDA/FTC regulations.
5. The Website’s content has been reviewed for clarity and appropriateness.
Subject to the Vitamin Lawyer Consultancy standard retainer agreement.
http://tinyurl.com/2cfoyb - Oversight Seal
--------------------------------------------------------
5. 7 Marketing Mistakes to Avoid when Promoting your Business
Entireweb Newsletter * October 2, 2007 * ISSUE #375
www.entireweb.com
Many people rush into business thinking it will be easy to run, but very soon
they realize that it is not as easy as it looks. A successful business is a
finely tuned machine. In order to keep your business running smoothly it is
important to avoid making mistakes. Here are the 7 most common mistakes to
avoid:
1. Not having clear objectives: Many business people start a business without
clear objectives. They fail to set realistic goals for their marketing and
consequently set themselves up for failure. It is important to make a list of
goals and objectives based on a quarterly time line...
2. Neglecting to analyse your potential customers: Neglecting to analyse your
potential customers is a dangerous mistake... When you do not analyse your
customers wants and needs you do not know what products and services to develop
for them. This will lead to targeting the wrong market and neglecting to
understand your own niche market...
3. Not testing: By not testing your sales copy and places you advertise with
split testing your advertising, you will be losing sales... If you do not test
your ad copy and marketing promotions you will not have a proper idea of the ads
and promotions that are pulling and what is not working...
4. Not budgeting: Budgeting is extremely important in business. Your business
should never run out of money. This is especially true with your marketing and
advertising ventures. It is important to have a monthly or quarterly budget for
your marketing... Start small, test and then build on successes. This will allow
you to always stay solvent and have enough for promotions.
5. Giving up too soon: Companies go out of business at an alarming rate these
days. One of the reasons is that the owners give up too soon... You need to give
your promotions at least 3 months before you decide to scrap them... As always,
test all marketing tactics before you launch a larger promotion...
6. Poor sales copy: How often have you wanted a product but when you read the
sales page you had serious doubts? Poor unprofessional ad copy will cost you
sales...
7. Not screening your employees carefully...
The golden rule is to diversify. You should always use multiple forms of
marketing promotions in your business. Do not just do one or two promotions and
then wait for results. This will slow company growth and your business will
stagnate...By avoiding these mistakes you will take your company to the success
you deserve... So plan ahead and be careful not to make these common mistakes.
About the Author: Sean McPheat is a leading authority marketing consultant and
helps businesses across the UK, Europe, US and the Middle East...
www.seanmcpheat.com
Index
… VLUeM – 09.28.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Update
2. How to Avoid Alienating Search Engines
3. Vitamin Label Warnings
4. Functional Beverages… the future of supplementation?
5. Are your papers in order?
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog - New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/
Does the FDA really want public comments?
--------------------------------------------------------
2. SE Tactics: How to Avoid Alienating the Major Search Engines
http://www.entireweb.com/newsletter/archive/2007/ISSUE373.html
Some more good advice from EntireWeb.com:
Each of the major search engines… have quality webmaster guidelines … prevent …
manipulation of search engine rankings …. These webmaster guidelines change
frequently … and those websites found engaging in these illicit practices are
consequently dropped from the search engine rankings....
Being banned or dropped from the search engine rankings can have dire effects on
your website traffic, online sales generation and site popularity…
If you wish to avoid alienating the major search engines then do not engage in
the following SE tactics:
1. 'Cloaking' or sneaky redirects - displaying different content to the search
engines than shown to your normal website visitors including hidden text and
hidden links. …
2. 'Doorway' pages created specifically for the search engines that are aimed at
spamming the index of a search engine…
3. Don't create pages that install viruses, Trojans or badware. 'Badware' is
spyware, malware or deceptive adware…
4. Avoid using software that sends automatic programming queries to the search
engines to submit pages or check rankings... you will be penalized for using it.
5. Don't load web pages with irrelevant words.
6. Don't link to 'bad neighborhood' sites who have: Free for all links pages,
Link farms - automated linking schemes with lots of unrelated links, Known web
spammers or the site has been dropped or banned by the search engines.
7. Avoid 'broken links' or '404 errors,' your site will be penalized for them.
8. Don't display pages with minimal content that is of little value to your site
visitors.
9. Do not duplicate content unnecessarily.
10. Do not use pop-ups, pop-unders or exit consoles.
11. Do not use pages that rely significantly on links to content created for
another website.
12. Do not use 'cross linking' to artificially inflate a site's popularity...
multiple sites cross linking … together, if all sites are hosted on the same
servers the search engines will pick this up and the sites will be penalized.
13. Do not misuse a competitors name or brand names in site content.
14. Sites with numerous, unnecessary virtual host names will be penalized.
15. Do not use techniques that artificially increase the number of links to your
web pages ie. Link farms.
16. Display web pages with deceptive, fraudulent content or pages that provide
users with irrelevant page content.
17. Using content, domain titles, meta tags and descriptions that violate any
laws, regulations, infringe on copyrights & trademarks, trade secrets or
intellectual property rights of an individual or entity….
About the Author: Rosemary Donald is an SEO Consultant with
www.rank1websitemarketing.com - & author of the SEO ebook 'Insider Secrets of
Rank 1 Websites'
--------------------------------------------------------
3. Vitamin Label Warnings…
In addition to the statutory FDA “…not evaluated…not intended…” disclaimer, here
are some warnings for you to consider for your labels; please note that the AER
warning may have to be modified when the final AER regulations are issued in the
next couple weeks.
Product Warnings:
- Keep out of reach of children.
- Do not exceed recommended dose.
- Do not use if outer or inner seal is broken or damaged.
- If you have a serious adverse reaction to product, discontinue use
immediately, seek medical attention if necessary, and contact us.
- If you are undergoing treatment for a medical condition or if you are pregnant
or lactating, consult your physician when taking this product.
In addition to the above, you may need a Food Allergy Warning:
“The term “major food allergen” means any of the following: (1) Milk, egg, fish
(e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or
shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and
soybeans.”
That warning should read: ALLERGY WARNING: contains [list allergens].
Finally, there is a special warning for iron containing pills or capsules:
“WARNING: Accidental overdose of iron-containing products is a leading cause of
fatal poisoning in children under 6. Keep this product out of reach of children.
In case of accidental overdose, call a doctor or poison control center
immediately.”
http://www.cfsan.fda.gov/~dms/secgiro2.html
--------------------------------------------------------
4. Functional Beverages… the future of supplementation?
Nutraingredients.com reports: “As part of its newsletter on equity research -
Healthy Living Monthly … highlighted an increased consumer focus on health and
wellness as a key driver of new trends… growth and innovation will stem from
more alternative segments. There will as such be opportunities for functional
beverage and ingredients manufacturers alike as these categories grow. But it
depends on how they align their resources and efforts.
"The beverage industry has become a leading delivery vehicle for functional
nutritional ingredients, is a major beneficiary of the convenience movement in
the US, and is desperate, in our opinion, for any new ideas to offset the
stagnant market for carbonated soft drinks," write the report's authors.
Canaccord Adams valued the US nonalcoholic beverage market at $100bn in 2005.
Carbonated soft drinks (CSDs) take up the majority of this market, with a
reported $64.7bn in sales. However, the analyst says growth in the nonalcoholic
segment is coming from categories other than soft drinks as consumers move
towards healthier options or, at least, options that are perceived as healthier.
The firm conjectures this interest in healthier beverages is in part due to the
fact US consumers are increasingly overweight. An estimated 66 percent of adults
in the US are either overweight or obese, based on results from the 2003-2004
National Health and Nutrition Examination Survey (NHANES). The rate of obesity
more than doubled from the previous NHANES survey - increasing from 15.0 percent
(1976-1980) to 32.9 percent (2003-2004).
In terms of recommending how manufacturers large and small ought to innovate in
this market, the report repeatedly highlights the example of the rise of energy
drink.
"The history of the energy drink category in the United States illustrates both
the opportunities and the risks that exist as change occurs within the beverage
industry," write the analysts.
While Canaccord Adams has identified emerging trends in the beverage market as
being fortification, functionality, and a shift towards premium, "green" and
organic products… For instance, instead of water, beverage manufacturers should
now look out for 'enhanced' water.
"Don't buy commodity bottled water today, despite its enormous profitability,"
states the report. "It is late in the trend, and the early adopters are telling
us that."
Waters fortified with healthy ingredients hold the biggest potential and are
being cashed in on by the beverage giants. Coca-Cola this year forked out $4.1bn
to acquire vitamin water company Energy Brands for the manufacture and marketing
of new nutritionally enhanced vitamin water lines.
These fortified categories are the way of the future, according to Canaccord
Adams… The analyst states that though dairy was once the bastion for beverage
fortification, it has given way to alternative drink sources that come with
perhaps less calories or fat.
http://www.nutraingredients-usa.com/news/ng.asp?n=80162&m=1NIU927&c=jegwylrviswtnqa
--------------------------------------------------------
5. Are your papers in order?
With the imposition of new regulations this year, including the long-awaited
Good Manufacturing Practices, are your Standard Operating Procedures up to date?
Take a look at my standard SOP format outline at: http://tinyurl.com/2eu6yj and
let me know how if can help your company organize for future success!
--------------------------------------------------------
Index
… VLUeM – 09.19.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Update
2. More EU machinations
3. Eco-friendly packaging
4. Boomers and Dietary Supplements…
5. Are your SOPs up to date?
--------------------------------------------------------
SEPTEMBER 19: Fairfield, New Jersey, 7pm. Dr. Laibow, Gen. Stubblebine III,
Ralph Fucetola (the Vitamin Lawyer), Prof. Murray Sabrin (spokesperson for
Presidential candidate and US Congressman Ron Paul) and a spokesperson for
Presidential candidate Dennis Kucinich are guest speakers at the Health Freedom
vs. Health Tyranny Rally.
VFW Post 7925, 45 Plymouth Road, Fairfield, NJ. 937-227-9600.
Your Rights to Natural Health Care are in Jeopardy!
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/
Asking Congress to demand FDA reporting on AERs
--------------------------------------------------------
2. Does the situation in Europe portend developments here?
The FDA’s public policy of “harmonizing” with international regulations suggests
so. Here is a report on what is happening in Europe, a potential market for many
US dietary supplements and model for US regulators.
“…the harmonization process for EU food laws, including maximum mineral and
vitamin levels, has "a long way to go" before completion. European Advisory
Services (EAS) said the "vastly different national approaches" currently in
place will continue to impact on companies launching onto the European
marketplace. Manager of scientific and regulatory affairs Efi Leontopoulou also
stressed the strategic importance of the evolving regulatory climate in non-EU
countries such as Russia and Turkey, which she described as being "two complex
but very promising markets for the food industry." She added that: "Bulgaria and
Romania have recently joined the EU and this creates new market opportunities
but also more challenges in terms of the harmonization process."
A lengthy wait is predicted due to the number or rules and complexity of the
current situation, but EAS was unable to say how long this might take prior to
publication. The warning means that uncertainty about what may or may not be
imposed for minerals and vitamins will continue to spread through the industry.
Some countries could suffer a blow if EU legislation were to proscribe the sale
of high dose products or vice versa. In the UK, for example, high dose products
account for 12 to 15 per cent of the £220m vitamin and mineral market and could
experience trouble... Member states at the moment vary dramatically on maximum
and minimum levels, which would come to an end once Europe-wide unification is
imposed.
Yesterday NutraIngredients.com reported how lobbyists from Consumers for Health
Choice have pleaded with the commission president José Manuel Barroso to not
stay away from a heavy-handed approach to maximum levels. The setting of maximum
levels forms part of the 2002 Food Supplements Directive, and the new with
fortified foods regulation...
"Working with all of these different national legislations in Europe can be
quite a minefield for companies, from issues such as the addition of nutrients
to foods and the types of ingredients permitted in countries, to details on new
product notification requirements and national approaches towards derogations
for vitamins and minerals."
…A working party of Member States is expected to sit down and discuss maximum
health claims next week, and the Commission is expected to propose a directive
with actual figures in 2009.”
www.nutraingredients.com/news/ng.asp?n=79835&m=1NIE918&c=jegwylrviswtnqa
--------------------------------------------------------
3. Eco-friendly packaging
A recent issue of a nutrition industry magazine carried an interesting article
on eco-friendly packaging. The two newest offerings are Polyactide (PLA) plastic
bottles (made from corn and readily biodegradable) and Tetra Paks. The PLA is
colorful, costs less than petroleum-based plastic and uses less energy to
produce. The Tetra Paks, vaguely rectangular in shape, are mostly recyclable
paper, but with a special aseptic process that allows liquids long shelf life
without degrading the ingredients high temperatures, irradiation, etc.
Tetra Pak is at: www.tetrapak.com and you can Google “Polyactide bottles” for a
number of links.
From “Design of the Times” September 2007 Nutrition Industry Executive –
www.niemagazine.com
--------------------------------------------------------
4. Vitamins, minerals and boomers…
“Men and women over the age of 51 who regularly take dietary supplements are
more likely to get adequate amounts of several vitamins and minerals than those
who do not, a study suggests. Researchers writing in the Journal of the American
Dietetic Association also found that a substantial portion of people in this age
range do not get enough vitamins and minerals from their diet alone and the use
of supplements is necessary. Not only do these results give the supplements
industry a boost, but they could also help supplement providers in deciding
which age group to target with marketing, as well as giving a clear indicator of
what nutrients should be included… They concluded that a large "proportion of
older adults do not consume sufficient amounts of many nutrients from foods
alone. Supplements compensate to some extent, but only an estimated half of this
population uses them daily…”
www.nutraingredients.com/news/ng.asp?n=79836&m=1NIE918&c=jegwylrviswtnqa
--------------------------------------------------------
5. Are your SOPs up to date?
With the imposition of new regulations this year, including the long-awaited
Good Manufacturing Practices, are your Standard Operating Procedures up to date?
Take a look at my standard SOP format outline at: http://tinyurl.com/2eu6yj and
let me know how if can help your company organize for future success!
Index
… VLUeM – 09.12.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Update
2. News bits… Vit. C shortage?
3. Reminder: Update Archives are at: http://tinyurl.com/rkneb
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog New Postings
http://vitaminlawyerhealthfreedom.blogspot.com/
Divesting the FDA and A Little History of Regulations
--------------------------------------------------------
From an FDA warning letter issued last week: "...FDA's focus on fraudulent
products marketed on the Internet for serious and life-threatening diseases.
Individuals and firms that do not resolve violations of the Federal Food, Drug,
and Cosmetic Act risk injunction to halt the illegal activities, seizure of
violative products, and other regulatory sanctions."
--------------------------------------------------------
2. News Bits…
From New Hope Media: Dietary ingredient shortage!
“Retailers may have to start charging their customers more for dietary
supplements containing vitamin C by the end of the year as manufacturers are
forced to pass on higher prices from suppliers. Prices for vitamin C are
ballooning because of supply shortages out of China, the world's primary
supplier, and the use of corn, a source of vitamin C for mass production, as a
biofuel, said Ed Keenan, vice president of marketing at New York-based
supplements manufacturer, FutureBiotics. Keenan said Chinese suppliers claim
they are shutting down plants to remodel them to meet Western standards of
production. China supplies about three quarters of the global vitamin C market.
"What they've done is squeeze production. They're holding back in their
production," Kennan said of the Chinese production companies. "The whole
industry is going to be hit by a severe shortage."
http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1436&strSite=FFNSite
AHPA Speaks Out:
The American Herbal Products Association has submitted comments to the US Food
and Drug Administration, urging it to assist the dietary supplement industry in
complying with good manufacturing practices, adverse event reporting, and new
dietary ingredient safety regulations. The Maryland-based association was
responding to calls for input from the FDA's Center for Food Safety and Applied
Nutrition. "The dietary supplement industry faces two major new regulatory
requirements, as does the agency: a final rule on current good manufacturing
practice for manufacturing, packaging, labeling, and holding dietary
supplements, which were released this past June, and the Dietary Supplement and
Nonprescription Drug Consumer Protection Act, a new law requiring serious
adverse event reports associated with dietary supplements and over-the counter
drugs be submitted to the FDA, which goes into effect this December," AHPA
stated.
NAC & Gambling:
“A common amino acid sold as a dietary supplement could help diminish
pathological gambling addictions, according to a new study. Researchers at the
University of Minnesota uncovered the link following an eight-week trial
involving 27 people who were given increasing doses of N-acetyl cysteine. By the
end of the pilot study, published in the September 15th issue of Biological
Psychiatry, 60 percent of the participants reported having less urges to gamble.
The potential significance of these findings is huge - given the widespread
damage caused by addictive gambling.”
http://www.nutraingredients-usa.com/news/ng.asp?n=79705&m=1NIU912&c=jegwylrviswtnqa
Symbols of Harmonization?
“The US government yesterday concluded a hearing examining the implementation of
a nation-wide food labeling system to provide consistent nutrition information
on product labels. .. FDA this week held a two-day meeting to gather comments
from industry, health groups, advocacy organizations and medical experts on the
use of a labeling program similar to the UK's traffic light system. Indeed, a
number of countries around the world have already instituted voluntary labeling
systems for government-designed nutrition symbols. These symbol systems vary in
their format. Some systems have detailed graphic illustrations that indicate the
content of a number of selected nutrients, while others simply present a single
icon indicating that a food is healthful, with further information available
elsewhere, such as in booklets and web sites. In the US, the food and beverage
industry has identified the need to spell things out simply for consumers..”
http://www.nutraingredients-usa.com/news/ng.asp?n=79708&m=1NIU912&c=jegwylrviswtnqa
And this, from Nutrition 21, indicating that the middlemen are moving into
marketing as the new GMPs become effective.
“Nutrition 21, the developer of chromium-based Chromax, announced it has entered
into definitive agreements to privately place shares and warrants to fund
$17.75mn for marketing and retailing of its condition-specific products. The New
York state-based company previously used its science portfolio to support
branded ingredient Chromax's use in supplements. However, the company has opted
for a change in direction and invested heavily in promoting Chromax directly as
a finished supplement product through food, drug and mass retail outlets. The
company is going to attempt to take the market by storm, because it says its
products have the potential to be attractive to a wide variety of consumers.”
http://www.nutraingredients-usa.com/news/ng.asp?n=79678&m=1NIU912&c=jegwylrviswtnqa
3. Reminder: Update Archives at: http://tinyurl.com/rkneb
Here are some of the topics of recent Updates.
08.31.07 - More on cGMPs impact
08.17.07 - Web Site Mistakes - Speaking in NJ 09/19
08.17.07 - Superfooods Market to Double by 2011
08.03.07 - AER Regulations about to be issued.
07.21.07 - FDA Warning; current issues bulletpoints
07.17.07 - Another FDA guidance and a DC Road Trip
07.10.07 - cGMPs, TX AG, Codex degrades standards
06.28.07 - Randomized Clinical Trials; cGMPs posted
06.23.07 - cGMP Rule issued; ingredient testing...
06.07.07 - Summer of Decisions; Define your Market
05.31.07 - Ron Paul's Bill is the Answer to FDA Failings
05.16.07 - Ephedra ban continued: Risk - Benefit Analysis Comes to Herbs
05.11.07 - OMB approves cGMPs- S.1082 amend confirmed
05.03.07 - Responding to Net Attacks; Victory in Congress!
04.26.07 - SUS Page Updates
… VLUeM – 08.31.07 - VITAMIN LAWYER UPDATE
e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Update
2. More on the GMPs
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/
More News on Lobbying Congress to Divest FDA of Food Authority.
http://www.globalhealthfreedom.org
--------------------------------------------------------
2. More on GMPs
I’ve been reading the GMPs that were issued in June. You can read my initial
blog on them at:
http://vitaminlawyerhealthfreedom.blogspot.com/2007_06_01_archive.html
.
Meanwhile, a number of organizations have also been reviewing the new Rules and
I’ve been reviewing what they are saying. AHPA (American herbal Products
Association) has been part of the process from the start. Here are excerpts from
a report they’ve prepared (my headings in ALL CAPS).
BACKGROUND: "…compared to the existing cGMP for conventional foods, which is
expressed … in just under six thousand words, the final rule on dietary
supplement cGMP will be codified in 21 CFR 111 in over sixteen thousand words."
"Publication of this final rule is the culmination of a process that was begun
in 1995 with the submission to FDA of an “industry draft” by AHPA, CRN, NDMA
(now CHPA), NNFA (now NPA), and UNPA. This draft was published as an advance
notice of proposed rulemaking on February 6, 1997, and followed by publication
of a proposed rule on March 13, 2003" The final rule was published June 22, 2007
and can be seen at: http://www.cfsan.fda.gov/~dms/dscgmps6.html
APPLIES TO: “The rule applies to all firms that manufacture, package, label or
hold dietary supplements for sale in the U.S. and Puerto Rico, with the
exception of retailers who hold dietary supplements “for the sole purpose of
direct retail sale to individual consumers.” The final rule notes, however, that
this retailer exception does not extend to “a warehouse or other storage
facility for a retailer,” or to “a warehouse or other storage facility that
sells directly to individual consumers.”
STRUCTURE OF RULE: The Rule is divided into 16 parts:
“Subpart A General Provisions (*)
Subpart B Personnel
Subpart C Physical Plant and Grounds (* as Buildings and Facilities)
Subpart D Equipment and Utensils (* as Equipment)
Subpart E Requirement to Establish a Production and Process Control System (*as
Production and Process Controls)
Subpart F Production and Process Control System – Requirements for Quality
Control
Subpart G Production and Process Control System **
Subpart H Production and Process Control System – Requirements for the Master
Manufacturing Record
Subpart I Production and Process Control System – Requirements for the Batch
Production Record
Subpart J Production and Process Control System – Requirements for Laboratory
Operations
Subpart K Production and Process Control System – Requirements for Manufacturing
Operations
Subpart L Production and Process Control System – Requirements for Packaging and
Labeling Operations
Subpart M Holding and Distributing
Subpart N Returned Dietary Supplements
Subpart O Product Complaints
Subpart P Records and Recordkeeping”
* From the Food GMPs
** “Requirements for Components, Packaging, and Labels and for Product That You
Receive for Packaging or Labeling as a Dietary Supplement”
APPLIES TO SOME CAM PRACTITIONERS: "FDA also noted in the preamble to the final
rule that it “would be appropriate to consider the exercise of our enforcement
discretion, on a case-by-case basis, to determine whether to apply the
requirements of this final rule” to health care practitioners, such as
acupuncturists, herbalists, and naturopaths who are “adequately trained in their
profession” and who provide supplements that they prepare in “one-on-one
consultation[s].” The agency stated, however, that it is “not considering
exercising our enforcement discretion with respect to practitioners who prepare
batches of herbs and sell them to individual consumers without determining
whether the dietary supplement is appropriate for each consumer’s needs in a
one-on-one personal consultation, or those that prepare batches of a dietary
supplement for which there is a known or suspected safety concern.”"
