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HEALTH CLAIM REGULATORY ACTIONS BY STATES WOULD REQUIRE FOREWARNING PROCEDURE UNDER NOV. 27 REGS; PREEMPTION CLAUSE SETS POTENTIAL MODEL FOR OTC DRUG AREA

Executive Summary

State governments will have to file notifications to FDA a month ahead of taking any actions against companies for false health claims, according to procedures under the federal preemption provision spelled out in the Nov. 27 Federal Register rules for nutritional labeling. Establishing procedures for the 30-day notification called for by the 1990 Nutritional Labeling and Education Act, the Nov. 27 proposed rule describes the content and "standard format" of the letters required from the states to FDA. The notification to FDA is described as a "bare bones" statement which will permit a rapid assessment and response by FDA. A state preparing a health claims action would have to explain briefly to FDA "the reason for and type of anticipated State enforcement" as well as the "specific products covered by the notification [and] the type and size of each product container." The proposed rules say that "this information will enable FDA to quickly review the proposed State action and to determine whether the agency is contemplating, or has undertaken, action against the food in question, or would undertake action in light of the facts brought to its attention by the State." If FDA does not agree with the proposed action by a state, then the agency can override the planned state action. "If FDA advises a state that its proposed action is inconsistent with FDA's interpretation," the Nov. 27 rule states, "FDA believes section 307 of the act requires that the state conform its interpretation to FDA's." Under the amendments, FDA has 30 days to answer a notification and inform a state "whether FDA has commenced an informal or formal enforcement action pertaining to the food that is the subject of the notification" or whether the agency is already "prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled informal or formal enforcement action pertaining to such food." If FDA has commenced an enforcement action, "the state may not bring its proceeding until an additional 60 days have passed." If FDA is "diligently prosecuting a proceeding in court" or already has settled such a proceeding, "the state may not institute a proceeding." The proposal also states that "FDA retains full authority to advise states of what FDA believes is the proper interpretation of any of the sections" of the 1990 amendments to the Food, Drug & Cosmetic Act. The health claims federal preemption plan is important to the OTC drug industry as a potential model to address the objection of national uniformity of regulation. The Nonprescription Drug Manufacturers Association tried unsuccessfully to ride the preemption provision in the food labeling amendments last year and remains interested in ways to get the preemption clause extended. NDMA was invited earlier this year by Rep. Dingell (D-Mich.) to consider pushing for national uniformity under the pending FDA enforcement bill. No overt attempts to add that provision to the bill have been made thus far. With the nutritional labeling federal preemption rules, two classes of FDA regulated products have provisions granting FDA preeminence in regulatory decisions. The medical device amendments of 1976 gave FDA dominance with a presumption of interstate commerce for medical devices. The proposed nutritional labeling rules acknowledge that "a state may initiate enforcement proceedings under its own statute or regulations in State court" but add that "to facilitate uniformity in enforcement, FDA encourages states to discuss their State-court enforcement activities with the local FDA district office." The rules say that "continued close cooperation between FDA and State regulatory agencies will ensure that the goals of uniformity and certainty underlying the act are met."

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