43.2 Rule Making TheFood and Drug Administration (FDA), a federal administrativeagency, is charged with enforcing the Food, Drug, and Cosmetic Act.This statute mandates that the FDA limit the amount of A????1poisonousor deleterious substancesA????1 in food. Pursuant to this authority, theFDA established certain A????1action levelsA????1 of unavoidablecontaminants, such as aflatoxins, in food. Food producers that sellproducts that are contaminated above the set action level aresubject to enforcement proceedings initiated by the FDA. Inannouncing these action levels, the FDA did not comply with thenotice and comment procedure required for the adoption of asubstantive or legislative rule. The FDA argued that the A????1actionlevelsA????1 are merely interpretive rules or statements of policy thatdo not require notice and comment. The Community NutritionInstitute, a consortium of consumer public interest groups, sued torequire the FDA to follow the notice and comment procedure. Whowins? Community Nutrition Institute v. Young, 260 U.S. App. D.C.294, 818 F.2d 943, Web 1987 U.S. App. Lexis 6385 (United StatesCourt of Appeals for the District of Columbia Circuit)
Cheeseman, Henry R. Business Law,VitalSource for DeVry University, 8th Edition. Pearson LearningSolutions, 02/2013. VitalBook file.