FDA GRAS Response Letter Offers No Safe Harbor from FDAAA § 912

In previous postings (here and here), we have observed that § 912 of the 2007 FDA Amendments Act (“FDAAA”), which added the new § 301(ll) prohibition to the FDC Act, could represent a fundamental shift in the dividing line between foods and drugs, and has the potential to deter innovation in the research and development of new food ingredients.  That potential is slowly starting to be realized.  To understand why, a brief recap of the Generally Recognized as Safe (“GRAS”) concept is necessary. 

Research and development of new food ingredients and of new uses of existing ingredients is typically oriented toward attempting to establish that the proposed use of the ingredient is GRAS.  Under FDC Act § 201(s), the use of an ingredient is GRAS if it is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.  A determination that the use of an ingredient is GRAS can be made independent of FDA, and does not require FDA approval.  However, because the marketplace generally demands it, ingredient developers seek FDA’s review of their GRAS determinations by submitting a GRAS notice to FDA.  If FDA has no questions about the notifier’s GRAS determination, FDA issues a letter saying so (a so-called “no questions” letter).  In its most recent “no questions” letter, issued to Mead Johnson & Co., FDA included the following paragraph on the new FDC Act § 301(ll) prohibition:

The Food and Drug Administration Amendments Act of 2007 that was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, a biological product licensed under section 351 of the Public Health Service Act, 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 its review of Mead Johnson’s notice that [its ingredient] is GRAS for use in infant formula powder, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing [the ingredient]. Accordingly, this response should not be construed to be a statement that foods that contain [the ingredient], if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

The inclusion of this paragraph is notable because “no questions” letters already contain a statement advising that it is the notifier’s continuing responsibility to ensure that food ingredients marketed by the notifier “are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.”  Evidently, FDA feels it necessary to specifically put all parties on notice that a “no questions” letter offers no safe harbor from FDC Act § 301(ll).

Beyond the inclusion of a § 301(ll) disclaimer in its “no questions” letters, FDA has begun raising potential  issues as it becomes aware of them during its review of GRAS notices and in pre-submission meetings.  In effect, FDA has begun implementing FDAAA § 912.  During a symposium moderated by Diane McColl at the recent Institute of Food Technologists annual conference and trade show in New Orleans, an FDA representative recommended that § 912 be “part of the product development calculus.”  Sound familiar?

By Diane B. McColl & Ricardo Carvajal