Document: 387 U.S. 167 87 S.Ct. 1526, 1530 18 L.Ed.2d 704 The TOILET GOODS ASSOCIATION, Inc., et al., Petitioners,v.John W. GARDNER, Secretary of Health, Education, and Welfare al. ABBOTT LABORATORIES Petitioners, v. John Nos. 336, 39, 438. Supreme Court the United States Decided May 22, 1967, 29, 1967. Nathan Lewin, Washington, D.C., for petitioners. Edward J. Ross, New York City, respondents. Mr. Justice HARLAN delivered opinion Court. 1 In Toilet Goods Assn. Gardner, 158, 1520, 697, we affirmed a judgment Appeals Second Circuit holding that judicial review regulation concerning inspection cosmetics factories was improper in pre-enforcement suit injunctive declaratory relief. present case is brought here by Government seeking Appeals' further three other regulations this type action proper. 360 F.2d 677. We likewise affirm. 2 For reasons stated our Abbott Laboratories 136, 1507, 68, find nothing Federal Food, Drug, Cosmetic Act, (52 Stat. 1040, as amended), 21 U.S.C. § 301 seq., precludes resort to courts preenforcement relief under Administrative Procedure 5 §§ 701—704 (1964 ed., Supp. II), Declaratory Judgment 28 2201. And follow, believe correct District did not err when it refused dismiss complaint with respect these regulations. 3 challenged were promulgated Color Additive Amendments 1960, 74 397, 321 376. These statutory provisions, brief, allow his delegate, Commissioner Food Drugs, 22 Fed.Reg. 1051, 25 8625, prescribe conditions use color additives foods, drugs, cosmetics. Act requires clearance every additive form prescribing particular additive, also certification each 'batch' unless exempted regulation. A defined 'a dye, pigment, or substance * (which) added applied food, drug, cosmetic, human body any part thereof, capable (alone through reaction substance) imparting thereto *,' 321(t)(1). 4 Under general rule-making power, 701(a), 371(a), amplified definition include all diluents, is, 'any component mixture itself has been intentionally mixed therein facilitate coloring drugs body.' CFR 8.1(m). By including diluents additives, respondents' view unlawfully expanded number items must comply premarketing procedure. included within coverage statute 'substance that, results function purely incidental its intended use, such deodorants. Lipstick, rouge, eye makeup colors, related are 'color additives." 8.1(f). Respondents alleged promulgating again impermissibly reach beyond clear intention Congress. 6 third respondents concerns exemption hair dyes conform requirement set out 601(e), 361(e). That provides totally exempt from if they display certain cautionary notice on their labels 'patch test' determine whether dye will cause skin irritation user. Commissioner's recognizes applies Amendments, but goes declare: 'If poisonous deleterious 'hair dye' one which caution inapplicable patch-testing no safeguard, does apply; nor extend may be introduced wetting agents, conditioners, emulsifiers, components shampoo, rinse, tint, similar dual-purpose alter hair.' 8.1(u). 7 contend too irreconcilable statute: whereas grants an across-the-board meeting patch-test requirement, purports limit cover only those test 'effective.' Moreover, said, appears coor ing ingredient require dye. 8 agree challenge ripe standards elaborated supra, namely appropriateness issues determination immediate severity regulations' impact upon plaintiffs. 9 issue framed parties straightforward legal one: what classifications ingredients fall Amendments? Both distribution forbidden (1) listed Drug Administration safe prescribed conditions, (2) comes 'certified' batch, specifically requirement. question raised sort additives.' outlined above purport elaborate definition; term classes items, e.g., finished cosmetics, dyes, assert purview at all. situation consideration underlying would necessarily facilitated context specific attempt enforce regulations.1 Rather, 'to extent apply requirements broad categories like products non-coloring define hair-dye exemption, appear, prima facie, susceptible reasoned comparison mandate without inquiry into factual ought first ventilated before agency.' 685. 10 bar posture. supra; Storer Broadcasting Co., 351 192, 76 763, 100 L.Ed. 1081; Frozen Express States, 40, 569, 730. 11 This result supported well fact self-executing, have substantial See 386 pp. 152—153, 1517—1518. noted earlier, prescribes penalties goods containing cleared both listing batch. Faced placed quandary. On hand can, suggests, refuse comply, continue distribute do defending against government criminal, seizure, suits them. proposed avenue beset impediments rendering inadequate satisfactory alternative action. 