Foods v. Drugs: FDAAA § 912 Revisited

In our October 2007 summary and analysis of the FDA Amendments Act (“FDAAA”), Hyman, Phelps & McNamara, P.C. noted that FDAAA § 912, concerning a new prohibition against foods to which drugs or biological products are added, is “of potential significance to the development of functional food ingredients.”  Further analysis convinces us that FDAAA § 912 could represent a fundamental shift in the dividing line between foods and drugs.  This makes it all the more important for both food and drug manufacturers to more closely examine FDAAA § 912 and consider its likely effect on their existing portfolios and product development strategies.

The first line of inquiry is whether a given substance falls within the scope of the § 912 prohibition. Section 912 prohibits the addition to food of an approved drug or a licensed biologic. It also prohibits the addition of “a drug for which substantial clinical investigations have been instituted and for which the existence of those investigations has been made public” (emphasis added).  The reference to “drug,” with its attendant uncertainties regarding the manifestation of intent, is not so bright a line as that provided by the FDC Act § 201(ff) dietary supplement exclusionary clause, which excludes articles for which an IND has been authorized. Contributing to the blurred distinction is the vague threshold of “substantial clinical investigations.” 

If a given substance falls within the scope of § 912, applicability of the exceptions to the prohibition must then be considered. Unfortunately, several of the exceptions are not straightforward. The grandfather exception hinges on the “drug” having been first “marketed” in food. The meaning of the term “marketed,” also present in the dietary supplement exclusionary clause, has never been resolved, although at least one court – the U.S. District Court for District of Utah (Central Division) – commented on it in dictum.  See Pharmanex, Inc. v. Shalala, 2001 WL 741419 (D.Utah). Another exception applies when FDA has issued a regulation, after notice and comment, approving the use of the “drug” in the food. This exception begs the question of whether an existing regulation, such as one approving a health claim for the “drug,” would suffice. Yet another exception requires that use of the “drug” in food be to “enhance safety,” and not to have an independent “biological” or therapeutic effect. One can readily imagine different ways that a substance could “enhance safety,” but it is more difficult to conjure up examples of substances that can be ingested without having a “biological” effect.

These are just a few of the difficult interpretive issues presented by FDAAA § 912.  FDA has made clear that it already has begun to grapple with those issues.  Members of the food and pharmaceutical industries would be well advised to do the same.

By Diane B. McColl and Ricardo Carvajal