Almay, Inc. v. Califano
United States Court of Appeals for the District of Columbia Circuit
569 F.2d 674 (1977)

- Written by Alex Ruskell, JD
Facts
Almay, Inc. (plaintiff) sued the Food and Drug Administration (FDA) after the FDA initiated informal rulemaking proceedings by publishing a definition of hypoallergenic that stated a product was hypoallergenic if it caused fewer reactions than 10 percent of competing market products. Almay objected to the comparison testing method because it could not predict the composition of selected reference products. Because of this, Almay believed the definition violated the arbitrary-and-capricious standard of agency rulemaking. The district court found that the FDA’s definition was justified by consumer surveys that showed a comparative definition would be helpful to consumers because adverse reactions to cosmetic products were relatively rare. Almay appealed.
Rule of Law
Issue
Holding and Reasoning (Markey, C.J.)
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