Yes, There is a Way to Market a Drug as a Supplement

November 5, 2009

By Ricardo Carvajal

Several Congressional representatives wrote a letter to FDA asking the agency to “fully implement” a provision of the FDCA that allows marketing as a dietary supplement of an article previously investigated for use as a drug.  Section 201(ff)(3)(B)(ii) excludes from the definition of a dietary supplement any article for which an IND was authorized and for which substantial clinical investigations were instituted and made public, unless the article was marketed as a food or supplement before the IND was authorized.  However, the dietary supplement exclusion can be rendered inapplicable to an article by FDA’s issuance of a regulation.  This somewhat cumbersome mechanism allows for the marketing of an article as a supplement even if it was previously studied as a drug.  Although the letter does not reference any specific products, a citizen petition pending with FDA asks the agency to issue a regulation allowing the marketing of homotaurine as a dietary ingredient under the rulemaking authority described above (see our prior post here). 

The Congressional representatives also expresses dismay over FDA’s request for comment on the issue of whether section 301(ll) applies to dietary supplements, given the “the absence of any indication that Congress intended for [section 301(ll)] to replace any existing law.”  For more on issues raised by FDA regarding its implementation of section 301(ll), see our prior post here