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Vitamin Lawyer Health Freedom Blog
Earlier postings:

Risk / Benefit Analysis comes to DS

 04/27/07 report on the FDA anti-CAM draft guidance!
Multiple Attacks on Health Freedom

 02/ 28/07
JAMA publishes another flawed attack on vitamins!

 12/15/06 reports:
 2005 U.S. Supplement Sales Up 4.5% to $21.3 billion

Vitamin Lawyer Interviewed on News Target: Ionic Silver

Adverse Event Reporting Law Effective 12/22/2007
Media Release
Institute Releases Draft AER Guide - 10/13/07

Rep. Ron Paul on FDA antiCAM Guidance:
"An abuse of FDA power..."

Tell the FDA to leave our supplements and alternatives alone:

Vitamin Lawyer on the FDA anti-CAM draft Guidance


Continuing Codex Developments

 What Does Codex Really Require? - 05/21/06

 Codex CCFL Meeting in Ottawa - 05/03/06

 Seen by a hundred thousand people on YouTube -
 Nutricide - the Codex Challenge

Codex Alimentarius (“Codex”) is the World Food Code, an international agency under the joint sponsorship of WHO (World Health Organization) and FAO (Food and Agriculture Organization), two primary organs of the United Nations.  According to its Statute, the first purpose of Codex is “protecting the health of the consumers and ensuring fair practices in the food trade.” Codex Statute - Article 1(a)



On October 18, 2005, at a Public Hearing at FDA Headquarters, an alternative to the recently adopted Codex Vitamin & Mineral Guideline was offered to the FDA, to preserve access to high potency nutrients while supporting UN Food & Agriculture Organization adopted international standards for the use of nutrition to promote health. (See FAO statement below).

Message from Dr. Laibow: "Please visit to sign to new Citizen's Petition which contains the Revised Vitamin and Mineral Guideline which can make the US Codex Compliant and preserve your rights to optimal health through nutrition. If you have signed it before, you can sign it again since the original Citizen's Petition has been revised." Revised VMG at:

FAO statement, in part:  The Food and Agriculture Organization (FAO) Expert Consultation on Food Safety: Science and Ethics, held in Rome, Italy, in September 2002, set out the following food, nutrition and health rights: “The human right to adequate food is recognized in several instruments under international law. […] The right of every human being to be free from hunger is fundamental and uncontested. The most important implication of the right to adequate food is that states and peoples must be supported to enable them to address situations of food insecurity themselves. The right to culturally acceptable food should not be regarded primarily as a right to receive a specific type of food aid, but as a right to be supported so as to create one's own food security. Support to address sustainable food security must therefore also include ensuring the capacity in recipient countries for food that is both safe and nutritious.

04/03/06 - White Paper by The Vitamin Lawyer Alternative Practices and the AMA Code of Ethics

JAMA's Latest Attack on Vitamins is Flawed Science

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.”

The language used in the reports about the meta-analysis does appear carefully chosen to overstate the risks and understate the benefits.


03/02 Update: Linus Pauling Institute blasts AMA fake meta-analysis: -- 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.


States the Life Extension Foundation about the JAMA article: "In today’s media frenzied world, science is practiced by ambush. The very day a medical study is published, it can become the headline news story of the day. This denies an opportunity for those who might disagree with the study’s design and methodologies to rebut what might be junk science. In the case of a recent study questioning value of certain antioxidant nutrients, the flaws are so significant as to cause its findings to have little or no meaning." See  for details.




Bulletin: Congressional Efforts to Defend DSHEA: See: HR2352

The Vitamin Wars battles intensify! - 08/01/05

Ephedra - 04/14/05

The Exceptional Safety of Dietary Supplements - 05/17/05
Dr. Hasslberger on Dr. Andrew Saul's Report on Vitamin Safety

Consumers Access to Health Information Act

On May 12, 2005, Congressman Ron Paul (14th District -- Texas) introduced the Consumers Access to Health Information Act (Bill 2352). The purpose of the bill is to ensure that "consumers can receive truthful information about how foods and dietary supplements can cure, mitigate, and prevent specific diseases." This bill will protect consumer access to information about the benefits of nutritional supplements, a right guaranteed under the First Amendment. For more information:|/bss/d109query.html.

