FDA Publishes Guidance on the Substantiation Needed for Supplement Claims

In December 2008, the FDA published its guidance regarding structure/function claims for dietary supplements in the form of non-binding recommendations to supplement industry manufacturers.

Contrary to the oft-repeated notion that dietary supplements are unregulated, under the Dietary Supplement Health and Education Act of 1994, the “FDA has exclusive jurisdiction over the safety, and primary jurisdiction over the labeling, of dietary supplements.” However, the 1994 Act never defined how the claims a dietary supplement manufacturer might make about its product would need to be substantiated.
The new FDA guidance includes this section:
Section 403(r)(6) of the Act requires dietary supplement manufacturers to have substantiation that structure/function, nutrient deficiency, and general well-being claims on a dietary supplement product’s labeling are truthful and not misleading. To meet this statutory requirement, we recommend that manufacturers possess adequate substantiation for each reasonable interpretation of the claims. We intend to apply a standard that is consistent with the FTC standard of “competent and reliable scientific evidence” to substantiate a claim. We consider the following factors important to establish whether information would constitute “competent and reliable scientific evidence:”
o Does each study or piece of evidence bear a relationship to the specific claim(s)?
o What are the individual study’s or evidence’s strengths and weaknesses? Consider the type of study, the design of the study, analysis of the results, and peer review.
o If multiple studies exist, do the studies that have the most reliable methodologies suggest a particular outcome?

o If multiple studies exist, what do most studies suggest or find? Does the totality of the evidence agree with the claim(s)?
With 65% of US healthcare consumers regularly using dietary supplements, it is critical that consumers receive substantive information so they can make an informed decision about supplement use. Four groundbreaking health impact studies from the Lewin Group found that supplements help manage diabetes better; that seniors who take certain dietary supplements live longer, more independent lives; and importantly in these tough economic times, that dietary supplement usage could save US consumers over $24 billion dollars in healthcare costs.