Since that’s written in bureaucratic “bass-ackwards” let’s make that clearer: IF
you do individualized one-on-one counseling, the FDA does NOT expect you to meet
GMPs; if you repackage ingredients without one-on-one consultations, you will be
treated as a distributor and be required to meet GMPs.
I’ve also read the United Natural Products Alliance report on the GMPs. In
general their analysis is similar to AHPA. Some points they note (quotes are
from the FDA Rule comments):
PRODUCT COMPLAINTS: “The final rule defines product complaint…examples of
product complaints are foul odor, off-taste, illness or injury, disintegration
time, color variation, tablet size or size variation, under-filled container,
foreign material in a DS container, improper packaging, mislabeling or DS that
are super potent, sub-potent or contain the wrong ingredient or contain a drug
or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead)…”
QUALITY: “Quality means that the dietary supplement consistently meets the
established specifications for identity, purity, strength and composition and
limits on contaminates and has been manufactured, packaged, labeled and held
under conditions to prevent adulteration…”
GMP TRAINING: While FDA will not provide GMP training materials, “…paragraph, §
111.14(b)(2) requires you to make and keep documentation of training, including
the date of training, the type of training and the persons trained.”
BATCH TESTING: “We are persuaded that as an alternative to testing each finished
batch of product, we can allow for the use of a statistically sound sampling and
testing program for finished batches of DS unless a manufacturer chooses to test
every batch. Such a sampling and testing program is feasible when controls are
implemented earlier than the final product stage in the manufacturing process.
Controls include the use of a C of A from a qualified supplier for
specifications other than the identity of a DI and the establishment and
monitoring of in-process manufacturing controls.”
“We agree with the comments that if we reduce the requirements for testing at
the finished batch stage, then it is critical that you determine whether
components meet specifications. We address this issue in the following two ways:
(1) Each manufacturer must confirm the identity of each component prior to use
(you must test or examine DIs to verify the identity but may rely on a C of A to
confirm the identity of components other than DS) and (2) Each company must
confirm other required specifications for components prior to use, either by
relying upon a C of A or by testing or examining the components.”
“Because of the critical importance of insuring the proper identity of DIs –
they are the central defining ingredient of a DS – we are requiring each firm
that uses a DI to perform its own testing or examination for identity of each DI
prior to use. Firms may not rely upon a C of A provided by suppliers to
determine the identity of a DI before use. … We believe that the minimum
criteria that we are establishing for a C of A, together with the requirement
that a firm relying on a C of A must qualify a supplier and periodically repeat
that qualification process can prevent the problems that have occurred with
faulty certificates in the past.”
“Under final § 111.75(a), a firm may rely upon a C of A from its supplier of a
component provided that certain criteria are met which include the following:
(1) The firm first qualifies the supplier by establishing the reliability of the
supplier’s C of A through confirmation of the results of the supplier’s tests or
examinations; (2) The C of A includes a description of the tests or examination
method(s) used, limits of the tests or examinations, and actual results of the
tests or examinations; (3) The firm maintains documentation of how it qualified
the supplier; (4) The firm periodically reconfirms the supplier’s C of A; (5)
The firm’s quality control personnel review and approve the documentation
setting for the basis for qualification (and re-qualification) of any supplier.”
PRODUCT SPECIFICATIONS: “The requirement to establish specifications is not
limited to when a manufacturer purports that its product possesses attributes of
strength and composition on the label. One comment asks for guidance as to what
constitutes an official or scientifically valid standard for specifications. We
are not aware of any officially recognized standard for specifications… the
manufacturer establishes the set of criteria to which a product should conform
to be considered acceptable for its intended use. In general, a specification
may include a list of tests, references to analytical procedures, and
appropriate acceptance criteria that are numerical limits, ranges or other
criteria for the tests described.”
COMPLIANCE NOTIFICATION: “…an unqualified statement such as ‘produced in
compliance with dietary supplement current good manufacturing requirements,’
without more, could suggest the product may be safe and effective or somehow
superior to other DS products that are subject to the same CGMP requirements
(id.) [and] would likely be considered misleading …, but that including language
clarifying to consumers that all DS must be manufactured in compliance with CGMP
requirements, and that such compliance does not mean that the DS is safe or
effective, may be a way to cure that unqualified statement … Thus, we are not
prohibiting voluntary statements on the DS label, provided that such statements
are truthful and non-misleading…”
GMP & AER: And, despite the new AER law, “We continue to strongly recommend that
firms that receive product complaints, that are not ‘serious adverse events’
notify us about any illness or injury, because, for example, we may have
additional expertise or data that may be helpful in investigating the complaint
or determining whether the problem applies to more than one product…We encourage
you to include our recommendations in the written procedures that you develop
for handling product complaints.”
CONCLUSION: Your bottom line: over the next three years, as GMPs become
effective first for large firms, then in 2 years for medium firms (under 500
employees) and finally in three years for small (under 20 employees) individual
firms will have to manage their compliance with the requirements. The Vitamin
Lawyer Consultancy will be available to help.
STANDARD SOP: Expect my revised Standard Operating Procedures (for Dietary
Supplement companies and for CAM practitioners) providing for phasing in the GMP
requirements, to be available in the next month or so. I’ll let you know as soon
as they are ready. You can see outlines of my pre-final rule SOPs at http://tinyurl.com/2eu6yj
- these will be re-organized to fit the 16 GMP categories noted above. I
estimate it will take 2 – 3 hours to customize the revised formats for each
operating company responsible for GMPs.
… VLUeM – 08.17.07 - VITAMIN LAWYER UPDATE
e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Update
2. Web Site Mistakes
3. Wiki Biased Editing Exposed
4. I’ll be speaking in NJ on September 19th
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/
New link established to allow Health Claims comments to FDA! Comments end:
08/31/08.
--------------------------------------------------------
2. Entireweb Newsletter * August 14, 2007 * ISSUE #361
* entireweb.com
Excerpts from: Do You Make These Mistakes With Your Web Site?
“… no web site is absolutely perfect… But there are some basic web site mistakes
…
- Not enough content. - …minimal information along with their contact
information on their web sites … today's web visitors are looking for … lots of
good quality content … build credibility for your business.
- Old or outdated content. - If you want visitors and search engines to pay
attention to your web site, you need to keep adding new content and updating the
existing information....
- Not being search engine friendly. - … in order to be included in the search
engine databases.
- Not monitoring your site in the search engines. - … Monitoring your web site
means that you can react to changes and take appropriate steps to make sure your
site shows up in the search results and that web traffic keeps flowing.
- The site is built using Frames or Flash. - Not too many web sites still make
this mistake…
Making your web site the best it can be is a very effective and affordable
marketing option for most small businesses. Of all the other types of
advertising and marketing that you do each year, your web site has the potential
to be seen by more customers, can continue to promote your company perpetually
through links, is always accessible to customers, and can instantly reflect
changes and provide fresh information to draw people in….”
About the Author: Lauren Hobson is the Editor of Biz Talk Newsletter and the
Five Sparrows Marketing Blog from Five Sparrows, LLC at www.fivesparrows.com/biztalk.
--------------------------------------------------------
3. Wiki Biased Editing Exposed
http://www.prisonplanet.com/articles/august2007/140807_wikipedia_credibility.htm
Has your company been the victim of derogatory Wikipedia postings?
Says PrisonPlanet.com: “The credibility of the online encyclopedia Wikipedia has
taken another dive after a newly developed software program exposed how the CIA,
corporations like Diebold and others routinely edit entries to bury criticism
and manipulate the truth . . . Now a CalTech graduate student has developed a
software tool that threatens to slam the final nail in the coffin of any
credibility Wikipedia had left… Wikipedia Scanner -- the brainchild of CalTech
computation and neural-systems graduate student Virgil Griffith -- offers users
a searchable database that ties millions of anonymous Wikipedia edits to
organizations where those edits apparently originated, by cross-referencing the
edits with data on who owns the associated block of internet IP addresses,"
reports Wired News.”
"The Wikipedia Scanner (http://wikiscanner.virgil.gr/) also allows users to type
in an IP range and find out which organizations are editing what pages on
Wikipedia."
Adds PrisonPlanet: "Though Wikipedia's raison d'etre is obviously based around
allowing users to edit the content, the checks to prevent abuse and organized
partisan attack campaigns against certain subjects or ideas are non-existent and
the absence of any kind of reasonable moderation is destroying Wiki's
reputation. ... Wikipedia is fast becoming a complete anathema to reliable
research and will see its wavering reputation as a trustworthy source for
information quickly evaporate if it continues to allow itself to be abused by
intelligence agencies, corporations and dedicated trolls."
Over the past two years we've noted that attempts to put positive postings on
Wikipedia about alternative healthcare and natural nutrients has been met with
attacks by "Quackwatch" types, even as the "official" Quackwatch sites and
founders have been found by courts to be untrustworthy of belief. Will see over
the next few months if Wikipedia is capable of reforming itself to regain its
credibility.
--------------------------------------------------------
4. I’ll be speaking in NJ on September 19th - Here’s
the flyer from NJNHP:
New Jersey Natural Health Professionals & Natural Solutions Foundation
Health Freedom vs. Health Tyranny: Your Voice Matters
September 19, 2007 7:00 p.m. - 10:00 p.m.
VFW Post 7925 - 45 Plymouth Road - Fairfield, New Jersey
973-227-9600
Guest Speakers:
Rima E. Laibow, MD
Founder Natural Solutions Foundation
Maj. Gen. Albert N. Stubblebine III (US Army Ret.)
President Natural Solutions Foundation
Ralph Fucetola, JD
Best known as “The Vitamin Lawyer”
Professor Murray Sabrin
Spokesperson for Presidential Candidate & U.S.Congressman Ron Paul
For more information/reservations, please contact:
Sharan Woods, President
New Jersey Natural Health Professionals
Fairfield, New Jersey
973-882-0181
… VLUeM – 08.11.07 - VITAMIN LAWYER UPDATE
e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Updates
2. Superfoods market to double by 2011
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog New Postings
http://vitaminlawyerhealthfreedom.blogspot.com/
AER Regulations Immanent… EU Backs off banning natural vitamins!!
--------------------------------------------------------
2. Superfoods market set to
double by 2011 - Alex McNally
“Aug. 10, 2007 - The superfood and drink market is expected to almost double in
the ten year period up to 2011, says a report published today, with soy products
and exotic fruits leading the charge.
…Michael Hughes, market analyst and author of the report Super Food and Drinks:
Consumer Attitudes To Nutrient Rich Products, said shoppers are actively seeking
nutrient rich fresh, organic and functional food and drinks and turning their
backs on foods high in fats, sugars and salts… Hughes said: "The trend towards
'positive nutrition' is well reflected by the recent popularization of
superfoods, especially in the UK and US."
As a result, superfoods and drinks, like acai and goji berries, are seeing a
surge in demand. Datamonitor defined superfoods for the purpose of the report as
foods rich in "specific nutrients and phyto-chemicals (i.e. anti-oxidants) and
are promoted as being able to improve health condition and/or disease
prevention." A spokesperson told NutraIngredients.com that the definition
includes both foods which are naturally high in nutritional value and those with
added nutrition. This means it can include much of the functional food market.
Many food and drinks associated with superfood status have also enjoyed healthy
growth in the last five years and this - in part - can be attributed to this
status, he added. Hughes said: "The popularization of superfoods means that many
food and drinks now have a 'healthy-halo' which significantly influences
consumer preferences."
Exotic, highly fashionable fruits such as acai berries, goji berries and
pomegranates have all risen in popularity, with pomegranate currently one of the
most fashionable superfood ingredients, the analyst said. In the period January
2005 to May 2007, there had already been a 500 per cent increase in the number
of products using pomegranate as an ingredient compared to the period 1999 to
2004.
Hughes added: "Right now, pomegranate is the hot ingredient, but this is likely
to be superseded given that new ingredients are being continuously touted.
"Monitoring these developments will be vital if industry players are going to
fully capitalize on the superfoods movement." … Green tea sales have grown
substantially in the US. The market grew from €18m ($119m) in 2001 to €116m
($160m) in 2006… Datamonitor also identified an opportunity for manufacturers to
respond to growing time constraints which are leading to people in Europe
missing around 100 meals a years because they do not have time. The report
suggests companies can take advantage of this by offering nutritionally enhanced
snacks as a substitution for missed meals.
http://www.nutraingredients.com/news/ng.asp?n=78969&m=1NIE810&c=jegwylrviswtnqa
… VLUeM – 08.03.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Update
2. AER Regulations Immanent
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/
FDA enabling act delayed! Hope abounds…
--------------------------------------------------------
This late breaking news from NutraIngredients. Please note this indicates that FDA is about to issue the Adverse Event Reporting regulations mandated by the law President Bush signed last December. The law is supposed to go into effect 12/22/07. These guidelines would be the 4th major guideline about Dietary Supplements issued by FDA over the past half year or so.... an unprecedented level of regulation enhancement.
www.nutraingredients-usa.com/news/ng.asp?n=78773&m=1NIU803&c=jegwylrviswtnqa
CRN urges FDA interpret adverse events bill with caution - By Clarisse Douaud
08/03/2007 - The Council for Responsible Nutrition (CRN) has expressed its concern to the US Food & Drug Administration (FDA) over alleged labeling requirements the agency may include in its upcoming adverse events reporting guidance ... The points in question pertain to a requirement for labels to include a full street address as well as introductory language informing customers how … [report adverse events] … ‘To issue guidance that would require de facto label changes would cause a great deal of confusion…’ wrote [CRN] in the July 31 letter addressed to … FDA's Center for Food Safety and Applied Nutrition… Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was passed in December 2007 and will oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers… now anticipating the imminent release of FDA's guidance on "the minimum data elements that should be included in a serious adverse event report". The document will essentially outline how the bill is to be interpreted … The so-called introductory language would instruct consumers how to use the contact information. For … example…: "To report an adverse event, contact..." and "If you experience problems with this product, contact…"
… VLUeM – 07.21.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Update
2. Recent FDA Warning Letter
3. Bulletin Points: Current Regulatory Issues
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog New Posting
New posting on newest FDA draft guidance on Health Claims:
http://vitaminlawyerhealthfreedom.blogspot.com/
Dr. Laibow remarks that the guidance is “apparently in direct response to Dr. Ron Paul's Health Freedom Protection Act, HR 2117…” and offers a link to protest this to the FDA:
--------------------------------------------------------
2. Here are excerpts from a warning letter FDA issued a couple weeks ago
It shows us current thinking on “drug” claims for Dietary Supplements and gives a “text book” example of what claims not to make:
“This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at … and has determined that the products … are promoted for conditions that cause the products to be drugs under … the Federal Food, Drug, and Cosmetic Act (the Act) ... The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. … Examples [X} “…Cancer Prevention and Treatment” … "The scientific community has recently had very positive results on the effect of … on certain types of cancers. In tests on a variety of tumor types, the treatment with … led to improvement of overall health status, prolongation of life span, and a decrease in tumor size. Also, in local applications of … to skin cancer, it reduced tumor formation and growth." … "For prevention … As part of Cancer therapy"
*** [Y] The Hangover Preventive" … "When you drink alcohol, the body tries to break down the toxins.... These toxins are not fully broken down and cause damage to your organs. The side effects of this damage, we call a `hangover' such as headache and nausea, as well as other ill effects that we can't see (liver damage)…. absorbs the toxins from the alcohol before they are processed into your organs."
The above claims about individual products are supplemented by claims on your homepage about your products in general and by metatags you use to bring consumers to your website. Examples of the metatags include "cancer prevention," "toxin removal," and "Natural supplements that... are proven to inhibit cancerous tumor growth, and will even prevent hangovers.... Effective … cure." ***
Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "new drugs"… New drugs may not be legally marketed in the U.S. without prior approval from FDA …. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
In addition, we note that your website states the following: "This form of [Y] is approved by the FDA as completely safe...." We have cited several examples in this letter to demonstrate that you are not in compliance with FDA requirements. Further, FDA has not reviewed the safety of [Y], nor its interactions with other substances. Therefore, the use of this statement to promote your products is false or misleading in that it implies FDA approval or sanction of your product and its purported uses. The false and misleading information misbrands your[Y] products ... ***
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. …Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.”
Students of the Vitamin Lawyer Red Flags Review School will readily see all the mistakes the marketer made… all the dangerous claims and over the line statements. A word to the wise…
--------------------------------------------------------
3. Some Bullet Points regarding current regulatory issues
The
opportunity should be clear: resubmit HR.2117 as the Health Freedom Restoration
and Protection Act with language addressing each of the pending challenges noted
above.
“It is all within our grasp,
the restoration of the republic and our sovereignty … federalism, free
enterprise, peace, prosperity, and the kind of future we all want for our
families, ourselves, and our fellow Americans. The dream can be a reality
… Instead of wars and inflation and spying and poverty, we can have peace and
freedom and the blessings for our children and grandchildren of doing better
than we have, of secure retirements and childhoods. No more theft -- of our
savings or our liberty.”
- Ron Paul at Google on 07/13/07
… VLUeM – 07.17.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Health Freedom Blog Update
2. Another FDA Guidance: Health Claims Substantiation
--------------------------------------------------------
1. Vitamin Lawyer Health Freedom Blog New Posting
The House passed the FDA enabling act last week and we visited Washington…
http://vitaminlawyerhealthfreedom.blogspot.com/2007/07/road-trip.html
Things are about to get very exciting as Dr. Ron Paul leads the way in countering recent attacks on Health Freedom by the FDA, Congress and Codex!
--------------------------------------------------------
2. New FDA Draft Guidance: “Evidence-Based
Review System for the Scientific
Evaluation of Health Claims” -
http://www.cfsan.fda.gov/~dms/hclmgui5.html
Following closely after the FDA draft anti-CAM guidance, this new draft guidance, just published, continues the FDA’s policy of more closely regulating the natural products industry. There is a 60 day comment period that should run until the end of August.
Says the introduction: “This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientific evidence for a health claim, 2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act … and 3) credible scientific evidence to support a qualified health claim. … This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners … The specific topics addressed in this guidance document are: (1) identifying studies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.”
This guidance attempts to impose a high standard on Health Claims. Dr. Ron Paul’s pending bill, the Health Freedom Protection Act, HR.2117 addresses this further FDA power grab by imposing the standard commercial substantiation requirement. Essentially this bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer." Thus, even "a scintilla" of scientific evidence would allow the making of claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.'' The text of the bill, reintroduced on May 7, 2007, can be found at: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117
This latest FDA Guidance needs further analysis and comments will be addressed to the FDA recommending that Dr. Paul’s approach be substituted for the overly bureaucratic approach favored by the Agency.
… VLUeM – 07.10.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Aspartame, etc. now Dietary Supplements?
2. Texas AG and Testimonial Claims
3. More on the new cGMPs
4. Health Freedom Blog Update
--------------------------------------------------------
1. Codex, the World Food Code, continues to degrade food standards…
Rome 07.06.07 – “…the Codex General Standard for Food Additives (GSFA), which sets down the conditions for permitted food additives for all supplements, has now agreed the higher levels for castor oil, polysorbates, polyvinyl alcohol, acesulfame potassium, aspartame, cyclamates, neotame, saccharin, and sucralose. A US-led working group had been charged with drawing up a list of allowed additives and with setting levels based on technical justification and safety. The group had previously drafted lower than expected guidelines….”
http://www.nutraingredients-usa.com/news/ng.asp?n=78020&m=1NIU709&c=jegwylrviswtnqa
You can keep up with the Byzantine world of the Codex Mandarins at www.globalhealthfreedom.org
--------------------------------------------------------
2.
“The
Texas Attorney General last week charged supplement manufacturer Mannatech for
illegally marketing using dubious claims and testimonials about the health
benefits of its products.
”Mannatech,
its owner and related entities were found in violation of the
Texas
Deceptive Trade Practices Act, which can result in civil penalties of $20,000
per violation, as well as going against the Texas Food, Drug, and Cosmetic Act,
which can result in up to $25,000 per day, per violation.
”State judgments such as these can pick-up where
the Federal Trade Commission - which is increasingly on the look-out for misuse
of consumer testimonials - has not reached, or not yet reached.
”Mannatech has in particular been charged with
encouraging salespeople to make use of misleading testimonials. …
"With today's enforcement action, the Office
of the Attorney General seeks to shut down an elaborate scheme to defraud
innocent consumers across the nation,"
Texas Attorney General Greg Abbott said in a written statement.
”According to the Office of the Attorney General,
exaggerated claims relating to the therapeutic benefits of Mannatech's dietary
supplements and products were used to unlawfully mislead consumers with cancer,
Down's syndrome, cystic fibrosis and other serious illnesses.”
http://www.nutraingredients-usa.com/news/ng.asp?n=78041&m=1NIU709&c=jegwylrviswtnqa
A word to the wise should be sufficient: Testimonials are not substantiation. Says the FTC in its Testimonial Guide,
“Endorsements must always reflect the honest opinions, findings, beliefs, or experience of the endorser. Furthermore, they may not contain any representations which would be deceptive, or could not be substantiated if made directly by the advertiser.”
--------------------------------------------------------
As I continue to read the 467 page Good Manufacturing Practices document recently issued by the FDA I will continue to send off “tidbits” that exemplify the spirit of the new regulations.
For example, from the Economic Impact section:
“We find that this final rule will have a significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business. …very small … and … small dietary supplement manufacturers … will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry.”