12 manufacturers might subject extensive. meet procedure declared 'unsafe,' 706(a), 376(a), hence 'adulterated,' 601, It 'prohibited act' introduce material commerce, 301, 331, subjec t o injunction, 302, 332, criminal penalties, 303, 333, seizure goods, 304(a), 334(a). price noncompliance limited formal penalties. note importance public good industry, reason fear disastrous announcement seized 'adulterated.' 13 challenging course, submit various embraced them clearance. cannot say record burden course than substantial, accepting, motion pleadings, allegations supporting affidavits true. area separate petitions 8.1(f), 8.1(m), 8.4(c), initial fee, refunds, $2,600, listing. 8.50(c). One respondent Kolmar Laboratories, submitted Court, asserted more 2,700 different formulae cost some $7,000,000 fees alone. According company uses 264 well. obtained mere application Physical chemical tests made petition, up $42,000,000. Detailed records maintained ingredient, 8.26, batches ultimately certified, 8.51. 14 Whether estimates exaggerated2 quite respondents, failing stage, elect await ultimate validity subsequent litigation, amount preliminary paper work, scientific testing, recordkeeping substantial. found denying dismiss: 'I conclude practical business sense plaintiffs threatened irreparable injury obviously consequences regulations, later piecemeal resolution controversy individual enforcement proceedings costly inefficient, represented defendants.' 235 F.Supp. 648, 651. 15 Like Appeals, think supports findings conclusions. shown governmental interest should lead us conclusion reached case. hold maintainable. 16 Affirmed. 17 BRENNAN took decision FORTAS, whom THE CHIEF JUSTICE CLARK join, concurring No. dissenting 39 19 I am agreement affirm authority promulgate there involved (hereinafter referred 'access' regulation) issued 1960 Act. 321—376. afford employees agency access manufacturing facilities, processes, manufacture intermediates, Drugs 'may immediately suspend service' so long denied. 6446, 8.28. 20 am, however, compelled dissent decisions 681, 438, Gardner Assn., 167, 704. cases involve 52 amended, seq. arises 1960. implements (the 'definition' regulations). amendments adopted 1962 requiring 'every time' proprietary trade-mark name drug printed materials, 'established' generic accompany regulation). considered constitutional questions. rest right time because lacks matters involved, procedures arbitrary unreasonable. Its based solely claim ground erroneous exercises agency's power. point two authorizes threshold injunction operation entirety reference situations. With respect, established principles jurisprudence, solidly rooted structure Government, intervene administrative process facts gross, shotgun fashion. governing law permit 336. none interference warranted fashion, test—on free-wheeling basis—whether content intendment. contrary dictated proper regard purpose regulatory effective administration; salutary rule pass concrete, questions particularized setting rather divorced facts. 23 today's opened Pandora's box. injunctions now threaten programs vast welfare. Court's strikes progras health. dangerous precedent even further. cold comfort—it little delusion—to read 'It scarcely doubted court postpone date could show delay detrimental health safety.' Experience dictates, contrary, can hardly hoped federal judge somewhere moved here, cries anguish distress regulated, grant disruptive injunction. 24 difference between majority me existence jurisdiction enjoin, occasions invoked. doubt residual power extreme situations enjoin actions absence provision where acted unconstitutionally jurisdiction—as distinguished allegedly But opinions 438 appear proceed principle exercise permissible Congress explicitly prohibited it, provided 'ripe' determination. novel breadth destructive implications illustrated application. As approach improperly unwisely gives district judges roving commission halt process, basis abstractions generalities instead concrete situations, broadens license means method statute. Act1 fundamental jurisprudence2 insist final, substantive seriously affects personal property rights. But, '(a)ll aside, how rights creates shall enforced. specification remedy normally excludes another.' Switchmen's Union North America National Mediation Board, 320 297, 64 95, 97, 88 61 (1943). Where review, requisite showing induce otherwise bring program customary hardships interim compliance. At least lack denial procedural due lie absent demonstration available 'adequate,' controversies decision, exists offsets private values litigation seeks vindicate. discuss, here. I. 26 Since enactment 1938, mechanism provisions understood. Except types ad refer, confined instituted Attorney General recommendation agency. recurrent debate over technique demonstrates, restricted deemed necessary direct urgent relationship field health.3 cases. 