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Proposed dietary supplement regs draw fire

Bombarded by more than 100ꯠ comments and a request from Sens. Orrin Hatch (R-UT) and Tom Harkin (D-IA), the Food and Drug Administration extended the comment period and will further review its proposed labeling regulations for dietary supplements.

Opponents say the proposed regs significantly narrow what can be said on supplement labels, thus depriving consumers of health-related information they need and want. The restrictions undermine Congress' intent in passing the Dietary Supplement Health and Education Act of 1994, they say. The Grocery Manufacturers of America (GMA) urged FDA to withdraw the proposed regulations, charging the agency's expanded definition of disease as any deviation from normal structure and function is "potentially limitless" and could encompass virtually all structure/function claims. In its comments, GMA noted the importance to its members of structure/function claims for all food products including dietary supplements. "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 FDA," said Dr. Stacey Zawel, GMA, vice president, Scientific and Regulatory Affairs. The consumer group Citizens for Health, which spearheaded opposition to the proposed rules, said the rules would outlaw label claims that promise relief from headaches, joint pain, hot flashes, etc. Another consumer group, the Council for Responsible Nutrition, asked FDA to establish a Dietary Supplements Advisory Committee to help the agency develop guidance on issues related to these products. It said a statement of regulatory guidance would be more appropriate and beneficial than a formal rule.

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