--------------------------------------------------------
The Vitamin Lawyer Health Freedom Blog is now at Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com
I just posted more information on the House and the pending FDA “revitalization” bill, based on contact from the office of a friendly Congressman.
… VLUeM – 06.28.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. RCT (Randomized Clinical Trials) and nutrients
2. New cGMPs now available on net
3.
http://www.vitaminlawyerhealthfreedom.blogspot.com
4. CRUSH media release: Silver Safety Standard
--------------------------------------------------------
1. RCT (Randomized Clinical Trials) and Nutrients
This article by Dr. Melton is cogent and worth reading. The article goes to the heart of the coming cGMPs – how will you substantiate the claims you make about your products? How will you prove the identity and quality of the ingredients? If you have the time to think about what your company will be doing in two years when the cGMPs become effective for small companies, this is something you need to think about… and, yes, you do need to start thinking now…
Clinical trials - gold standard or white elephant?
25/06/2007
-
Randomised clinical trials are the ultimate. Forget what the observational
studies tell us, if the RCT gives us an answer it must be the final word, right?
Wrong.
The
value of such trials for the food industry is undeniable, but too often
nutrients are pulled out of context, following the same methodology as used for
the testing of drugs.
But let's not forget that by following the
drug model we are supplementing the diet with one or two nutrients, each at a
single dose, for a set period of time. Can a time-constrained randomised trial
really capture a lifetime of consumption with respect to chronic disease?
Randomised clinical trials work by
randomly assigning a group of volunteers to receive an active compound, be it a
drug or nutrient(s), or a non-active comparison, be it an inactive form of the
active compound or a placebo. Observational studies, as the name suggests,
observe a population and relate dietary intakes of food and nutrients to the
occurrence of disease.
We need to
consider the science as a whole and not blinker ourselves with results of one
big clinical trial, regardless of how much money it costs and what universities
were involved.
For
food items that do not normally form part of the usual food chain,
randomised clinical
trials are the best of the
best because such compounds can be tested and retested successfully.
Phytosterols, probiotics, or botanical
supplements, for example, fit into this category.
Indeed, clinical trials on phytosterols
have shown time and again that daily consumption of 1.5 to 3 grams of
phytosterols/-stanols can reduce total cholesterol levels by eight to 17 per
cent, representing a significant reduction in the risk of cardiovascular
disease.
Studies
looking at how these results transfer into real free-living populations have
backed up the clinical trials, showing a stabilisation of cholesterol levels in
certain populations.
So
we know the benefit of clinical trials. But when we start using this approach
for vitamins, minerals, antioxidants and other nutrients, we come a little
unstuck.
Some
may say that I'm over-reacting, but let's just look at the report published in
the New Scientist magazine that slammed antioxidant supplements as myth.
Despite a vast body of observational/ epidemiological studies linking an
increased dietary intake of antioxidants from fruits and vegetables to reduced
risks of a range of disease, including cancer, cardiovascular disease and
diabetes, when such antioxidants have been extracted and put into supplements,
the results, according to RCTs, do not produce the same benefits and may even be
harmful.
So
the author of the article, Dr. Lisa Melton from the London-based registered
charity, the Novartis Foundation, concluded that antioxidant supplements are too
good to be true.
Is
this really the answer or is it due to poor study design? Would a two-year trial
of vitamin E, let's say, really produce a reduction in the risk of a chronic
disease?
To
illustrate this point further, we only need to go back to last year's Women's
Health Initiative (WHI) trial that followed 18,176 post-menopausal women taking
calcium (1000 mg) and vitamin D (400 IU) supplements. A similar population
(N=18,106) was given a placebo. The subjects were followed for about seven years
and the researchers reported that the supplements 'had no effect' on the risk of
colorectal cancer.
None
of the women had the cancer at the start of the study and colorectal cancer has
a long latency period of 10 to 20 years, which begs the question - could we
really have expected to see an effect?
We
also need to remember that nutrients often work in synergy with one another and
exert effects on multiple body tissues, unlike pharmaceuticals.
Additionally, many randomised clinical trials look at the effect of nutrients in
diseased populations. Surely the damage of a lifetime's poor nutrition has
already been done. When we obtain negative or null results from such trials,
should we really be surprised?
The
power of nutrients is in the prevention, not cure, of disease.
So
what should we do? I don't pretend to have any answers. These are for ladies and
gentlemen with infinitely bigger brains than me.
Realistically, there are no viable alternatives out there at present.
Randomisation is the best way of limiting bias that creeps into every study, and
controlling, specifically with placebo, is the best way to make comparisons.
For
those times where randomised trials clearly aren't the best option, then we
probably need to look at the observational studies and mechanistic studies in
greater depth, and place more value on them.
The
research community as a whole must work together to re-evaluate how to get the
most from research into nutrition. Lots of different types of studies are out
there. Let's make the most of what we already have.
Stephen
Daniells is the Food Science Reporter for NutraIngredients.com and
FoodNavigator.com. He has a PhD in Chemistry from Queen's University Belfast and
has worked in research in the Netherlands and France.
If
you would like to comment on this article please contact
stephen.daniells'at'decisionnews.com
http://www.nutraingredients.com/news/ng.asp?n=77611&m=1NIE625&c=jegwylrviswtnqa
-------------------------------------------------------- Index
2. FDA publishes Current Good Manufacturing Practices for Dietary Supplements
I’m reading them, but so can you, at: http://www.cfsan.fda.gov/~lrd/fr07625a.html (467 pages when downloaded to MS Word; the actual rule doesn’t start until page 426, after 359 comments…).
Here are some comments by FDA, from the commentary
preceding the new rule, that tell us a lot about where the present
administration of FDA is taking us: “…we disagree with the comments asserting
dietary supplements have a track record of safety such that dietary supplement
CGMP requirements are unnecessary. Section 402(g) of the act does not require us
to establish a ‘bad’ track record of safety in the manufacture of dietary
supplements before we may issue a dietary supplement CGMP rule. Furthermore, we
disagree with the comments comparing dietary supplement safety to drug safety;
there are different statutory requirements, different regulatory requirements,
and different safety evaluations for dietary supplements and drugs.”
We can hope there will be a change of Agency attitude when the Administration
changes in about a year and a half; especially if the good doctor from Texas
replaces the current Texan occupying the White House. I’ll provide more tidbits
as I read the materials.
--------------------------------------------------------
The Vitamin Lawyer Health Freedom Blog is now at Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com
I just posted a link there to an 8 minute presentation I taped for Natural Solutions Foundation, for use with health-friendly delegates at next week’s Codex Commission meeting in Rome.
--------------------------------------------------------
4. CRUSH Silver Safety Standard
The Committee on the Responsible Use of Silver in Health (of which I am a member) is releasing the final version of its Silver Safety Standard (The “12 for 25 Rule). The media release will be posted on PRWeb shortly and can be seen at www.silverfacts.com or on my Blog.
-------------------------------------------------------- Index
… VLUeM – 0623.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1.
cGMP “Final Rule” Issued: all ingredients to be tested within 3 years!
2. Vitamin Lawyer starts Health Freedom Blog at
Blogspot.com
-------------------------------------------------------- Index
1. Excerpts from the FDA announcement follows. The terminology is fairly much what I had predicted in previous postings, focusing on “identity, purity, strength, and composition” – however, the enforcement procedures seem more extreme than had been predicted from the draft rule and may represent a further ratcheting of enforcement in general.
Announcement: “The U.S. Food and Drug Administration today (06/22/07) announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. ***
The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints. ***
Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.
The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling. ***
FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing … if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. ***
The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with … less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html
It is certainly time to make sure your Standard Operating Procedures meet the new standards, as those standards become effective. I will continue to monitor this situation and inform this email list as modified SOP documents are ready.
--------------------------------------------------------
2. Health Freedom Blog Upgraded
The Vitamin Lawyer has just started a Health Freedom Blog at Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com – the earliest postings from my original health freedom blog at http://tinyurl.com/yo5t4t have been reorganized to start the replacement Blogspot blog. Additional material is added as available.
-------------------------------------------------------- Index
… VLUeM – 06.07.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Summer of Decision “Not Unreasonable…”
2. Entire Web: Define Your Target Market
-------------------------------------------------------- Index
1. A Summer of Decision: Suggested Amendments to FDA "Revitalization" bill - "Not Unreasonable"
This is a summer of significant decisions in the Dietary Supplement and Natural Products marketplace.
Take Action: Natural Solutions: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344
Wellness Resources: http://capwiz.com/wellnessresources/issues/alert/?alertid=9773656&PROCESS=Take+Action
From Wellness Resources: "The Senate has recently passed bill S.1082, commonly known as the FDA Revitalization Act. ...the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use this legislation to undermine my access to safe and effective dietary supplements. There must be no confusing the safety of drugs and the safety of food and food ingredients – which are governed by different laws. ...members of Congress are not intending to create such concern among the 150 million Americans who rely on dietary supplements to assist their health, and this matter is easily corrected with the following amendment, which will not in any way stop the FDA from identifying truly contaminated food that poses a risk to human health.
"Changes in Existing Law. The following provides a print of the existing statute or part or section thereof to be amended or replaced so as to delete the words “or unreasonable” (existing law proposed to be omitted is enclosed in black brackets, existing law in which no change is proposed is shown in roman):
"CHAPTER IV – FOOD - SEC. 402 (f) – (1) If it is a dietary supplement or contains a dietary ingredient that – (A) presents a significant [or unreasonable] risk of illness or injury under — (i) conditions of use recommended or suggested in labeling, or (ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use:
"Changes in Proposed Bills Proposed amendment to S.1082 and HR.1561:
"The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with health benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use..."
My comment: it may seem small, but the words "not unreasonable" do have a big impact... and it is in the small space made by such words (or their deletion!) that Health Freedom has room to grow. This amendment, together with the wording of Dr. Paul's HR.2117, would go a long way toward protecting our access to truthful information about the health benefits of foods. Please note that S.1082 does not explicitly mention Dietary Supplements (except for the DSHEA Exemption Amendment adopted 94 to 0) so the suggested Emord Amendment would change existing law to be more protective of Dietary Supplements by attaching the change to the pending pro-FDA bill, the same parliamentary procedure that has been suggested with Dr. Paul’s bill.
One concern I do have with this amendment is that the recent Supreme Court Ephedra decision, not to review the appeals court upholding the Ephedra ban, effectively means that nearly any risk of illness may be considered "significant" and therefore, the amendment may not be strong enough. However, it may be possible to get it adopted… one step at a time!
This is an especially exciting time to be in the Dietary Supplement / Natural Products market. While stricter regulations seem on the way, scientific advances and ongoing clinical studies point the way to better and more effective products. The problem is not in the science or the production; the problem is in the politics. These products are generally recognized as safe when used as directed, like any food. We therefore need to reject the big government notion that tells us we will only be safe if bureaucrats have more control over us. That nostrum is provably wrong, as we see from the failure of government, with plenary power over approving drugs (as to efficacy and safety) to protect the public from what some estimate to be hundreds of thousands of unnecessary deaths each year from lawfully utilized prescription drugs.
The next few weeks, as the FDA “revitalization” bill is amended or not, and adopted, or not, will tell us a lot about the future of this market. Other important regulatory events are happening this summer as well: the FDA anti-CAM guidance may be finalized; the new Dietary Supplement “Good Manufacturing Practices” have been finalized and should be issued. And, as always, the FDA’s announced intent to “HARMonize” our freedoms to international rules (even where that decreases our access to safe products), operating through the North American Union, Codex and the new US/EU cooperation agreement, remains an ever present threat.
This will be a summer of rapid events; stay up to date, even between VLUeM Memos, by checking my Vitamin Lawyer Health Freedom Blog at: http://tinyurl.com/yo5t4t - updated every couple days; also http://www.globalhealthfreedom.org . . .
--------------------------------------------
Advertisement – Now more than ever - “your papers must be in order…” Check my SOP/GMP Information Web Page at: http://tinyurl.com/2eu6yj to learn what you need in order to stay on top of changing regulations.
-------------------------------------------- Index
2. Defining Your Target Market
This Entireweb newsletter could be so useful to especially new companies that I am forwarding the entire piece…
> Entireweb Newsletter * ISSUE #340 - www.entireweb.com
> Define Your Target Market in 5 Easy Steps
> This report is designed for entrepreneurs, small business owners, independent contractors and anyone who needs to build relationships and develop leads or referrals in order to promote and increase their business.
> The information in this report is given based on the assumption that YOU know your product and service inside and out and you have already defined your business goals and have somewhat of a business plan in order.
> The next step would be to narrowly and clearly define your target market, your ideal prospect.
> Some people believe that their products or services would be perfect for everyone. For example, Mary Kay Cosmetics - no offense to my MK friends or other people in the health industry who say 'anyone with skin' needs a facial or 'anyone who has stress' need a massage. Then there are people in the home improvement industry who say, 'anyone with a house' needs my landscaping, my windows, my furniture or my loan, etc.
> For most small businesses however (1-5 employees or even more), I don't believe this is the most effective way to try to generate new leads and customers. If you determine the right target market to fit your business, you figure out the best ways to reach them AND if you figure out the best message to reach them with you will be spending your marketing dollars wisely. Business owners who don't plan ahead to figure out who their target market is before they open their doors end up spending a whole lot more money trying to figure it out by trial and error and that's expensive.
> Would you shell out $200 for a pair of shoes without trying them on? Plunge into a steaming bath without dipping a toe in first? Of course not-but people do the business equivalent every day. Many an entrepreneur has found out too late that nobody wants to buy hand-quilted Christmas stockings at $24.99 a pop, or that wealthy customers won't schlep to the unfashionable part of town for luxury stationery.
> The irony: Conventional market research is expensive (corporations regularly budget tens or hundreds of thousands of dollars for it), but no one needs it more than a startup entrepreneur. A couple of marketing blunders won't put a giant manufacturer out of business, but just one can sink an entrepreneur like a bolt of lightning.
> Defining Your Target Market
> Your "target customers" are those who are most likely to buy from you. Resist the temptation to be too general in the hopes of getting a larger slice of the market.
Try to describe them with as much detail as you can, based on your knowledge of your product or service and how it will benefit them.
> Step 1: Ask yourself some questions to get started
> 1. Are your target customers male or female?
> Figure 75-80% of your target customers would be which? If it's split, narrow it down another way but more than likely you can narrow down the gender.
> 2. How old are they?
> Give an age range of 10-20 years max, otherwise you might have two target markets. Remember, the marketing messages towards different age groups will be quite different most likely depending on your product or service.
> 3. Where do they live?
> Is geography a limiting factor for any reason? Can you narrow it down to specific zip codes or counties? The larger the geographical area you choose, the more people you will find but the less likely you'll be able to afford to market to all of them so narrow it down and expand out later.
> 4. What do they do for a living?
> You can get a mailing list by industry or profession and specific title for example.
> 5. What does their specific profession say about their lifestyle?
> Is it very busy with little time to shop? Would they be likely to be familiar with the internet for their shopping, researching, news and event information? Would they be commuting more in their car?
> 6. How much money do they make?
> This is most significant if you're selling relatively expensive or luxury items. Most people can afford a latte. You can't say the same of custom murals. Narrow this down to a specific range also and high enough that you will weed some people out or again, you'll have way too many people to afford to market to.
> 7. Are there kids in the household?
> What ages might they be? How many would there likely be? What does this say about their lifestyle - are they carpooling, or soccer parents where they are rarely home? Do they possibly eat out a lot or have less 'family' bonding time? Or are they empty nesters where they might spend more time at home watching television or reading?
> Step 2: Get specific
> What other aspects of their lives matter? Here are some examples to think about, see how your target market compares or how you can get more specific with them.
> * If you're launching a roof-tiling service, your target customers probably own their homes. In addition, they probably own homes with older roofs like shake roofs; you can get a list of homes by their age.
> * If you're a realtor, you might be interested in targeting first time homebuyers in which case you might find them to be likely to live in apartments or rentals of which you can get a list of those too.
> * If you're selling your own individual artwork but you can't create multiple paintings with the same picture, you may have to sell the unique pieces at local art shows rather than selling them online.
> * If you're planning to open a custom-tailoring shop and need busy executives to come for three fittings, you may need to limit it to your local area.
> * If you're a direct jewelry consultant needing women to gather for parties in someone's home, you'll want to go where many women meet like mom's groups, women's professional organizations, day cares or grocery stores.
> * If you're a business or life coach and want to coach only over the phone then you'll most likely want to do more online marketing and make sure to have a really top notch website since that's mostly what people are going to see for their first impression. You can network locally too but the more 'known' you are in person, the more people will want to do business with you in person.
> Step 3: Keep your mind open to any information
> Keep a list of primary research questions handy, such as:
> * Who influences your customers and how? Spouses, neighbors, peer groups, professional colleagues, children and the media can all affect buying decisions. Look for hints that one or more of these are a factor for you.
> * Why do they buy? Distinguish between the features and the benefits your product or service offers. Features describe what it is; benefits are what your customers get out of it. The latter is why your customers pay you. Are they looking for a status symbol, a savings in time or energy, a personal treat or something else?
> * Why should customers choose you and not your competition? What can you offer that the competition doesn't?
> * How do your customers prefer to buy? Many businesses benefit from the broader market provided by the Internet and mail order, while others do better with a physical presence. Don't assume you fall into one category or the other; customers may surprise you.
> Step 4: Identify Your Ideal or Favorite Client
> Think about your favorite client - who are they, name them, write down everything you know about them, their family status, age, sex, marital status, where they live, where they work, possible income level, their shopping characteristics.
> * Do they like to use coupons or shop on certain days?
> * Do they call you at the last minute to get something from you?
> * Do they value your service/product?
> * Is that type of client the most profitable type you have or the most non-profitable and you just like them?
> Step 5: Determine their profitability to your business
> Which type of clients will make you the most money, bring you joy and refer you tons of business? These are the types of clients you ultimately want, now where are they?
> Ask Yourself:
> * Who is the most profitable type of client? The one who will make you the most amount of money the fastest and with the least effort - do you like working with them? If not, you won't be totally happy with only this type of person, maybe you need a combination of the two.
> * How often will they be able to buy or consume your product or service? If they can only possibly purchase your services every 10-20 years (getting a new roof for example), do you never market to them again after the sale or do you heavily market to them after the sale by every means possible for at least 1 year to get all the referrals you could possibly get out of them in that time?
> * How likely are they to know others like them they can refer to you? Normally, very likely, in which case following up with them before, during and after the sale is huge - and if you don't ask for referrals in each stage of the sale continuously then shame on you.
> * What is really important to them when it comes to your product or service? Not what you think they should know or like, but actually what they care about, like, ask for, thrive on, are passionate about, etc. These are your target market's "Hot Buttons" and these are what you should be addressing in your headlines, letters and marketing efforts at all times because these are why the client would choose to buy.
> Defining your business' target market is absolutely critical to any small business. Everything you do in your marketing, advertising, design, publicity and networking will depend on who your target market is and what matters to them. Making decisions on your marketing and advertising without fully defining your target market or knowing them in depth could be detrimental to your business and you could be making some costly mistakes!
> About the Author: Katrina Sawa, Relationship Marketing Expert, helps entrepreneurs and independent consultants build their database of clients and prospects, determine the best ways to market their business to their target market, teach them how to network, develop follow up systems, marketing and advertising plans and find ways to get free or low cost publicity which all lead to more customers and increased sales! Visit her at http://www.ksawamarketing.com/.
--------------------------------------------------------
…
SPECIAL VLUeM – 05.31.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
Ron Paul’s Health Freedom Protection Bill is the
answer to the FDA’s failings…
Head of FDA wants to work more closely with Drug Companies...
Report from Gardner Harris - "May 30 - When Dr. Andrew C. von Eschenbach took
over the Food and Drug Administration in 2005, the agency had a crisis over drug
approvals that had missed or ignored dangerous side effects in Vioxx,
antidepressants and other prominent medications. Dr. von Eschenbach promised
improvements, and agency officials said they would no longer be caught
flatfooted on drug safety. But this month, The New England Journal of Medicine
published a study suggesting that a major diabetes pill, Avandia, might increase
the risk of heart attacks.
Concerns over that drug and others have led Republicans and Democrats in the
House and the Senate to call for investigations. A House hearing is planned for
June 6. Dr. von Eschenbach said in a briefing on Wednesday that his agency
needed to collaborate more closely with drug companies.
’The point is that we need to look at the role of the F.D.A. in being a bridge
to the future, not a barrier to the future,’ he said at his office here."
My question: is working closely with Drug Companies the solution... or the
problem?
I suggest that a better solution would be promoting natural remedies without
dangerous side effects; not putting up bureaucratic barriers to them. This
can best be done by allowing people access to truthful information about
traditional, non-drug approaches; by letting natural product purveyors make
serious health claims... exactly what Ron Paul's Health Freedom Protection Act
would do.
In the twelve hours since
www.globalhealthfreedom.org sent an email blast seeking support for the Paul
bill over 10,000 people have written their
congresspeople supporting the bill! We still need hundreds of thousands to move
Congress.
Here's where to do it:
http://tinyurl.com/3xwmjm or
http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11754
Protect our herbs, vitamins, minerals and natural remedies from bureaucratic
meddling!!
--------------------------------------------------------
ndex
SPECIAL VLUeM – 05.16.07 -
VITAMIN LAWYER UPDATE e-MEMO
EPHEDRA BAN CONTINUED: Risk - Benefit Analysis Comes to Herbs
The United States Supreme Court decided not to hear the Ephedra
case appeal on May 13, 2007. This decision leaves standing the appeal court
reversal of the Utah district court's voiding of the FDA's ban on the Chinese
herb Ephedra. Take a deep breath! That means, in effect, a drug industry
risk/benefit standard has been imposed on at least part of the Dietary
Supplement industry. Instead of the standard of “safe if used as directed,”
which is the standard that applies to all foods, herbs can now be subjected to
the type of analysis that applies to drugs.
But not equally, as the Ephedra case shows. Let's take Aspirin for example: tens
of millions use it daily; 1500 die each year. Apply Risk/Benefit Analysis: drug
allowed. Another example: Viagra(R) - hundreds of thousands use it; hundreds are
harmed yearly. Drug allowed. Now take Ephedra: at its height, 25,000,000 used it
daily. Over ten years, there were 5 deaths that may have been associated with
Ephedra abuse; not using it according to directions. Result: the herb is banned.
