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Assume that the Food and Drug Administration (FDA), using proper procedures, ado

ID: 457600 • Letter: A

Question

Assume that the Food and Drug Administration (FDA), using proper procedures, adopts a rule covering future investigations involv-ing the FDA’s regulation of food additives. According to the new rule, the FDA will not regulate food additives without giving food companies an opportunity to cross-examine witnesses. Some time later, the FDA regulates methylisocyanate, a food additive. In its investigation of methylisocyanate, the FDA has not allowed producers to cross-examine witnesses. Producers protest, saying that the FDA promised cross-examination. The FDA responds that the Administrative Procedure Act does not require such cross-examination and that it can freely withdraw the promise made in its new rule. If the producers challenge the FDA in a court, on what basis could the court rule in their favor?

Explanation / Answer

Case:

The court will consider first whether the agency acted and compiled procedures as per the Administrative Procedure Act (APA). FDA had stated that they would not regulate food additives without giving food companies an opportunity to cross-examine witnesses. But later, it breaches the promise and made an informal rulemaking procedure by examining methylisocyanate without cross-examination.

Law and conclusion:

The Administrative Procedure Act (APA), Pub.L. 79–404, 60 Stat. 237, enacted June 11, 1946, is the United States federal statute that “governs the way in which administrative agencies of the federal government of the United States may propose and establish regulations”.

The administrative procedure act allows agencies like FDA to make their own rule and compile it to make it legally valid and effective. FDA has adopted its new rule in the following way. Thus, FDA is bound to follow the new rules. FDA hasn’t formally rescinded the rule, thus it has breached and performed against the law. Thus, the court will rule in favor of the food producers. If the FDA had removed the rule of cross examination and had compiled with the court, the court would rule in favor of the FDA.