 Vitamin News
 Vitamin Lawyer News

 Latest Items are marked with an *!

Actions to Save Health Freedom *!

Breaking News *!

*! August 2005 Update
Actions to Save Health Freedom, CODEX, European Union Vitamin Directive

   NJ Natural Health Professionals meeting

02/03/05 - The recently formed grouping of New Jersey Natural Health Professionals are meeting on Friday, February 11, 2005 at 7 PM at the Sharma Holistic Medical Center at 131 Milburn Avenue, Milburn, NJ 07041 (973-376-4500). Directions at For more information, contact Dr. Glenn Gero at 973-471-5758.

Theme of the meeting: Are our Rights to Natural Therapies & Nutritional Supplements in Jeopardy?

Speakers will include Dr. Al Lupanacci, Kim Kalina and others. This is a major step forward and everyone interested in Health Freedom needs to attend. I'll be presenting information about the latest devleopments in the EU case challenging CODEX.

02/12/05 -
Comments on the Meeting: The Codex Threat

 *! My Opinion:  The Codex Threat - 02/12/05

Meeting of Health Freedom Activists to
Defend DSHEA, Defeat Codex [Here]
- 04/23/05.

Ralph Fucetola, JD
Attorney at Law
Credentials, Biography & Articles
The Vitamin Lawyer's Nutrient Picks
The Internet Injunction Lawyer .com
Lawyer 4 Asset Protection .com
Site Use, Privacy, Disclaimer Statements for Sale!

Vitamin Lawyer Links
Other Health News Links
Vitamin News Index:
Breaking News *!

Recent News
2003 News Notes
2001-2002 News Archives

2006 Developments

Click Here To Join the Global Health Freedom eList . . .


Ephedra Unbanned!! - 04/14/05

NJ Natural Health Professionals 02/11/05 Meeting

From the Vitamin Lawyer:  Oversight Seal
New Web Site from the Vitamin Lawyer: www.Nonprofit

January 2005 *!

Institute of Medicine calls for reversal of DSHEA!

IOM issues report recommending that dietary supplements be subject to much more stringent rules governing safety and effectiveness similar to the way prescription drugs are regulated.

DSHEA, the 1994 Act that allows Dietary Supplement Claims, distinguished such claims from drug claims.  IOM recommendation would, in essence, ask Congress to reverse existing law.
See report:
Complementary and Alternative Medicine in the United States

What does the public think?

*! Support Rep Ron Paul's
Health Claims Bill!
H.R.2352 "To amend the Federal Food, Drug, and Cosmetic Act to ensure that health claims for foods and dietary supplements include accurate statements of the curative, mitigation, treatment, and prevention effects of nutrients on disease or health-related conditions, and for other purposes."

The Codex Threat


*! Actions to Save Health Freedom, CODEX, European Union Vitamin Directive - 08/01/05

NJ Natural Health Professionals
02/11/05 Meeting *!

May 27, 2004
Internet Injunction Granted
In Internet Trademark Cybersquatting Case!
Details: Injunction

"Further Ordered that Defendants, their assigns and successors, and all internet search engines, registers or other persons, wherever located, in concert with them, are hereby RESTRAINED, until further Order of this Court, from linking to, posting or maintaining on the Internet and World Wide Web, any web page, directly or indirectly, ...that includes, in its file name, URLs, Metags or text, the trade names or Trademarks of the Plaintiff, ... in any form, format or design."

"Don't subject our dietary supplement rights  to WTO - CODEX controls,
instead, Harmonize the rest of the world to
American freedoms protected under DSHEA."

Ralph Fucetola JD on the Gary Null Show, 06/11/03.
Health Freedom Action: Click Here

Herb Watch List

FDA continues to penalize non-compliant vitamin companies: Click Here

Some Good News on CODEX...
Another positive outcome from this years Codex meeting was that South Africa managed to retain the Chairmanship of the working group that will be setting the new nutrient reference values (NRVs). The South African delegation have consistently drawn attention to the fact that the traditional RDA approach to nutrition does not promote optimum health, and they will now be arguing for the NRVs to be set at levels which take into account the prevention and reduction of diseases and the maintenance of an optimum nutritional status." P.A. Taylor

Take Action for Your Company's Survival

Recent Developments in Vitamin Law

NJ Natural Health Professionals
02/11/05 Meeting *!

