Natural Foods Merchandiser

Food Health-Claim Rules Eased

A new U.S. Food and Drug Administration initiative will allow more food manufacturers to make health claims about their products, which should help consumers maintain or improve their health by making sound dietary decisions.

FDA Commissioner Mark B. McClellan announced the Consumer Health Information for Better Nutrition Initiative on Dec. 18. McClellan hit the ground running after he was sworn in Nov. 14, quickly beginning work on the initiative that likely will increase the number of legal health claims for food beyond the current 14, and also pledging to step up enforcement under the Dietary Supplement Health and Education Act of 1994.

"Our mission at FDA is to improve health outcomes for the nation and some of the best opportunities for improving health involve informed choices by consumers," McClellan said.

If the initiative is successful, shoppers may begin to see labels touting, for example, the health benefit of omega-3 fatty acids in salmon, lycopene in tomatoes and lutein in blueberries.

"Our foods have long since moved beyond meeting only the basic dietary needs of American consumers," said Alison Kretser, director of scientific and regulatory policy for Grocery Manufacturers of America. "This decision will now allow food manufacturers to inform consumers about the health benefits of their foods and to develop new products to meet consumer demand."

Critics, however, worry that relaxing the rules will allow snake oil to carry the same health claims as fish oil. But FDA officials said food makers still must prove their claims before putting them on a label. The agency has already begun cracking down on DSHEA violations, beginning with the Dec. 16 seizure of 3,000 bottles of EverCLR, a supplement marketed by Halo Supply Co. of San Diego using unproven claims about its use as a "natural" treatment for the herpes virus and for cold and flu protection.

Under the new rules, food manufacturers and growers now will have to prove health claims using a "weight of the scientific evidence" standard rather than the previous "significant scientific agreement" standard.

The standard-of-proof change was the result of the ruling in the 1999 court case Pearson vs. Shalala, which gave supplements makers permission to make "qualified health claims," meaning no consensus has been achieved but a preponderance of scientific research affirms a particular nutrient's beneficial effect on health. Qualified health claims are not as airtight as "significant scientific agreement."

The proposed policy change is an abrupt departure from the agency's long-held position that no nutrient-disease claims should be allowed for foods or dietary supplements unless proven to a near-conclusive degree. "As never before, companies will be able to inform consumers of the disease risk-reducing and disease-preventive effects of certain foods and dietary supplements," said Jonathan W. Emord, principal of Emord & Associates, a Washington, D.C., law firm that has repeatedly sued the agency for just such a change.

Incoming acting president of the Washington, D.C.-based Council for Responsible Nutrition Annette Dickinson, Ph.D., also applauded the change and said it is a "logical position that qualified health claims should be available for all categories of food, because they all provide beneficial nutrients that promote good health and help protect against disease."

McClellan also announced the formation of the Task Force on Consumer Health Information for Better Nutrition and set a June 2003 deadline for the group to create a framework that will give consumers accurate, up-to-date, science-based information about food and dietary supplements. The group also is charged with developing rules for applying the "weight of evidence" standard and with developing the regulations that will allow the rules to be enforced.

Natural Foods Merchandiser volume XXIV/number 2/p. 1, 9

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