FDA Determines That Pyridoxamine Is Excluded From the Definition of Dietary Supplement Under FDC Act § 201(ff)(3)(B); Implications for FDA’s Interpretation of § 301(ll) Could Be Significant

By Diane B. McColl & Ricardo Carvajal –

In response to a citizen petition filed on behalf of a pharmaceutical company, FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning of FDC Act § 201(ff) and “may not be marketed as such.”  Although pyridoxamine is a dietary ingredient within the meaning of § 201(ff)(1), FDA determined that pyridoxamine is excluded under § 201(ff)(3) because: (1) pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public; and (2) there is no “independent, verifiable evidence” of prior marketing of pyridoxamine as a food or dietary supplement.  Among the conclusions reached by FDA:

• an “article authorized for investigation as a new drug” includes not only the active ingredient (i.e., pyridoxamine hydrochloride), but also the active moiety (i.e., pyridoxamine);
• consistent with the position taken by FDA in Pharmanex v. Shalala, 2001 WL 741419, the “mere presence” of a substance in the food supply, even at high levels in foods, does not alone constitute marketing within the meaning of § 201(ff)(3)(B);
• affidavits, without more, are insufficient to support a claim of prior marketing.

FDA further states that "the marketing of pyridoxamine in a dietary supplement is essentially equivalent to the marketing of an investigational new drug as a dietary supplement."  Thus, it appears that FDA regards products containing pyridoxamine as drugs subject the new drug provisions of the FDC Act.

The implications of FDA’s § 201(ff)(3) analysis could be significant for the agency’s interpretation of § 301(ll).  As we have discussed in prior postings, § 301(ll) was added to the FDC Act by the FDA Amendments Act of 2007.  In relevant part, § 301(ll) prohibits the addition to food of an approved drug or a “drug” for which substantial clinical investigations have been instituted and their existence made public, unless the “drug” was first “marketed in food.”  We have noted that there are differences between the text of § 201(ff)(3)(B) and that of § 301(ll).  Whereas the former refers to an “article” that is “marketed as a food or dietary supplement,” the latter refers to a “drug” that is “marketed in food.”  These differences are among the issues on which FDA requested comment to gauge the potential impact of alternative interpretations of § 301(ll). Notwithstanding these differences, the rationale expressed by FDA in support of its determination with respect to pyridoxamine suggests that FDA is likely to adopt an interpretation of § 301(ll) that is much more favorable to the pharmaceutical industry than what many food and dietary supplement manufacturers have advocated.