Document: 529 U.S. 120120 S.Ct. 1291146 L.Ed.2d 121 NOTICE: This opinion is subject to formal revision before publication in the preliminary print of United States Reports. Readers are requested notify Reporter Decisions, Supreme Court States, Washington, D. C. 20543, any typographical or other errors, order that corrections may be made goes press.FOOD AND DRUG ADMINISTRATION et al., Petitionersv.BROWN & WILLIAMSON TOBACCO CORP. al. No. 98-1152. SUPREME COURT OF THE UNITED STATES Argued December 1, 1999 Decided March 21, 2000 CERTIORARI TO APPEALS FOR FOURTH CIRCUIT Syllabus The Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 seq., grants Food Drug Administration (FDA), as designee Secretary Health Human Services (HHS), authority regulate, among items, "drugs" "devices," §§321(g)-(h), 393. In 1996, FDA asserted jurisdiction regulate tobacco products, concluding that, under FDCA, nicotine a "drug" cigarettes smokeless "devices" deliver body. Pursuant this authority, promulgated regulations governing products' promotion, labeling, accessibility children adolescents. found use Nation's leading cause premature death, resulting more than 400,000 deaths annually, most adult smokers begin when they minors. therefore aim reduce by minors so substantially prevalence addiction future generations, thus incidence tobacco-related death disease. Respondents, group manufacturers, retailers, advertisers, filed suit challenging FDA's regulations. They moved for summary judgment on ground, inter alia, lacked products customarily marketed, is, without manufacturer claims therapeutic benefit. District upheld but Fourth Circuit reversed, holding Congress has not granted products. court concluded construing FDCA include would lead several internal inconsistencies Act. It also evidence external FDCA-that consistently stated 1995 it over tobacco, enacted tobacco-specific statutes fully cognizant position, considered rejected many bills have given agency such authority-confirms conclusion. Held: Reading whole, well conjunction with Congress' subsequent legislation, plain marketed. Pp. 8-40. (a) Because case involves an agency's construction statute administers, Court's analysis governed Chevron A. Inc. v. Natural Resources Defense Council, Inc., 467 837, which reviewing must first ask whether directly spoken precise question at issue, id., 842. If so, give effect unambiguously expressed intent. E.g., 843. not, defer long permissible. See, e.g., INS Aguirre-Aguirre, 526 415, 424. determining specifically addressed should confine itself examining particular statutory provision isolation. Rather, place context, interpreting create symmetrical coherent regulatory scheme. Gustafson Alloyd Co., 513 561, 569. addition, meaning one affected Acts, particularly where subsequently topic hand. Estate Romani, 523 517, 530-531. Finally, guided degree common sense manner likely delegate policy decision economic political magnitude administrative agency. Cf. MCI Telecommunications Corp. American Telephone Telegraph 512 218, 231. 8-10. (b) Considering clear intended exclude from jurisdiction. A fundamental precept product regulated remains market safe effective its use. §393(b)(2). That potential inflicting physical injury offset possibility Rutherford, 442 544, 556. rulemaking proceeding, quite exhaustively documented unsafe, dangerous, great pain suffering illness. These findings logically imply if were required remove them FDCA's misbranding, see, §331(a), device classification, §360e(d)(2)(A), provisions. fact, based provisions, previously within jurisdiction, removed because impossible prove their Congress, however, foreclosed ban choosing instead distinct scheme focusing labeling advertising tobacco. Its express protect commerce national economy while informing consumers about adverse health effects. See 15 1331. Thus, plainly contradict congressional Apparently recognizing dilemma, actually "safe" banning greater harm public leaving market. But safety determination-focusing relative harms caused alternative remedial measures-is substitute those FDCA. Various provisions require determine least some consumers, product's benefits outweigh risks illness serious injury. cannot do, unsafe obtaining inescapable conclusion there no room used safely purpose, yet banned, simply do fit. 10-20. (c) history legislation demonstrates Since 1965, six separate addressing problem human health. Those statutes, things, warnings appear all packaging outdoor advertisements, see 1331 1333, 4402; prohibit