Source: https://supreme.justia.com/cases/federal/us/387/158/case.html
Timestamp: 2018-06-20 22:44:30
Document Index: 768969145

Matched Legal Cases: ['§ 701', '§ 2201', '§ 8', '§ 704', '§ 374', '§ 10', '§ 704', '§ 701', '§ 130', '§ 10', '§ 706']

Toilet Goods Assn., Inc. v. Gardner, (full text) :: 387 U.S. 158 (1967) :: Justia US Supreme Court Center
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Toilet Goods Assn., Inc. v. Gardner,
In our decisions reversing the judgment in Abbott Laboratories, ante, p. 387 U. S. 136 and affirming the judgment in Gardner v. Toilet Goods Assn., post, p. 387 U. S. 167, 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
28 Fed.Reg. 6445-6446; 21 CFR § 8.28. [Footnote 1]
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.
As to the first of these factors, we agree with the Court of Appeals that the legal issue, as presently framed, is not appropriate for judicial resolution. This is not because the regulation is not the agency's considered and formalized determination, for we are in agreement with petitioners that, under this Court's decisions in Frozen Food Express v. United States, 351 U. S. 40, and United States v. Storer Broadcasting Co., 351 U. S. 192, there can be no question that this regulation -- promulgated in a formal manner after notice and evaluation of submitted comments -- is a "final agency action" under § 10 of the Administrative Procedure Act, 5 U.S.C. § 704.
See Abbott Laboratories v. Gardner, ante, p. 387 U. S. 136. Also, we recognize the force of petitioners' contention that the issue as they have framed it presents a purely legal question: whether the regulation is totally beyond the agency's power under the statute, the type of legal issue that courts have occasionally dealt with without requiring a specific attempt at enforcement, Columbia Broadcasting System v. United States, 316 U. S. 407; cf. Pierce v. Society of Sisters, 268 U. S. 510, or exhaustion of administrative remedies, Allen v. Grand Central Aircraft Co., 347 U. S. 535; Skinner & Eddy Corp. v. United States, 249 U. S. 557.
These points which support the appropriateness of judicial resolution are, however, outweighed by other considerations. The regulation serves notice only that the Commissioner may, under certain circumstances, order inspection of certain facilities and data, and that further certification of additives may be refused to those who decline to permit a duly authorized inspection until they have complied in that regard. At this juncture, we have no idea whether or when such an inspection will be ordered and what reasons the Commissioner will give to justify his order. The statutory authority asserted for the regulation is the power to promulgate regulations "for the efficient enforcement" of the Act, § 701(a). Whether the regulation is justified thus depends not only, as petitioners appear to suggest, on whether Congress refused to include a specific section of the Act authorizing such inspections, although this factor is, to be sure, a highly relevant one, but also on whether the statutory scheme as a whole justified promulgation of the regulation. See Wong Yang Sung v. McGrath, 339 U. S. 33, 339 U. S. 47. This will depend not merely on an inquiry into statutory purpose, but concurrently on an understanding of what types of enforcement problems are encountered by the FDA, the need for various sorts of supervision in order to effectuate
the goals of the Act, and the safeguards devised to protect legitimate trade secrets (see 21 CFR § 130.14(c)). We believe that judicial appraisal of these factors is likely to stand on a much surer footing in the context of a specific application of this regulation than could be the case in the framework of the generalized challenge made here.
We are also led to this result by considerations of the effect on the petitioners of the regulation, for the test of ripeness, as we have noted, depends not only on how adequately a court can deal with the legal issue presented, but also on the degree and nature of the regulation's present effect on those seeking relief. The regulation challenged here is not analogous to those that were involved in Columbia Broadcasting System, supra, and Storer, supra, and those other color additive regulations with which we deal in Gardner v. Toilet Goods Assn., post, p. 387 U. S. 167, where the impact of the administrative action could be said to be felt immediately by those subject to it in conducting their day-to-day affairs. See also Federal Communications Comm'n v. American Broadcasting Co., 347 U. S. 284.
of inspection. Unlike the other regulations challenged in this action, in which seizure of goods, heavy fines, adverse publicity for distributing "adulterated" goods, and possible criminal liability might penalize failure to comply, see Gardner v. Toilet Goods Assn., post, p. 387 U. S. 167, a refusal to admit an inspector here would, at most, lead only to a suspension of certification services to the particular party, a determination that can then be promptly challenged through an administrative procedure, [Footnote 2] which in turn is reviewable by a court. [Footnote 3] Such review will provide an adequate forum for testing the regulation in a concrete situation.
the regulation. [Footnote 4] Whether or not this assumption is correct, given the fact that only minimal, if any, adverse consequences will face petitioners if they challenge the regulation in this manner, we think it wiser to require them to exhaust this administrative process through which the factual basis of the inspection order will certainly be aired and where more light may be thrown on the Commissioner's statutory and practical justifications for the regulation. Compare Federal Security Adm'r v. Quaker Oats Co., 318 U. S. 218. [Footnote 5] Judicial review will then be available, and a court at that juncture will be in a better position to deal with the question of statutory authority. Administrative Procedure Act § 10(e)(B)(3), 5 U.S.C. § 706(2)(C).
[For concurring opinion of MR. JUSTICE FORTAS, see post, p. 387 U. S. 174.]