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 pre-enforcement suit, that a case and controversy existed, that
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, and the Toilet Goods Association and other plaintiffs in the present case. We granted certiorari in both instances, 385 U.S. 813, as we did in Abbott Laboratories v. Gardner, No. 39, 383 U.S. 924, 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, ante, p. 136, and affirming the judgment in Gardner v. Toilet Goods Assn., post, p. 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
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:
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 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.
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, 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
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. 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.
This is not a situation in which primary conduct is affected—when contracts must be negotiated, ingredients tested or substituted, or special records compiled. This regulation merely states that the Commissioner may authorize inspectors to examine certain processes or formulae; no advance action is required of cosmetics manufacturers, who since the enactment of the 1938 Act have been under a statutory duty to permit reasonable inspection of a "factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials; containers, and labeling therein." § 704 (a). Moreover, no irremediable adverse consequences flow from requiring a later challenge to this regulation by a manufacturer who refuses to allow this type
It is true that the administrative hearing will deal with the "factual basis" of the suspension, from which petitioners infer that the Commissioner will not entertain and consider a challenge to his statutory authority to promulgate
For these reasons the judgment of the Court of Appeals is
MR. JUSTICE DOUGLAS dissents for the reasons stated by Judge Tyler of the District Court, 235 F.Supp. 648, 651-652.
MR. JUSTICE BRENNAN took no part in the consideration or decision of this case.
[For concurring opinion of MR. JUSTICE FORTAS, see post, p. 174.]