Rule Making The Food and Drug Administration (FDA), a federal administrative agency, is charged with enforcing the Food, Drug, and Cosmetic Act. This statute mandates that the FDA limit the amount of poisonous or deleterious substances in food. Pursuant to this authority, the FDA established certain action levels of unavoidable contaminants, such as aflatoxins, in food. Food producers that sell products that are contaminated above the set action level are subject to enforcement proceedings initiated by the FDA. In announcing these action levels, the FDA did not comply with the notice and comment procedure required for the adoption of a substantive or legislative rule. The FDA argued that the action levels are merely interpretive rules or statements of policy that do not require notice and comment. The Community Nutrition Institute, a consortium of consumer public interest groups, sued to require the FDA to follow the notice and comment procedure. Who wins? Community Nutrition Institute v. Young, 260 U.S. App. D.C. 294, 818 F.2d 943, Web 1987 U.S. App. Lexis 6385 (United States Court of Appeals for the District of Columbia Circuit)
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Cheeseman, Henry R. Business Law, VitalSource for DeVry University, 8th Edition. Pearson Learning Solutions, 02/2013. VitalBook file.