Ricardo Carvajal

Diane McColl

By now, you may have heard murmurs about a new law in the United States referred to as section 912. Perhaps you attended the presentation on section 912 at the recent IFT Annual Meeting & Food Expo® in New Orleans, or participated in the subsequent IFT webcast (www.ift.org/cms/?pid=1001659) on the subject.

In brief, section 912 of the FDA Amendments Act of 2007 added section 301(ll) to the Federal Food, Drug, and Cosmetic Act (FDC Act), which prohibits the addition to food of an approved drug, a licensed biological product, or a drug or biological product for which substantial clinical investigations have been instituted and their existence made public. From a historical perspective, this marks a significant change in the regulation of food and drugs.

Prior to the advent of section 301(ll), there was considerable flexibility in the regulatory categorization of a substance as a food, a drug, or both. Section 301(ll) greatly reduces that flexibility. Under section 301(ll), if there is no evidence of prior marketing of a substance in food, and the substance is approved as a drug or licensed as a biological product, then it can not be added to food, except in very limited circumstances.

We will leave it to others to judge whether this loss of flexibility represents an advance or a retreat in the protection and promotion of public health— perhaps only time will tell. Suffice to say that it is a significant departure from the status quo.

In addition to marking a historic shift in the regulation of food and drugs, section 301(ll) introduces significant uncertainty into the food ingredient development and supply sectors. This is because the section 301(ll) prohibition extends not just to an "approved drug" and a "licensed biological product," but also to a "drug" and a "biological product" (for which substantial clinical investigations have been instituted and their existence made public).

Unfortunately, the precise meaning and scope of "drug" and "biological product" as used in section 301(ll) are not clear. It is possible that section 301(ll) could apply to any substance that has merely been the subject of publicized clinical investigations for a therapeutic use. Given the general shift within the food industry toward the use of clinical studies, and the high level of interest among academic researchers in exploring the potential therapeutic uses of food constituents, section 301(ll) could harbor some unpleasant surprises for food ingredient developers and suppliers. Surprises of this nature typically are not welcome in either the business or investment communities.

Recent activity by pharmaceutical companies that targets the dietary supplement industry suggests that section 301(ll) may quickly be put to use. The dietary supplement exclusionary clause in section 201(ff)(3)(b)(ii) of the FDC Act bears many similarities to section 301(ll). Essentially, this clause forbids the marketing as a dietary supplement of an approved drug, a licensed biologic, or an article authorized for investigation as a new drug or biological for which substantial clinical investigations have been instituted and their existence made public (unless there is evidence of prior marketing). Relying on the dietary supplement exclusionary clause, a pharmaceutical company submitted a citizen petition to FDA in November 2008 asserting that all dietary supplements containing pyridoxal 5’-phosphate (or P5P, a form of vitamin B6) are unlawful because that company has been authorized to investigate as a new drug a product that contains P5P as its active ingredient. The petition further contends that all P5P dietary supplements on the market are being marketed illegally, and therefore evidence of that marketing can not be relied on to defeat the dietary supplement exclusionary clause. Among other things, the petition asks FDA to remove all P5P dietary supplements from the market. Regardless of whether the petition succeeds, it would not be surprising to see similar arguments being made under section 301(ll), given its similarities to the dietary supplement exclusionary clause.

The FDC Act does not provide a private right of action, and thus parties can not seek to implement section 301(ll) directly through litigation. However, FDA has made clear that it will not ignore section 301(ll). FDA recently published a Federal Register notice asking for comment on a number of issues related to implementation of section 301(ll). FDA has signaled that it believes it has the legal prerogative to interpret section 301(ll) in any reasonable manner, but wants to know what the potential effects of different interpretations might be. Among the many interpretations available to FDA, some could be more favorable to the food industry, and others to the pharmaceutical industry.

As counsel to both food and pharmaceutical clients, we are strongly encouraging participation in the public consultation that FDA has initiated so that the agency’s implementation of section 301(ll) is well informed. Comments can be submitted to Docket No. FDA–2008–N–0389 at www.regulations.gov until October 27, 2008.

by Ricardo Carvajal ( [email protected] ), a member of IFT, is Of Counsel
by Diane McColl (
[email protected] ), a professional member of IFT, is Director, Hyman, Phelps, & McNamara, P.C., www.hpm.com , www.fdalawblog.net .