To this observer, this does not appear to be equal treatment. Or based on
science and reason.
According to NutraIngredientsUSA, "The most recent court ruling on Ephedra blurs
the distinction between supplements and drugs and could force the industry to
conduct clinical tests, says the Natural Products Association..." The
"once-popular herbal, was banned by the FDA's final rule in 2004 on the grounds
that it does not present a significant health benefit to outweigh the reported
increased risk of heart attack, stroke and death. ... A year later the ban was
successfully challenged by Nutraceutical in a Utah court since the 1994 Dietary
Supplements Health and Education Act (DSHEA) does not make mention of
risk-benefit balance in establishing whether a supplement presents an
unreasonable risk. Rather, the FDA drew on the medical devices provisions of the
Food Drug and Cosmetics Act, which does state that this is a determining factor.
... Since then the pendulum has swung back and forth on appeal..." http://www.nutraingredients-usa.com/news/ng.asp?n=75628-pa-ephedra
Judge Campbell's reasoning, however has not been rejected by the Supreme Court,
as it decided in its discretion, not to hear the case. Future cases asserting
the same legal claim, that Congress intended Dietary Supplement law to be
harmonized with food law, not drug law, could be further strengthened by steps
the US Senate took last week to exempt Dietary Supplements when it approved
enhanced powers for FDA.
In the 2005 case, Judge Tena Campbell held, “...the legislative history of the
DSHEA indicates that Congress generally intended to harmonize the treatment of
dietary supplements with that of foods when it added the dietary supplement
subsection to the food adulteration provision…”
It is therefore incumbent upon Congress to protect this salutary policy and
further enhance it, by writing a much stronger exemption for all foods and
natural products into S.1082, the FDA Revitalization Act of 2007 when it comes
before the House. Keep your mouse-tail twitching and stay tuned to get ready to
bombard Congress with one simple demand:
"Protect our herbs, vitamins, minerals and natural remedies from bureaucratic
meddling!!"
Check
www.globalhealthfreedom.org for further details.
To contact Congress:
http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344
VLUeM - 05/11/07 - Vitamin Lawyer Update Memo
--------------------------------------------------------
1. New GMP Standards Cleared by OMB
2. Vitamin Lawyer Health Freedom Blog: DSHEA Exemption?
---------------------------------------------------------
1. New GMP Standards Cleared by OMB – as reported on the Internet
May 9th,
2007 – SEN. HATCH: DIETARY SUPPLEMENT GMPS FINALIZED
Completes Effort to Implement Key Aspect of DSHEA
>Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of
Management and Budget has given final clearance for good manufacturing practices
(GMP) regulations for dietary supplements.
>
>“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been
pushing the FDA to publish these for more than a decade.”
>
>Hatch is one of the principal authors of the Dietary Supplement Health and
Education Act of 1994, which gave the FDA the authority to write GMP guidelines
specific to supplements. GMPs are the standards inspectors will use to assure
purity, potency, and all the other requirements of clean, legal manufacturing.
The GMPs are expected to be published within the next five weeks.
>
>“GMPs are crucial because they assure the public that the products they are
buying live up to their labels,” Hatch said. “Since it took an unusually long
time to issue these final guidelines, I want to review the final version very
carefully to make certain they are good regulations. Every indication leads me
to believe the Administration was very sensitive to the impact the GMPs might
have on the industry, especially on small businesses.”
We are likely to get a look at the GMPs within the next few
weeks. I will keep this elist informed of these developments, that I have long
predicted. When the GMPs are issued, I will update the standard Vitamin Lawyer
Consultancy SOPs (Standard Operating Procedures) to conform. My current formats
are outlined at:
http://tinyurl.com/2eu6yj
-------------------------------------------------------------------
2. Vitamin Lawyer Health Freedom Blog
The political situation, as it impacts Dietary Supplements and Alternative Practices is moving so fast that a couple of Update eMemos a month cannot keep up, so I’ve started a blog on these issues: http://tinyurl.com/yo5t4t - you need to be aware of the latest developments… and two of those are: (1) Dr Ron Paul, congressman from Texas and presidential candidate, called the draft FDA CAM guidance “an abuse of FDA power…” and (2) despite some confusion on the issue, we have written confirmation from Sen. Kennedy’s office that the Senate did approve SAmend 1022 (94 to 0), exempting DSHEA products from the Kennedy FDA enhancement bill (but, the broader exemption for all food and natural products needs to be added when the House considers the bill). More at www.globalhealthfreedom.org
Let Congress hear from you: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344
VLUeM – 05.03.07 - VITAMIN LAWYER UPDATE e-MEMO
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Please take a look at www.vitaminlawyer.com – we have a new look and better indexing.
--------------------------------------------------------
1. Strategies for Responding to Net Attacks – Fake
Ratings Sites
2. Strategies for Responding to Net Attacks – DoS
Preparation
3. Health Freedom Issues: VICTORY IN CONGRESS
TODAY!
--------------------------------------------------------Index
1. Strategies for Responding to Net Attacks – Fake Ratings Sites
Here is a copy of an email I just provided to one of my regular clients:
“There are
several strategies that can be used to respond to fake "third party" sites that
are actually competitor sites designed to denigrate competing products. These
responses vary from mild to extreme; from inexpensive to very expensive.
But, before getting to those strategies, some preliminary issues may help
understanding how far to go.
First, who actually owns the offending site? I searched the WhoIs database at
NetworkSolutions.com and find a "private registration" through Network Solutions
(NS is the original & "Cadillac" of the URL registrars). The problem is, the
register does not have to cooperate without starting a lawsuit and serving a
subpoena on it; one trick is to start a small claims action (which is relatively
cheap) and issue the subpoena from that.
Second, does anyone actually see the offending site? I checked the Alexa.com
rating for the offending site. It has worse than a 3,000,000th
rating. Your rating is in the Top One Million. So this offending site may not be
much of a problem. By the way, being in the Top One Million is a good thing!
Here are some options:
0. Create & promote a
competing site with similar name & image to dilute the offending site's search
engine status.
1. Legal letter from attorney to offender, sort of saying: “Cease & Desist your
defamatory posting and stop using our trademark!” with copies to URL register
and ISP.
2. Written complaint for unfair competition, false claims, to appropriate
Attorney General Consumer Protection Agency; copy to offender.
3. Same as #2, but to Federal Trade Commission, if more of a federal issue
situation.
4. Lawsuit in state court for unfair competition, trademark violations, etc.
5. Lawsuit in federal court under cyber protection laws (such as the
Cybersquatting Act).”
--------------------------------------------------------Index
2. Strategies for Responding to Net Attacks – DoS Preparation
It takes a sophisticated opponent to engineer Denial of Service (DoS) attacks on a web site. Individual computers and even local networks have to be commandeered and turned to the nefarious task of massively requesting information from the attacked site, so it crashes under the assault. Since the attack is coming from many IP addresses, it is difficult to stop.
These are certain simple steps you can take, with your webmaster, to minimize the threat. The first step is to always have a mirror site on another server. Then, if attacked, the alternate site can take over until the attack stops. There is a certain way to code your site that can minimize the effect of a DoS attack. I acknowledge receiving this information from Mike Adams of www.newstarget.com – a great Internet source of information. For various reasons, I am not publicly releasing this information. If you would like to know more about this, please email me at ralph.fucetola@usa.net and put “DoS” in the subject line.
-------------------------------------------------------------------
3. Health Freedom Issues Continue to Reach 100,000’s
During the past 5 weeks we have seen an awesome outpouring of citizen protest against a growing list of FDA, congressional and international pressure on our health freedoms. Around 180,000 people sought to file comments with the FDA about the draft CAM guidance, before the comment period ended. At the same time, several troubling bills are wending their way through Congress and Codex, the UN food agency, continues to be a battleground. Commenting on this, Dr. Rima Laibow, MD, Medical Director of the Natural Solutions Foundation - www.globalhealthfreedom.org – recently stated on her blog:
"Right now
the American Public is being whipsawed: first the dangerous FDA CAM Guidance
(Complimentary and Alternative Medicine/Modalities) which threatens to turn all
health practices into medicine which only physicians could practice and the
foods and supplements supporting natural health into
unlicensed drugs – and, yes, there is a real danger to your health freedom
despite a good deal of internet chatter to the contrary!) - and now the sudden
advancement of Senator Ted Kennedy disastrous bill, S 1082 (“the FDA
Revitalization Act of 2007”, plus the identical House bill) from Committee to
the floor of the Senate for a vote in the immediate future without public
hearings. It would be easy to succumb to “health freedom vigilance fatigue”,
which is, I believe, exactly what the intended effect is supposed to be. There
is even speculation that Senator Kennedy moved this bill forward so rapidly
BECAUSE the American public responded so vigorously to the CAM Guidance and are
presumed to be preoccupied with it."
You can keep up with the latest developments at the Health Freedom Blog: http://www.healthfreedomusa.org/index.php?page_id=219
VICTORY IN CONGRESS! And some very good news: Congress has accepted the following amendment to S.1082 - Enhancing Drug Safety and Innovation Act of 2007 - from Sen. Durbin. It appears that Congress heard our concerns! Hundreds of thousands of messages to FDA no doubt reverberated through the halls of Congress. The amendment was adopted with 94 out of 100 votes.
Sec. X08. Rule of Construction
Nothing in this title (or an amendment made by this title) shall be construed to affect--
(1) The regulation of dietary supplements under the Dietary Supplement Health and Education Act; or
(2) The adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
Like many victories in Congress, you hardly ever get everything you want. A leading supplement industry lawyer, J. Emord originally proposed exempting all "foods" from the new law (Counsel stated: "It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury.") This approach would have offered even greater protection for natural products, but we are grateful that enough members of Congress heard the loud shout from the public and responded so quickly to at least protect DSHEA products -- the power of Internet politics at its best.
VLUeM – 04.26.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Dietary Supplement SUS page update
2. Vitamin Lawyer on Internet Radio this Friday
--------------------------------------------------------Index
1. Dietary Supplement SUS page update
One of the main services The Vitamin Lawyer Consultancy provides to its vitamin purveyor and alternative health care practitioner client base is to keep you updated with the latest changes in the Disclaimers and Disclosures that you need on your web site. Due to recent legal developments, I’ve modified my standard Site Use, Privacy, Disclosure, Disclaimer Statement by adding two new paragraphs. If you are using my format, you would add these after the section on food allergen labeling. The new clauses are:
"This Organization is in compliance with the terms of the Dietary Supplement and Non-Prescription Drug Consumer Protection Act of 2006 and will make all required Adverse Event Reports (AER).
To the best of the knowledge of the Organization, none of our products are classified as “CAM” (Complementary and Alternative Medicine) Products and they are not labeled with claims to treat disease."
For more information about SUS contents, see: www.siteusestatement.com – if your web site needs a proper SUS, please email me with “SUS” in the subject line.
--------------------------------------------------------Index
2. Vitamin Lawyer on Internet Radio this Friday
I’ll be chatting with counsel Jim Turner on his Of Consuming Interest Internet Radio show this Friday, April 27th from 3 to 4 PM, EDT - www.prncomm.net - this is Gary Null’s internet radio network. Our prime topic will be Complementary and Alternative Modalities.
We will discuss the latest developments in the FDA anti-CAM guidance public outcry. To date, over 144,000 people have told the FDA , “We’re as mad as hell and we won’t take it any more!” While the FDA spin masters now assure us we have nothing to fear, lawyers in the field view the guidance as potentially dangerous to health care freedoms. We’re happy to take your questions and comments about this and the other pending attacks on health freedom, like CODEX, the NAU (Trilateral Cooperation Charter) and a bunch of bad bills recently introduced or threatened by the friends of Big Pharma in Congress. We will also focus on strategy going forward: how to deconstruct an agency that has confusing and conflicting authority and a record of mounting failure. It is sobering to realize that as many people die each year of properly prescribed, FDA approved, drugs, as have protested the anti-CAM guidance!
VLUeM – 04.20.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Affiliate Program Upgrade: Higher Commissions!
2. FDA Anti-CAM Guidance Update: Hot Button Issue!
---------------------------------------------------------
1. Magnets for Wellness: Just a note to my clients with online businesses: BiomagScience has seriously upgraded its affiliation program: raising the commission rate from ten to 25% and the override (for sites that join through your site) from five to 10%! As I noted in past eMemos, joining affiliation programs is a quick way for you to bump up sales on your site; just remember to set up the html so the banner opens a new window, that way people don’t leave your site when the click through. You can join at: http://www.biomagscience.com/cmd.php?af=520607.
The “Body Electric” is also a body magnetic and the use of magnetism in self-help and as a therapy that may benefit normal structure and function is growing. Sports medicine, especially, is beginning to accept the benefits of magnetism in promoting healing and raising cellular energy levels. BiomagScience offers magnet products and clearly described protocols developed by the Foundation for Magnetic Science.
--------------------------------------------------------Index
2. FDA Anti-CAM Guidance Update: For those of you who have been trying to reach me with less success than usual, I apologize. I’ve been “riding a tiger” with the FDA’s proposed new controls on Complementary and Alternative Practices – over 90,000 comments have been generated to FDA in a bit over a week! This has been very controversial, with some observers suggesting the new “Guidance” does not represent a new power grab by FDA. Naïve, Naïve! Here is my latest commentary on the issue:
CAM Practices, Products and FDA Regulation: A Threat Assessment
The US Food and Drug Administration is a confusing and confused agency, charged with administering federal controls over foods, drugs and medical devices under a patchwork of laws and regulations that have drastically increased costs to American consumers and slowed health care progress, without demonstrable safety benefits. It is therefore inevitable that many actions taken by the agency are likely to do more harm than good. Such is the case with the proposed Complementary and Alternative “Medicine” (CAM) guideline that the agency proposed at the end of December, public comment period to extend through April 30th. You can go to http://tinyurl.com/2u7ghc to make your comments.
It is true the FDA anti-CAM guidance merely restates the existing law [as FDA sees it] -- that, if you intend to "treat disease" with a CAM product, that product (for example, says FDA, a “juice”) is a "drug." By codifying this in a guidance document, FDA is setting the stage for another push to control and restrict CAM practices. The FDA uses the term “CAM product” in the guidance, although Congress has never defined such a term. The agency seeks to create a “status” of being a certain type of product when all Congress has authorized is that the FDA can regulate certain products “intended” to “treat disease.” Of course, the responsible FDA Senior Science Advisor did say, in a very recent interview, this is not FDA’s “intent” and using “CAM Products” is just a matter of convenience. Of course, as good Americans, we should all believe exactly what the FDA tells us; trust the agency’s intent; shut up and take all our prescriptions.
In addition to telling us that a juice intended to “treat disease” would be a drug, a careful reading suggests even items used in religious healing ceremonies could now be subject to regulation as drugs or medical devices. Holy water, anointing oils, prayer beads, rosaries, sweat lodges and even religious paintings or icons could be classified as drugs or medical devices and essentially outlawed by the FDA. Does this sound absurd? Well, it is absurd!
Certainly, all this appears a bit less
absurd if we are considering using an herb or dietary supplement to stay
healthy. Says the FDA, if any supplement is used to treat a symptom, then it is
a drug and will be regulated by the FDA, just like any prescription drug.
The FDA does give us a little hope -- the supplement will be exempted if it is
"generally recognized, among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of drugs, as safe and
effective for use under the conditions prescribed, recommended, or suggested in
the labeling." This is essentially the same standard used for substantiating
drug claims. In 2004 the FDA gave us the standard for making claims about foods
and dietary supplements: "FDA intends to apply a standard for substantiating
claims for dietary supplements that is consistent with the Federal Trade
Commission's (FTC's) standard for dietary supplements and other health related
products of 'competent and reliable scientific evidence'.'' Quite a difference!
This is just one difference the anti-CAM guidance will codify. And after
codification comes enforcement. All alternative practitioners should take note!
In other words, your freedom to use a
dietary ingredient as therapy that may benefit a condition will be at the
discretion of FDA “experts” who will determine whether to regulate it as
“medicine.” Given the abysmal track record of FDA experts, this could be really
bad news.
With so much latitude, I cannot predict just how far the FDA might go to
restrict access to herbs, minerals and supplements, as well as other CAM
products. Many pro-health freedom groups are offering their concerns too. For
instance, one commentator, Jenny Thompson of the HSI Newsletter suggested,
“…[FDA] could take a widely used supplement off the market if the label states a
benefit; such as using lutein to reduce the damage from age-related macular
degeneration, or using chondroitin and glucosamine to reduce joint pain, or
using probiotics to address digestive problems - the list goes on and on…” The
AAHF (American Association for Health Freedom is concerned that “the
two biggest [problems with the guidance] are broadening the definition of
“health claim” and the desire to pre-empt the states in the regulation of some
health care issues”
The health freedom movement began to take notice of the pending anti-CAM
guidance in late March. At the start of April, I assisted one group, Natural
Solutions Foundation, to write its commentary to submit to the FDA, with
emphasis on what we see as the important distinction between "treatment of
disease" and its non-medical alternative, under AMA Ethics Code Opinion 3.04,
"therapies that may benefit." The comments raised three demands:
1. A public hearing by the FDA before the finalization of the guidance.
2. Changing the title of the guidance to use the phrase “Complementary and Alternative Modalities” and not the prejudicial “Complementary and Alternative Medicine” as in the draft.
3. FDA recognize that “therapies that may benefit” are not the same as “treatment of disease” and do not have to be regulated as “medicine.”
The organization then alerted its elist and asked its supporters to also file comments with the FDA, supporting the group’s requests. We apparently touched a hot button issue; over the following week the buzz spread on the Internet
Propelled by this strong public support, I believe we now have an opportunity to turn this FDA "end run" around and use it to protect CAM practices. We are now seeking support from members of the US Congress to demand that FDA hold public hearings before making the guidance final. If FDA fails to hold such hearings, it would be time for Congress to step in, hold hearings, and propose legislation to protect CAM practices from FDA action that would deny Americans access to alternatives. With John Galt, we want to say, “Get out of my way!”
It has been settled law in this Country for over a century that medical regulations exist to protect the public, not to entrench licensed allopathic medicine to the detriment of all the evolving healing arts, which would refer to as “CAM practices” – though Traditional and Advanced Health Care might be a more appropriate term.
"The state has not restricted the cure of the body to the practice of medicine and surgery -- allopathy, as it is termed, -- nor required that, before anyone can be treated for any bodily ill, the physician must have acquired a competent knowledge of allopathy and be licensed by those skilled therein. To do that would be to limit progress by establishing allopathy as the state system of healing, and forbidding all others. This would be as foreign to ours ystem as a state church for the cure of souls. All the state has done has been to enact that, when one wished to practice medicine or surgery, he must, as a protection to the public [not to the doctor], be examined and licensed by those skilled in surgery and medicine. To restrict all healing to that one kind -- to allopathy, excluding homeopathy, osteopathy, and all other treatments -- might be a protection to doctors in surgery and medicine; but that is not the object of the act, and might make it unconstitutional, because creating a monopoly." North Carolina's Supreme Court in State v MacKnight, 42 S.E. 580, 1902 at p 582.
As NSF’s medical director, Rima Laibow, MD, has noted,
“Throughout the world today people are looking to traditional methodologies and leading-edge CAM techniques because they offer alternatives to toxic, expensive drugs with their dangerous side effects, other invasive technologies of modern medicine, and un-manageable and unreasonable costs. This search for alternatives is protected by the fundamental right of individuals to communicate and learn; to heal and be healed.”
You can read more about this issue and add your comments to the FDA through the Natural Solutions Foundation, a non profit NGO at http://www.healthfreedomusa.org and submit your comments from the home page. Since the FDA Dockets Supervisor tells us her 9 member staff is overwhelmed -- apparently the system crashed and only about 102,000 of the over 245,000 people who have tried to post comments have succeeded so far – we have now made arrangements to email directly to the FDA and expect all future comments to get through, so if you did not succeed last week, please try again. The last time Americans got this mad about health freedom, we got DSHEA. This time, we will protect our complementary and alternative practices; our vitamins, herbs, minerals and healing arts. We are “mad as hell” and “we aren’t going to take it any more!”
--------------------------------------------------------------------Index
Ralph Fucetola, JD - The
Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved
VLUeM – 04.07.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. MLM – Multilevel Marketing
2.
Wanted: Testing for Supplements
3. Updated SoP Outline
4. AHPA on AERs
5. FDA to issue Guidance on CAM – comments
requested!
---------------------------------------------------------Index
MLM Marketing, of which Online Affiliate Marketing is a subset, appears increasingly important in the Vitamin Industry, while, at the same time, every successful MLM seems to feature vitamin products. Here is what Wikipedia has to say about Multi-Level Marketing" -
"In a typical multi-level marketing or network marketing arrangement, individuals associate with a parent company as an independent contractor or franchisee and are compensated based on their sales of products or service, as well as the sales achieved by those they bring into the business. *** Multi-level marketing has a recognized image problem due to the fact that it is often difficult to distinguish legitimate MLMs from illegal scams such as pyramid or Ponzi schemes. MLM businesses operate legitimately in the United States in all 50 states and in more than 100 other countries, and new businesses may use terms like "affiliate marketing" or "home-based business franchising". However, many pyramid schemes try to present themselves as legitimate MLM businesses."
And what it says about "Pyramid Schemes" -
"A pyramid scheme is a non-sustainable business model that involves the exchange of money primarily for enrolling other people into the scheme, usually without any product or service being delivered. Pyramid schemes have existed for at least a century. *** There are other commercial models using cross-selling such as multi-level marketing (MLM) or party planning which are perfectly legal and sustainable."
It was in 1979 that the Federal Trade Commission (FTC) ruled in the case of In re Amway (93 F.T.C. 618) that MLM marketing was legal. Some of the largest marketing companies in the world use MLM systems to provide goods and services to the public. Some famous examples come to mind. Amway. Mary Kaye. Market America. Nikken. Shaklee or Tupperware. These companies market billions of dollars in products and services annually.