advertisement through electronic communication medium Federal Communications Commission, §§1335, 4402(f); HHS report every three years research concerning tobacco's addictive property, 42 290aa-2(b)(2); make States' receipt certain federal block contingent prohibiting manufacturer, retailer, distributor selling distributing individuals age 18, §300x-26(a)(1). created specific And was adopted against backdrop resolutely stating times authority. Indeed, actions area evidenced intent preclude meaningful policymaking role Further, prohibits additional regulation respect consequences, central aspect Under these circumstances, evident ratified previous, long-held position lacks subject, excludes regulation. 20-37. (d) inquiry shaped, measure, nature presented. deference premised theory statute's ambiguity constitutes implicit delegation fill gaps. U.S., 844. extraordinary cases, reason hesitate delegation. hardly ordinary case. Contrary inception until 1995, now industry constituting significant portion economy. contends provide "reasonable assurance safety," entirely. highly unlikely leave determination sale regulated, even discretion cryptic fashion. Telecommunications, Given unique history, breadth asserted, obliged expansive statute, consistent deny power. 37-39. (e) No matter how important, conspicuous, controversial regardless hold Executive Branch politically accountable, power interest always grounded valid grant Congress. Courts take care extend scope beyond point indicated stop. Article Bacto-Unidisk, 394 784, 800. P. 40. 153 F.3d 155, affirmed. O'Connor, J., delivered Court, Rehnquist, Scalia, Kennedy, Thomas, JJ., joined. Breyer, dissenting opinion, Stevens, Souter, Ginsburg, Opinion Justice O'Connor Court. 1 troubling problems facing our Nation today: thousands occur each year after having expressly disavowed since inception, 61 Fed. Reg. 44619-45318. (FDCA Act), 52 Stat. 1040, amended, "combination products" 44397 (1996). consumption Id., 44615-44618. believed reaching curbing could generations 44398-44399. 2 Regardless seeks address, exercise "in inconsistent structure into law." ETSI Pipeline Project Missouri, 484 495, 517 (1988). although agencies generally entitled interpretation administer, "court, agency, Congress." 842-843 (1984). case, we believe clearly precluded asserting Such overall light intent, assertion impermissible. 3 * FDA, Services, "devices." 321(g)-(h), 393 (1994 ed. Supp. III). defines "articles (other food) affect function body." 321(g)(1)(C). "device," part, "an instrument, apparatus, implement, machine, contrivance, -- similar related article, including component, accessory, §321(h). so-called products," "constitute combination drug, device, biologic product." §353(g)(1). construed giving drugs, devices, both. 44400 4 On August 11, published proposed rule 60 41314-41787. rule, included restrictions sale, distribution, designed availability attractiveness young people. 41314. comment period followed, during received 700,000 submissions, "at time subject." 44418 5 28, issued final "Regulations Restricting Sale Distribution Cigarettes Smokeless Tobacco Protect Children Adolescents." 44396. determined "drug delivery devices," had marketed-that 44397, 44402. First, " 'affect body' "has pharmacological effects." 44631. Specifically, "exerts psychoactive, mood-altering, effects brain" sustain addiction, both tranquilizing stimulating effects, control weight. 44631-44632. Second, "intended" "are widely known foreseeable [they] deemed been manufacturers," 44687; "predominantly nearly exclusively" obtain 44807; statements, research, manufacturers revealed "have 'designed' pharmacologically active doses consumers," 44849. because, addition containing nicotine, components controlled amount body, 45208-45216. 6 Having resolved jurisdictional question, next explained justifications regulations, detailing deleterious associated "the single preventable States." 44398. According "[m]ore people die illnesses, cancer, respiratory heart disease." Ibid. only way mortality level goal accomplished preventing adolescents starting 82% cigarette half already become regular age. beginning smoke younger age, youth smoking recently increased, existed accordingly number who can diminished, correspondingly reduced data suggest anyone does childhood adolescence ever begin." 44399. 7 Based findings, access persons 18; retailers verify photo identification purchasers 27; quantities smaller 20; distribution free samples; sales self-service displays vending machines except adult-only locations. 