Questions arise about Section 912 and its impact on functional foods

by Jeff Gelski
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KANSAS CITY — People in the food and beverage industry may have questions about the potential effects on new product innovation under Section 912 of the Food and Drug Administration Amendments Act of 2007. Even Michael M. Landa wants clearer definitions on specific words, and he’s deputy director for regulatory affairs for the F.D.A.’s Center for Food Safety and Applied Nutrition.

"I think this is a really difficult statute to parse," Mr. Landa said Sept. 24 during an Institute of Food Technologist’s webinar called "Section 912: Potential Threat to Food Innovation."

Section 912 amends Section 301 of the Federal Food, Drug and Cosmetic Act. It prohibits the interstate shipment of certain foods that have had an approved drug or alicensed biological product added to them. It also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public.

The F.D.A. will accept comments on Section 912 until Oct. 27. More information may be found in a July 28 listing in the Federal Register.

Mr. Landa said he seeks clarification on the words "substantial" and "public" in Section 912 and Section 301 (11). Does "substantial" mean the investigations need to include a certain number of subjects or do the investigations need to last at least for a certain amount of time? He also asked could "public" mean a company revealed the investigation results to venture capitalists or could it mean investigation results appeared in a peer-reviewed journal?

"Again, we’re going to need answers as we go about instituting this statute," Mr. Landa said.

Section 301 (11) created by Section 912 provides exceptions to the prohibition of adding a drug or biological product to a food. One exception says it’s okay if the drug or biological product is used to "enhance the safety of the food . . . and not to have independent biological or therapeutic effects on humans."

Mr. Landa seeks further clarification on "enhance the safety." Does it involve inhibiting microbial risk solely or could it also mean improving the nutritional qualities of a food, such as by reducing trans-fatty acids?

Section 912 also may affect potential structure/function claims and qualified health claims, said Dr. Ashley Roberts, M.D., vice-president of food and nutrition for Cantox Health Sciences International, a consulting firm with a U.S. office in Bridgewater, N.J.

"Is this the end of health claims on food products as we know it?" Dr. Roberts asked during the I.F.T. webinar.

He said food and beverage companies, when designing clinical trials, should avoid making them drug-like because that route may trigger problems with Section 912. Reports of the trials should avoid words like "cure" and "treat." Section 912 may undermine clinical research for health claims and make it more difficult for companies to use human studies, which often are needed to obtain F.D.A. health claims, Dr. Roberts said.

He gave an example of a qualified health claim passed Sept. 8, 2004, for two omega-3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The F.D.A. claim states, "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease."

Under Section 912, a qualified health claim such as this may run into problems because of the human studies involved, Dr. Roberts said.

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