It can be fairly said that Multi-Level Marketing appears here to stay and has been strengthened by the rapid development of the Internet Market (for both ease of record keeping and direct online sales). While, in the past, there may have been some abuses by some companies, the continued participation by millions of people in MLM companies (around the world) and the rapid growth of online affiliate sales, shows strong market acceptance and a continuing role in the global economy.
---------------------------------------------------------Index
2. Wanted: Testing for Supplements – An important Nutraingredients commentary:
http://www.nutraingredients.com/news/ng.asp?n=75425&m=1NIE402&c=jegwylrviswtnqa
02/04/2007
- The
dietary supplement industry needs an independent testing program that is
recognizable to consumers in order to enhance the credibility of its products as
well as encourage solid science and sourcing.
As
it stands now, the industry lacks a familiar stamp of approval on labels that
can let consumers know if the product in their hand stands out in any way from
others on the shelf. This means companies that go the extra mile - those that
invest heavily in research and development or oversee all sourcing of their
ingredients - are not necessarily rewarded.
Many
other consumer goods industries - such as dental products - have stamps of
approval that can help point consumers to products with effective value-added
ingredients, etc. The dietary supplement industry should apply a similar model,
but with the added clout of a testing program behind the labels.
The
obstacles frequently cited against this type of program are the cost of such an
initiative, as well as what group or groups would assume the responsibility.
While the Natural Products Association, NSF International and US Pharmacopeia
offer testing programs in the United States, they are either not yet wide enough
in scope, or are not recognizable as label 'stamps of approval' to consumers.
The
story in Europe is differs slightly with the finer points of the 2002 food
supplements directive (especially vitamin and mineral) still to be hammered out.
EU regulations. But even though industry may have its eye elsewhere, building
consumer confidence in should always be a priority.
As
such, a universal testing program would require an advertising campaign to
familiarize consumers with the concept so that they know what to look for on
product labels.
And
once consumers start to look for stamps of approval on bottles, industry will be
compelled to follow all the necessary steps to get such certification. This will
also buffer the effect of allegations in the industry that target some companies
and not others.
In
January, American ConsumerLab.com allegedly found high lead content in certain
supplement brands, including a multivitamin for women sold by The Vitamin
Shoppe. Traces of dangerous compounds are a genuine concern for the industry and
until one independent body tests decides what constitutes 'dangerous' levels,
the charges made by businesses such as ConsumerLab.com will continue to scare
consumers without providing any straight forward solution.
An
independent testing program would also urge companies to become accountable for
their ingredients and oversee the entire supply chain before their product goes
to market. This could dissuade companies from relying on suppliers that contract
from other suppliers in such a way that the end manufacturer has never even set
foot in the facility where its product may have originated.
Also, any companies that cut their active ingredients with undeclared fillers
would also be punished or, at least, would lose out on the bonus of
certification.
Adulterated versions of relatively expensive ingredients such as hoodia gordonii
or saw palmetto would become less easy for companies to proffer. Sold as an
appetite-suppressant, cactus-like plant hoodia is sourced from South Africa,
while saw palmetto for supporting prostate health is sourced and wild-harvested
from Florida.
Consumers would finally know that what is on the label is what is really in the
bottle.
However, none of this will come about until the majority of the industry is
motivated enough to invest in its own long term livelihood instead of letting
some companies take the easy way out while others invest in science and the
consumer is caught somewhere in the middle trying to decide which product is
legitimate.
Clarisse Douaud is a reporter with NutraIngredients-USA.com and has lived
and worked in Canada, Ireland, Argentina and France. If you would like to
comment on the piece, send an email to:
clarisse.douaud'at'decisionnews.com
---------------------------------------------------------Index
I’ve compiled the information presented in various Update eMemos regarding Standard Operating Procedures on the updated outline page at: http://tinyurl.com/2eu6yj
---------------------------------------------------------Index
The natural products industry is starting to get ready for Adverse Event Reporting, as this article shows -
“4/4/2007 - The American Herbal Products Association has joined the ranks of trade associations preparing the dietary supplement industry to comply with impending adverse events reporting (AER) legislation... Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was introduced in June 2006 as a means of obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports. The AER legislation is set to come into practice by the end of 2007, meaning companies will have to have their reporting systems in place… Following the bill's passing at the 'eleventh hour' in December, the responsibility of informing industry was left in the hands of trade associations…. AHPA claims companies will be able to distinguish between a complaint and an adverse event.”
http://www.nutraingredients-usa.com/news/ng.asp?n=75506&m=1NIU404&c=jegwylrviswtnqa
More on AER services: www.aer-consultants.com
---------------------------------------------------------Index
5. FDA to issue Guidance on CAM – Comments requested!
The Food and Drug Administration is about to issue its “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” The “guidance” is just as bad as you imagine… however, first, they have to accept comments from the public on the proposal, and we hope to force a public hearing. Comments due by April 30th.
Guidance at: http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm
You can submit your comments through Natural Solutions Foundation at: http://tinyurl.com/2u7ghc
I helped write the NSF comments and would appreciate
your support by submitting your comments in support of ours!
-------------------------------------------------------------
Well, wish me a Happy Birthday – I was born this date in ’45.
Ralph Fucetola, JD - The Vitamin Lawyer.com
Consultancy
http://www.vitaminlawyer.com
All Rights Reserved
Index
VLUeM – 03.31.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Your SoP & Substantiation Notebooks & FDA
Inspections
2. Grow Your Online Affiliation Program!
---------------------------------------------------------
1. Your SoP & Substantiation Notebooks & FDA Inspections
I’ve been asked what a Dietary Supplement marketer ought to have available for an FDA visit, in the event of a surprise agency inspection.
Ideally, you ought to have a couple loose leaf note books, (a) one entitled "Standard Operating Procedures Notebook" (or “SoP Notebook”) and (b) the other entitled “Substantiation Notebook.”
(A) The first Notebook should contain your:
(1) Operations Manual/SoPs and
Employee Manual
(2) Formula sheets
(3) Label copies (with dates as to when they were in use)
(4) Literature copies (likewise dated)
(5) Copies of your Structure and Function Notices
(6) Insurance Policy binder page
(7) Certificate of Incorporation (or LLC Certificate of Formation)
(8) EIN and Bank Account number information
(B) The second Notebook contains information that substantiates the claims you are making. This Notebook should have a section for each product and each claim for the product, by ingredient.
(1) Abstract pages of scientific
journal articles regarding the ingredients
(2) Clinical study reports about the
ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters
If you are ever visited by FDA,
for one of their famous "surprise visits" having this stuff together so you can
give them a copy would make them very happy.
---------------------------------------------------------Index
2. Grow Your Affiliate Program
The Vitamin Lawyer Consultancy does provide Affiliate Program Rules. Let me know if you want to establish an Affiliation Program.
Besides the right Rules, of course, you need the right software. One good program that I can recommend is the program used by BiomagScience.com for its online biomagnet sales program. It is a two step program, so, typically, you will see two banners from it on Affiliate web sites. One is for retail sales of biomagnets (for which you receive a sales commission), and the other is a “Become a Biomagscience Affiliate” banner, where another web site can join as an Affiliate, and your site earns an override on all retail sales through that site. If you go to the following page, you can see that banner: http://home.earthlink.net/~lifespirit23/support-lifespirit.htm .
But that’s just the start. After you have your web site and your affiliation program, you need to market it! If you do it right, you can expect very significant sales growth!
Here are excerpts from a piece through Add Me Newsletter about being an affiliate marketer.
---------------------------------------------------------Index
www.addme.com
How To Immediately Boost Your Affiliate Marketing Sa'les
By Titus Hoskins
Affiliate marketing is a very competitive field. Savvy affiliate marketers use every tactic they know to get the upper hand over their competition. It can mean the difference of whether or not they get that all important sa'le.
One of the best ways to boost your affiliate sa'les is to take full advantage of brand name recognition. … Popular brand names with popular trendy products sell the best.
If you're an affiliate marketer you must choose the products you promote with the utmost care; in many cases this is where you will determine the outcome of your marketing efforts…
As an affiliate marketer you can promote anything, why not choose the most popular brands and products. Just look for popular trends and join the bandwagon. Sure, the competition might be stiffer but the demand for these products will also be greater.
If you join affiliate networks like Commission Junction [or, for another example, eAffiliatez.com – rf] they will show you the companies with the highest sa'les volume in their system. Study this sa'les data before you pick your affiliate companies or products.
You can even use Google Trends to tell which products are popular and in which countries. Do some market research first and pick the most popular products to promote.
Many marketers keep an eye on their PPC (Pay Per Click) keywords for any surges in searches or impressions. A big jump could mean an increase in popularity for that product or company.
* Be Aware of “The Buzz” Factor …Certain brand names and products have buzz. …
* Can It Only Be Bought Online? … One of my most successful tactics has been to pick products or offers that are only available online. Dell products come quickly to mind. … Online coupons and exclusive deals also increases your affiliate sa'les. Look for these and display them along with your popular brands for they will increase your sa'les. Everybody loves a deal!
* Use Brand Names In Your Site Copy and PPC Advertising … You must always check with your affiliate company what rules they have about displaying brand names and trademarks on your site copy. Most companies will supply their affiliates with web content they can use for promotion.
Most Companies have strict rules prohibiting affiliates from using certain brand name keywords in their PPC advertising. Each company is different, so check before you proceed with any PPC campaigns.
However, one of the most effective ways for PPC advertising is to use the particular brand name and product name in your PPC ads. Savvy affiliate marketers have figured this one out long ago, it mainly has to do with finding the buyer at the right stage in their buying process. If they're looking a particular product ; they may already have their minds made up and are ready to buy…
* A Rose Is A Rose Is A Sa'le! … In conclusion… Keep your eyes peeled for popular trends and shifts in the marketplace so you can adjust your marketing to meet these new demands….
About the Author - The author is a full-time online marketer. For the latest and most effective web marketing tools try: Internet Marketing Tools - http://www.titushoskins.com/ © 2007 Titus Hoskins.
---------------------------------------------------------Index
Well, that’s all for now.
Ralph
Fucetola, JD
The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved
VLUeM – 03.16.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Making Claims & New Dietary Supplements
2. Record Keeping SoP and Employee Manual – Online
Outlines Available
3. Health Freedom Site Attacked
---------------------------------------------------------
1. MAKING CLAIMS & NEW DIETARY INGREDIENTS
Say your company needs a "DSHEA compliance" letter from The VitaminLawyer.com Consultancy about a new product. The threshold issue is whether the product is a "new dietary ingredient". We start by noting whether the product is found in the IBIDS data base. Then we check to see if similar products are found in the general FDA data base and look for references indicating whether FDA treats the product as a new dietary ingredient.
Journal abstracts showing the product being studied prior to the DSHEA "grandfathering" date of June, 1994 can be useful. Such information could show that the product was part of the food supply before the grandfathering date. This will negate the new dietary ingredient issue (which would have required prior FDA approval before marketing -- with proof of safety).
The other part of the DSHEA compliance issue has to do with the claims to be made for the product. If there are no claims being made, other than "a good source of [ingredient]" or "advanced bioavailable form of [ingredient]" (with substantiation for these claims, of course) then there would be no claim issues. Simple general “support of normal structure and function” claims are allowed. Even “immune system support” claims could be allowed:
"A “claim that a product "supports the immune system" is not specific enough to imply prevention of disease because the immune system has both structure/function and disease fighting roles. A general claim of this type doesn’t specifically focus the intended use of the product on the disease aspect of the system’s function."
Here is access to the FDA guidance: http://www.fda.gov/ohrms/dockets/98fr/98n-0044_gdl0001.pdf. Once these threshold issues are resolved, it becomes possible to provide a DSHEA compliance letter for use with potential distributors, online affiliates and joint venturers.
---------------------------------------------------------Index
2. RECORD KEEPING SoP AND EMPLOYEE MANUAL
SoP – Standard Operating Procedures – are an important part of cGMPs (current Good Manufacturing (Marketing) Practices. I’ve created a new web page with outlines of the contents of the SoP and EM documents - http://tinyurl.com/2eu6yj
A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.
To make it as simple as possible, I’ve developed a shorter and simpler “Record Keeping SoP” version of my Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For a bit over an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at ralph.fucetola@usa.net with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.
You can now also take a look at the Tables of Contents of the Record Keeping SoP (actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee Manual (22 single-spaced pages) that I’ve posted at: http://tinyurl.com/2eu6yj
---------------------------------------------------------Index
3. HEALTH FREEDOM SITE ATTACKED ON 03/12:
The websites of the Natural Solutions Foundation - www.globalhealthfreedom.org and www.healthfreedomusa.org – disappeared from the Internet within hours of the site exposing the genocidal agenda “the illness industry.” The sites are online again, but with a number of images and other information still missing. You can read the original article and the Internet attack at: http://www.healthfreedomusa.org/index.php?page_id=219
Here is what Dr. Laibow had to say in an email blast while the sites were down: “…our hosting company… locked our site with no reason given, no warning and no explanation. When I called to talk to someone about this I was told that the supervisor was "on leave," the manager was "not here," probably would not call me back when he got there, and that there was no one to talk to about the fact that my site was locked for no apparent reason at all. All this after 19 minutes and 45 seconds of international phone call holding. Why is our site blocked? Because, according to the technical services person, the site was locked in the computer with no explanation and can not be unlocked until I talk with the right person. Who is that? He does not know… The War on Freedom IS a War on Health Freedom… I wrote about the genocidal intent of the illness industry called Big Pharma in my latest email to you. Funny, immediately after that our site is mysteriously locked for no reason. Hmmmmm. Could it be that the Power Beast does not want you to know about these realities? Looks like it, doesn't it…”
As of today, the two parts of the site that still do not work, curiously, are the email sign-up and the Organics 4 U Shop. So no one can join or help support NSF*. Curious and curiouser… If you’ve chosen to be in this industry, you need to acknowledge its realities.
Ralph Fucetola
JD
http://www.vitaminlawyer.com
* The Foundation can receive donations
through PayPal, however.
You can PayPal to
naturalsolution@optonline.net and the donation will go directly to the
Foundation.
Also, do see Nutricide, now on YouTube at: http://video.google.com/videoplay?docid=-5266884912495233634&q=Nutricide
VLUeM – 03.02.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Record Keeping SoP and Employee Manual – Online
Outlines Available
2. New Meta-Analysis Attacks Antioxidant Vitamins: Is
it flawed? What to do?
3. Web 2.0 – What the Entrepreneur Should Know
---------------------------------------------------------
1. RECORD KEEPING SoP AND EMP MANUAL
[I was asked to repeat this information from previous eMemos. I’ve created a new
web page with outlines of the contents of the SoP and EM documents -
http://tinyurl.com/2eu6yj
]
A primary concern of small, leading edge dietary supplement purveyors is how to
deal with the new wave of regulation that seems to be sweeping the
industry. The first rule of bureaucracy is, “Are your papers in order?” Well,
are they? In the context of current Good Manufacturing/Marketing
Practices (cGMPs) your “papers” are the documentation of your business
activities, from buying your products, through advertising, selling and
shipping them. And then, dealing with customer issues, refunds, recalls, adverse
event claims, etc., etc.
To make it as simple as possible, I’ve developed a shorter and simpler “Record
Keeping SoP” version of my Standard Operating Procedures/Employee
Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary
supplement and alternative therapy companies. For a bit over an hour of my
time, I can customize the Record Keeping SoP format for your company, so you
will know what documents you need to keep and for how long. Just email me at
ralph.fucetola@usa.net
with “Record SoP” in the subject line and I’ll let you know what information I
need and how you can reserve the time for your
SoP.
You can now also take a look at the Tables of Contents of the Record Keeping SoP
(actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee
Manual (22 single-spaced pages) that I’ve posted at:
http://tinyurl.com/2eu6yj
---------------------------------------------------------Index
2. FLAWED ANALYSIS – OR NEW APPROACH NEEDED FOR
PRODUCTS?
Study alleges link between antioxidants and increased mortality.
“2/28/2007 - A meta-analysis of 68 randomized trials with antioxidant
supplements has reported that vitamins A and E, and beta-carotene may increase
mortality risk by up to 16 per cent, but vitamin C did not have an effect on
mortality and the antioxidant mineral selenium was associated with a nine per
cent decrease in all-cause mortality. … The pooled analysis, published in the
Journal of the American Medical Association, could have significant
negative effects on the sale of antioxidant dietary supplements… The new pooled
analysis has already drawn criticism from both inside and outside the
dietary supplements industry concerning the methodology applied, and the
conclusions drawn. … The most prevalent criticism of the study has come from
the diverse nature of the studies pooled together, described by one industry
expert as comparing "apples and oranges"… A wealth of epidemiological
evidence has linked dietary antioxidant intake to reduced risk of a wide-range
of diseases, such as cancer and cardiovascular disease, but when such
antioxidants have been extracted and purified, or synthesized and put into
supplements, the antioxidants, according to randomized clinical trials (RCTs),
do not always produce the same positive results. … [The meta-analysis] findings
contradict the findings of observational studies… that antioxidants improve
health.”
http://www.nutraingredients-usa.com/news/ng.asp?n=74582&m=1NIU228&c=jegwylrviswtnqa
The language used in the reports about the meta-analysis does appear carefully
chosen to overstate the risks and understate the benefits. The bottom line for
vitamin purveyors: (1) if these allegations begin to impact the market, consider
substituting whole food sources of ingredients for extracts; (2) budget the
funding needed for RCTs and (3) note the astoundingly positive results for
Selenium: a 9% decrease in mortality. Think Whole Food Supplements!
[03/02
Update: Linus Pauling Institute blasts AMA fake meta-analysis:
http://www.sciencedaily.com/releases/2007/02/070228172604.htm -- the
Institute points out obvious flaws in the report and show the bias of the
authors, who started with 815 trials, selected out 68 of them, ignored the most
valid trials, and then manipulated the statistics to provide the preordained
result. Voodoo science at its most obvious.]
---------------------------------------------------------Index
3. WEB 2.0 FOR “NEWBIES”
Excerpts from: Becoming the Spider: Next Generation SEO Tactics
"Just when you believed you had all your SEO tactics figured out, the web goes
and changes on you. ... Web 2.0 changes the whole ballgame. It not only places
the Internet user squarely in the middle of things, but it gives that user the
means and power to create and manipulate data. Web 2.0 dramatically changes how
we view and use the web. ... Just what exactly is Web 2.0? ...perhaps the simple
definition can be found in the word "you"! Time magazine probably summed it up
best by making reference to the "you" in user generated content. Web 2.0 is
basically all the platforms that give us this brave new
user-powered interactive Internet, generally referred to as 'social media'. ..
Web 2.0 can be seen or manifested in such sites as YouTube, MySpace,
Del.icio.us, Digg, Squidoo. ... Web 2.0 uses scripting languages such as Python,
Perl PHP, RSS... to construct interactive platforms that websites can
use to create all this user-generated content. ... If you have used Google
Earth, you will realize how powerful and revolutionary these new applications
can be, not to mention, they are a whole lot of fun. ... all webmasters should
optimize their sites for this new Web 2.0 and take full advantage of all the
SEO possibilities presented by this brave new Internet. … Here are a few SEO
suggestions you can try:
1. RSS/Blogging. You must place a blog and RSS feed on all your sites. This is a
fairly simple procedure to do with free server-based programs... Having a
blog and RSS feed will place your site into the whole tagging process. Each
category you create in your blog will be seen as a tag by such sites as
Technorati. RSS stands for 'Really Simple Syndication' and your RSS feeds will
get your content distributed across the web. ...
2. Create some Google Juice! Join as many of these highly interactive sites as
you can: MySpace, YouTube, Del.icio.us, Digg, Wikipedia ... my favorite is
Squidoo, where you can create Lenses on different topics that interest you. User
driven content that's utilized by all the major social media sites. Of
course, link back to your sites in your posts and creations in these
user-created content havens and watch your PR ratings go way up.
3. Use Interactive Scripts. Place interactive JavaScripts and platforms on your
own sites. Have membership forums, polls, blogs, feedback forms,
user-contributions... to build unique content driven sites. Become the spider!
4. Tagging (Folksonomy). Be constantly aware of the tags (keywords) you're
creating with your blogs and sites. This can have a very beneficial effect on
your traffic and rankings. Closely relate these tags to the content on your
sites and build higher rankings in all the major search engines.
5. The Long Tail. Especially important for affiliate marketers, you need to
cover special niches where there is less competition and content. These narrow
niches make up a large portion of the whole vast web, creating content in these
unique areas will get your site included in the search engines a lot
quicker and keep them there a lot longer.
6. Holistic Web 2.0! Be constantly vigilant in placing your sites in the whole
'Interactive Game', building links and partnerships with the important
YouHubs: MySpace, Del.icio.us, YouTube, Digg, Squidoo... the more connections
you have, the more your own sites will prosper.
"... Web 2.0 will play an ever increasing role in the development and evolution
of the web. Make sure your sites are optimized and in the 'You'
game. Create blogs, RSS feeds, interactive forums, membership areas,
user-generated content and truly make your sites interactive havens in their
own right. Just remember to tag everything and your sites will reap the benefits
of this new Web 2.0 generated SEO gold rush. ... The author [Titus
Hoskins] is a full time Internet Marketer with numerous sites on the web,
including two niche sites on Internet Marketing. His main site is
www.bizwaremagic.com ...”
Well, that’s all for now. Remember to check the SoP contents tables at:
http://tinyurl.com/2eu6yj
Ralph
Fucetola JD
http://www.vitaminlawyer.com
VLUeM – 02.23.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Harvard Joins
Anti-Nutrient Crusade
2. The Future for Healthcare: $4.1 Trillion!
3. Record Keeping Short
Form SoP
---------------------------------------------------------
1. HARVARD MEDICAL SCHOOL REPORT PERPETUATES ANTI-NUTRIENT LINE
The report speaks for itself, but do note how it is being used to create publicity for the idea of implicitly pre-market controls over nutrients, as though nutrients were not as safe as any other category of food.
“The report, "Vitamins and Minerals: What You Need to Know", gives consumer advice…Directed at the general public, the report could stir up the issue in the nutraceutical industry surrounding what body should give a stamp of approval for supplements, and whether an independent body is needed for such a purpose.
