Gardner v. Toilet Goods Association

The Color Additive Amendments of 1960 (the CAA), 21 U.S.C. §§ 321-76, required all color additives to be cleared and each batch certified as a matter of public safety. A color additive that did not satisfy these requirements was considered unsafe and adulterated, and anyone who placed such additives into the market was subject to injunctions, criminal penalties, and seizure of goods. The CAA authorized the Secretary of Health, Education, and Welfare, Gardner (defendant), and the Commissioner of Food and Drugs (Commissioner) to implement regulations giving effect to these requirements. The Commissioner issued a rule that all diluents, which are color additive mixtures that are not themselves color additives, were subject to the CAA. The Commissioner determined that any substance intended only to color the human body, like most makeup, was a color additive within the meaning of the CAA. Lastly, while hair dyes were exempt from certain regulations if the labels included a notice instructing the user to conduct a patch test to check for skin irritation, the Commissioner nevertheless concluded that if patch testing did not provide a safeguard, the exemption was inapplicable. Multiple producers (plaintiffs) of goods that fall within the Commissioner’s definition of color additives filed a pre-enforcement suit to enjoin the regulations. The government asserted that such a challenge was improper before enforcement had occurred, but the plaintiffs asserted that unnecessary compliance would cost tens of millions of dollars, and noncompliance would subject them to severe penalties. The district court and the United States Court of Appeals for the Second Circuit held that a pre-enforcement suit was proper, and the government petitioned the United States Supreme Court for review.