December 2008

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Section 912 should not impede innovations in research, AHPA tells FDA

December 3, 2008 — The American Herbal Products Association (AHPA) filed comments with the Food and Drug Administration (FDA) regarding the implementation of Section 912 of the Food and Drug Administration Amendments Act (FDAAA) of 2007. This section, which was effective immediately upon the passage of FDAAA on Sept. 27, 2007, is titled, “Prohibition Against Foods to Which Drugs or Biologics Are Added.”

FDAAA section 912 creates new section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA). It prohibits interstate commerce in foods to which an approved drug or a licensed biological product has been added, and also prohibits the addition to foods of any drug or biological product that has been the subject of publicly-disclosed substantial clinical investigations.

There are exceptions to these prohibitions, most importantly for any ingredient that was marketed in a food before it is approved as a new drug or licensed as a biological product, or before it becomes the subject of substantial clinical

In the association’s comments, AHPA expresses positions on several specific topics, including:

• New section 301(ll) does not replace or amend DSHEA, so that dietary supplements are not in any way affected by this new law.

• This law should be implemented for other food categories (e.g., conventional foods; foods for special dietary use; medical foods; etc.) in a manner that does not in any way disincentives or adversely impact incentives for investigations of the safety, functional effect, or health benefits of substances that may be added to foods.

• FDA should refrain from developing new definitions for terms that are already defined in the FFDCA, such as “drug,” or for which the common language meaning is perfectly clear, such as “marketed.”

Source: American Herbal Products Association, www.ahpa.org

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