Gardner v. Toilet Goods Association

Under the Color Additive Amendments, the FDA Commissioner (defendant) issued rules expanding the definition of regulated color additives to cover diluents and cosmetics intended solely to color the body, and limited a hair-dye labeling exemption where patch testing wouldn't actually safeguard against irritation. Cosmetics producers (plaintiffs) subject to these expanded rules sued before any enforcement action, arguing the Commissioner exceeded his authority; compliance would cost tens of millions of dollars, while noncompliance risked injunctions, seizures, and criminal penalties. The lower courts allowed the pre-enforcement challenge to proceed, and the government sought Supreme Court review.