“"Choose products that bear the US Pharmacopeia Dietary Supplement Verification Program (USP-DSVP) mark, which indicates that the supplement manufacturer has complied with certain standards," says the report.
“Via its recommendations, the Harvard report is also critical of dietary supplements that go beyond the vitamin and mineral category.
“"Generally, if you're hoping for phytochemical benefits, you'll do better in the produce department than the supplement aisle," according to the report. "There is virtually no evidence that herbs and other nonvitamin ingredients added to supplements, such as echinacea, are essential for your health."
“The report questions another key area for the supplement industry - the benefit of different sourcing for vitamins in minerals.
“"It doesn't matter whether vitamin C is derived from organic rose hips or synthesized in large batches in a laboratory," says the report. "Your body will use the resulting product similarly."”
www.nutraingredients-usa.com/news/ng.asp?n=74406&m=1NIU221&c=jegwylrviswtnqa
---------------------------------------------------------Index
2. HEALTHCARE SPENDING TO INCREASE
FDA News reports today: “”Healthcare spending will continue to grow more quickly than the economy over the next decade … according to a report from economists at the Centers for Medicare & Medicaid Services (CMS). Healthcare spending in 2016 could reach $4.1 trillion, representing 20 cents out of every dollar spent, according to the report, which was published in Health Affairs. In 2006, healthcare spending was $2.1 trillion, the economists estimated. …
spending growth will reach 7.8 percent by 2009 because of accelerating medical price inflation and increases in pharmaceutical use. By 2016, health spending could be 19.6 percent of the gross domestic product, the report said.
---------------------------------------------------------
3. RECORD KEEPING SHORT FORM SoPs
A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.
To make it as simple as possible, I’ve developed a shorter and simpler version of my 50+ page Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at ralph.fucetola@usa.net with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.
Well, that’s
all for now.
Ralph Fucetola JD
http://www.vitaminlawyer.com
Index
VLUeM – 02.09.07 - VITAMIN LAWYER UPDATE e-MEMO
The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… ;)
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb and my Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq .
This issue focuses on two areas: (1) FTC plans to police the vitamin market and (2) some more tips from Entire Web.
--------------------------------------------------------
1. FTC Enforcement Plans
2. Increase
Conversion with Situational Selling
---------------------------------------------------------
1. FTC Enforcement Plans from Nutra Ingredients USA (article excerpts below)
http://www.nutraingredients-usa.com/news/ng.asp?n=74055&m=1NIU208&c=jegwylrviswtnqa
“2/8/2007 - The Federal Trade Commission has said that it will continue to prioritize policing dietary supplement marketing practices, thereby sending out a warning to companies making exaggerated or unsubstantiated claims. .
“The deceptive marketing of products that may affect consumer health and safety will continue to be an FTC priority,” said the FTC in its budget request summary submitted to Congress on February 5. “The FTC will focus on health care products, including dietary supplements.”
“The authority rang in the New Year with a $25m-clamp-down on parties behind the deceptive marketing of four major weight-control supplements: Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart. [The Vitamin Lawyer notes: none of my clients!] . . .
“Going forward, the FTC will continue its aggressive program by focusing its law enforcement on violations that create the greatest risks to consumer health.” . . .
---------------------------------------------------------Index
2. Increase Conversion with Situational Selling from EntrieWeb - www.entireweb.com (article excerpts below)
“. . . [R]eally good salespeople are trained to discover details about the customer before trying to pitch a particular item. A question like, "Hi, how are you? What sport do you play?" is a great opening line. It gets the customer to focus on a general topic, and then persuades him or her to narrow down the choices. And a focused customer is a buyer, not a browser.
“What does this have to do with your online sales? Plenty. Especially if you'd like to increase your conversion by 50 percent or more.
“You see, if you focus just on increasing traffic without increasing your profit per visitor, well, you're missing out on more money. Or more e-mail opt-ins. Or whatever it is that you do to monetize your site. Fewer clicks and more sales should always be the goal. You'll improve those two metrics when your site successfully gets visitors to focus right away on the homepage and then proceed directly to checkout.
“That's where the "situational sell" can be your super-cybersalesperson. On a website, you can give visitors a few choices that best describe their situation, and entice them to click on the description that puts them into a specific segment of the market.
“The situational sell is a way to pitch products and information strictly from the customer's point of view. If you're selling sports merchandise online, you would want to get customers to click on their favorite team right away, and then choose the item they want to buy. … Think of the situational sell as pre-qualifying your visitors, before they get a chance to wander aimlessly through your site. If you pre-qualify them, you can funnel them through the sales process a lot faster.
“One traffic school website who tried this tactic ended up increasing its email opt-ins by a whopping 60 percent! How did they do it? Instead of simply listing the names of the courses it offers, the website asks visitors what type of driver they are, literally. On the site you'll see 3 boxes in a row in the main body area. Each box contains a unique headline, a photo to illustrate the idea, and a description of services within the category.
“Box #1 contains the headline "New Driver?" and includes a picture of teenagers laughing and hanging out in a school parking lot. Box #2 carries the headline "Too Many Tickets?" and includes a picture of a driver getting a ticket. Finally, Box #3 has the headline "Trying to pass the state exam?" along with a picture of a recent immigrant holding paperwork.
“Under the headlines, a series of links appear. This is also a great place to include your top-tier keywords. Once a visitor clicks on one of those links, he or she is guided to a page specifically geared to sell products or services to their demographic
“The beauty in setting up a 'situational sell' website is that it's a very flexible way to market one type of product to a wide selection of site visitors.
“If you're selling e-books or informational products, there will be different features or advantages that you'll want to highlight, depending on the visitor. By segmenting your visitors first on your homepage, you can funnel them to specialized pitches.
“The situational sell sounds logical because it is logical. But in the day-to-day minutia of maintaining a website, the big details sometimes get lost in the shuffle. Take a fresh look at your homepage and give your visitors a fresh perspective. Try the situational sell. It will make your visitors comfortable, they'll feel as if you already understand their point of view, and you'll most likely be rewarded with higher conversions.”
--------------------------------------------------------------------------------
About the Author: Diane Metz writes about website marketing and development. She offers free, unique content to select websites. Her companies include Crown CD Manufacturing, which specializes in CD duplication and CD replication, for marketing, music, promotions and software - http://www.crowncd.com/ .
--------------------------------------------------------------------------------
I am happy to be able to bring you Diane Metz’ interesting piece on Situational Selling. I think it is a useful marketing concept that can help you design a stronger web site. The great genius of the Internet is its ability to connect people and information. The more you are able to link the right people with the right product the more likely you are to have a sale. So good luck on your web site optimization!
Well, that’s
all for now.
Ralph Fucetola JD
http://www.vitaminlawyer.com
Index
VLUeM – 01/2707 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
Vitamin Lawyer on HealthRadio; Vitamin Shoppe under attack; DEATH by medicine
Vitamins are
under major media attack -- again. A new Adverse Event Reporting Law has
been signed by the President. These issues are so important for Dietary
Supplement Purveyors, that I reproduce below most of the report from
Nutraingredients-USA and devote this entire issue of my Update eMemo to the
attack:
---------------------------------------------------------
The Vitamin Shoppe calls for independent testing procedures - By Clarisse Dou
1/26/2007- Following the withdrawal of its women’s multivitamin product - as a result of allegations of high lead content by ConsumerLab.com - the Vitamin Shoppe has expressed both its desire to get to the truth of the matter and for industry to devise new testing methods.
NutraIngredients-USA ran an article Wednesday on the Vitamin Shoppe's decision to withdraw its "Especially for Women" multivitamin. The decision was sparked by the highly publicized results of a study conducted by industry watchdog ConsumerLab.com that pinpointed 11 products - out of 21 tested - as not meeting their labeled contents and standards.
The Vitamin Shoppe… said… “Our industry badly needs an independent testing procedure that truly has the best interests of the consumer at heart…”
ConsumerLab said the Vitamin Shoppe’s multivitamin was contaminated with 15.3 micrograms of lead per daily serving. This is more than ten times the amount of lead permitted without a warning label in California – the only state to regulate lead in supplements – and several times the normal daily exposure to lead…
The Vitamin Shoppe has also stood by its assertion that its products are manufactured according to Good Manufacturing Practices (GMPs). “We have strict checks and record keeping requirements that follow "Good Manufacturing Practices" for food and all products delivered to our distribution facility.”
Draft current GMPs were published in 2003, but the final version of the guidelines are reported to still be going through a law-making process at the Office of Management and Budget.
“There is a proposed regulation for GMPs that are specific for dietary supplements that have been in discussion since 1995… “We regularly audit our contract labs to assure that they are complying with our educated best guess as to what these proposed regulations will entail and for the legally required compliance with food GMPs.”
Copyright
- Unless otherwise stated all contents of this web site are © 2000/2007
http://www.nutraingredients-usa.com/news/printNewsBis.asp?id=73719
---------------------------------------------------------
So, what does this mean to the average vitamin company? These are the points to consider –
First: cGMPs are about to become a center of the attack on the industry.
Second: the
attack continues, in different ways and places. Just a week ago Tuesday, the
New York Times carried a major article attacking vitamins as potential
poisons – my comments and those of Maury Silverman – prepared for my
appearance last Saturday on HealthRadio - Dr. Alan Pressman,
www.drpressman.com - are below:
---------------------------------------------------------
Date: Thu, 18 Jan 2007
03:26:45 PM EST
From: "Ralph Fucetola JD" <ralph.fucetola@usa.net>
To: <healthradio@aol.com>
Cc: <maurysil@earthlink.net>
Subject: The Safety of Dietary Supplements
Well, Dr. Pressman, I looked
at the NY Times propaganda piece.
http://www.nytimes.com/2007/01/16/health/16diet.html?ref=science
I'd be happy to appear on your show this Saturday. What strikes me is the
extraordinary SAFETY of supplements -- one death in 60,000 complaints, for
example, with many ten millions of users - 230 deaths in 23 years. Compare that
to aspirin - 1,500 deaths per year, every year. Etc.
With the new Adverse Event Reporting law, we may get better statistics over the
next few years. See:
http://www.aer-consultants.com .
Among other failures, the Poison Control people are not collecting the right
information. It has been suggested by some critics of such studies that often
the adverse reaction is caused by the interaction with drugs and it is the drug
that is to blame, not the food substance.
Maury Silverman recently wrote me (about implementing the new AER law):
"Implementing 'objectively'
has been stated many times here, meaning to first identify concurrent use of
foods and dietary supplements with drugs of any kind, be they prescription, OTC,
or illegal/illicit/counterfeit.
"Once that is done on the MedWatch form your company now must fill out once a
complaint comes to you that must be reported to FDA, the FDA should screen out
drug-drug interactions & drug-nutrient interactions, (which are inherently drug
problems). The current MedWatch form is very inadequate to gather this
information.
"This is important so that:
" (1) the dietary supplement ought not be blamed for a serious adverse event
prompting a lawsuit against your company, or yourself since you are so
numerous on the record as disbelieving and/or being delusional on this matter.
" (2) The FDA can require labeling of the drug, for contra-indications, known
drug-drug and/or drug-nutrient interactions. As drugs are so inherently
more dangerous than foods and dietary supplements, better labeling of drugs,
first, is vital importance to the nutrition industry and the public health.
" (3) Drugs can be labeled for the nutritional deficiencies they cause. That
goes also for alcohol, caffeine, and nicotine when poor nutrition is concurrent.
" (4) More 'E' can be put into the full implementation of DSHEA. This means more
quality information from the nutrition community on how to avoid
adverse events, when there is concurrent usage with drugs.
"The problem is too often that the medical establishment does not educate or
train its practitioners on nutrition and the healing qualities of natural
products. They are more likely than not, drug salespeople. From when I was a
youngster, I do remember that people grew up on food and good nutrition, not
DRUGS.
"I suggest here that you look at the article in the October 9, 2006 issue of
Archives of Internet Medicine titled: "Factors Associated with Dietary
Supplement Use among Prescription Medication Users". (166: 1968-74, 2006)"
Allen, Thanks for the opportunity to respond to obvious BS.
---------------------------------------------------------
Third: The current attack on vitamins needs to be seen in light of AER – Adverse Event Reporting. AER implementation will be directly tied to these developments. And, a word to the wise: The new AER law is not concerned with the general propaganda that nutrients are not safe, as a class of food. Nutrients are generally recognized as foods, and foods are generally recognized as safe when ingested as directed. AER is concerned with specific batches of specific products and whether they are contaminated or otherwise unwholesome. AER may provide the ammunition to yet again prove nutrients safe.
Please review what we have to say about AER developments on the AER Consultants web page, www.aer-consultants.com – we will post information on developments there. AER Consultants will engage with the FDA on the issues that need to be covered by the AER regulations to protect the industry as well as the consumer. Your thoughts on that would be appreciated, so please let me know what you think needs to be included.
What can concerned citizens, health freedom activists, alternative practitioners and dietary supplement purveyors do to protect their access to wholesome, high potency nutrients? Stay informed! Be ready to make your views known. Support health freedom groups like www.healthfreedomusa.org - if you are in the industry, realistically analyze the situation and remember, “Management manages…”
And now for the counter-punch... DEATH by medicine:
Previously published by the
Life Extension Foundation, Gary Null and several other healthcare professionals
lay it out: government-approved, standard medicine is the single greatest CAUSE
of preventable death in the USA. While we've known this for a while, it's useful
to see the statistics all brought together in one article, especially now that
Dietary Supplements and natural alternatives seem under heavy media attack.
http://www.lef.org/magazine/mag2004/mar2004_awsi_death_02.htm
Well, that’s all for now.
Ralph
Fucetola JD
http://www.vitaminlawyer.com
Index
VLUeM –
01/13/07 - VITAMIN LAWYER UPDATE e-MEMO
For those of you who are new to the VLUeM, the purpose of this
e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my
contacts and client list. You got on this e-list by opting in or becoming a
client of the Vitamin Lawyer Consultancy. If you want to be taken off the list,
please “reply” to this email with the word “remove” in the subject line. On the
other hand, you are welcomed to forward this to your own elist… :)
And do remember to check out the Online VLUeM Archives: http://tinyurl.com/rkneb
and my Online Seminar listing of briefs and white papers: http://tinyurl.com/ua9lq
.
--------------------------------------------------------
Here’s what I cover in this memo:
1. Vitamin Industry continues rapid growth.
2. Handling negative search engine postings
--------------------------------------------------------
1. RAPID GROWTH! -- It’s going to be a great new year!
The latest figures show that Vitamin Industry sales have increased to over
$28,000,000,000 – that’s 28 billion dollars – per year! As recently as 1993 some
sources list annual dietary supplement sales at under one billion dollars. In
about a decade and a half, sales may have risen at the astounding average annual
rate of two billion dollars a year! What’s your share of the industry? Where
will this rate of growth take it over the next decade? Are you ready to rise
with this rising tide – or, rather, with this tsunami of sales? Looks like an
interesting year ahead!
--------------------------------------------------------
Index
2. NEGATIVE WEB PUBLICITY -- I’ve recently been asked
by several people to help clear search engines of negative postings. While their
own web sites rank near the top for their chosen search terms, or for their own
names or company names, they also found some rather negative postings also
having very high search engine positions. This is especially true regarding
negative postings from such sources as the now largely discredited “Quackwatch”
web sites. Once a “quack attack” has been launched, though, it tends to linger
on the web. When, as was recently the case, a negative posting including
confidential government investigative materials that are privileged by law, a
strongly worded Cease and Desist letter from a lawyer to the Internet Service
Provider (ISP) providing the web space for the offending site will often cause
the deletion of the page. Other times, litigation is necessary. See my site,
http://www.internetinjunctionlawyer.com . The Vitamin Lawyer is available to
send C&D notices for you, or to consult with local counsel if litigation is
needed. The sooner you start, the quicker the negative web pages will disappear!
But, often, there are “lawyerless” approaches that can help reduce the search
engine ranking of negative postings. The following excerpts from a recent issue
of Entireweb Newsletter contain a wealth of ideas to deal with negative press.
"Entireweb Newsletter * January 9, 2007 * ISSUE #299
www.entireweb.com - Ten Tips To Clear Search Engines of Negative Press
"What do you see when you search for your company or brand name? Is there
anything on the first page of the search engine results that you wouldn't be
proud to display on your home page? Consumer review sites, blogs and forums have
made it easy for anyone to say whatever they want about your company, whether
they be disgruntled customers or competitors who like to play dirty. ... If
you're in a situation where negative publicity is front and center in search
results, there are ways you can reclaim search engine real estate for your
corporate identity. Though you can't make negative results disappear from the
search engine indexes entirely, the following strategies can help them slip off
the first few pages of search engine results.
"1. Good Old Fashioned Networking - Even if you take none of the advice
following in this article, the first thing you should do is contact the
webmasters of the sites in question with a polite request for removal of
negative comments. There's a good chance they'll be willing to co-operate. ...
"2. Tap Into the Power of Wiki - Wiki websites allow users not only to add their
own content, but also edit pages. ... There are many wiki pages like AboutUs.org
and LoveToKnow.com that you can use to create content about your company. ...
"3. Raise Your Profile - Some websites like PR.com allow you to post your
company's profile. ...
"4. Wet Your Pen - Articles can help you kill three birds with one stone. Not
only can articles rank for your company name, they also build valuable backlinks
to your site and position you as an expert in your field. You can use your
company name in the resource box at the end of an article along with a link back
to your site...
"5. Become A Socialite - Using social bookmark sites like Netvous and
Del.icio.us is an easy way to quickly create a page that ranks for your name.
... The links themselves are not given much weight by search engines, but you
have an opportunity to use your company name in the titles and descriptions of
your bookmarks and photos. ...
"6. Become A Lensmaster - A company blog is certain to rank well, and it's
easier than ever to create one with Squidoo.com. When you create a "lens" for
your site, you can easily upload pictures and also make use of tags. Unlike
other blogs, Squidoo won't show the posting date, so your lens won't look
neglected if you ever stop posting. You can build your blog's link popularity by
submitting it to blog directories like LSBlogs and BlogHub, and linking to it
from your site...
"7. Broadcast Yourself - Do you have promo videos or other visual media about
your site? Why not create a channel [on sites like YouTube]..
"8. Explore Shopping Engines - If you sell products online, consider listing
them in comparison shopping sites, or "shopping engines" like Shopping.com,
Bizrateor Nextag. ...
"9. Use Directories For Deep Links - Search engines still consider a page's
number of relevant backlinks to be a strong indicator of quality and relevance
to a search term. Octopedia, WorldSiteIndex and Microsoft's Small Business
Directory are a few examples of solid directories ...
"10. Post An E-Help Wanted Sign - Leverage the strength of sites like
Craigslist.org to post your company's current job offerings. Make sure you use
your company name first in the posting headline...
"Tracking Results - I strongly recommend setting up an account with Google
Alerts (free) which monitors the top 50 results, or with Google Alert, a
professional tracking system that will monitor the top 200 results for you for
as little as $4.95/month. You will be notified daily when new references to your
name have been found in Google - not only to see when your articles, profile
pages, blog posts and so on get indexed, but also to keep on top of any new
negative or positive references to your name outside of your own reputation
management efforts.
"How Long Will This Take? - Results may vary but they won't come overnight. You
will get out of your reputation management efforts what you put in. It could
take anywhere from a few months to a year. Expect monitoring and tweaking your
strategy to be a long-term activity. As new pages are being added daily to the
Web, search results for your name can fluctuate daily, even hourly... The key is
to look at reputation management as a long term activity and to take advantage
of all the options you have to keep the search engine results positive.
"About the Author: Linda Bustos is the Marketing Director for Image X Media, a
Vancouver web design and Internet marketing firm. She also blogs about social
media and business."
--------------------------------------------------------
Well, that’s all for now.
Prosperous New Year!
Ralph Fucetola JD
http://www.vitaminlawyer.com
VLUeM – 1212/06 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
Here’s what I cover in this memo:
1. Paying for
Complementary, Alternative Medicine (CAM) Therapies.
2. More on SEO…
3. Knock, knock… a year-end opportunity!
4. Emergency Management SoP
--------------------------------------------------------
NCCAM - the federal agency that is supposed to represent the public’s interest in Advanced Healthcare (what the gov’t calls “Complementary and Alternative Medicine”) has a web site with some useful information for practitioners. For example,
“In tax year 2005, the IRS allowed taxpayers to deduct medical expenses for a limited number of CAM services and products, such as acupuncture and chiropractic care. These expenses were generally allowed for taxpayers and their spouses and dependents.”
To find out more about resources for funding such health care costs, see: http://nccam.nih.gov/health/financial/index.htm
-------------------------------------------------------- Index
2. Search Engine Optimization.
EntireWeb.com is an excellent source of information about searching the web. That’s why I’ve forwarded a number of their articles to this elist. Last week's article has good some really good advise. What particularly struck me were:
“Let's clear the decks, your opening headline (which should be an H1paragraph, by the way) should say in no uncertain terms what it is you are offering vis-a-vis service or product. (Not to mention the benefit of owning the damn thing.) This is the line that both search engine and customer will see first. It is the line that convinces both to stick around. In addition, this headline should reflect and tie-in neatly with your HTML meta tags of Title, Description and Keywords. *** Make no mistake, your headline is crucial for winning good search engine listings and for making sales.”
“Google, Yahoo and MSN seemingly account for around 75% of the Internet's search traffic. And if you are nuts enough to want to add that lot up, you may find that it will run into many billions of searches per month. *** Anyhow, by extrapolation, it appears that the remaining, lesser known search engines must handle 25% of the traffic between them, which I can tell you with some accuracy amounts to about 950 million searches a month. *** “Wow!” you say. And quite right, too. What seems plain from all of this is that if you aren't deliberately targeting the smaller engines, you are neglecting, even rejecting some 25% of your potential customers.” - Entireweb Newsletter - December 5, 2006 - #289
-------------------------------------------------------- Index
3. Knock, knock… an end of the year opportunity!
As some of you may know, I am the Chairman of the Board of Directors of MagnetoCore Corporation – http://www.biomagscience.com - which is licensed to sell Foundation of Magnetic Science certified products. That site is about our wellness products. The company is also developing a line of Fluid Conditioning products for uses that range from engine enhancement to agricultural applications. You can see some more about those applications at a site maintained by one of our Manufacturer’s Reps, http://tinyurl.com/tzgcl - these products will also shortly have their own web site. The Board, at its monthly meeting last week, adopted a resolution allowing us to sell some shares in the company at a special rate. The opportunity is limited to $5,000 per investor (minimum, $500) and includes one warrant per share purchased. If you are interested, let me know and I’ll arrange for a conference call with our new President, Lou Elwell. I’ll need to know the best number and time to call.