January 2005 *!
IOM calls for reversal of DSHEA?

FDA Commissioner Warns Vitamin Industry
- 04/19/04

Herb Watch List - 03/05/04

FTC Announces Guidance for Media
Weight Loss Advertising
- 12/09/03
New Red Flag List

Act NOW to Save Health Freedom:
Actions to Save Health Freedom *!
EU Food Supplement Directive Lawsuit
CODEX & other developments...

What happens when the FDA stages a
of a dietary supplement company!
FDA Inspection Concerns

Weight Loss Claims to Avoid!
FTC Red Flag List

FDA Structure and Function
Claims Notice Requirements

CGMPs are Coming to the Vitamin Industry!
Proposed Current Good Manufacturing Practices
Is Your Company Ready?!?  Click below to learn more!
Vitamin Lawyer Report

FDA - CBP Imported Food
Bioterrorism Preparedness Guide

FDA Chief Speaks on
"DSHEA Umbrella Strategy"
10/27/04 - 11/11/04 *!



ACT TODAY to save health freedom!

Pending Litigation & Political Actions
Threats to Health Freedom Escalate!
November 2004 CODEX Meeting

November 2003 CODEX Meeting
[Reports from P. A. Taylor]

The Codex Threat - 02/12/05
CODEX Acts on Vitamin Upper Limits

Observer Magazine
Reports on EU Suit

EU Lawsuit filed!
Details here.
Developments in Europe:
Law Suit Moves Forward

While the ANH sues to overthrow the
EU Food Supplements Directive,
A sneak attack from the Pharmceuticals Directive


ANH Brief before EU Court - 08/02/04

EU Food Directive Held Invalid
Details Here

The Right of the Public to the Truth
Nutrient Marketing and
Commercial Free Speech
The Standard of Substantiation
Legal Developments in Allowable Claims

What every marketer needs
to know about
Dry-Test Marketing

Express your opinion to your Senators

Jury Nullification
The Final Defense of Freedom

FDA Umbrella Strategy for DSHEA

Report from FDANews - 10/28/04 - The FDA will implement an "umbrella strategy" to ensure the quality and safety of dietary supplements, the agency's acting commissioner said this week. The new strategy represents the FDA's current thinking on how to implement the 10-year-old Dietary Supplement Health and Education Act, acting Commissioner Lester Crawford said during a speech at the Council for Responsible Nutrition's annual conference, "Our goal is to promote transparency, consistency and predictability in dietary supplement products," Crawford said. The umbrella strategy outlined by Crawford consists of three main elements: monitoring and evaluating product and ingredient quality, assuring product quality, and monitoring and evaluating product labeling. The intent of the strategy is to "refine and clarify the direction the agency is taking in the regulation of dietary supplements," Crawford said.  The Acting Commissioner also said that the agency also expects to issue a "blizzard" of documents in the next few weeks leading up to a Nov. 15 meeting regarding dietary supplements.

Update:  11/11/04 -- Over the past weeks, leading up to a meeting with industry leaders scheduled for 11/15, the FDA has exposed its three-pronged surveillance and quality assurance strategy, to enhance the predictability and consistency of the agency's scientific evaluations of dietary supplements and the safety of product ingredients.

FDA’s regulatory strategy consists of guidance documents, regulations and science-based compliance and enforcement mechanisms. "These initiatives refine the direction the agency is taking to regulate dietary supplements," said FDA acting Commissioner Lester Crawford. "We now have a clear roadmap to share with the dietary supplement industry"

The FDA's strategy focuses on monitoring and evaluating product and ingredient safety, with special emphasis on (1) new dietary ingredients; (2) ensuring product quality; and (3) surveying and evaluating product labeling.