27 scheme follows: 'Prohibited acts' 1042, 331. Subsequent sections authorize institute proceedings. First, 1043, he If violated, jury trial assured demand accused. Second, 304, 1044, 334, libel seek orders misbranded adulterated device, cosmetic. Third, prosecution authorized violations, report violation prosecution, affected person opportunity views. 305, 1045, 335. concededly reviewable Apart contains hearing appeals certain, enumerated Act—not involved. 701(f) 1055, 371(f). Section 701, subdivision (a), Secretary's authority, exercised cases, 'regulations efficient Act).' Subdivisions (e) (f) provide hearings, findings, subsection (e).4 agrees unaffected. Then, review—and them—subparagraph (6) specifies '(t)he remedies addition substitution law.' 'saving clause' refer enumerated, argument inconsistent wording placement clause.5 29 times, 701 amended initially subjected 701(f). Indeed, congressional issue, 701(e), 376(e) Amendments. significantly, 336 same true 1962, 780. Subsection enlarged, included. taken vigorous enacted amendments. 30 rejected proposal given restrain regulations.6 bill became 1938 originally contained hearings specified (substantially supra). empowered accordance section 24' (which 701(a)). S. 5, 75th Cong., 1st Sess. (1937). House Committee eliminated latter substituted (f). draft only.7 Even enjoining met bitter opposition 'would indefinitely consumer protection' 'hamstring' Act's 'amount nullification bill.'8 Conference then drafted enacted, revision except significant change: So concerned lest administration intervention th pecified reviewing courts.9 criticism single who injunction.' exactly today decrees. Rejected along original suggestion Department Justice, 83 Cong.Rec. 7892 (1938), leave hands courts' traditional powers—although resuscitates lost cause, too. 31 held Ewing Mytinger & Casselberry, 339 594, 600—601, 70 870, 873, 94 1088 (1950), 'This highly selective manner (in Act) reinforces inference probable (for seizure) suit.' evaluating force effect realize arming Nation designed protect people Restraining temporary safety laws pending years litigation—a schedule illustrate.10 They enough, regardless outcome. validation attack vital suits, plaintiffs—or hunting license; respectfully submit, mischief aggression richly rewarded subjection interests believes required interest. opinion, contemplated available. seems announce doctrine, new startling law, courts, determining look see another governed 'prohibited' holds 'judicial final aggrieved cut off persuasive Congress.' this, produces support. Board Governors Reserve System Agnew, 329 441, 67 411, 91 408 (1947), removal office bank directors. Had individuals correctness administrator's ignoring risking prison five years. No evidence hostility adduced.11 Heikkila Barber, 345 229, 73 603, 97 972 (1953), remotely support contention. Immigration 1917 Attorne G eneral 'final' deportation order What termed liberties relied discussed below. present, agencies function, always—to accepted Congress—not failure prohibit—will faithfully searched implemented unusual extraordinary essentially adequate review. Compare Leedom Kyne, 358 184, 79 180, 210 (1958), Myers Bethlehem Shipbuilding Corp., 303 41, 58 459, 82 638 (1938); Adams Nagle, 532, 687, 999 (1938). 32 effect, says always judgement relief: since granted appropriate characterize surprising revelation. Despite controversial nature many possibility realized ingenious aggressive counsel food industries until time. briefs cite prior preceded scheme. Morgan Nolan, 143 (D.C.S.D.Ind.1933), aff'd, 69 471 (C.A.7th Cir. 1934). matter instances 701(e) (f), defense aware generation effect.12 33 statute, administration, separation powers Constitution, withhold equitable discretionary inadequate. then, recognizes, Any doctrine this—any far departs restraint recogniton agencies—is bound disruptive. mean statutes wide variety not, providing procedures, said 'thou shalt limine.' 34 applicability entirely clear. precluded sorts 'adequate.' merely presents supply answer. Certainly, revolutionary refers 'seminal.' real sense; seed produce lush, tropical jungle attacked limine expressly prohibits Davis, Law Treatise 22.08 (1958). 35 legislate policy, implement contradict laid intend apart controversy, intent being unsafe, potentially harmful, 'misbranded' devices, way Congress' judgment, after much special protection disruption. arrogate ourselves override judgment. Not cited arose kind background legislative courts. 36 error, problem; and, show, error permissive decision. II. 37 come terms evaluation competing interests. discuss together adequacy ripeness interrelated. raised, indeed, properly exercised. 