GARDNER V. TOILET GOODS ASSOCIATION
387 U.S. 167 (1967)
NATURE OF THE CASE: Gardner (D) by delegation from the Secretary of Health, Education,
and Welfare, issued three regulations under the Color Additive Amendments of 1960 to the
Federal Food, Drug, and Cosmetic Act. Toilet (P) challenge in a pre-enforcement action on
the ground that D impermissibly expanded the reach of the statute. The regulations (1)
amplified the statutory definition of color additives by including diluents therein, (2)
included certain cosmetics within the scope of color additives, and (3) limited the
exemption for hair dyes to those as to which the 'patch test' is effective and excluded from
the exemption certain components other than the coloring ingredient of the dye. The Court of
Appeals affirmed the District Court's judgment that it had jurisdiction to hear the suit.
The Supreme Court granted certiorari.
FACTS: The Secretary of Health, Education, and Welfare and his delegate, the Commissioner
of Food and Drugs, can prescribe conditions for the use of color additives in foods, drugs,
and cosmetics. The Act requires clearance of every color additive in the form of a
regulation prescribing conditions for use of that particular additive, and also
certification of each 'batch' unless exempted by regulation. A color additive is defined as
a dye, pigment, or other substance . . . [which] when added or applied to a food, drug, or
cosmetic, or to the human body or any part thereof, is capable (alone or through reaction
with other substance) of imparting color thereto. Under his rule making authority D
amplified the statutory definition to include as color additives all diluents, that is, any
component of a color additive mixture that is not of itself a color additive and has been
intentionally mixed therein to facilitate the use of the mixture in coloring foods, drugs,
or cosmetics or in coloring the human body. P claims this is unlawful as the expanded the
number of items must comply with the pre-marketing clearance procedure. In Toilet Goods
Assn. v. Gardner, the Court affirmed a judgment of the Court of Appeals for the Second
Circuit holding that judicial review of a regulation concerning inspection of cosmetics
factories was improper in a pre-enforcement suit for injunctive and declaratory judgment
relief. The present case is brought here by D seeking review of the Court of Appeals'
further holding that review of three other regulations in this type of action was proper.
ISSUE:
RULE OF LAW:
HOLDING AND DECISION:
LEGAL ANALYSIS:
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