Toilet Goods Association v. Finch

The federal Food, Drug, and Cosmetic Act (FDCA) generally prohibited using poisonous or deleterious substances in cosmetic products. In 1960, Congress enacted the Color Additive Amendments to the FDCA. The amendments exempted coal-tar hair dye from the poisonous-or-deleterious-substances prohibition, provided the dye’s label conspicuously stated that the product could cause skin irritation and that consumers should conduct a patch test for irritation before using the product. In 1963, the Food and Drug Administration (FDA) promulgated a regulation in response to the Color Additive Amendments. The regulation provided that a product would qualify for the statutory exemption if the product’s label conspicuously included the statutorily required caution statement and gave adequate instructions for conducting the preliminary patch test for irritation. The regulation further provided that the exemption did not extend to hair-dye products containing substances for which the caution statement was inapplicable and for which a preliminary patch test would not disclose the product’s dangers. Additionally, the regulation stated that the exemption did not apply to poisonous or deleterious diluents (i.e., diluting agents used to thin a product) that were added as components of color shampoos, rinses, tints, or other hair-color-altering cosmetics. The Toilet Goods Association and others involved in the cosmetics industry (collectively, TGA) (plaintiffs) brought an action against the FDA commissioner and the federal secretary of health, education, and welfare (collectively, the officials) (defendants) to challenge the FDA’s regulation. The district court invalidated the regulation, and the officials appealed.