Scientific Substantiation - What Are in Your Files?

DSHEA gives authority to dietary supplement manufacturers and/or distributors to make statements of nutritional support, but requires the company to possess "adequate" substantiation before it makes the claim. The FDA and FTC agree that substantiation files should contain: 1) the Notification letter of the statement(s) of nutritional support submitted to the FDA, 2) the identity and quantity of ingredients covered by the statement, 3) evidence of safety, 4) scientific substantiation for claims made, 5) an assurance of GMP compliance from the manufacturer, 6) an interpretive summary of key evidence and/or scientific research authored by an expert reviewer, and 7) documentation of the expert reviewer's qualifications.

The dietary supplement industry can relatively easily meet most of these recommendations. However, the industry is skeptical of the feasibility of including in its structure/function claim substantiation files an interpretive summary of the key evidence and scientific substantiation authored by an expert reviewer. This increases costs associated with product marketing and distribution, decreases the flexibility by which a company chooses to evaluate scientific literature prior to making claims, and limits use of products for which more anecdotal than scientific literature is available.

The regulatory agencies believe that the interpretive summary could assist companies in drafting claims that accurately reelect the supporting evidence and be a starting point for the FDA and the FTC in assessing dietary supplement claims during any subsequent investigative or litigation process. Now the burden is on industry to provide scientific substantiation to an inquiring agency and to explain its significance. This is in direct contravention from the literal reading and intent of DSHEA. It also shifts the financial burden associated with data analysis to the private sector. FDA and FTC arguments that this self-regulation is positive for the industry cloaks the reality of an agenda that propels dietary supplements further from food regulation and closer to regulation as drugs.

Neither the FDA nor the FTC have stated what quantity of scientific evidence it requires to “adequately” substantiate a structure/function claim. However, the FDA has stated that claims should not be made based only on preliminary data, and the appearance of conflicting data should prompt the company making the claim to conduct further research. For further information, please contact Weaver & Amin (

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