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Executive Summary

FDA's FOOD HEALTH CLAIMS RECORD ATTACKED AS EVIDENCE OF OMB (Office of Management & Budget) intrusion into FDA regulatory prerogatives. In a Nov. 16 report authored by the House Government Operations Committee, OMB is accused of stepping into FDA's regulatory decisionmaking "at virtually every step" in the process for food health claims. The agency "kowtowed" to OMB on every complaint, the Hill report alleges. The report is entitled "FDA's Continuing Failure to Prevent Deceptive Health Claims for Foods"; it is based on investigations conducted by the Human Resources and Intergovernmental Relations Subcommittee, chaired by Rep. Weiss (D-N.Y.). The Weiss report contends that OMB's influence on the health claims issue restructures "the regulatory chain of command." Ever since OMB forbade FDA from taking regulatory action against Kellogg's All-Bran [cereal] in 1984, food companies have flooded the marketplace with a barrage of false and misleading health claims. In the process, FDA's regulatory powers have been "neutered," the House report asserts. The charges against OMB are significant as part of the swelling interest on Capitol Hill in giving FDA structural autonomy within the Executive Branch. Other top Hill aides have recently mentioned the autonomy issue as a prominent Congressional interest (see related story, p. 8). If Capitol Hill sets out to correct what it views as undue influence with a legislative fix, it may create other problems for FDA. The majority of former FDA top officials commenting on the agency's autonomy have stressed that FDA's position within HHS and the Public Health Service is generally a positive factor for agency managers ("The Pink Sheet" July 23, p. 4). Too broad an attack on OMB oversight could damage other useful relationships. Painting a picture of intrusion, the Weiss report contends that, in 1988, "OMB prevented FDA from publishing" a final rule that would have placed greater restrictions on health claims. The report adds that "OMB's assertion that it merely provides advice that agencies are free to ignore is, at best, disingenuous." OMB's authority to review regulations was created by Executive Orders 12291 and 12498 signed by President Reagan in the early 1980s. Among its recommendations, the committee would like the HHS Secretary to instruct FDA to "prohibit" all disease-specific health claims until a final rule allowing those claims is promulgated, and until "sufficient enforcement resources are made available to regulate false or misleading health claims." FDA is directed to report back to the committee within 30 days "about all actions it will take to implement this recommendation, including an analysis of [FDA Center for Food Safety and Applied Nutrition] CFSAN's resource needs." FDA believes the recently enacted Nutrition Labeling and Education Act (P.L. 101-535) will probably require the withdrawal and reissuance of the agency's February 1990 food claims regulation. The new legislation differs significantly from the currently proposed regulation. Signed into law Nov. 8, the new statute states that a claim may be allowed only if other nutrients are not present in amounts that increase the risk of health-related conditions or disease ("The Pink Sheet, Oct. 29, T&G-3). While OMB was reviewing the 1988 draft final rule, the report concludes that some manufacturers "exploited the weaknesses in the 1987 proposal by placing deceptive health claims on product labels that FDA failed to take any enforcement action against." OMB's review of the document took eight months. One example of products with claims cited in the report as misleading was the General Mills' psyllium-containing cereal Benefit, introduced last year and promoted as a cholesterol lowerer. Benefit was taken off the market after less than a year. "The psyllium health claims presented FDA with the clearest case imaginable of a disease prevention claim transforming a food into a unapproved new drug" under the Food, Drug and Cosmetic Act, the report contends. "FDA's failure to take any regulatory action against these claims is inexcusable." FDA issued a new proposed rule governing health claims on food labels on Feb. 13, 1990 ("The Pink Sheet" Dec. 18, 1989, T&G-7). The proposal was a reworked version of the 1988 draft final rule that never cleared OMB. The report asserts that the net effect of the reissuance "is one of tremendous delay." The draft reproposal followed a series of hearings conducted by the Weiss subcommittee. At one hearing, the subcommittee elicited a promise from FDA Commissioner Young that the proposal was forthcoming quickly. OMB subsequently assured the subcommittee that it was willing to clear an agency proposal addressing misleading food health claims. The committee report also criticizes FDA for having "serious internal communication problems," stating that "it took one full year" for FDA's Center for Food Safety and Applied Nutrition (CFSAN) to find out that the agency's Center for Drug Evaluation and Research had rejected health claims similar to those used by Benefit for the psyllium-based OTC laxatives. Metamucil maker Procter & Gamble and Fiberall maker Ciba-Geigy have both been trying since 1987 to get FDA to include cholesterol-lowering claims in the OTC laxative monograph.(ITEM 200)#000126M001NFW1TT# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1990 F-D-C Reports, Inc., The Pink Sheet, November 26, 1990



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