Section 301(ll) Update: FDA NDI Response Is No Safe Harbor from FDC Act § 301(ll); FDA Offers Party-Specific Extension for Comments

By Ricardo Carvajal –

In its most recent response letters to New Dietary Ingredient ("NDI") notifications submitted pursuant to FDC Act § 413(a)(2), FDA included the following paragraph:

Based on the information in your submission, it is possible that a recently enacted law may affect the legal status of dietary supplements containing [the NDI].  Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food (including a dietary supplement) that contains a drug approved under 21 U.S.C. 355, a biological product licensed under 42 U.S.C. 262, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In our review of your notification, FDA did not consider whether section 301(ll) or any of its exemptions apply to dietary supplements containing [the NDI]. Accordingly, this response should not be construed to be a statement that a dietary supplement containing [the NDI], if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

We previously reported that FDA began to include a similar paragraph in its “no questions” letters issued in response to GRAS notices.  The inclusion of the above paragraph in response letters to NDI notifications suggests that, at a minimum, FDA is keeping the door open to interpreting “food” as used in § 301(ll) to include dietary supplements.  This is one of the issues on which FDA requested comment  with regard to possible interpretations of § 301(ll).  Although that comment period closed on October 27, numerous requests asking for an extension of the comment period were submitted to FDA.

According to FDA, the deadline for submission of comments has been extended until November 25, 2008.  When asked, FDA officials have responded orally that the extension is party-specific; that is, only those parties that submitted a timely request for an extension can be assured that comments submitted during the extension period will be considered.  However, in the past FDA has ordinarily considered relevant comments even when submitted after the deadline has expired and no extension period is granted, and it would be surprsing for FDA to reject comments on § 301(ll) except from those who have formally requested an extension, given the potential importance of this new section to the food, dietary supplement and drug industries.