Newly-Enacted Section 912 Should Not Impede Innovations in Research, AHPA Tells FDA

The American Herbal Products Association (AHPA) today 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 September 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 investigations. Similar prohibitions, with the attendant exceptions, have been in place for dietary supplements since the adoption of the Dietary Supplement Health and Education Act (DSHEA) in 1994.

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.”

“FDA must look to the intent of Congress, and narrow its implementing rules to ensure that the intended prohibitions are in place and that incentives are maintained for companies to establish the clinical efficacy of drugs and biological products,” said AHPA President Michael McGuffin. “Too broad an interpretation of this statute, however, would be a disservice to American consumers if such a regulatory approach curtailed access to newly-developed beneficial food ingredients any time a marketer conducts research on its ingredients.”

AHPA’s full comments are available here: 912_Final.pdf

The July 29, 2008 Federal Register notice soliciting comments on the implementation of Section 912 is available here:

The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Website:

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