"Supporting Industry Compliance with FDA and FTC Regulations."


Page Index:

· Weight Loss Red Flags
· Certificates of Export
· VLC Seal
· Dry Test Markeing
· cGMPs - SOPs
· Bioterrorism
· Links
· Contact Me
· Top

  The Vitamin Lawyer Consultancy

Ralph Fucetola JD

Dealing with the FDA and FTC


Table Index:

 FDA Red Flag WordsFTC Red Flag Weight Loss Claims
 What to do if you are raided by the FDA or FTC

 Latest FDA and FTC Vitamin Law News
 FTC Warning on Supplement Claims
 FDA Allowed Qualified Health Claims

 FDA Claims Notice Procedure 
 FDA Certificates of Export
 Surprise FDA Inspections

 Vitamin Lawyer Oversight Seal of Approval
 Rules for Botanicals in Dietary Supplements
 "Dry" Test  Marketing

 cGMPs for Vitamin Industry
 BioTerrorism Food Import Compliance Guide

 Some Label Content Considerations

Vitamin Lawyer Oversight Seal

 Some Additional Links


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... Services...


See Vitamin Lawyer News for Red Flag Weight Loss Claims - updated.


What to do if you are raided by the FDA or FTC*

It's sad to say, but there is not much you can do after the raid has begun...
a good Disclaimer Page can help!

What to expect from a SURPRISE FDA inspection: fdainspection.htm

* 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?


FDA and FTC Vitamin Law News

Some of the latest information from FTC and FDA including important information on the FDA Structure / Function Claims and Health Claims filing Rules. www.vitaminlawyernews.com.  From Vitamin Lawyer News -

NEW 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
"[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 http://www.cfsan.fda.gov/~lrd/certifi3.html.

General information on Imports and Exports is at http://www.cfsan.fda.gov/~lrd/imports.html

"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 web site."

·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."

FTC Guidance, http://www3.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm.


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
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: vitfdacgmpreport.htm

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 about this.

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: http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm.

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 typical."

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 details.


Some Additional Links:

Structure & Function Claims Notice Procedure, claimnotice.html
Marketers MUST file this notice within 30 days of offering a new dietary supplement product.

FTC DS Ad Guide, http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm

Facility Registration, http://www.cfsan.fda.gov/~furls/cpgreg2.html

DSHEA: the basic law, http://www.cfsan.fda.gov/~dms/dietsupp.html

Traditional Use Claims .htm

Some Label Content Considerations

FDA - Consolidated Institutional Review Board Guidance:

FDA - New Label Claims Page: http://www.cfsan.fda.gov/~dms/lab-hlth.html

FDA - Brief Summary of All Claims that Can Be Made for Conventional Foods
and Dietary Supplements http://www.cfsan.fda.gov/~dms/hclaims.html

FDA - OTC Labeling Overview (not Dietary Supplements)

FTC - Complying with the Telemarketing Sales Rule,

FTC - Fair Credit Billing Act (FCBA).

FTC - Lost or Stolen Cards, http://www3.ftc.gov/bcp/conline/pubs/credit/atmcard.htm

FTC - Fair Credit Reporting Act, http://www3.ftc.gov/os/statutes/fcra.htm

FTC - Consumer Guide to E-payments, http://www3.ftc.gov/bcp/conline/pubs/online/payments.htm

FTC on internet pharmacies, http://www.ftc.gov/os/2003/03/030327internetprescriptions.pdf
& the Rennert case, http://www.ftc.gov/os/2000/07/iogordrennert.htm

FTC Weight Loss Claims Guidance, http://www.ftc.gov/bcp/conline/edcams/redflag/index.html

FDA Bioterrorism Preparedness Guide, http://www.cfsan.fda.gov/~pn/cpgpn.html

FTC Testimonial Use Guide, http://www.ftc.gov/bcp/guides/endorse.htm

FDA Device Advice, http://www.fda.gov/cdrh/devadvice/ide/index.shtml

Food Allergen Labeling Law, http://www.cfsan.fda.gov/~dms/alrgact.html

Homeopathic Remedies, http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg400-400.html

FDA Small Entity Label & Claim Guidance, http://www.cfsan.fda.gov/~dms/ds-label.html

FDA Qualified Health Claims, http://www.cfsan.fda.gov/~dms/lab-qhc.html

FDA Dietary Supplement Guidance Documents, http://www.cfsan.fda.gov/~dms/guidance.html#ds

FDA Certificate of Free Sale, http://www.cfsan.fda.gov/~dms/ds-cert.html

FDA Guidance on Qualified Health Claims, http://www.cfsan.fda.gov/~dms/qhcqagui.html

General FDA Guidance Document Index, http://www.cfsan.fda.gov/~dms/guidance.html

Bioterrorism Act, http://www.fda.gov/oc/bioterrorism/bioact.html

Labeling & Internet Advertising, http://www.cfsan.fda.gov/~dms/labwww.html

Homeopathic Products Marketing Guide, http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg400-400.html

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 Guidance - http://www.cfsan.fda.gov/~dms/flguid.html

GRAS FAQs - http://www.cfsan.fda.gov/~dms/grasguid.html

New Dietary Ingredients - http://www.cfsan.fda.gov/~dms/ds-ingrd.html

Label Guideline (2005) http://www.cfsan.fda.gov/~dms/dslg-1.html

Substantiation Guideline: 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 - www.vitaminlawyernews.com

Back to Vitamin Lawyer Consultancy:  www.vitaminlawyer.com

© 2000 - 2006, 2007, 2008


Breaking News!
Vitamin Lawyer News
Updated Often!

cGMPs & SoPs are Coming to the Vitamin Industry!
Proposed Current Good Manufacturing Practices
Is Your Company Ready?!?  Click below to learn more!
1. Vitamin Lawyer Report

2. Preparing for a Surprise FDA inspection!
3. Outline of my standard SoPs; Employee Manual

Vitamin Lawyer On Line Seminar - FREE!


 Ralph Fucetola JD

Email me with questions:

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Oversight Seal of Approval
on Nutrient Web Sites

Vitamin Lawyer Oversight Seal

Seal Requirements


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Site Use Statement -
Disclosure - Privacy - Disclaimer Page
The Vitamin Lawyer has the right form for you!
LEGAL PROTECTION!  www. SiteUseStatement.com


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