Dairy groups urge 'narrow interpretation' of Section 912

by Keith Nunes
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The development of new products with functional benefits has proven profitable for the manufacturers of dairy products. Whether it is the addition of probiotics to yogurt and cheese or the fortification of fluid milk with omega-3 fatty acids or plant sterols, both consumers and manufacturers have embraced the trend of delivering healthy attributes to consumers via dairy products.

In an effort to maintain the product development progress, both the International Dairy Foods Association (I.D.F.A.) and the National Yogurt Association (N.Y.A.) filed comments in late October urging the Food and Drug Administration to narrow its interpretation of Section 912 of the F.D.A. Amendments Act of 2007 (F.D.A.A.A.). Section 912 is a congressional mandate that could restrict the marketing of foods with added biological ingredients.

Congress passed the F.D.A.A.A. in September 2007. Charged with its implementation, the F.D.A. issued a request for comments in July. The original deadline for comments was Oct. 27, but the F.D.A. later extended the comment period to Nov. 25.

Section 912 amends Section 301 of the Federal Food, Drug & Cosmetic Act (F.F.D.C.A.) and prohibits the marketing of any food to which an approved drug or licensed biological product has been added and of any food that was added a "drug or biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public."

Under a broad interpretation of Section 912’s mandate, dairy foods with functional ingredients, like omega-3 fatty acids, plant sterols and probiotic cultures, might have to receive drug approval and be marketed as drugs, not food, according to the trade associations. One section of the act calls for prohibiting products containing an added drug or biological product that has undergone "substantial clinical investigations."

Under the rule, it is conceivable a substance for which a clinical investigation was instituted in 2000 but not made public until 2008 may prevent a food company that, in the intervening years, introduced a food product that contained the substance that was part of the clinical trial, from marketing the product. Under the legislation, the food company would find itself in violation of law and have to withdraw the product containing the substance from the market.

In their comments, the associations asked the F.D.A. to exclude foods and ingredients that were clinically studied to substantiate health claims.

"Clinical trials are vitally important in developing the necessary substantiation to support health and structure/function claims that are appropriate and expressly permitted for use in food labeling," the associations said.

The comments also point out that too broad an interpretation may stifle health-related research on foods with functional benefits.

"What’s really at issue is the definition of the products that would be prohibited," said Michelle Matto, I.D.F.A. assistant director of nutrition and labeling. "The current interpretation is so broad and vague that it’s hard for our members to know which products are included."

In its concluding comments, the trade associations requested the F.D.A. narrowly interpret Section 912.

"A broad interpretation, and one that fails to recognize that the mere study of a product does not determine its intended use for purposes of determining the regulatory status of the product, may dramatically lower the number of health-related studies conducted on food and food components. This would lead to fewer food and food component options, thereby depriving consumers of many potential beneficial food products that could help them achieve a balanced and healthy diet, and reduce their risk of diet-related diseases."

This article can also be found in the digital edition of Dairy Business News, November 2008, starting on Page 13. Click here to search that archive.

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