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Executive Summary

FOOD HEALTH CLAIMS REGULATION PROVIDED IN FDA DRAFT PROPOSAL which has left the agency for a topside review in the Health and Human Services Department and the Office of Management and Budget. The draft proposal will allow the agency to take regulatory action against particularly fraudulent health claims for foods, although it will not bar health claims. OMB is reportedly being informally consulted by HHS in order to facilitate release of the draft proposal, or "reproposal" as the agency is calling it. The new document is a reworked version of a 1988 FDA draft final rule which never cleared OMB. The reproposal will supersede a 1987 proposed rule which has led to some of the potentially misleading disease-prevention claims currently in the marketplace. FDA's 1988 draft final rule would have allowed health claims but also established a set of procedures to ensure the acceptability of health messages linking calcium and osteoporosis; sodium and hypertension; lipids and heart disease; lipids and cancer; and fiber and cancer. The procedures include model label statements as well as scientific summaries, consumer health message summaries and a consumer guide to food labeling. FDA is anxious to get the new proposal out in order to avoid future legal tangles like the problem involving heart-disease prevention claims for the food supplement, Exachol. In July, a New York federal court denied an FDA request for summary judgment in its motion for seizure action against Exachol based on the fact that the agency had deferred regulatory action, under the 1987 proposal, against such products as Kellogg's All Bran cereal, which made similar claims. FDA also apparently expects to assuage recent criticism it has received for allowing the current proliferation of food claims linking ingredients to disease prevention. The proposal will serve as an interim measure while the agency continues to develop a more comprehensive food labeling policy. An initial proposal articulating the food labeling policy is not expected before the spring of 1990. The development of the draft proposal closely follows a series of Congressional oversight hearings on FDA's inaction against potentially misleading health claims for foods. FDA Commissioner Young promised the interim proposal at an Oct. 31 hearing by Rep. Weiss' (D-N.Y.) House Government Operations/Intergovernmental Relations Subcommittee ("The Pink Sheet" Oct. 31, p. 9). At a subsequent day of hearings on Nov. 9, OMB Office of Information and Regulatory Affairs Acting Director James MacRae indicated the office's willingness to clear an agency proposal to address misleading health claims ("The Pink Sheet" Nov. 13, p. 6). In a statement responding to the FDA draft, Weiss indicated the proposal does not go far enough toward restricting food claims. "Our committee concluded in 1988 that FDA's current health claims policy violates the federal law that requires FDA to approve any products making a disease-prevention claim prior to marketing," he said, adding: "FDA's new proposal suffers from the same legal problem." The subcommittee chairman maintained that "Congress should allow such claims only if it provides FDA with adequate resources to review claims and effectively police the marketplace." He continued: "Until FDA is adequately armed to protect consumers from deceptive labels, health claims do far more harm than good."

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