The agency has also issued a draft guidance to assist companies in gathering the scientific information needed to support a labeling claim.  The guidance describes the amount, type and quality of evidence needed to substantiate a labeling claim on a dietary supplement, as required under section 403(r)(6) of the Federal Food, Drug and Cosmetic Act. That section requires that dietary supplement labeling claims, including nutritional deficiency, structure/function or general well-being claims, must be truthful and not misleading.

To meet this statutory requirement, companies must possess adequate evidence for each reasonable interpretation of the claim. The agency said it would use the FTC standard of "competent and reliable scientific evidence" to substantiate a claim.

The draft guidance, titled "Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug and Cosmetic Act," was published in the Nov. 9 Federal Register and can be found at:

Practitioners Form Medical Truth Alliance  -
International Medical Veritas Association (IMVA) - 5/24/04

"IMVA) was founded upon the idea that reforms are urgently needed in medicine. The IMVA seeks to initiate a climate of change in basic health care, working to merge truths from diverse medical systems. The goal is to create a new form of medicine that will be more effective than could otherwise be achieved by separate systems alone. Thus we are inviting a broad coalition of primary health care professionals to join us, to forge an evolved medical paradigm that encompasses core truths from allopathic, chiropractic, homeopathic, naturopathic, oriental and other medical systems. The need for medical truth (Veritas) has never been greater and the IMVA represents the dawn of a new era in its dissemination."

Congressperson Ron Paul introduces Health Freedom Bill
H.R. 4004

Dr. Paul introduced a bill to allow access to truthful and understandable dietary supplement claims.  HR 4004 - Health Information Independence Act - prevents the Federal Government from restricting the distribution of a dietary supplement or other nutritional food because the manufacturer makes health claims unapproved by the Food and Drug Administration (FDA) if: (1) the product has a label clearly stating that its health claims are not FDA-approved; (2) the FDA lacks evidence establishing probable cause that the claims contain misleading information posing a threat to the safety and well-being of those who use the product. Requires an independent review of a determination by the FDA that there is such probable cause. (

November 14, 2003 - According to FDA News ( - A company that marketed "Royal Tongan Limu" dietary supplements, promoted as a treatment for a variety of ailments, has voluntarily destroyed an inventory of 90,000 units, the FDA announced. NBTY, of Bohemia, N.Y., destroyed $2.7 million worth of the supplement last month under FDA supervision, the agency said. Promotions for the product said it had the ability to make cancer cells self-destruct and to halt arthritis pain, according to the FDA. NBTY initially was warned about its claims in a 2002 "cyber letter," which the FDA followed up with an investigation this year, leading to the company's voluntary efforts to withdraw and destroy the supplement, the agency said.

Factoid: "The Congressional Budget Office predicts the US economy will grow at an annual rate of 2.1 percent over the coming decade - an increase of 0.9 percent over US growth for the period 1974 - 1995. Varian et al. estimate that the Internet will account for 48 percent of this increase..." from Trust, the Internet and the digital divide - IBM Systems Journal, Vol. 42, No. 3, 2003

Actions to Save Health Freedom

September 18, 2003
FDA Continues to Penalize Non-Compliant Vitamin Companies

From an FDA press release describing the seizure of certain herbal products, "Today’s action continues FDA’s stepped-up enforcement actions against dietary supplements that falsely claim they can treat life-threatening diseases. This year alone, the agency has taken the following actions against firms making false and misleading claims about its dietary supplements:

  • issued 73 warning letters and cyber letters (letters to internet sites illegally marketing FDA regulated products) to marketers of dietary supplement products,
  • refused import of 368 foreign shipments of dietary supplement products offered for entry to the U.S.,
  • and supervised the voluntary destruction of $515,000 worth of dietary supplements promoted with unsubstantiated structure/function claims.

To date FDA has received no reports of illnesses associated with taking the products that were seized today." -

New from the Vitamin Lawyer

 Ralph Fucetola JD

Look for the Vitamin Lawyer
Oversight Seal
on Nutrient Web Sites

Vitamin Lawyer Oversight Seal

Seal Requirements

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Actions to Save Health Freedom: Click Here  - Updated!
European Alliance for Natural Health web site

  05/13/07 - EPHEDRA BAN CONTINUED - The United States Supreme Court decided not to hear the ephedra case appeal. This decision leaves standing the appeals court reversal of the Utah district court's voiding of the FDA's ban on ephedra. In effect, a risk/benefit standard has been imposed on the Dietary Supplement industry:

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..."