-------------------------------------------------------- Index
Following up on the Emergency Management note in the last issue of this eMemo, I’ve prepared a new page for my form Standard Operating Procedures Manual. That page codifies an Emergency Planning structure for your business. If you are a retainer client of mine, you will receive a copy of the new page by separate email. If you are a client who has ordered a SoP Operations Manual in the past and want a copy of the update page, just send me an email note and I’ll send you the page. If you do not have a SoP manual but want one, let me know and I’ll quote you a price to customize it for you.
--------------------------------------------------------
That’s all for now – I hope you find this information useful!
And -- happy holidays and a prosperous new year!
Ralph Fucetola JD
www.vitaminlawyer.com
VLUeM – 11/16/06 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
Here’s what I cover in this memo:
1. Managing a Crisis: Preparing for the Unexpected
2. Quick Dissolve Strip Vitamin & Nanotech Delivery
System
-------------------------------------------------------- Index
The late Harold Geneen, the creator of one of the early, great conglomerates, ITT, wrote in his classic book Managing that “Management Manages…” and this mantra is especially useful to remember when your business finds itself in a sudden crisis. But also remember that old saw: within every adversity are the seeds of a greater benefit, or as the Chinese put it, every crisis is an opportunity.
Companies, especially in volatile industries that are subject to regulatory reversals and strong competition, need to pre-plan to deal with the unexpected. How would you deal with a manufacturing error that might make your product dangerous? What would you do if someone that everyone in the company relies upon were suddenly taken away by illness or other emergency? What if a key employee is called to active duty, or arrested, or leaves for a better job? Crises take many forms, from surprise regulatory inspections to accidents and litigation to a blizzard. Management needs to have - in place - contingency plans, or at least someone who can consider contingencies, before the crisis.
Here are some things to consider:
* Pre-position a
crisis management committee – an Emergency Manager needs to be ready in advance
Consider - staffing the committee, day-to-day management, setting and meeting
goals
Review insurance coverage; maintain emergency contact
information; SoP status
* Pre-position your outside experts for availability during an emergency
* Pre-position media outreach – spin to turn losing into winning
* Prioritize the targeted audiences with whom you need to communicate during a crisis:
* What message for what group: customers, employees, investors and, agencies
* Who delivers what message to whom and how does it get out: fax, phone, email
* Interact with the FTC, FDA and state authorities during a company crisis
* Deal with concerns from local, national or international audiences
“Management manages…” and you need to prepare for emergencies and discontinuities in advance. Your Standard Operating Procedures are important here: during an emergency good SoPs allow others in the company to perform the tasks normally handled by an absent team member. Remember that The Vitamin lawyer Consultancy has small-business friendly SoP – Operation Manual formats available.
Perhaps the most important duties of the Emergency Manager before the crisis is to make sure that (1) insurance, (2) emergency contact information and (3) SoPs are all in place. When the crisis comes upon the company, reacting quickly and communicating the right message to the key audiences becomes the priority.
--------------------------------------------------------------------------------Index
2. Quick Dissolve Strips – an advanced delivery system to consider for water-soluble dietary supplements, herbals, homeopathic and nanotech products. Take a look at Winning Business Solutions for more information: http://tinyurl.com/y8o5fj
--------------------------------------------------------
That’s all for now – I hope you find this information useful!
Thank you and have a joyful, family-filled Thanksgiving!
Ralph
Fucetola JD
www.vitaminlawyer.com
VLUeM - 10/23/06 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
Here’s what I cover in this memo:
1. SoPs – More on Operating Procedures
2. Top Ten SEO Factors – from Entire Web
-------------------------------------------------------- Index
1. SoPs - More on Standard Operating Procedures
I know I’ve been telling you quite a bit over the past couple months on Standard Operating Procedures. There is an important business reason for that: bit by bit the FDA is coming out with more requirements that apply to dietary supplement companies, enforcing a provision in the 1994 DSHEA law giving FDA authority to codify current Good Manufacturing/Marketing Practices in the industry.
In comments to one member of Congress, discussing a meeting on SoPs, FDA stated: “The agenda included topics regarding the small business entities' manufacturing practices and standard operating procedures for: (1) personnel; (2) buildings and facilities; (3) equipment; (4) laboratory operations; (5) production and process controls; and (6)
warehousing, distribution and post-distribution of' raw, intermediate and final products . The meeting included a discussion about the verification of the identity, purity and composition of dietary supplements and dietary supplement ingredients.”
http://www.fda.gov/ohrms/dockets/dockets/96n0417/96n-0417-c000098-vol3.pdf
There has been continuing controversy regarding SoPs for the industry. GNC made its position clear in 2003, “FDA asserts that “dietary supplements have their own set of unique requirements as a result of the characteristics and hazards due to their ‘hybrid’ nature, e.g., dietary supplements can be considered as falling somewhere along the continuum between conventional foods on the one hand and drugs on the other.” Dietary supplements in fact fall within the food category and were treated as a food item for their entire history. DSHEA in 1994 confirmed the food status of dietary supplements and provided an expanded definition of the category.”
http://www.fda.gov/ohrms/dockets/dailys/03/Aug03/081803/96N-0417_emc-000197-01.doc
As a result, the original intention of FDA to have formal cGMP in place several years ago has been delayed. Now the agency seems to be imposing the regulations in a more piecemeal strategy. I’ve recently been reading FDA warning letters that cite a lack of an SoP as a concern of the agency.
To anticipate these developments, I’ve created a standard Operations Manual for my Vitamin Lawyer Consultancy clients. As the SoP is developed, it will cover all the areas cited by the FDA above. The most recent addition to the SoP is a page of instructions about reviewing Advertising Claims, whether on labels, literature or web sites. Those clients who are on a regular monthly retainer agreement with me have received that additional page already.
As an “added value” to my extended client base, I would be happy to provide a copy of this SoP page upon request. Of course the best way to be kept up to date is to be a regular monthly retainer client. And, you receive two added bonuses: a lower hourly rate and the use of my Vitamin Lawyer Oversight Seal. Drop me an email if you’d like more details.
See also [includes outline of SoP]:
07/05/06
See also [Crisis SoP]: 11/16/06
------------------------------------------------------ Index
2. Some more good SEO advice from Entire Web -
"Entireweb Newsletter - October 24, 2006 - ISSUE #277
www.entireweb.com
Top Ten SEO Factors
These are what I believe to be the top 10 most important things (not necessarily in order) that you need, in order to get your website found in the search engines.
There are many other factors as well, but if you follow these guidelines, you'll stand a much better chance, and you'll be off to a good start.
1. Title Meta Tags
The title tag is what displays as the headline in the SERPs (Search Engine Results Pages). It's also what displays in the top blue band of Internet Explorer when your site is displayed
Your title tag of your website should be easy to read and designed to bring in traffic. By that, I mean that your main keyword phrase should be used toward the beginning of the tag. True there are websites being found now that do not use the phrase in the title, but the vast majority still do as of this writing.
Don't make the mistake of putting your company name first, unless you are already a household name, like Nascar or HBO. People are likely searching for what you have to offer, not your name.
Your title tag should be written with a capital letter starting the tag, and followed by all lowercase letters, unless you're using proper nouns. Some people prefer to capitalize every word, too.
2. Description Meta Tag
The description tag is the paragraph that people will see when your page comes up in the search results.
Your description tag should be captivating and designed to attract business. It should be easy to read, and compel the reader to act right now and follow your link. Without a description tag, search engines will frequently display the first text on your page. Is yours appropriate as a description of the page?
A proper description tag is what people will see below your title. You should make proper use of punctuation, and with readability, use your subject and geographical references.
3. Keywords Meta Tag
The importance of Meta keyword tags fluctuates from month to month among different search engines. There is a debate in the SEO community as to whether or not they help at all on certain search engines. In fact, in the summer of 2004 it appeared as if they were losing importance altogether.
However, you'll NEVER be penalized on any search engines for using relevant targeted keywords in moderation, and they can only help you with most, especially Yahoo.
Avoid stuffing your keyword metatags with too many keywords. Just use relevant tags that apply directly to the content of that particular page, and don't overdo it.
4. Alt Tags
The small yellow box that comes up when your mouse cursor is placed over an image is called the ALT tag. Every relevant image should have an alt tag with your key words or phrases mentioned in the tag.
A proper ALT tag goes after the file name, and before the Align indicator. * - The ALT tag is no longer being considered for ranking purposes by some search engines. That said, it still cannot HURT you, and will still help you with some engines. My recommendation is to continue to use them, but be sure to avoid keyword stuffing. Besides, who knows when the pendulum will swing back the other way?
5. Header Tags
The text of each page is given more weight by the search engines if you make use of header tags and then use descriptive body text below those headers. Bullet points work well too. It is not enough to merely BOLD or enlarge your text headlines.
6. Link Text
Search engine spiders cannot follow image links. In addition to having image links or buttons on your web pages, you should have text links at the bottom or elsewhere. The text that the user sees when looking at the link is called the link text. A link that displays products does not carry as much weight to the search engines as a link called oregon widgets. Link text is very important, and is actually one of the most frequently overlooked aspects of web design that I've seen.
7. Site Map
Using a site map not only makes it easy for your users to see the entire structure of your website, but it also makes it easier for the search engines to spider your site. When the search engine spiders come to visit, they will follow all of the text links from your main index page. If one of those links is to a site map, then the spiders will go right to the sitemap, and consequently visit every page you have text linked to from that site map. On the site map page, try to have a sentence or two describing each page, and not just a page of links.
8. Relevant Inbound Links
By relevant, I mean similar industry or subject related sites. Right now, no single strategy can get your site ranked higher faster than being linked to by dozens of other relevant websites. It used to be that the quantity of incoming links mattered most, but today, it's much better to have three highly relevant links to you from other popular related websites than 30 links from unrelated low ranked sites. If there are other businesses in your industry that you can trade links with, it will help your site enormously. Link to others, and have them link to you. It's proven, and it works. To see who's linking to you, in Google type the following... links: yourdomain.com
9. Your Content
Not to be forgotten of course, is the actual content of your webpage. It must be relevant helpful information that people want to read. These days, each webpage should be laser focused on one specific product or subject, in order to rank highly for that search phrase. The days of writing one webpage to appeal to dozens of search terms are long gone. Ideally, each page should have between 400 to 650 words on it. Too few, and the search engines won't consider it to be relevant enough. Too many words and the search engine spiders may have a hard time determining the actual subject or focus of the page.
Use your keywords or phrases often, and use them at the beginning of your paragraphs wherever possible. Don't overuse them and make the page sound phony, but don't write a page about a certain subject, and not mention that subject repeatedly either. Reading it out loud to yourself is a great way to judge how natural your text sounds.
Concentrate on writing quality pages that actually appeal to the human reader. Write pages that provide the reader with exactly what they are looking for; that is, information about the exact search phrase they've entered.
10. Avoid Cheating
With all of these tidbits of information, it's tempting to think that you can stuff 100 keywords into your title, or create a page with the phrase oregon widget company being used 100 times in headers, text links, ALT tags, bullet points etc. but that cannot help you. In fact, it can penalize you, and get your website banned from certain search engines.
--------------------------------------------------------------------------------
About the Author: Scott Hendison is an internet consultant that specializes in search engine optimization and internet marketing. He has written over 100 articles that are available on his website. He has also developed a tutorial area for beginning search engine optimization, at 'SEO101'."
--------------------------------------------------------------------------------
That’s all for now – I hope you find this information useful!
10/12/06 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
Here’s what I cover in this memo:
1.
Vitamin Lawyer Free Online Seminar
2. Codex DVD and Committee Meeting
--------------------------------------------------------
1. Vitamin Lawyer Free Online Seminar: Over the years I’ve written many briefs and white papers about dietary supplement regulation and about alternative health care practices. I’ve posted these on an index page that you can find at:
Here are some of the titles:
Alternative Practices and
the AMA Code of Ethics
The Practice of Alternatives is not the Practice of Medicine
Mum Marketing -- Niches on the Internet
The Right of the Public to the Truth - Current Vitamin Marketing Rules
The Herbalists' Charter -- Ancient Rights for Modern Practitioners
-------------------------------------------------------- Index
2. Here’s some insider information on the Codex Alimentarius (World Food Code) issue and the future of international regulation of the Dietary Supplement marketplace.
“Codex is a winnable battle. It takes awareness, motivation, hope and tools to win. And it takes people. You know that we don't have the major media fighting to be first in line to tell the story of Codex and the industrialization/pollution of our food supply. They are not itching to let everyone in America know that despite the fact that nutrients are safe and effective, to say nothing of inexpensive, they make most drugs unnecessary…” Dr. Rima Laibow.
See exciting excerpts from Dr. Laibow’s hard-hitting DVD, Nutricide, now posted at:
http://video.google.com/videosearch?q=Nutricide
The Codex Nutritional Foods Committee (CCNFSDU) is meeting in Thailand at the end of this month, and for the first time ever, the organization’s autocratic chair will be held by someone who is more favorable to nutrients than the current leadership. This same meeting is required to consider the WHO/FAO Global Strategy on Diet, Physical Activity and Health, having before it the 11 pro-health principles offered by South Africa. You can see a media release regarding these at:
http://www.prweb.com/releases/2006/10/prweb444957.htm
It is important to SUPPORT the Natural Solutions Foundation, who helped develop the 11 Point Program, and thereby ensure that Foundation representatives can get to Thailand for what will be a very important meeting that will effect the way Vitamin Companies in the U.S. do business, not just globally, but domestically as well. It is expensive for NGO (Non-Governmental Organization) groups like NSF to fund such efforts, since they must rely entirely on private donations, unlike the bureaucrats and pharma cartel lobbyists who have plenty of money!
Check the video to learn why. Then donate, as though your Health Freedom depended on it, which, in my humble opinion, it does:
http://www.healthfreedomusa.org/action/donate.shtml
Thank you!
Ralph
Fucetola JD
www.vitaminlawyer.com
10/06/06 - VITAMIN LAWYER UPDATE e-MEMO
For those of you who are new to the VLUeM, the purpose of this e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. You got on this e-list by opting in or becoming a client of the Vitamin Lawyer Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own elist… J
Here are the items I am covering in this e-memo:
1.
Registration of Food Processing Facilities
2. Nanotech Coming to the Vitamin World – are you as
ready as the FDA?
3. VLUeM Archives now online!!
----------------------------------------------------------------
1. Registration of Food Processing Facilities
Says FDA – “Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA.” Among the foods included are that class of foods known as Dietary Supplements. See: http://www.cfsan.fda.gov/~furls/ovffreg.html
“Who must register? Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.” The web page states that this requirement applies to Dietary Supplements.
There are three simple steps on the web site to register:
“1. Verify that
your computer system meets the minimum system requirements.
2. Create an Account for the online FDA Industry Systems.
3. Register or Update a Food Facility.”
If you do not do your own manufacturing, processing, packaging or holding, the company you contract with for those services needs to be registered. You should ask for that company’s registration information.
------------------------------ Index
2. Nano Technology
Here are excerpts from a recent online report; note how innuendo and distortion are used to equate dangerous drugs that kill hundreds of thousands each year with generally safe food products [my comments in brackets]:
FDA not ‘nano-ready’, says report
By Clarisse
Douaud
http://www.nutraingredients-usa.com/news/ng.asp?n=71078&m=1NIUO05&c=jegwylrviswtnqa
10/5/2006 - A former FDA deputy commissioner for policy has denounced the agency's capacity to properly regulate nanotechnology products including supplements, a criticism that could inflame debate leading up to the agency’s first major public meeting on the atomic technology.
In a report commissioned by the Woodrow Wilson Center's project on emerging nanotechnologies, University of Maryland School of Medicine professor Michael Taylor concluded the US Food & Drug Administration's resource base is severely eroded. This is despite what appears to be a recent nanotechnology policy kick-start at the FDA.
The report reveals regulatory weaknesses affecting new products, such as certain dietary supplements and cosmetics, using the technology. Critics say questions over nanotechnology safety have not been answered and the FDA is not in a position to effectively police it. . . .
Nanotechnology is the ability to control things at an atomic and molecular scale of between one and 100 nanometers and has been met with enthusiasm across a variety of industries. Critics highlight the murky area of how nanoparticles affect toxicity and say nanoparticles should be treated as new, potentially harmful materials and tested for safety accordingly.
[A word to the wise: Foods (which is what Dietary Supplements are, after all) are NOT TOXIC chemicals, like pharmaceutical drugs are, and there is no evidence that nano-sized particles of those same Foods are any different. After all, the body breaks the nutrients down to molecular particles in order to use them. The above statement by the “expert” follows the political line laid down by new world order entities such as Codex, the World Food Code control organization.] …
Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Under the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act, only ingredients not marketed in the US before October 1994 must be approved by FDA before use in consumer products.
Thus, as it stands, pre-market regulation of nanotechnology in dietary supplements does not fall under FDA's regulatory umbrella, nor – according to Taylor – can fit into the agency's budget. . . .
"Business and health leaders alike should join in ensuring that FDA has the scientific tools and knowledge it needs to say 'yes' to safe and effective new products," said Taylor.
[Note: the “safe and effective” standard is the Drug standard. By law and court decision, Dietary Supplement Foods need only be safe when used as directed. The government does not evaluate the efficacy of Foods, only consumers on the open market can do so.]
The market stands to benefit from nanotechnology and therefore, stands to lose a lot according to Taylor, if it is not thoroughly regulated.
[The above statement is only possible from a former government employee who has never heard about the self-regulating abilities of the marketplace and has purposely remained ignorant of the disasters of government regulation, which have led to millions of unnecessary deaths.] …
FDA's nanotechnology public meeting will take place October 10, 2006 in Bethesda, Maryland. …
“FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices…” states an online FDA notice for the upcoming meeting. ...
------------------------------ Index
3. VLUeM Archives now online!
I’ve provided update memoranda to my regular clients for several years. I’ve now begun to create an Online Archives of the memos, working backward. So you can find everything you ever wanted to know about regulating the vitamin industry… sort of. See the Index at: http://tinyurl.com/rkneb. I would appreciate any feedback.
09/15/06 - VITAMIN LAWYER UPDATE e-MEMO
VLN - http://www.vitaminlawyernews.com
The FDA issued the following press release last week: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01446.html
Excerpts:
"At the request of ...(FDA), on September 5, 2006, U.S. Marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules... valued at approximately $55,000.00."
[Note the following claim that the NEW drug and misbranding provisions apply to dietary supplements as well as to drugs, when the DS is being promoted, in FDA's opinion, as a "drug."]
"The products are alleged to be in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act."
"Although these products are labeled as "dietary supplements," they are being promoted with claims typically associated with drug products. These claims are evident in the products' labeling, including various promotional literature, an audio cassette tape, and two Internet Web sites owned and used by the firm. ..."
"[Company's] labeling promotes and markets these products for serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia and seizures."
[And now, what to expect.]
"Following an investigation of the firm's marketing practices, FDA advised Advantage Nutraceuticals that the claims related to prevention or treatment of diseases in many of its products' labeling make these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to take sufficient steps to come into compliance with the Act. During subsequent inspections, FDA inspectors found that the offending claims were still being made."
------------------------------ Index
Note that "sufficient steps to come into compliance..." was the issue. This case appears to be another example of "guilty until proven innocent" in that no independent third party determined that the steps the company took were "sufficient." The companies that will survive in what is becoming a much stricter regulatory climate are those that are ready to react quickly. Oh, and if you are one of those companies trying to take "sufficient steps," not keeping a large inventory in your main plant is probably a good idea too.
You need to pay attention to your site claims on a continuing basis, and that is what the Vitamin Lawyer Oversight Seal program is all about. See: http://www.vitmainlawyer.com for details.
09/08/06 - VITAMIN LAWYER UPDATE e-MEMO
For those of you who are new to the VLUM, the purpose of this e-memo is to
update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and
client list. You got on this e-list by opting in or becoming a client of the
Vitamin Lawyer Consultancy. If you want to be taken off the list, please “reply”
to this email with the word “remove” in the subject line. On the other hand, you
are welcomed to forward this to your own elist…R
Here are the items I am covering in this e-memo:
1. Adverse Event Reporting – the latest on the bill to
grant the FDA new powers to control Vitamins.
2. Ephedra re-banned!
3. The Vitamin Lawyer Oversight Seal and Quality Control
(QC) Practices.
1. ADVERSE EVENT REPORTING
Is "AER" coming to the Dietary Supplement world? The Dietary Supplement and
Non-Prescription Drug Consumer Protection Bill, S.3546 was introduced on June
21st and was put on the Legislative Calendar on September 5th. It is expected to
be voted on before the election this November.
Says FDA News: “The Senate is planning to vote on one drug safety bill this week
and another before the end of the month, a spokesman for Senate Health,
Education, Labor and Pensions (HELP) Committee Chairman Mike Enzi (R-Wyo.) said.
First up will be "The Dietary Supplement and Nonprescription Drug Consumer
Protection Act," which would amend the Federal Food, Drug, and Cosmetic Act (FDCA)
to require OTC and dietary supplement companies to provide notice of serious
adverse events to the FDA. The bill… is expected to go to the Senate floor this
week..” Some suggest that AER will be bad for the industry and I understand
their concerns: nutrients are foods and should not be subjected to “drug-like”
controls. But consider, if AER rules had been in place a decade ago, would
Tryptophan have been banned because one manufacturer made one bad batch? Would
Ephedra have been banned if a reporting system had been in place to show the
actual safety of that herb, when used as directed? You can get more
information at:
http://www.aer-consultants.com.