38 There abstract mechanical provisions. status considerable ease Cf. Rusk Cort, 369 367, 787, 809 (1962); cf. (1953).13 postponement obtain avoiding disruption plan justifiable. (1950); Behl ehem (1938).14 dramatically illustrates point. involves us. Appellee filed multiple products. claimed unconstitutional Due Process Clause, had arbitrarily 'in instituting' (through General) seizures affording appellee 'probable cause' seizures. three-judge convened. reversed grounds event, determination.15 answer out, does, precise plaintiff recommending important processes invoked following quotation Douglas' demonstrates controlling case: 40 'Judicial phase fit serve policy numerous determinations suit. 305—306, 99, 61. step in, stay institution seizures, hears case, denied speedy seizures.' U.S., S.Ct., 873. 41 Ewing, company's recourse defend actions, availing consolidation desired. 602, 874. hardshp publicity seizures—a serious hardship profoundly affect cases—this 'Congress weighed potential articles purveyor article decided favor speedy, preventive device 42 sharply enactments day jurisprudence. passing 'traditional avenues relief.' 'traditional' about Eloquent testimony paucity pertinent precedents. 43 principally primarily noteworthy analogy. brought. despite remedy. 44 Columbia 316 407, 62 1194, 86 1563 (1942), FCC station entered network contracts. CBS, licensee, regulation, claiming Commission's 402(a) Communications (48 1093) makes applicable Urgent Deficiencies 'suits enforce, enjoin,' etc., Commission exceptions relevant. Thus, Commission. problem 'reviewable' CBS so, premature—not might, consistently scheme, entertain circumstances, settled maintained. most, intervened proceeding controlled applying license—if proceeding.16 therefore licensee. cry authorization procedure, face design, invoke equity studied deliberate 45 1081 (1956), limiting television stations licensed person. denied, rule, Storer, owned stations, additional station. appealed, rulemaking order. Appeal h '(a)ny party aggrieved.' 1130, 1034. standing maintain petition 'final order' purposes limitation Again, assertion overriding design intent. utilized sought reviewed weight record. commence action, pursuant conflict 46 910 (1956). ICC order, investigation hearing, commodities 'agricultural' obtaining certificate convenience necessity Interstate Commerce motor carrier sued aside Commission.' 1336. Accordingly, too, furnishing forum provide. therefore, touch key instant relevant 'ripeness'—an intensely involving considerations which, rejection actions.17 47 Considering 'ripeness' two-dimensional. meaning, accused clear, simple, obvious. None warp woof pattern, intimately woven design. apt take shape modified give-and-take works, example, realities complex world cosmetic exception depends independent enforcement. stark, two-dimensional depend specifics consonance change short, proceeded framework Congress, circumstances make sensible, realistic matched authority.18 factors Analysis will, believe, demonstrate 48 (involving 'free access' plants, additives') concludes 'that presently resolution.' bases factors: inspection, access, decide withdraw manufacturer products; understanding problems encountered FDA, need supervision safeguards devised legitimate trade secrets. defer demanded services suspended. suspension shutdown, pro tanto, says, optimism probably shared 'prompt' had. 49 Precisely demonstrate, similarly immune suits. promote 'safety-in-use' additives. states, 'amplified definition' dyes. 399, 376(a)(1)(A), product additive' 'adulterated' tested FDA certified certification. Distribution compliance runs risk General. refine 'amplify' way, items. 50 Now, clearly, transparently, unsuited adjudication controversy. Every advanced 'excess' equal greater repel effort secure stage. pointed Similarly, impossible ascertain stage situation. First most obvious if, situation, unfair unduly burdensome or—more significantly—if falls outside definitional self-enforcing. measure self-help withholding services, wishes refuses ov ered, 51 influenced legality actual needs supervision. agree. suggest simple investigatory plants compelling defining How, possibly detailed information problem? describes Amendments?' 'this regulations.' statements reality. includes 'other substance' 'when thereto.' 