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.

04/14/05 - Ephedra Ban Voided [superseded information] – notes from internet news sources.

In a decision with broader implications, Judge Tena Campbell ruled in favor of a Utah supplement company that challenged the Food and Drug Administration's ban. The Judge held that Congress does not want Dietary Supplement rules "harmonized" with drug regulations.

The company claimed that ephedra "has been safely consumed" for hundreds of years, and that ephedra was wrongly being regulated by the FDA as a drug and not a food.

The judge agreed that federal law places restricts the FDA when it tries to ban foods as opposed to drugs; the law requires the FDA to prove that a dietary supplement is harmful, rather than having the manufacturer prove it is safe, as required with drugs.

U.S. District Court Judge Tena Campbell's ruling sends the matter back to the FDA "for further rulemaking consistent with the court's opinion." The news reports that the Judge’s action prevents the agency from enforcement action against the companies.

The company president was reported as saying, “The Court made it clear that FDA has authority under DSHEA to remove unsafe dietary ingredients from the market. But the Court also clarified that FDA must follow DSHEA and cannot treat dietary supplements like drugs or medical devices. The Court made other important findings, pointing out that Congress intended that dietary supplements be treated as a subset of foods and, like other foods, are 'presumed to be safe.'"

Under the Court's Order, FDA's Final Rule on Ephedra has been remanded to FDA for further rulemaking consistent with the Order, and FDA has been enjoined from taking enforcement action against Nutraceutical or Solaray for the sale of dietary supplements containing 10 mg. or less of ephedrine alkaloids per daily dose. FDA has the right to appeal the Court's decision.

The decision is posted at:

Among the important explanations of DSHEA that the Court offered, was the following, citing the Senate Report on DSHEA:  “..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…”  The FDA’s attempt to apply a drug standard “risk – benefit” analysis was contrary to law. The Court further held that the statute requires a dose specific analysis, not an outright ban on all dosage levels.  Therefore the final Order of the Court enjoins the FDA from taking enforcement action against the companies for “their sale of a dietary supplement containing 10 mg or less of ephedra alkaloids per daily dose.”

This ruling may return “low dose” ephedra products to the market.  It also includes strong language from the Judge on Congress’s intent regarding dietary supplements.  Any FDA attempt to “harmonize” US law with drug-like international standards will now have even less chance of being upheld by the US courts. Vitamins are foods, not drugs! If food supplement laws are to be harmonized, DSHEA (as correctly understood by jurists like Judge Campbell) is the model. 

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Acting FDA Commissioner Dr. Lester M. Crawford Outline
"Science-Based Plan" for Dietary Supplement Enforcement

FDA Press Release (4/29/04): Speaking before the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences, Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), today outlined the agency's science-based approach to protecting American consumers from unsafe dietary supplements.

Dr. Crawford said the agency would soon provide further details about its plan to ensure that the consumer protection provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA) are used effectively and appropriately. Through DSHEA, which sets up a distinct regulatory framework for dietary supplement products, Congress attempted to strike a balance between providing consumers access to dietary supplements and giving FDA regulatory authority to act against supplements or supplement ingredients that present safety problems, are marketed with false or misleading claims, or are otherwise adulterated or misbranded.

"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," said Dr. Crawford. "Unlike most foods, some dietary supplements are pharmacologically active. And we have seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose."

In the last 6 months, FDA has inspected 180 domestic dietary supplement manufacturers; sent 119 warning letters to dietary supplement distributors; refused entry to 1,171 foreign shipments of dietary supplements; and seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products. "We will continue to aggressively enforce DSHEA against unsafe or mislabeled products," Crawford said.

