Warning Letter & Draft Guidance on Clinical Trials

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 and a new guidance on when FDA permission is required to conduct a clinical study.

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.

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