US SUPREME COURT DECISIONS

The Commissioner of Food and Drugs, 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, which the respondents challenge in a pre-enforcement action on the ground that the Commissioner 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. See Toilet Goods Assn. v. Gardner, ante, p. 387 U. S. 158.

Held: Under the standards set forth in Abbott Laboratories v. Gardner, ante, p. 387 U. S. 136, namely, the appropriateness of the issues for judicial determination and the immediate severity of the regulations' impact on the respondents, the pre-enforcement challenge to these regulations is ripe for judicial review. Pp. 387 U. S. 170-174.

(a) The issue as framed by the parties, what general classifications of ingredients fall within the coverage of the Color Additive Amendments, is a straightforward legal one, the consideration of which would not necessarily be facilitated if it were raised in the context of a specific attempt to enforce the regulations. Pp. 387 U. S. 170-171.

(b) These regulations, which are self-executing, have an immediate and substantial impact on the respondents, providing extensive penalties and substantial preliminary paper work, scientific testing, and recordkeeping for the cosmetic manufacturers. Pp. 387 U. S. 171-174.

360 F.2d 677, affirmed. chanrobles.com-red

Page 387 U. S. 168