44616-44617. promotion black-and-white, text-only format unless appears read almost exclusively adults; 1,000 feet playground school; promotional T-shirts hats, bearing manufacturer's brand name; sponsoring athletic, musical, artistic, social cultural event using name. 44617-44618. requires statement, "A Nicotine-Delivery Device Persons 18 Older," packages. 44617. 8 pursuant "restricted devices." 360j(e). §353(g)(1) Act's drug authorities, both, depending "how goals act best accomplished." 44403 flexibility authorities appropriate basis regulating tobacco." 44404. 360j(e), "require restricted upon conditions [the FDA] prescribe regulation, if, potentiality harmful collateral measures necessary use, determines otherwise reasonable effectiveness." reasoned fell §360j(e) providing safety. 44405-44407 9 Middle North Carolina Coyne Beahm, 966 F. 1374 (1997). grounds exceeded violated First Amendment. Second Brief Support Plaintiffs' Motion Summary Judgment 2:95CV00591 (MDNC), Rec. 97-1604 (CA4), Tab 40; Third 42. respondents' motion part denied part. Supp., 1400. held authorizes marketed permissible, exceed §360j(e). 1380-1400. stayed implementation (except prohibition minors) certified immediate interlocutory appeal. 1400-1401. 10 Appeals 155 (1998). Examining inconsistencies. 162-167. sold allowed remain market, proceeding "dangerous" "unsafe." 164-167. apparently result contrary apparent anomaly, concluded, did intend 167. confirms Importantly, position. 168-176. reasoned, 170-171. This, along absence enacting 1938 withhold FDA. 167-176. address 360j(e) violate F.3d, 176, n. 29. 11 We Government's petition certiorari, 1086 (1999), II 12 founded conclusions Again, satisfying stimulation tranquilization, weight produce 44632-44633 As initial matter, respondents issue reading "intended," arguing term art refers vendor product. Respondent Brown Williamson 6. makes claim benefits. 6-7. need resolve assuming, arguendo, "intended body" absent medical benefit, contravenes 13 threshold framework analyzing 837 Chevron, "whether issue." done end; "must 843; Haggar Apparel 380, 392 (1999); Holly Farms NLRB, 392, 398 424 Auer Robbins, 519 452, 457 justified "[t]he responsibilities assessing wisdom choices resolving struggle between competing views judicial ones," supra, 866, familiarity ever-changing facts circumstances surrounding subjects Rust Sullivan, 500 173, 187 (1991). 14 meaning-or ambiguity-of words phrases placed context. Gardner, 115, 118 (1994) ("Ambiguity creature definitional possibilities context"). "fundamental canon context view scheme." Davis Michigan Dept. Treasury, 489 803, 809 (1989). interpret "as scheme," 569 (1995), "fit, possible, parts harmonious whole," FTC Mandel Brothers, 359 385, 389 (1959). Similarly, 530-531 (1998); Fausto, 439, 453 231 (1994). With principles mind, find here 16 Viewing core objectives ensure "effective" 393(b)(2) ed., III) (defining mission); More Information Better Patient Care: Hearing Senate Committee Labor Resources, 104th Cong., 2d Sess., 83 (1996) (statement Deputy Commissioner Schultz) ("A country proven sold"). essential purpose pervades For instance, "mission" "protect[ing] ensuring drugs effective" "there effectiveness devices use." premarket approval new limited exceptions, states "shall refusing approve application" purpose. §§355(d)(1)-(2), (4)-(5). discovers ineffective, "shall, due notice opportunity hearing applicant, withdraw approval" drug. 355(e)(1)-(3). classify categories. §360c(b)(1). category chooses, device." 360c(a)(1)(A)(i), (B), (C) III); 44412 Even device" prevent marketing "potential benefit." 556 (1979). 17 "tobacco unsafe," "dangerous," "cause illness." "presents risks," disease, often painful deaths," "[t]obacco alone kills acquired immunodeficiency syndrome (AIDS), car accidents, alcohol, homicides, illegal suicides, fires, combined." characterized "a pediatric disease," 44421, "one out will prematurely result," Consider, first, misbranding devices. introduction interstate food, cosmetic adultered misbranded." 331(a). two render misbranded §352(j) deems "[i]f dangerous dosage manner, frequency duration prescribed, recommended, suggested thereof." "dangerous health" prescribed. "[u]nless bears adequate directions form, protection users," "not health." §352(f)(1). consequences adequately consumers. deem introduced commerce. dissent's contention, admits once misbranded. 19 regulates classifications. relies device's classification Instead, represent "general controls," entitles impose advance classification. 