201(t)(1), Can contended question, example diluent—solvent serving dilute—meets one,' 'necessarily facilitated' context? frailty pronouncement footnote persuaded technical adjudication, presented'! alone, dictate faced, now; raise adjudicated general, 'concrete setting' unsuitable circumstances. places public-safety mercy counsel's ability marshall deploy horrible examples logic accommodate, reality repel. Our training lawyers judges, awareness complexities life warn trap abstract, generalized, gross 53 relates amendment prescription print material, 'established name' 'prominently half large used thereon designation drug.' 502(e)(1), 790, 352(e)(1). Obviously, elucidation, either case-by-case pronouncement, done time,' once label pamphlet, per panel, differently circulars, doctors' literature directions patients, etc. ami nistrative Commissioner, acting delegation Secretary, steps specification. He invited comments used. manufacturer—or violates regulation—has mislabeled product. seized; sought; mislabeler criminally prosecuted. 54 petitioners' claims expense inconvenience risks deferring noncompliance, decrees reverses Third Circuit. confronts 'real dilemma.' dilemma citizens connection countless rules SEC, FTC, FCC, ICC, agencies. heretofore regarded provided. is—or be—that implementing outweighs interest; impressed rules. Somehow, concluded damage petitioners engage redesign reprint materials during tedious months cure possible danger deceit peddling plain medicine fancy trademarks prices rightly wrongly, impelled enact legislation. stronger trouble defiance. Actually, assault, experience reasonably sophisticated common orderly disaster predicted reasonable adjustments intransigence violations occurred, specific, result. refusal respond vastly overdrawn reflect healthy skepticism, other. represent solicitude modesty competence properly—and not—attempt generally light differ depending pamphlets labels, 55 invitation firmly rejected. approaching stringent undertake deliberately declined afford. Those relieve uti l undertaken. function—to iron differences, accommodate problems, exemptions, general—because peculiarly quality confine ourselves—as jurisprudence dictates—to actual, controversies, analysis. attacks, warrant place programs, essential interest, others affect, peril judge. 'adequate remedy' regulations; decision; call disproportionate accept abandon insistence facts, massive onslaught utterly discrete judgments competence. disrupted non-adjudicable mass assault. 'necessarily' advisedly, dismiss. summary called evidentiary hearing. presented. observed 'Very likely figures exaggerated *.' F.2d, 682, n. 5. 'While suspect, records-keeping laboratory testing costs themselves extremely plaintiffs.' 652. (Footnote omitted.) 378, II). St. Joseph Stock Yards Co. 298 38, 84, 56 720, 740, 80 1033 (1936) (concurring Brandeis). Hart Wechsler, Courts 312—340 (1953). Compare, 28.18 874, (1950). 371(e) 401, 1046, 341 (identity food), 403(j), 1048, 343(j) (misbranded purporting dietary purposes), 404(a), 344(a) (conditions imposed requirements), 406, 1049, 346 (tolerances pesticides), 501(b), 351(b) (deviations strength, quality, purity standards, drugs), 502(d), 1050, 352(d) (warnings habit-forming 502(h), 352(h) (packing labeling deteriorative drugs). addition, incorporate 371(f) (g) procedures: 506, 851, 356 (certain portions pertaining c ertification insulin), 507, 59 463, 357 (with dealing antibiotic Finally, 505(h), 1053, 355(h) denials appeals. saving clause, carefully 'remedies subsection.' (Emphasis added.) anomalous clause applicability. history particularly broadly conceived acceptance corroborates clause's language position Dunn, Statement Legislative Record 225, 609—610 (1938) Dunn). Contrary majority's contention, location common-sensical. save needed Appeals. indicates, complete pre-effectiveness advisable. broader shock agency, practitioners, almost undetected, omnibus slumbered 2800, 73d 2d (1934), floor Senate. 78 8958—8959 (1934); Dunn 157—159. successor bill, 74th (1935), provision, 702, approved 8356 (1935). 330 510. H.R.Rep. 2139, 3d Id., Pt. II (minority statement). H.R.Conf.Rep. 2716, published four ago, June 20, 1963, 6375. begun September yet put force. 6439, 6446. Litigation November operative. nonpersonal liberty Court: Shields Utah Idaho Central R. 305 177, 160, 111 oppose remedy, cicumstances why needed. 183 163—164. Stark Wickard, 288, 559, 733 (1944), contest 'plain' Congressman Lea, principal manager told colleagues retroactive, pre-existing unreviewable re-enacted. 7776-7777 See, Jaffe, Judicial Control Action 372. 599, 'it discretion sufficient, concerned, Phillips Comissioner Internal Revenue, 283 589, 596—597, 608, 611, 75 1289; Bowles Willingham, 503, 520, 641, 650, 892; Yakus 414, 442—443, 660, 675, 676, 834.' created obliteration, 1337, relating 'arising regulating commerce protecting restraints monopolies.' NLRB bargaining unit supervisory nonsupervisory personnel—concededly 95 leading commentator noted, basic CBS' standing. op. cit. 394. Harlan dissented 'the squarely developed withheld development.' 45, 572. Although Fod definition, comparable complex, subtle,

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