These are the "dirty (half) dozen" words that
will get you noticed by the Government -- "diagnose,
prescribe, treat, prevent, mitigate and
cure" -- but, my complete proprietary list of allowed and
disallowed terms is four pages long...
See Vitamin Lawyer
News for Red Flag Weight Loss Claims - updated.
It's sad to say, but there
is not much you can do after the
raid has begun...
But, a good
Disclaimer Page can help!
What to expect from a SURPRISE FDA
* Early in 2000 the White
House announced a ten million dollar "initiative" to pay for closer
FDA/FTC scrutiny of internet nutrient purveyors... when is your turn?
Some of the latest
information from FTC and FDA including important information on the FDA
Structure / Function Claims and Health Claims filing Rules.
From Vitamin Lawyer News -
NEW FDA "Science Based Initiative" -
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] 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."
Exporting Dietary Supplements -
Certificates of Export
FDA provides Certificates of Export
for dietary supplements (and the other products it regulates). Full
details are at
General information on Imports and
Exports is at
"Dry" Test Marketing - the
Rules for test marketing products.
FDA Allows Qualified Health Claims
"FDA's 2003 Consumer Health Information for
Better Nutrition Initiative provides for the use of qualified health claims when
there is emerging evidence for a relationship between a food, food component, or
dietary supplement and a reduced risk of a disease or health-related condition.
In this case, the evidence is not well enough established to meet the
significant scientific agreement standard required for FDA to issue an
authorizing regulation. Qualifying language is included as part of the claim to
indicate that the evidence supporting the claim is limited. Both conventional
foods and dietary supplements may use qualified health claims. FDA uses its
enforcement discretion for qualified health claims after evaluating and ranking
the quality and strength of the totality of the scientific evidence. Also, FDA
now has a process for the public to view qualified health claim petitions,
comment on these petitions, and submit comments on these petitions through its
·Qualified Health Claims Questions and Answers
·Summary of Qualified Health Claims Permitted
For a discussion of the distinction among General Wellness,
Structure & Function and Health Claims, see Labeling
Rules Opinion Letter.
On August 28, 2003, FDA
published a proposed and companion direct final rule on ingredient labeling of
dietary supplements that contain botanicals. FDA is proposing to amend its
regulation on declaring botanical ingredients in dietary supplements to
incorporate by reference the 2000 editions of Herbs of Commerce and the
International Code of Botanical Nomenclature (Saint Louis Code).
· Direct Final Rule (http://www.regulations.gov/fredpdfs/03-21980.pdf)
· Proposed Rule (http://www.regulations.gov/fredpdfs/03-21981.pdf)
FTC states, "supplement marketers are cautioned that the FTC will require both strong scientific support and careful presentation for... claims. *** Supplement marketers should ensure that anyone involved in promoting products is familiar with basic FTC advertising principles. The FTC has taken action not just against supplement manufacturers, but also, in appropriate circumstances, against ad agencies, distributors, retailers, catalog companies, infomercial producers and others involved in deceptive promotions. Therefore, all parties who participate directly or indirectly in the marketing of dietary supplements have an obligation to make sure that claims are presented truthfully and to check the adequacy of the support behind those claims."
Your web site
needs a proper SUS
Site Use Statement -
Disclosure - Privacy - Disclaimer Page
The Vitamin Lawyer has the
right form for you!
LEGAL PROTECTION! www.
Disclaimers for Sale.com
Good Manufacturing Practices
THE VITAMIN LAWYER CAN HELP!
FDA Imposed cGMPs [Current Good Manufacturing Practices]
and SOPs [Standard Operating Procedures]
have come to the Vitamin world as of June 2007
Latest Information: Outline of SOPs
What can you do to prepare?
- Ask me!
Original 2003 Report:
Question and Answer from the Vitamin Lawyer
Q: "> ...if there were a solution for this and
documentation other than anecdotal evidence,
> it would make the front pages of every paper..."
A: "... Your note betrays a typical
misunderstanding about how claims are allowed to be made for health care
products under US law. Both FDA and FTC rules have something to teach us
The FDA tells us that there are several levels of substantiation which can
accompany claims. These range from (at the "lower" end of the spectrum)
anecdotal (testimonial) information and traditional use information through
(at the other end) double blind clinical studies. What the law requires is that
marketers be truthful and not misleading as to the level of substantiation for a
particular product claim.
Thus, a medicine that claims to cure a disease must have a very high level of
substantiation (and FDA prior approval) while a traditional combination of
homeopathics that is offered not as a cure but only as a "therapy that may be of
benefit" (to quote AMA Opinion 3.04) would just require reference to traditional
uses and less than "proof beyond a reasonable doubt", see:
X is not offered as a cure for [disease]. It is offered as a palliative that may
help some people who experience [condition]. Since there are not usually "side
effects" to nutrients in homeopathic dilution, and the product is not expensive,
one might as well try it and see what happens. It may help; it may not. That's
exactly what anecdotal evidence is all about -- due to individual differences,
we do not know if it will help a particular person, but it appears that it did
help this person or that person. Or, as the FTC requires, "results may not be
X is not claimed as a cure for disease. If there were a "cure" - and a if
pharmaceutical company could patent it so that it might be worth (to them) the
many millions it takes for a cure to become FDA approved - you are right, you
would probably have heard about it. But, since that is not the case, all the
marketplace can do is offer anecdotal hope."
December 11, 2003
FDA and Customs Issue Joint Bioterrorism Guideline
Compliance required immediately.
See www.vitaminlawyernews.com for
Some Additional Links:
Structure & Function Claims Notice Procedure,
Marketers MUST file this notice within 30 days of offering a new dietary
FTC DS Ad Guide,
DSHEA: the basic law,
Traditional Use Claims .htm
Some Label Content Considerations
FDA - Consolidated Institutional Review Board
FDA - New Label Claims Page:
Brief Summary of All Claims that Can Be Made for Conventional Foods
and Dietary Supplements
FDA - OTC Labeling Overview (not Dietary
FTC - Complying with the Telemarketing Sales
FTC - Fair Credit Billing Act (FCBA).
FTC - Lost or Stolen Cards,
FTC - Fair Credit Reporting Act,
FTC - Consumer Guide to E-payments,
FTC on internet pharmacies,
& the Rennert case,
FTC Weight Loss Claims Guidance,
FDA Bioterrorism Preparedness Guide,
FTC Testimonial Use Guide,
FDA Device Advice,
Food Allergen Labeling Law,
FDA Small Entity Label & Claim Guidance,
FDA Qualified Health Claims,
FDA Dietary Supplement Guidance Documents,
FDA Certificate of Free Sale,
FDA Guidance on Qualified Health Claims,
General FDA Guidance Document Index,
Labeling & Internet Advertising,
Homeopathic Products Marketing Guide,
Is it a cosmetic, a drug, or both (or
is it a soap?) - http://www.cfsan.fda.gov/~dms/cos-218.html
Functional Foods Labeling & Claims
GRAS FAQs -
New Dietary Ingredients -
Label Guideline (2005)
http://www.cfsan.fda.gov/~dms/dsclmgu2.html - December 2008
AER Label Guideline:
http://www.cfsan.fda.gov/~dms/dsaergu3.html - December 2008
Vitamin Lawyer News - regular updates -
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