44404-44405. Although prescribes deadline rulemaking" 44412. regarding Class III application available controls, "presen[t] unreasonable risk injury." 360c(a)(1)(C). process. 360c(a)(1)(C) 360e; prohibited approving showing 360e(d)(2)(A). finding fulfilled obligation allow 20 them. taken "they us[e]." Public Cigarette Amendments 1971: Hearings Commerce Subcommittee S. 1454, 92d 239 (1972) (hereinafter 1972 Hearings) Charles Edwards). Labeling Advertising: House Interstate Foreign Commerce, 88th (1964) 1964 Department Health, Education, Welfare (HEW) An- thony Celebrezze amendments "smok- ing product[s]" "might completely outlaw cigarettes"). removal Code currently force greatest basic industries ramifying activities foreign point, stable therein general welfare." 1311(a). importantly, occasions 1965. Advertising (FCLAA), Pub. L. 89-92, 79 282; Smoking 1969, 91-222, 84 87; Alcohol Abuse 1983, 98-24, 97 175; Comprehensive Education Act, 98-474, 98 2200; 1986, 99-252, 100 30; Alcohol, Abuse, Mental Reorganization 102-321, §202, 106 394. When known, nicotine's Welfare, Surgeon General's Advisory Committee, 25-40, 69-75 Report) (concluding causes lung coronary artery chronic bronchitis emphysema, various stimulation, appetite suppression); Service, Consequences Women 7-12 (1980) (finding rates disease increased women men smokers, pregnancy unborn fetus newborn child); Why People Smoke (1983), Prevention H. R. 1824 Environment Energy 98th 1st 32-37 (1983) 1983 (stating widespread example dependence country," "affect chemistry brain nervous system"); Smoking: Nicotine Addiction 6-9, 145-239 (1988) 1988 addicting much same heroin cocaine, addiction). Nonetheless, stopped short ordering ban. "commerce protected maximum extent with" "be[ing] informed decisions adopt protecting extent" reveal collective premise continue States. policy. 22 recognized dilemma somewhat ironically, promulgating conceded conventionally understood." consider presented countervailing product, permitting marketed." 44412-44413. Applying standard, high users, "dangerous." 44413. particular, current users suffer extreme withdrawal, system pharmaceuticals might able meet treatment demands black offering legally develop. "while taking off becoming addicted others, record establish response act." 23 be, asserts, "these factors developing achieves products." "is achieving ban," ibid., determinations operative Several probable harm. 555 ("[T]he considers expected gain justifies entailed use"). contrast, conception "safety" "dangerousness," compare aggregate actions. qualitatively different inquiry. throughout 24 Consider 360c(a)(2), specifies purposes performance standards, approval. Title 360c(a)(2) provides 25 determined- 26 "(A) whose represented intended, 27 "(B) 28 "(C) weighing benefit 29 straightforward dictates weigh consumer Applied purported benefits-satisfying sedation, control-outweigh To accommodate safety, "any stemming consumers' continued though reduction raison d' ;tre words, forced contend very evil combat "benefit implausible. 30 incompatible provision. "misbranded" "it understanding, health," §352(j), when, comparison "adverse consequences" aggregate. Quite simply, inquiries. detrimental aggregate, still directed. Section 352(j) focuses dangers measures. 31 Consequently, analogy dissent toxic cancers unpersuasive. 44413 (1996); post, (opinion J.). sense, patients, Accordingly, properly described 352(j). true detail, means effect. 32 outright 'dangerous' 14, "perverse" 21. misunderstands holding. virtually poses conditions. What conclude yet, time, objective effective. 33 FDA-but banned-must ramifications consumer. delivering "unsafe" purposes. recent, legislation. B 34 detail past 35 years. At enacted, range plausible meanings. Over acts shape focus "classic task reconciling laws getting 'make sense' combination, necessarily assumes implications altered later statute." 453. earlier broad embodied [earlier] ha[s] amended." pieces 1965 14. communication" Commission (FCC), (HHS) property tobacco," making unlawful "for sell distribute individual 18," 36 adopting acted repeated statements manufacturer. period, effectively health, scheme, presently constructed, precludes 37 January 1964, General released Health. concluding, relevant "that contributes diseases rate." Report 31. identified "stimulation," "tranquilization," "suppression appetite." 