Toilet Goods Association v. Ga Rdner, 336

• Court: United States Supreme Court
• Citation: 87 S.Ct. 1520,387 U.S. 158,18 L.Ed.2d 697
• Docket Number: No. 336,336
• Parties: The TOILET GOODS ASSOCIATION, Inc., et al., Petitioners, v. John W.GA RDNER, Secretary of Health, Education, and Welfare et al
• Decision Date: 22 May 1967

387 U.S. 158 87 S.Ct. 1520 18 L.Ed.2d 697 The TOILET GOODS ASSOCIATION, Inc., et al., Petitioners,

v.

John W.GA RDNER, Secretary of Health, Education, and Welfare et al.

No. 336. Argued Jan. 16, 1967. Decided May 22, 1967.

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Edward J. Ross, New York City, for petitioners.

Nathan Lewin, Washington, D.C., for respondents.

Mr. Justice HARLAN delivered the opinion of the Court.

Petitioners in this case are the Toilet Goods Association, an organization of cosmetics manufacturers accounting for some 90% of annual American sales in this field, and 39 individual cosmetics manufacturers and distributors. They brought this action in the United States District Court for the Southern District of New York seeking declaratory and injunctive relief against the Secretary of Health, Education, and Welfare and the Commissioner of Food and Drugs, on the ground that certain regulations promulgated by the Commissioner exceeded his statutory authority under the Color Additive Amendments to the Federal Food, Drug and Cosmetic Act, 74 Stat. 397, 21 U.S.C. §§ 321—376. The District Court held that the Act did not prohibit this type of preenforcement suit, that a case and controversy existed, that

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the issues presented were justiciable, and that no reasons had been presented by the Government to warrant declining jurisdiction on discretionary grounds. 235 F.Supp. 648. Recognizing that the subsequent decision of the Court of Appeals for the Third Circuit in Abbott Laboratories v. Celebrezze, 352 F.2d 286, appeared to conflict with its holding, the District Court reaffirmed its earlier rulings but certified the question of jurisdiction to the Court of Appeals for the Second Circuit under 28 U.S.C. § 1292(b). The Court of Appeals affirmed the judgment of the District Court that jurisdiction to hear the suit existed as to three of the challenged regulations, but sustained the Government's contention that judicial review was improper as to a fourth. 360 F.2d 677.

Each side below sought review here from the portions of the Court of Appeals' decision adverse to it, the Government as petitioner in Gardner v. Toilet Goods Assn., No. 438, 387 U.S. 167, 87 S.Ct. 1526, 18 L.Ed.2d 704, and the Toilet Goods Association and other plaintiffs in the present case. We granted certiorari in both instances, 385 U.S. 813, 87 S.Ct. 96, 17 L.Ed.2d 53, as we did in Abbott Laboratories v. Gardner, No. 39, 383 U.S. 924, 86 S.Ct. 928, 15 L.Ed.2d 844, because of the apparent conflict between the Second and Third Circuits. The two Toilet Goods cases were set and argued together with Abbott Laboratories.

In our decisions reversing the judgment in Abbott Laboratories, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681, and affirming the judgment in Gardner v. Toilet Goods Assn., 387 U.S. 167, 87 S.Ct. 1526, 18 L.Ed.2d 704, both decided today, we hold that nothing in the Food, Drug, and Cosmetic Act, 52 Stat. 1040, as amended, bars a pre-enforcement suit under the Administrative Procedure Act, 5 U.S.C. §§ 701—704 (1964 ed., Supp. II), and the Declaratory Judgment Act, 28 U.S.C. § 2201. We nevertheless agree with the Court of Appeals that judicial review of this particular regulation in this particular context is inappropriate at this stage because, applying

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the standards set forth in Abbott Laboratories v. Gardner, the controversy is not presently ripe for adjudication.

The regulation in issue here was promulgated under the Color Additive Amendments of 1960, 74 Stat. 397, 21 U.S.C. §§ 321—376, a statute that revised and somewhat broadened the authority of the Commissioner to control the ingredients added to foods, drugs, and cosmetics that impart color to them. The Commissioner of Food and Drugs, exercising power delegated by the Secretary, 22 Fed.Reg. 1051, 25 Fed.Reg. 8625, under statutory authority 'to promulgate regulations for the efficient enforcement' of the Act, § 701(a), 21 U.S.C. § 371(a), issued the following regulation after due public notice, 26 Fed.Reg. 679, and consideration of comments submitted by interested parties:

'(a) When t appears to the Commissioner that a person has:

'(4) Refused to permit duly authorized employees of the Food and Drug Administration free access to all manufacturing facilities, processes, and formulae involved in the manufacture of color additives and intermediates from which such color additives are derived; 'he may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken.' 28 Fed.Reg. 6445—6446; 21 CFR § 8.28.¹

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The petitioners maintain that this regulation is an impermissible exercise of authority, that the FDA has long sought congressional authorization for free access to facilities, processes, and formulae (see, e.g., the proposed 'Drug and Factory Inspection Amendments of 1962,' H.R. 11581, 87th Cong., 2d Sess.; Hearings before the House Committee on Interstate and Foreign Commerce on H.R. 11581 and H.R. 11582, 87th Cong., 2d Sess., 67 74; H.R. 6788, 88th Cong., 1st Sess.), but that Congress has always denied the agency this power except for prescription drugs. § 704, 21 U.S.C. § 374. Framed in this way, we agree with petitioners that a 'legal' issue is raised, but nevertheless we are not persuaded that the present suit is properly maintainable.

In determining whether a challenge to an administrative regulation is ripe for review a twofold inquiry must be made: first to determine whether the issues tendered are appropriate for judicial resolution, and second to assess the hardship to the parties if judicial relief is denied at that stage.

As to the...