Document: 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 al. No. 336. Argued Jan. 16, 1967. Decided May 22, Edward J. Ross, New York City, for petitioners. Nathan Lewin, Washington, D.C., respondents. Mr. Justice HARLAN delivered the opinion Court. 1 Petitioners in this case are Toilet Goods Association, an organization cosmetics manufacturers accounting some 90% annual American sales field, 39 individual distributors. They brought action United States District Court Southern seeking declaratory injunctive relief against Commissioner Food Drugs, on ground that certain regulations promulgated by exceeded his statutory authority under Color Additive Amendments to Federal Food, Drug Cosmetic Act, 74 Stat. 397, 21 U.S.C. §§ 321—376. held Act did not prohibit type preenforcement suit, a controversy existed, issues presented were justiciable, no reasons had been Government warrant declining jurisdiction discretionary grounds. 235 F.Supp. 648. Recognizing subsequent decision Appeals Third Circuit Abbott Laboratories v. Celebrezze, 352 F.2d 286, appeared conflict with its holding, reaffirmed earlier rulings but certified question Second 28 § 1292(b). affirmed judgment hear suit existed as three challenged regulations, sustained Government's contention judicial review was improper fourth. 360 677. 2 Each side below sought here from portions Appeals' adverse it, petitioner Gardner Assn., 438, 167, 1526, 704, Association other plaintiffs present case. We granted certiorari both instances, 385 813, 96, 17 53, we Gardner, 39, 383 924, 86 928, 15 844, because apparent between Circuits. two cases set argued together Laboratories. 3 In our decisions reversing Laboratories, 136, 1507, 681, affirming decided today, hold nothing Drug, 52 1040, amended, bars pre-enforcement Administrative Procedure 5 701—704 (1964 ed., Supp. II), Declaratory Judgment 2201. nevertheless agree particular regulation context is inappropriate at stage because, applying standards forth presently ripe adjudication. 4 issue 1960, 321—376, statute revised somewhat broadened control ingredients added foods, drugs, impart color them. exercising power delegated Secretary, 22 Fed.Reg. 1051, 25 8625, 'to promulgate efficient enforcement' 701(a), 371(a), issued following after due public notice, 26 679, consideration comments submitted interested parties: '(a) When t appears person has: 6 '(4) Refused permit duly authorized employees Administration free access all manufacturing facilities, processes, formulae involved manufacture additives intermediates which such derived; 'he may immediately suspend certification service continue suspension until adequate corrective has taken.' 6445—6446; CFR 8.28.1 7 petitioners maintain impermissible exercise authority, FDA long congressional authorization (see, e.g., proposed 'Drug Factory Inspection 1962,' H.R. 11581, 87th Cong., 2d Sess.; Hearings before House Committee Interstate Foreign Commerce 11581 11582, Sess., 67 74; 6788, 88th 1st Sess.), Congress always denied agency except prescription drugs. 374. Framed way, 'legal' raised, persuaded properly maintainable. 8 determining whether challenge administrative twofold inquiry must be made: first determine tendered appropriate resolution, second assess hardship parties if stage. 9 As these factors, legal framed resolution. This agency's considered formalized determination, agreement Court's Frozen Express States, 351 40, 76 569, 100 L.Ed. 910, Storer Broadcasting Co., 192, 763, 1081, there can regulation—promulgated formal manner notice evaluation 'final action' 10 704. See 681. Also, recognize force petitioners' they have it presents purely question: totally beyond statute, courts occasionally dealt without requiring specific attempt enforcement, Columbia System 316 407, 62 1194, 1563; cf. Pierce Society Sisters, 268 510, 45 571, 69 1070, or exhaustion remedies, Allen Grand Central Aircraft 347 535, 745, 98 933; Skinner & Eddy Corp. 249 557, 375, 63 772. These points support appropriateness resolution are, however, outweighed considerations. serves only circumstances order inspection fail ities data, further refused those who decline complied regard. At juncture idea when will ordered what give justify order. asserted 'for 701(a). Whether justified thus depends only, appear suggest, include section authorizing inspections, although factor sure highly relevant one, also scheme whole promulgation regulation. Wong Yang Sung McGrath, 339 33, 47, 70 445, 94 616. depend merely into purpose, concurrently understanding types enforcement problems encountered FDA, need various sorts supervision effectuate goals safeguards devised protect legitimate trade secrets (see 130.14(c)). believe appraisal factors likely stand much surer footing application than could framework generalized made here. 11 led result considerations effect regulation, test ripeness, noted, how adequately court deal presented, degree nature regulation's relief. analogous System, supra, Storer, additive where impact said felt subject conducting their day-to-day affairs. Communications Comm'n 284, 593, 699. 12 situation primary conduct affected contracts negotiated, tested substituted, special records compiled. states authorize inspectors examine processes formulae; advance required manufacturers, since enactment 1938 duty reasonable 'factory, warehouse, establishment, vehicle pertinent equipment, finished unfinished materials; containers, labeling therein.' 704(a). Moreover, irremediable consequences flow later manufacturer refuses allow inspection. Unlike action, seizure goods, heavy fines, publicity distributing 'adulterated' possible criminal liability might penalize failure comply, see refusal admit inspector would most lead services party, determination then promptly through procedure,2 turn reviewable court.3 Such provide forum testing concrete situation. 13 It true hearing 'factual basis' suspension, infer entertain consider regulation.4 assumption correct, given fact minimal, any, face manner, think wiser require them exhaust process factual basis certainly aired more light thrown Commissioner's practical justifications Compare Security Adm'r Quaker Oats 318 218, 589, 724.5 Judicial available, better position authority. 10(e)(B)(3), 706(2)(C). 14 For affirmed. Affirmed. 16 DOUGLAS dissents stated Judge Tyler Court, 648, 651—652. BRENNAN took part listings 'if extent suitable safe * *.' 706(b)(1), 376(b)(1). certification, diluents diluents, batches 706(c), 376(c). A 'deemed unsafe' unless either batch exempted requirement, 706(a), 376(a). cosmetic containing 'unsafe' deemed adulterated, 601(e), 361(e), prohibited interstate commerce. 301(a), 331(a). 8.28(b), 130.14—130.26. denial cause inconvenience possibly hardship, depending upon large supply manuac turer have, rapidly conducted, temporary remedial protective provisions, compliance reservation pending litigation, available say speculative provided information weight should attached possibility. explicit lie, Friendly suggested, Cir., F.2d, 687, appeals 701(f) 706(d) district appeal order,' 130.26, Act. 130.31; compare 505, 355. purposes necessary ascertain any denying drug manufacturer, therefore decide review. cite refusal, objections 'This law cannot resolved taking evidence hearing.' 31 7174. Davis, Law Treatise 20.03 (1958).

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