FDA Outlines Claims Substantiation Cost, Requirements

WASHINGTONThe Food and Drug Administration (FDA) filed a document with the Office of Management and Budget (OMB) offering guidance on the requirements for substantiation of dietary supplement claims made under the Federal Food, Drug and Cosmetic Act. While the guidance covers the amount, type and quality of evidence FDA recommends a dietary supplement manufacturer have to substantiate a claim under section 403(r)(6) of the act, it does not discuss the types of claims that can be made concerning the effect of a dietary supplement on the structure or function of the body, nor does it discuss criteria to determine when a statement about a dietary supplement is a disease claim.

Among the changes FDA made to its guidance since its last publication in 2004, was a change from one hour to 44 hours as the estimate of the burden of preparing the information needed to substantiate a claim on a dietary supplement when the claim is widely known and accepted. The agency disagreed with comments alleging significant increased operating and personnel costs associated with preparing the claim substantiation evidence, calling the costs nominal for most companies; FDA also disagreed with comments about the need to maintain a botanical library collection of historical references and current scientific journals. FDA (www.fda.gov) wrote: Dietary supplement manufacturers will only need to collect information to substantiate their products nutritional deficiency, structure/function, or general well-being claim if they chose to place a claim on their products label. Gathering evidence on their products claim is a one-time burden; they collect the necessary substantiating information for their product as required by section 403(r)(6) of the act. FDA will accept comments until July 6, 2007.