DSHEA Post-IND: Can A Supplement Be Marketed After Its Inclusion in an IND?

New questions have arisen concerning the approval of substances as dietary supplements which may have first been the subject of an approved investigational new drug (IND) and which may have also been the subject of a substantial clinical investigation. Logically, the pertinent section of the Dietary Supplement Health and Education Act (DSHEA) is §201(ff), often referred to as the “exclusionary clause” and defines a dietary supplement (Portions of the statute that are not relevant to this discussion have been redacted.):

(ff) The term “dietary supplement”… (3) does -… (B) not include -…

(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.

To give an example of how this clause has been applied in the past, the pharmaceutical company Biostratum, l filed a citizen petition (permitted under 21 CFR 10.30) in 2005, to request that pyridoxamine (one of the two active forms of vitamin B6) be disqualified as a dietary supplement. The basis for the petition was that pyridoxamine had been the subject of an IND application for diabetic kidney disease filed in 1999. The petition was made in response to internet sales of pyridoxamine that began after the IND was submitted. Ultimately, the FDA decided in favor of Biostratum’s petition in 2009 with the result that pyridoxamine cannot be legally sold in the US as a dietary supplement.