Commissioner's Comments Update

In a speech to the National Food Policy Conference on May 6, 2004, the acting commissioner commented:   "FDA has focused its enforcement efforts over the past year to ensure consumers are not being harmed as a result of claims that overstate the effectiveness of dietary supplement products..." For details:

STED Program - MORE "Harmonization" on the way - 09/15/03
Summary Technical Documentation for Demonstrating Conformity to the
Essential Principles of Safety and Performance of Medical Devices"

Says FDA - "The Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA) is pleased to announce a pilot program to assess the feasibility of using an internationally harmonized format in review of submissions for device safety and performance *** for the benefits that will accrue to the medical device community." -

"The discovery of effluent and cockroaches at the latest banned drug company, Australian Pharmaceutical Industries, has triggered a criminal investigation under the drug regulator's beefed-up powers. API is under investigation for breaches of good manufacturing practice, which became a criminal offence in the wake of the mess the TGA uncovered five months ago at Pan Pharmaceuticals.",4057,7229292%5E2,00.html

Nuts Get First Modified Health Claim for Foods:
- July 2003

FDA "Science Based Initiative" - FDA Press Release - 07/10/03
"FDA's Task Force on Consumer Health Information for Better Nutrition unveiled a process for FDA to review... health claims. This process will rely on expertise from the Agency... coupled with enhanced consumer studies, to review health claims before they appear in food labeling. In addition to the report, FDA is announcing enhanced enforcement activity against dietary supplement manufacturers and others who make misleading claims about health benefits that are not based on science.Task Force Report

FDA Issues Statement on Increased Enforcement - FDA Statement  - 06/30/03
is committed to pursuing Federal Food, Drug, and Cosmetic Act violations. Enforcement activities include warning and untitled letters, injunctions, recalls, arrests, and convictions. Overall, these point to dramatically increased enforcement, particularly in areas related to the most serious threats to public health, such as arrests and convictions on criminal charges involving potentially dangerous activities and actions against manufacturers making misleading claims about product risks and benefits."


 September 3, 2003 - The FDA has announced the formation of a special inspection team, changes in its pre-approval inspection program, and the release of four draft guidance documents and a final guidance on various manufacturing issues as part of a continuing effort to improve current good manufacturing practices (cGMPs).

The agency hopes these steps will help make pharmaceutical manufacturing "more efficient and safer," FDA Commissioner Mark McClellan said. The guidances are intended to help the pharma industry and the agency "focus their efforts where they are most beneficial, on critical and risky areas," he said Wednesday.  The five guidances, published in today's Federal Register, were:

  1. A draft guidance establishing a dispute resolution process for science and technical issues related to cGMPs;
  2. A draft guidance setting guidelines for using comparability protocols to implement changes in manufacturing processes after obtaining marketing approval for protein-based human and veterinary drugs and biological products;
  3. A draft guidance establishing a regulatory framework to encourage voluntary implementation of new manufacturing and quality assurance technologies;
  4. A draft guidance updating recommendations on aseptic processing for sterile drug products; and
  5. A final guidance outlining the FDA's enforcement of 21 CFR Part 11, dealing with electronic records and signatures.

The guidances and other actions are part of a two-year agency initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach."

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FTC 12/09/03 Media Guide Weight Loss Advertisement Announcement
New Red Flag List

"The centerpiece of the FTC campaign is educational guidance to the media that identifies seven common weight-loss claims made for products available over-the-counter, including nonprescription drugs, dietary supplements, creams, wraps, devices, and patches that are scientifically infeasible at the current time. These claims include:

  • Causes weight loss of two pounds or more a week for a month, or more without dieting or exercise.
  • Causes substantial weight loss, no matter what or how much the consumer eats.
  • Causes permanent weight loss (even when the consumer stops using the product).
  • Blocks the absorption of fat or calories to enable consumers to lose substantial weight.
  • Safely enables consumers to lose more than three pounds per week for more than four weeks.
  • Causes substantial weight loss for all users.
  • Causes substantial weight loss by wearing it on the body or rubbing it into the skin."

