Nature of the Case
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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 the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto. Under his rulemaking 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.
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