Quimbee logo
DMCA.com Protection Status
From our private database of 16,300+ case briefs...

Gardner v. Toilet Goods Association

United States Supreme Court
387 U.S. 167 (1967)


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.

Rule of Law


Holding and Reasoning (Harlan, J.)

Concurrence/Dissent (Fortas, J.)

What to do next…

  1. Unlock this case brief with a free (no-commitment) trial membership of Quimbee.

    You’ll be in good company: Quimbee is one of the most widely used and trusted sites for law students, serving more than 97,000 law students since 2011. Some law schools—such as Yale, Vanderbilt, Berkeley, and the University of Illinois—even subscribe directly to Quimbee for all their law students. Read our student testimonials.

  2. Learn more about Quimbee’s unique (and proven) approach to achieving great grades at law school.

    Quimbee is a company hell-bent on one thing: helping you get an “A” in every course you take in law school, so you can graduate at the top of your class and get a high-paying law job. We’re not just a study aid for law students; we’re the study aid for law students. Read more about Quimbee.

Here's why 370,000 law students have relied on our case briefs:

  • Written by law professors and practitioners, not other law students. 16,300 briefs, keyed to 223 casebooks. Top-notch customer support.
  • The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
  • Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
  • Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.

Questions & Answers

Have a question about this case?

Sign up for a free 7-day trial and ask it

Sign up for a FREE 7-day trial