“We know that no publication or station wants to print or air false weight-loss claims,” Chairman Muris said. “This booklet provides specific examples of bogus claims, along with explanations that will allow media advertising personnel to avoid bogus weight loss claims and stop them before they injure consumers. We encourage the media to use it.”  - Also Compare to November 2002 Red Flag List

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FDA  and Customs Issue Joint Bioterrorism Guideline - Compliance required immediately

FDA & CBP Bioterrorism Preparedness Guide, issued December 11, 2003 can be read at (Please use your browser Back button to return to this page.)

"The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), section 307, added section 801(m) to the Federal Food, Drug, and Cosmetic Act (the Act) to require that FDA receive prior notice for food imported or offered for import into the United States.  Section 801(m) also provides that if an article of food arrives at the port of arrival with inadequate prior notice (e.g., no prior notice, inaccurate prior notice, or untimely prior notice), the food is subject to refusal of admission"

"On October 10, 2003, FDA and CBP issued interim final regulations establishing the requirements for registration and requiring that FDA receive prior notice of the importation of food beginning on December 12, 2003"

See:  cGMP Report Update

(Please use your browser Back button to return here)

FTC Seizes SeaSilver
Cited for Unproven Disease Cure Claims - 06/19/03

FTC joins OECD International Anti-Fraud Guidelines - 06/17/03

Vitamin Lawyer Report on the Proposed Current Good Manufacturing Practices (CGMPs) for Dietary Supplements.
How the new rules will impact small marketers with their own labeled products - 05/16/03

Aussie Attack on Nutrient Industry
Main alternative and nutrient manufacturer in Australia lost its license, over 1,500 products recalled! - Europe too!
IMPORTANT! - Int'l Advocates for Health Freedom -
Help ANH -

Vitamin Lawyer Precedent Setting Permanent Injunction Update
Internet Defamation, Trademark & Harassment Case -
Here - 01/17/03

Sharry Edwards with 19 Tips to Protect IP from Computer Criminals, Here - 06/07/03

FDA Structure and Function Claims Notice Requirements

The "Watch List" Herbs
According to Vitamin Lawyer contacts...

As of 3/1/04, the following, in all forms, derivatives or extracts,
are generally considered uninsurable.

Jin Bu haun
Gamma Hydroxy Butrate – GHB
Gamma Butyrate – GBL
Ephedra, ephedrine


Speaking in mid January, 2004, at the University Mississippi School of Pharmacy, FDA commissioner Mark McClellan said that the agency, "will be doing more work in the coming months to more closely evaluate the potential safety risk of these products, and we could take further action to remove unsafe dietary supplements
from the market."

"Mr. McClellan said he was "concerned" about several dietary supplements, specifically mentioning three that are used in some weight-loss formulas: bitter orange, aristolochic acid and usnic acid."


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Actions to Save Health Freedom - Updated!

Traditional Uses of Dietary Supplements as Substantiation for Advertising Claims, Click Here - 06/15/03

US Supreme Court Considers Commercial Speech Issues -
Will the Court continue recent trend supporting freedom of speech in commercial communications? -04/23/03

FDA announces new initiatives involving dietary supplement ingredient Standards - 03/07/03
" part of the agency's ongoing effort to help Americans take more control over their own health..."

FTC planning new actions - 11/15/02 -Updated, Red Flag List

The Vitamin Lawyer protects SUNNIE® trademark in decision against Kellogg Co.
SUNNIEtm.html 7/31/02 - updated 6/23/03, Trade Mark Registration 2,726,137 issued.

The Right of the Public to Know

Your web site needs a proper SUS - Site Use Statement -
Disclosure - Privacy - Disclaimer Page -
The Vitamin Lawyer has the right form for you -

The Vitamin Lawyer's On Line Seminar - FREE! - vitonlinesem.html

Sharry Edwards with 19 Tips to Protect IP from Computer Criminals, Here - 06/07/03

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National Center for Complementary and Alternative Medicine (NCCAM)
Pressroom -

An example of an FDA May 2002 Cyber Warning Letter

Commercial Free Speech - 04/29/02
The High Court addresses Claims and Disclaimers, emphasizing the proper use of such statements.

The Vitamin Lawyer on Labeling and Advertising, fdaftcspeech.html.

The Institute for Health Research has established a 9/11 Aftermath Message Board.

