Alaskan Native Art, Structure Function Claims and the FTC

Late last summer while visiting the Alaska State Museum in Juneau,  a postcard with a photo of a decorated canoe caught my eye.  On the front it said, "Genuine Alaskan Native Art" and on the back was a blub about the Federal Trade Commission (FTC) and  FTC information on Alaskan Native Art. There are specific guidelines on when terms such as 'Alaska native' can be used.

The FTC has recently gotten the attention of the food and dietary supplement industries by requiring two clinical trials for support of structure function claims.  No where in FDA regulations is this required.  Companies must have data supporting the claims they make as discussed in this FDA guidance but there is no stipulation that 2 clinical trials are required. FDA Law Blog has written very good pieces about the conflict between POM Wonderful and the FTC.

Today FDA published an announcement in the Federal Register  that the Office of Management and Budget had approved the agency's request to collect information from industry on substantiation of structure function claims.  It will be important for industry to respond with realistic information about the time and effort proper vetting of claims takes.

The associates at  FDALabels.com can review your claims and supporting data to help you determine if you have proper substantiation. 

Warning Letter & Draft Guidance on Clinical Trials

Hello!

The FDA has been busy lately, issuing many guidance documents and warning letters.  Two that are of particular interest to the dietary supplement industry are a series of warning letters to companies marketing chelation/detoxification products (see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229320.htm) and a new guidance on when FDA permission is required to conduct a clinical study (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf)

The FDA press release about the warning letters on chelation products cites examples that were clearly marketed inappropriately due to claims being made about autism and heavy metal poisoning.  Other products were marketed as dietary supplements but were not made to be ingested.  FDA’s press release also provides insight into the agency’s objection to the term ‘detoxification’.  Many of the chelation products talk about removing heavy metals and pollutants and it is clear that FDA views any detoxification as a disease prevention or treatment process.  While these letters address chelation, anyone wishing to market product for colon health should also avoid the term ‘detoxification’.

The guidance document on clinical studies is also very relevant for dietary supplement companies.  All claims made about dietary supplement products must be substantiated with scientific studies. Traditionally, the industry has relied upon a collection of studies on individual ingredients to support claims made on a product consisting of many ingredients.  Recent FDA and FTC enforcement actions indicate that regulators from these agencies believe that studies should be conducted on the final product in order to make claims.  Recent findings from the National Advertising Division of the Better Business Bureau, which reviews food and dietary supplement product claims, support this view. 

Back to the new guidance:  A quandary for the industry is presented by the newly published guidance which notes that if a study has an endpoint that looks at the effect of the dietary supplement on a disease condition, then FDA requires submission of an Investigational New Drug (IND) application.  However, it seems to me that submission of an IND would in effect mean that the company conducting the study has declared that their product is a drug and not a dietary supplement.  The net effect is that studies must be carefully designed and the subject population carefully screened to avoid running afoul of dietary supplement regulations. 

The good news is that the guidance is a draft and FDA is seeking public comments. It will be very important for dietary supplement manufacturers to pay attention to this issue and support efforts by trade groups to fight back.  Otherwise, this guidance could be a small step that could dramatically effect what dietary supplement products will remain in the marketplace. 

I plan to discuss this guidance with two attorneys who will be speaking on Dietary Supplement Claim Substantiation at the Regulatory Affairs Professionals Society conference sessions I am chairing next week in San Jose, CA.  http://s36.a2zinc.net/clients/raps/annual10/public/SessionDetails.aspx?SessionID=26 

If any of you will be at the conference or in the area, please let me know so that we can meet.