------------------------------ Index
2. EPHEDRA RE-BANNED!
An appeals court has just overturned Judge Campbells’ well-reasoned decision
from April 2005, that “…the legislative history of the DSHEA indicates that
Congress generally intended to harmonize the treatment of dietary supplements
with that of foods when it added the dietary supplement subsection...” This
appeal court action is being appealed further to the US Supreme Court that will
thereby have an opportunity to confirm that Nutrients are Foods, not Drugs!
3. QC and the VITAMIN LAWYER OVERSIGHT SEAL
An important part of the developing “Current Good Manufacturing Practices” (cGMPs)
in the vitamin industry is Quality Control. The Vitamin Lawyer has developed
format Operations Manual sections for QC that tracks FDA requirements and the
probable requirements of the AER bill. One of the keys to meeting the new
requirements will be standardized QC controls – in a manual format for the FDA
to review if (and when) they come to your plant for a surprise inspection.
Please contact me if you need help with your Operations Manual.
One way to assure your customers quality claims is to qualify for and post the
Vitamin Lawyer Oversight Seal -- the seal is proudly displayed on web sites that
meet exacting standards for claim language and disclaimer usage. See
www.vitaminlawyer.com for a sample of
the Seal. The Vitamin Lawyer’s monthly retainer clients not only have the
privilege of using the Oversight Seal, but also receive discounted rates for
services. Let me know if you are interested.
That’s all for now. Have a great autumn!
07/05/06: VITAMIN LAWYER UPDATE e-MEMO
This Vitamin Lawyer Update is addressed primarily to the Dietary Supplement formulators and marketers on my eList.
--------------------------------
1.
FDA Inspection - What to expect from an FDA site
inspection
2. Codex Meeting in Geneva - Latest
internationalist regulations
3. SoP- Operations Manual - Why a good SoP Manual helps
with QC requirements.
------------------------------ Index
1. FDA inspections
According to the respected vitamin industry publication FDA News, "The FDA conducted more than 19,000 inspections, issued more than 6,000 Form 483s and sent out 535 warning letters in fiscal 2005 alone. With an estimated $22 million in new user fees in 2007, the FDA plans to fund increased reinspections and follow-up work."
While most of these inspections are in the other areas FDA regulates: drugs, cosmetics, OTCs and devices, the number of inspections are increasing in the Vitamin industry as well.
So, how do you prepare for a possible inspection?
Primarily by having your physical location clean and orderly while making sure your paper work is in order.
This is what FDA will look for:
1. Quality Control
to assure that every product is tested upon receipt from manufacturer
2. Complaint procedures to ensure that all adverse reactions are identified
3. Training programs for customer service and sales people
4. Disclaimers must be located at the site of the claim
5. New dietary ingredient, structure and function and health claim filings
6. Copies of labels and ads will be required to be provided.
See: http://www.lifespirit.org/fdainspection.htm
Of the above, the most important are probably:
1. Copies of your Structure and Function Notices to the FDA (this notice is required within 30 days of whenever you make or change a claim made about a dietary ingredient). Up 'til now, FDA has not had the resources to police the S&F Notice requirement so few marketers file them; I recommend that marketers do prepare and file these notices for at least their most important products. Of course, The Vitamin Lawyer has proper formats for the notice; estimate: about 1 hour legal time to do a notice properly.
2. Copies of your labels and ads.
3. Operations Manual – including QC, complaint (adverse reaction) and staff training information; a standard Employee Manual and the Rules for your online affiliation program could be part of this too. The Vitamin Lawyer has the proper formats available for much of this.
------------------------------ Index
2. Codex Meeting in Geneva
The Codex Commission is meeting this week in Geneva. The international organization appears to be increasingly chaotic as various nations try to assert their interests against the globalizing interests of the US and EU.
From the standpoint of the US Dietary Supplement industry, the most important development thus far at the meeting was an admission by the Codex Secretary that, in the proposals before the Commission, “No sentence provides that Codex standards and related guidelines are mandatory…” This admission, in keeping with the provision in the Codex Statute that its guidelines are “advisory” means the US supplement industry can continue to develop regardless of international regulations – so long as Congress does not adopt those restrictive international norms, or permit the FDA to “backdoor” those restrictions under the guise of “harmonization.”
For an up-to-date report on one observer’s view of what is happening in Geneva, see: http://blog.healthfreedomusa.org/.
------------------------------ Index
3. SoPs Manual - Standard Operating Procedures
The summer time tends to be a little less hectic than other times of the years, so this might be the best time for you to engage the Vitamin Lawyer in preparing your Operation Manual so you can be ready in the event of a surprise FDA visit. Good Quality Control (QC) procedures necessitate the existence of an Operations Manual. My simple format for small supplement purveyors includes the following sections.
|
A. Refund, Delivery & Returns Policies |
Contact me at ralph.fucetola@usa.net if you want a customized OPs Manual; please put "Op Manual" in the subject line.
[03/16/07 update: For an outline of the VL standard SoP and Employee Manual, see: http://tinyurl.com/2eu6yj.]
Well, that’s all for now.
Ralph Fucetola JD
http://www.vitaminlawyer.com
------------------------------ Index
06/08/06 - VITAMIN LAWYER UPDATE e-MEMO
1. Search Engine Optimization
2. FTC to Police Vitamin Claims
3. Citizen's Health Freedom Petition
4. Site Use Statement Updates
This memo is going out to the Vitamin Lawyer eList. If you do not want to receive occasional information from me, please let me know. The purpose of the Vitamin Lawyer Update Memo is to keep my client base and others involved in the nutritional and complementary markets up-to-date on developments.
1. SEO - Search Engine Optimization - Since many recipients are Internet marketers, I often provide information about optimizing search engine ranking. At the end of this email is a copy of a recent piece from Entire Web that I think you will find interesting. Link to Article.
2. The FTC is getting more active in the vitamin world - "Lee Peeler, Deputy Director of the FTC’s Bureau of Consumer Protection, said [in Congressional testimony], “Although many supplements offer the potential for real health benefits to consumers, unproven products and inaccurate information can pose a threat to the health and well-being of consumers and cause economic injury.”
“The Commission has focused its enforcement priorities on national advertising claims for products with unproven benefits; products promoted to treat or cure serious diseases; products that may present significant safety concerns to consumers; and products that are deceptively marketed to or for children and adolescents,” the testimony stated. The FTC has filed fourteen complaints in the past year against companies making allegedly unsubstantiated or false advertising claims for dietary supplements and other natural healthcare products, including oral sprays, creams, and patches. Also, in the past year, the Commission obtained orders against forty companies and forty-four individuals, which prohibited the unlawful practices and required the defendants to pay a total of $35.5 million in consumer redress, disgorgement, and civil penalties."
Please read the above , again, carefully… “a word to the wise…”
3. Health Freedom – Here’s a link to the Citizen’s Petition pending before the FDA on certain health freedom issues.
http://www.fda.gov/ohrms/dockets/dockets/05p0433/05p-0433-sup0002-vol1.pdf
4. Note to clients: If you haven't had your web Site Use Statement (Disclaimer / Disclosure / Privacy statements) reviewed in over a year, you should consider having it reviewed. I've added several paragraphs to my standard SUS format to cover recent changes in the law, including the recent Food Allergens Notification law and some even more esoteric developments. I charge 1/2 hour to update your SUS.
Ralph Fucetola JD
www.vitaminlawyer.com
----------------------------
Basic On-Page Search Engine Optimization - www.entireweb.com
There are 2 different types of search engine optimization, on-page and off page. Here you'll learn the differences between them, and basic tips to getting your website optimized for the search engines.
What Is The Difference Between On-Page And Off-Page Search Engine Optimization
The difference is that on-page optimization involves changing elements of your actual webpages that most visitors to your site wont even notice. For example, having your keywords in specific places or writing the title a certain way. Basically it's tweaking all elements of a page which are a factor for ranking well in the search engines.
Where as off-page optimization , is partially out of your control. You do have some control over it, but it's largely dependant on what others think about your website, unless you take an active role in off-page optimization. Off page optimization is quite a large topic, so I'll talk about it in a separate article.
Basic On-Page Elements You Need To Tweak:
For starters , you need to give your pages a title between the <title></title> tags in the head section of the page. Make it a descriptive title with at least 1 keyword. 4 words maximum is usually enough. Please don't leave the title as "untitled", and don't set it to "home" or "Page 1" or anything like that. Doing so won't help your search engine rankings one bit.
Next you need to write a description using the description meta tag i.e. <meta name="Description" content="yourdescriptionhere">. This should go in the head part of the html, after the </title< tag preferably. This only need to be about 1 sentence long and contain your keywords once or twice. Any more than that and it might look a bit spammy.
Now You need to use the keyword meta tag . Just as a side note, most search engines don't often use meta tags anymore, but it certainly wont hurt your rankings. Here's what the keyword meta tag looks like, <meta name="Keywords" content="your,keywords,here">. Include each keyword / keyphrase once. Do not repeat your keywords over and over in the keywords tag, once each is fine.
Ok now we need to change elements of the page than people will actually see. The stuff you just typed in will only be readable by search engine spiders when they crawl your pages, apart from the title of your page of course.
First you need to have a header in a <h1> tag. It doesn't look particularly pretty, but it's effective. It lets the search engine spider know, that the piece of test in the <h1> tag is important. Now you need to write a header in the <h1> that contains your keywords. It's pretty similar to just having the page title on the actual page. Doesn't need to be long, just a few descriptive words about what the following page is about.
This next one is the part I'm going to have to leave in your hands. If you haven't got any content on the page, then you need to write it. Try to include the keywords about 3 times in the top third of the page. Only put them where it will read correctly. For example don't put them all in one sentence because it will sound silly. Try to make your content an absolute minimum of about 400-500 words.
Do you have images on your webpage ? Then you need to give them "alt" tags. These are just incase a user cannot display or chooses to not display images for whatever reason. Instead, they will see whatever you place into your alt tag. Only put in your keyword as part of the alt tag if it is relevant. The alt tag should be descriptive to the image.
Make the above changes to your webpages and you should see a nice rise in your search engine ranks when they next index your site. It will definately pay off in the end. Best of luck!
About the Author: Stephen Warren is the creator of www.MakeAGreatSite.com. There you'll learn how to make a great site and turn it into a money making machine in no time. Your free to publish this article on any website, providing it is unedited and complete, t
------------------------------ Index
01/12/06 - VITAMIN LAWYER UPDATE e-MEMO
On January 5th the US president signed another complex and confusing law that has a serious threat to Internet communications buried in it.
The law is The Violence Against Women and Justice Department Reorganization Act, and the relevant section is 113. It states:
"Whoever...utilizes any device or software that can be used to originate telecommunications or other types of communications that are transmitted, in whole or in part, by the Internet... without disclosing his identity and with intent to annoy, abuse, threaten, or harass any person...who receives the communications...shall be fined under title 18 or imprisoned not more than two years, or both."
It is my opinion that this restriction will most likely not stand up against constitutional scrutiny. There is law backing anonymous political statements, reviewed by Justice Thomas in '95 - http://straylight.law.cornell.edu/supct/html/93-986.ZC1.html
"After reviewing the weight of the historical evidence, it seems that the Framers understood the First Amendment to protect an author's right to express his thoughts on political candidates or issues in an anonymous fashion."
I'm sending this alert out so that people are aware of this new law and can more carefully express themselves. For example, if you were to post an anonymous comment about, say, some company CEO, you might want to include some sort of disclaimer, such as "This statement is being made to express my opinions and understanding of the truth in the matter; it is not intended to annoy, abuse, threaten, or harass any person."
I still don't understand why Congress doesn't get it -- the First Amendment states explicitly "Congress shall make no law..." abridging freedom of speech -- "no law" means just that: NO LAW.
Here is a cogent comment I received from a knowledgeable source:
“It turns out that the statute can only be used when prohibiting the speech would not violate the First Amendment. If speech is protected by the First Amendment, the statute is unconstitutional as applied and the indictment must be dismissed. An example of this is United States v. Popa, 187 F.3d 672 (D.C. Cir. 1999). In Popa, the defendant called the U.S. Attorney for D.C on the telephone several times, and each time would hurl insults at the U.S. Attorney without identifying himself. He was charged under 47 U.S.C. 223(a)(1)(C), and raised a First Amendment defense. Writing for a unanimous panel, Judge Ginsburg reversed the conviction: punishing the speech violated the Supreme Court's First Amendment test in United States v. O'Brien, 391 U.S. 367 (1968), he reasoned, such that the statute was unconstitutional as applied to those facts.”
------------------------------ Index
01/09/06 - VITAMIN LAWYER UPDATE e-MEMO
This is your periodic Vitamin Lawyer update memo, provided to my client base and others interested in dietary supplement matters. If you don't want to receive such occasional messages, please reply to this email with "remove" in the subject line.
This issue covers:
1. New FDA Allergy label rules
2. Media Release: New challenge from credit card
processors
3. Vitamin Lawyer biography
Happy new year!!
Ralph Fucetola JD
-------------------------------------
1. FDA Allergy Label Rule
The Food Allergen Consumer Protection Act went into effect 01/01/06. The Act is at: http://www.cfsan.fda.gov/~dms/alrgact.html
On 12/14/05 a Guidance was published at: http://www.cfsan.fda.gov/~dms/alrguid2.html
The new law requires disclosure on the label of any ingredient including a major food allergen: "The term `major food allergen' means any of the following: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans"
There is no exemption for dietary supplements.
-------------------------------------
2. PR Web MEDIA RELEASE: Credit Card Processors Compliance Letters
January 9, 2006
On-line Lawyer Reports Internet Merchants May
Now Need Credit Card Website Compliance Letter
Newton, NJ: Ralph Fucetola, J.D., confirms reports that major credit card companies have recently demanded its dietary supplement and online pharmacy merchants obtain regulatory compliance letters from an attorney expert in the field.
Over the past two weeks, Counsel Fucetola has learned from certain clients who prefer to remain anonymous that MasterCard has been contacting merchant services and vendors with on line pharmacies and nutritional websites. The credit card company now appears to require merchants to provide a form letter from a qualified attorney stating that their websites comply with all government rules and regulations. Additionally, they must acknowledge an attorney will review the site annually to assure continued compliance.
Ralph Fucetola, a.k.a. as The Vitamin Lawyer (www.vitaminlawyer.com) has been retained by a number of merchants to review specific websites and provide the required documentation. As an attorney of 34 years, he has been reviewing web content for regulatory compliance for over a decade. He is available to consult on a retainer basis; rates are reasonable and due to Internet accessibility, clients can expect a timely response. Please contact him at ralph.fucetola@usa.net.
For general FDA compliance, the Vitamin Lawyer (www.vitaminlawyer.com) offers a service that allows the site to display the Vitamin Lawyer Oversight Compliance Seal.
-------------------------------------
3. Biography: Ralph Fucetola JD received a B.A. with Distinction from Rutgers University, 1967 and a Juris Doctor (Doctorate in Law) from Rutgers Law School, 1971. He practiced law for 34 years, specializing in Nutrient and Alternative Health Law. Counsel Fucetola has been widely recognized as a leading attorney in the field, receiving numerous awards, including a Citation of Merit from the National Health Federation (www.thenhf.com) in 1979 and a Meritorious Service Award (from the institute for Health Research, www.inhere.org) for his role in the 1995 DHEA Cases on behalf of the Life Extension Foundation. Counsel Fucetola limits his consultancy to claims, advertising and label review, asset protection, and consulting with marketers, consumers, advocates and local attorneys regarding Health Care Freedom issues, petitions and litigation.
------------------------------ Index
10/31/05 - VITAMIN LAWYER UPDATE e-MEMO
Happy Halloween! First the Trick, then the Treat . . .
Did you know that the number of FDA warning letters has increased over 300% during the past year? The FDA’s ad bureau indicates it intends to take whatever action is necessary to stop “misleading” advertisements. Even if you do not sell directly to the public, your website claims and exhibit booth signs at trade shows can be Red Flags. In addition to the language you use, your images, colors or even font variations could lead to citations for violations! In the increased regulatory climate spurred by recent developments in international trade regulations, all companies need to review their claims and revise the language they use to be even more carefully considered.
And the Treat . . .
While there is controversy in the nutrient world at present, there is also hope. The series international meetings and decisions that have occurred since April of this year, moving international regulation into new areas, will continue to impact the industry in the coming months (there’s a UN Food Safety Agency meeting soon). In July Codex, the World Food Code, adopted what could turn out to be more restrictive regulations (the Vitamin and Mineral Guideline - what do international “upper limits” for foods/nutrients have to do with promoting international trade?).
However, there is some hope that saner approaches may yet prevail. Some observers see that hope in comments made at the same Codex meeting in July that adopted the VMG, by representatives of Codex’s UN parent, WHO/FAO, demanding that the agency take into consideration the value of nutrition in health. Others see a real potential for the parent organizations to enforce their views, thereby limiting the impact of the new restrictions. A 2002 Joint WHO/FAO Report chastised Codex for a number of failings and WHO/FAO have adopted policies favoring nutrition for health, something that does not yet appear on the Codex agenda. That Report is at: http://www.who.int/foodsafety/codex/en/codex_eval_report_en.pdf
How can your company insure that Codex VMG restrictions will not adversely affect you? One step I’ve been involved in is helping to prepare an alternative VMG (a pro-freedom version of the Codex regulations adopted in July) that actually promotes dietary supplementation and does not subject vitamins and minerals to “toxic risk analysis” as though they were dangerous medications or industrial chemicals, instead of food! Since Codex Guidelines, according to the Codex Statute, are only "advisory" (Codex General Principle 1), countries can adopt the alternative VMG instead and remain WTO compliant.
The alternative VMG could very well be adopted by a number of countries that are unhappy with Codex restrictions on traditional nutritional approaches (especially countries that cannot afford getting “addicted” to the pharma cartel’s toxic drugs). My take on this is that small to mid-sized companies will continue to find international and domestic US markets in high potency nutrition. Our vigilance is necessary, though, since international trade agreements (such as CAFTA) typically include language subjecting their provisions to Codex standards.
The revised VMG has now been posted on the internet, at: http://www.healthfreedomusa.org/action/step3/Revised_VMG_Markup.pdf - you can also go to the Health Freedom site - www.healthfreedomusa.org - and sign a petition supporting the revised VMG. This revision was presented to the FDA, at a public hearing, on October 18th. I am told that it came as a surprise to some of the attendees. That’s good.
I think some people in the vitamin field will be very surprised to see that a positive approach of engaging the international bureaucracy could result in real advances toward greater freedom of choice, worldwide. While some may feel more comfortable “taking to the streets,” I am convinced that our best chances now rest with a policy of engaging the international bureaucracy so freedom of choice views get noticed and accommodated.
------------------------------ Index
01/13/05 - VITAMIN LAWYER UPDATE e-MEMO
Happy new year! It’s time for your annual Nutrient Claims check-up!
The FDA continues to increase enforcement of its regulation of Dietary Supplements. In a recent Warning Letter to one vitamin company, for example, it found that the following statements were “drug claims:” "Nature’s answer to prescription medication" and "Nature’s alternative to prescription medication." The FDA also cited phrases such as, “seems effective in . . . reducing depression . . . ." In another recent warning letter, the FDA complained against the phrase, “the number one remedy against obesity.”
In yet another warning letter, Neutraceutica was told that its claim, “possibility of cancer and other diseases may be eliminated in the first days of the use” was an unproven drug claim. This is one time when I find myself agreeing with the FDA.
Staying up to date with changes in the law is also important. For example, a little known clause in the Farm Security and Rural Investment Act amended the Food and Drug Act to provide that the term “ginseng” can be used only for derivatives of the genus Panax, not the genus Eleutherococcus (though both are commonly known as “ginseng”).
What changes have you made in your web site during the past year that may put you at risk? If you have added new claims, have you notified the FDA of the new structure and function claims?
Now’s the time (while I’m snowed in here in the hills of Sussex NJ) for us to catch up on these necessary aspects of your legal needs. Please give me a call at 973-300-1519 so we can discuss your needs. These issues can be critical – and expensive -- for your company, if not addressed in a timely manner. That’s why I’ve sent you this email to remind you it is time for your annual FDA/FTC compliance check-up.
Ralph Fucetola JD
PS – if you need help in creatively constructing structure and function claims, let me know. In the first example above, “the number one remedy against obesity” the company could have stated, “a leading supplement to support normal weight…” As always, clients on regular retainers are guaranteed no increase in fee rates and may qualify for the Vitamin Lawyer Oversight Seal (see www.vitaminlawyer.com for details).
------------------------------ Index
10/04/04 - VITAMIN LAWYER UPDATE e-MEMO
STANDARD OPERATING PROCEDURES - SoPs (Operations Manual)
2006 UPDATE: The Vitamin Lawyer has a model Op Manual format for you! See: #07/05/06-3
For OTC and pharmaceutical companies, the Number One violation citation in FDA review letters is Failure to Establish or Implement SoPs.
As cGMPs (Current Good Manufacturing Practices) are imposed on the Vitamin Industry, similar concerns will become important to you.
One important step in getting ready for GMPs is to begin to document your procedures. Get a loose leaf note book and start to include the steps you need to take to meet cGMPs. Include at least the following areas:
1. SoPs - Some of the elements to consider in developing
your SoPs -
Information gathering procedures
Laying the framework — components, types and formats
Who's responsible for writing, reviewing, approving,
distributing and maintaining your company's SoP
How detailed should they be?
How frequently should they be reviewed and updated?
Steps for auditing your procedures
How to manage changes and updates
How to motivate staff to follow them
2. Adverse Event Reporting & Consumer Complaint Records
3. Packing and shipping procedures & records
4. Risk Managment Policy
5. Document Retention Policy
6. Banking Procedures
7. URL maintenance and management
Eventually, you will need to develop an Operations Manual encompassing the above and other issues. As a small business owner, you should be able to feel confident that you can absent yourself from the business and the normal business procedures will be sufficiently documented that others can carry on while you are... on vacation... learning new things... whatever!
2006 UPDATE:
The Vitamin Lawyer has a model Op Manual format for you! See:
#07/05/06-3
See also [Crisis SoP]: 11/16/06
------------------------------ Index
All rights reserved.
Index
©2000, 2001, 2002, 2003, 2004,
2005, 2006, 2007
Privacy -
Disclaimer Site Use Statement*
