Section 912 and the blurring of the supplement-drug line

Section 912, which forms part of the FDAAA enacted by Congress in September last year, could represent a major shift in the divide between foods and drugs.

However, this potential impact on the supplements industry is essentially due to lack of clarity in the interpretation of the act. Supplements trade associations do not appear overly worried that it will come to pass, but they have stressed the importance of filing comprehensive comments with FDA to request a clear interpretation of the provision.

In July this year, the regulatory agency issued a request for comment (73 Fed. Reg. 43937), with an initial deadline of this week. To access the Federal Register notice, click here​.

In response to calls for an extension of the comment period from trade groups such as the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), FDA has agreed to extend the deadline by 29 days, or until November 25 2008.

What is Section 912…? ​

Concerns about the provision are based on the fact that it could prevent products from being marketed as dietary supplements if they contain a substance that has been subject to clinical investigations if these have been made public.

It is generally thought that the ‘proper’ implementation of the act would not have much of an impact on supplements. However, since its wording is open to interpretation, there is a risk that it would stifle innovation because as soon as a clinical trial is conducted – which would be necessary to obtain scientific substantiation for any new ingredient – the product would be kicked out of the marketplace.

“We don’t think that’s what Congress intended, so we need to submit clear comments,” ​said Michael McGuffin, director of the trade group American Herbal Products Association (AHPA) in a seminar last week at SupplySide West in Las Vegas.

Daniel Fabrical, VP of Scientific and Regulatory Affairs at NPA agreed: “The intent didn’t match the actual language. That’s where the comments are needed to clarify – otherwise [the provision] can be interpreted broadly and doesn’t make sense because there are already laws on the books that that clearly enforce [these areas of regulation],”​ he told NutraIngredients-USA.com this morning.

Interpretation​

The inconsistencies in interpretation stem from the fact that the provision creates a conflict between two federal statutes.

Section 912 establishes a new provision of the Federal Food, Drug, and cosmetic Act (FDCA), § 301 (ll), and prohibits the shipment in interstate commerce of foods to which certain articles have been added.

The issue in question is whether § 301 (ll) should extend to include dietary supplements, which are currently subject to the provisions of § 201 (ff) of the FDCA.

In comments already filed with FDA by Marc Ullman, a lawyer with Ullman, Shapiro & Ullman, the conflict is explained as follows:

“Section 201 (ff) applies expressly and specifically to dietary supplements. Under this provision, absent the promulgation of a regulation, an article may not be marketed as a dietary supplement if it has undergone substantial clinical investigations that were made public and conducted pursuant to an NDI [Investigational New Drug] application.”​

“On the other hand, ​§ 301 (ll), which applies generally to the category ‘food’ shipped in interstate commerce, prohibits the addition to ‘food’ of articles that have undergone substantial clinical investigations – irrespective of the existence of an IND – if those investigations were made public and unless a regulation was promulgated.”​

“If ​§ 301 (ll) is interpreted to apply to dietary supplements, it will be in direct conflict with the preexisting standard for dietary supplements set under ​§ 201 (ff)”.​

What Ullman and industry trade groups are calling for is that § 301 (ll) does not apply to supplements, and that § 201 (ff) remains in effect and sets the standard that is specifically applicable to supplements.

Petitions fill the loophole​

A citizen’s petition that attempts to take advantage of this loophole has already been submitted with FDA. This seeks to regulate the emerging sweetener stevia as a drug.

The petitioner, identified as Coburn & Coffman PLLC in Washington DC, contends that stevia glycosides (SGs) are drugs and therefore cannot be legally added to conventional foods.

The petition focuses on § 301(ll), and was made on the grounds that SGs have been studied for therapeutic uses, such as effects on blood pressure and blood sugar levels, with clinical trials supporting these therapeutic uses.

In its call for comments on § 912, FDA has specifically requested information on the applicability of § 301 (ll) to supplements.