Email rumors got you? Check them first at

Information on Vaccine Issues, News & Links - vacinfo.html
Federal Government Vaccine Injury Compensation Program,

FDA allows "Diabetiks" as brand name 08/21/01
Using disclaimer language crafted by The Vitamin Lawyer.

Note:  "WTO" is the World Trade Organization.  CODEX is the international Food Code,  US laws may be subject to its jurisdiction.

"Harmonize" is a term used to describe the process whereby international agencies cajole nations into subjecting their laws to international standards.  In the case of Dietary Supplements, these "standards" are more restrictive than US policy as determined by Congress and demanded by vitamin users.

"DSHEA" is the 1994 Dietary Supplement Health and Education Act that codified the right of Americans to truthful and not misleading information about dietary supplements in a open marketplace.

Health Freedom supporters throughout the US are demanding that our DSHEA rights be preserved and that our trading partners harmonize their restrictive vitamin regimes to our free market.

Back to Breaking News.


On November 19, 2002, the FTC hosted a workshop on dietary supplement weight loss claims.  At the workshop, a 10-member science panel discussed various claims that appear in weight-loss ads and voted that each of these claims was not supported by science.

The claims are:


* Claims that a product will work for all people.
* Claims of permanent weight loss.
* Claims that users can eat all that they want and still lose weight.
* Claims that weight loss can be targeted to specific areas of the body.
* Claims related to fat absorption or fat blockers.
* Claims related to transdermal or "patch" products.
* Claims of easy weight loss with no effort.
* Claims of safety for weight loss exceeding three pounds per week.

The science panel also expressed its opinion that weight loss is only possible by increasing exercise and/or decreasing calorie consumption.

The panel consisted of representatives from Harvard Medical School, the National Institutes of Health (NIH), the American Society of Bariatric Physicians, Columbia University, the University of Pennsylvania, Slim Fast Foods Co., ImagiNutrition, the University of California-Davis, the University of Pennsylvania and Health Management Resources.

Return to December 2003 New Red Flag List.

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New Dietary Supplement Ingredient Standards

Updates:  Report (05/13/03)
FDA Structure and Function Claims Notice Requirements

"FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements

"March 7, 2003 -- TODAY'S ACTION:

"The Food and Drug Administration (FDA) today took action to help Americans get accurately labeled and properly manufactured dietary
supplements, through its Proposed Rule for Dietary Supplement Current Good Manufacturing Practices (CGMPs). FDA is submitting this proposed
rule as part of the agency's ongoing effort to help Americans take more control over their own health.

"FDA's Proposed Rule for Dietary Supplement Labeling and Manufacturing Standards

"This proposed rule would establish the standards necessary to ensure that dietary supplements and dietary ingredients are not adulterated
with contaminants or impurities and are labeled to accurately reflect the active ingredients and other ingredients in the product.

Specifically this proposal would:

* Require the use of new industry-wide standards in the manufacturing, packing, and holding of dietary supplements, thus reducing risks associated with dietary supplements that are contaminated with harmful or undesirable substances such as pesticides, heavy metals, or other impurities or are not properly labeled to accurately describe what they contain.

* Ensure that the identity, purity, quality, strength, and composition of dietary supplements are accurately reflected on the product label, which would be a significant step in assuring consumers they are purchasing the type and amount of ingredients declared.

"Science-Based Consumer Protection.

"Previously, dietary supplements have not been subject to mandatory standards for manufacturing or labeling. Congress gave FDA the authority to develop and implement CGMPs as part of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

"The proposed rule addresses the quality of manufacturing processes for dietary supplements, and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements, or address the safety of their ingredients, or their effects on health when proper manufacturing techniques are used. Rather, the proposed rule creates a level playing field for the industry by ensuring that every firm uses high-quality manufacturing procedures and uses the same rules for describing their ingredients. ***

"Under DSHEA, dietary supplement manufacturers have an essential responsibility to substantiate the safety of the dietary ingredients they use in manufacturing a product. Manufacturers are also responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading." ***

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Other Health News Links

The Bolen Report
The Tan Sheet
Natural Products Insider
Red Flags Weekly

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