Industry Warns FDA that Broad Interpretation of Section 912 Could Trample Supplement, Food Ingredient Innovation

The U.S. Food and Drug Administration closed the comment period regarding the implementation of Section 912 of the Food and Drug Administration Amendments Act (FDAAA) of 2007 on Nov. 25. 


More than 80 companies, organizations and individuals filed comments about the section, which has stirred much debate and concern in the U.S. nutrition industry because it establishes a new provision to the Federal Food, Drug and Cosmetic Act (FDCA) and essentially bars the interstate commerce of foods to which certain drugs or other biological products have been added.

The relatively short Section 912, which mostly went unnoticed when the legislation went into effect last year, says: The FDA is instructed to prohibit a food from entering the market if it “contains an approved drug or biological product for which substantial clinical investigations have been instituted and the existence of those clinical investigations have been made public, unless the food was marketed first.”

Because the wording of the act is open to interpretation, some in the industry believe Section 912 could significantly change the way dietary supplements are regulated in the United States. Specifically, some are concerned that the legislation could prevent products from being marketed as supplements if they contain ingredients that have been subject to clinical investigations that have been made public. There is also concern that the provision could dampen innovation because new ingredients backed by clinical trials might be removed from the market. “We don’t think that is what Congress intended, so we need to submit clear comments,” Michael McGuffin, president of the American Herbal Products Association (AHPA), said during a presentation at SupplySide West in Las Vegas last month.

In its comments to the FDA, the AHPA pointed out that similar prohibitions “have been in place for dietary supplements since the adoption of the Dietary Supplement Health and Education Act [DSHEA] in 1994.” It also noted that the section does not replace or amend DSHEA, therefore “dietary supplements are not in any way affected by this new law.” Furthermore, the AHPA said the new law should be implemented for other food categories—for example, conventional foods, foods for special dietary use and medical foods—in a way that does not stifle innovation or “adversely impact incentives for investigations of the safety, functional effect, or health benefits of substances that may be added to foods.” Finally, the AHPA asked that the FDA “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,” McGuffin said in a statement. “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.”

In its 32-page comment, which was filed with the FDA also on the behalf of the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition echoed the argument that too broad an interpretation of the act would trample innovation and new product development for the many different types of products defined as “food” under the FDCA. “It would create the opportunity for almost anyone to conduct a few clinical trials for a supposedly ‘drug’ purpose on any ingredient under development for inclusion in food and effectively thwart the ability of food manufacturers to market a product containing that ingredient,” CRN and CHPA wrote.

Nutrition Business Journal will provide additional information about the potential impact of Section 912 on ingredient innovation in our annual Raw Material & Ingredient Supply issue, which publishes this month. To order a copy of the issue or to subscribe to NBJ, go to www.nutritionbusinessjournal.com.

If you are an NBJ subscriber and would like to read more of NBJ’s coverage of DSHEA, click the following:

New Supplement Regulations Most Important for Industry since Passage of DSHEA

Institutional Opposition to DSHEA Underpins Media Bias

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