GMA Urges FDA to Withdraw Supplement Proposal

The Grocery Manufacturers of America (GMA) is urging the FDA to withdraw proposed regulations governing dietary supplements, saying the agency's expanded definition of "disease" would "unlawfully restrict the ability of food manufacturers to communicate important health information to consumers." The rules would also create "endless controversy and litigation" and provide "no useful guidance to either the FDA or the regulated industry," said GMA.

"Foods play an absolutely critical role here," said Stacey Zawel, GMA vice president, Scientific and Regulatory Affairs. "Consumers are very interested in learning more about what steps they can take in managing their health and protecting themselves against disease. Responsible food manufacturers invest in sound scientific research to back up their food claims, but they must be able to clearly communicate product benefits to consumers. Unfortunately, the FDA proposal makes that virtually impossible."

Zawel added that the FDA's proposed definition of disease is so sweeping that "few, if any, food companies will be able to make health information available to the public without running the risk of having their products regulated as unapproved drugs by the FDA." That, Dr. Zawel said, could stymie further research and development among food companies.

In written comments submitted to FDA, GMA outlined the interests of its member companies in the use of "structure/function claims" (which represent that the product may affect the structure or functioning of the body for maintenance of good health and nutrition) for all food products, including dietary supplements.

"A structure/function claim may be made for a conventional food product whether or not the effect derives from the 'nutritive value' of the food," wrote GMA in its letter to FDA. "There is no statutory or policy basis for limiting structure/function claims to dietary ingredients that have 'nutritive value' and there are strong policy reasons, recognized elsewhere by FDA, for continuing to achieve parity between claims for conventional food and claims for dietary supplements.

"The proposed regulations unlawfully expand the definition of 'disease' beyond that established by FDA in January 1993. The proposed redefinition is so expansive that, if it were applied literally, it would potentially engulf all structure/function claims.

"FDA should withdraw its proposed redefinition of the term 'disease' and retain the January 1993 definition on the basis of which Congress enacted the Dietary Supplement Health and Education Act of 1994 (DSHEA), " added GMA. The 1994 law allows consumers to obtain current information on the relationship between dietary substances and human health and disease.

FDA currently defines disease as "damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease)."