The Incremental Development of an Extra-Statutory System of Regulation: A Critique of Food and Drug Administration Regulation of Added Poisonous and Deleterious Substances

Federal regulation of added poisonous and deleterious substances in food by the Food and Drug Administration has become an administrative quagmire. Although responsibility for this situation evades precise assignment, FDA regulatory problems typically arise through the operation of three factors. First, the applicable statutory provisions are highly ambiguous, far exceeding the level of ambiguity traditionally viewed as necessary to administrative flexibility and efficiency. Even resort to the legislative history of these provisions often leaves many questions unanswered. Second, the perpetual amendment of the original Federal Food, Drug, and Cosmetic Act without the simultaneous repeal of all the inapplicable and inconsistent language generated by the resultant changes, has reduced what was intended to be a well-structured system of classification to a regulatory morass. Many of the provisions are incapable of reconciliation while others generate confusion on the basis of their individual "merit." Third, the regulatory policies of the FDA have failed to minimize the variety and magnitude of the problems flowing from an admittedly inadequate statute. Rather than exercising its power to promulgate regulations in a sincere attempt at clarification, the agency has chosen to take advantage of the statute's ambiguity to enhance its regulatory powers, often assigning strained interpretations of the statute to advance the agency's perceived goals. Although the ambiguity, frequent amendment and selective interpretation of the statute provoke serious questions as to the agency's effectiveness in carrying out its charge, they also permit the FDA to facially succeed in its current regulatory endeavors. This Comment will focus solely on the regulation of added poisonous and deleterious substances as an illustration of the illusion of structured regulation cultivated by the FDA.