US SUPREME COURT DECISIONS

Pursuant to the Color Additive Amendments of 1960 to the Federal Food, Drug, and Cosmetic Act, the Commissioner of Food and Drugs, by delegation from the Secretary of Health, Education, and Welfare, issued a regulation which provided that, where a person has refused to permit Food and Drug employees free access to all manufacturing facilities and processes used in preparing color additives, the Commissioner

"may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken."

Petitioners, cosmetics distributors, manufacturers, and an association of cosmetics manufacturers, challenged this regulation and three others on the ground that the Commissioner exceeded his authority under the Act, and maintained that this regulation is impermissible, since the Food and Drug Administration has long sought congressional authorization for free access to facilities, processes and formulae, which was denied except for prescription drugs. The District Court held that the Act did not prohibit this type of pre-enforcement action, that a case and controversy existed, that the issues were justiciable, and that the Government presented no reasons to warrant declining jurisdiction on discretionary grounds. In light of a later conflicting decision by the Court of Appeals for the Third Circuit in Abbott Laboratories v. Celebrezze, 352 F.2d 286, the District Court reaffirmed its rulings, but certified the question of jurisdiction to the Court of Appeals for the Second Circuit. The Court of Appeals sustained the Government's contention that judicial review was improper as to the regulation involved here, although it affirmed the District Court's judgment that it had jurisdiction as to the other challenged regulations.

Held: Pre-enforcement judicial review of the regulation involved here is not appropriate as the controversy is not ripe for adjudication under the standards set forth in Abbott Laboratories v. Gardner, ante, p. 387 U. S. 136. Pp. 387 U. S. 160-166. chanrobles.com-red

Page 387 U. S. 159

(a) The legal issue as presently framed is not appropriate for judicial resolution, as it is not known whether or when the Commissioner will order an inspection, what reasons he will give to justify his order, and whether the statutory scheme as a whole, notwithstanding Congress' refusal to include a specific statutory section authorizing such inspections, justified promulgation of the regulation. Pp. 387 U. S. 162-164.

(b) The regulation will not affect the primary conduct of petitioners' business, and, since only minimal, if any, adverse consequences will face petitioners if they challenge the regulation upon enforcement, they should exhaust the administrative process before obtaining judicial review. Pp. 387 U. S. 164-166.

360 F.2d 677, affirmed.