74-75. Seven days report's release, Trade (FTC) rulemaking, 530-532 (1964), June requiring "to disclose, prominently, pack, box, carton container cancer diseases," 8325. but, request postponed enforcement months. Cipollone Liggett Group, 505 504, 513-514 (1992). 38 FTC's convened hearings problem." 1. During deliberations, representatives testified Terry asked HEW "authority label packages there." 56. "we existing Administration." Rankin claims." Advertising-1965: 2248 89th 193 Hearings). Letter Directors Bureaus, Divisions Districts Bureau Enforcement (May 24, 1963), 240 ("[T]obacco chewing accompanying claims, definitions cosmetic"). urged amend cover "smoking report, "provision cigarettes. what, understand, experience 18th amendment, acceptable people." 18. 39 disavowal inception. concedes, never here. Petitioners 37; Appellee (FDA) Action Harris, 655 F.2d 236 (CADC 1980), 4, pp. 14-15 ("In 73 enactment original 41 promulgation modern repeatedly establishing behalf vendor"). 40 Before adoption 1938, predecessor Chemistry, announced Pure 1906, ch. 3915, 768, claims. Agriculture, Service Regulatory Announcements (Apr. 1914) (Feb. 1914 13, Chief Alsberg). 1929, bill "[t]o Drugs 30, extending 1468, 71st 71 Cong. 2589 (1929) (remarks Sen. Smoot). And, admits, text legislative applicability 22, 4. significance extremely ambit discussion matter. Of course, determinative; ultimately rather principal concerns legislators governed." Oncale Sundowner Offshore 75, TVA Hill, 437 153, 185 (1978) ("It us speculate, less act, stance events anticipated"). certainly understanding representations background Moreover, FCLAA proposals April 1963, Representative Udall applicable 5973, Two months later, Senator Moss identical Senate. 1682, Sess. (1963). discussing his proposal floor, "this amendment places foods, cosmetics." 109 10322 Rhodes another amended "by striking 'food, cosmetic, inserting lieu thereof product.' 9512, §3 five passage FCLAA, again 2248, None became law. decided extensive "comprehensive program deal relationship §2, 282. advertising, warning, "Caution: May Be Hazardous Your Health," §4, 283. "Declaration Policy," balance hazardous extent." 282 (codified 1331). 43 Not reject explicitly preempted labeling: "No statement relating shall package." §5(a), integral today. requirements imposed essentially 352; 352 (1964 IV). discussed earlier, bear "adequate 352(f)(1); 352(f)(1) ed.); pathological 352(f)(2); 352(f)(2) thereof," 352(j); ed.). was-and remains-incompatible say FCLAA's preemption 518-519. important factor position-that approach contemplated 44 evidences exercising provided "[n]o labeled conformity Act." §5(b), reaction attempt reserving exclusive itself. 45 Subsequent followed pattern. By own terms, expire July 1969. §10, 284. anticipation provision's expiration, FCC rules 1959 (1969) (FCC "ban broadcast commercials radio television stations"); 7917 (FTC disclose 'that bronchitis, pulmonary diseases' "). After debating proper Advertising-1969: 91st pt. (1969), advertisements "on Commission" strengthening warning §§4, 6, 88-89. extended indefinitely (again despite importance FDCA). 88 1334(a)). forbade action pending 1971, FTC, proceed thereafter, rule's §7(a), 89. chairman committee originated stated, Congress-the body elected people-must involved legislation-and up appointed officials." 116 7920 (1970) Rep. Staggers). 46 Four transferred substances covered Substances (HSA) Consumer Products Safety (CPSC), Association, joined Moss, petitioned CPSC yielding milligrams tar. 236, 241 1980); Kluger, Ashes 375-376 HSA cigarettes, did, ordered reexamine petition. Association Product [1972-1975 Transfer Binder] CCH Prod. Guide 75,081 (DC 1975), vacated moot, 75-1863 1976). action, mooted eliminated Improvements 1976, 94-284, §3(c), 90 503 1261(f)(2)). acknowledged "legislation, effect, reverse[d]" decision, 23563 (1975), observed episode "particularly" "indicative limit Agencies," (ASH) Director Banzhaf Goyan (Nov. 25, App. 59. underscored legislation's "unmistakably reaffirm mandate dealing further sensitive complex reserved Congressional action." 94-251, p. (1975) (additional Sens. Hartke, Hollings, Ford, Beall). 47 Meanwhile, maintain 1972, Edwards "cigarettes recommended pleasure 239, 242. He "demonstrates domain Congress," "labeling step take[n] Any move intent." 48 1977, ASH citizen requesting citing motivated Citizen Petition, 77P-0185 26, 1977), 1-10. strong physiological body; precisely effects; annually. denying ASH's petition, Kennedy vendors." (Dec. 5, 47. proceeded litigation, argued brief comprehended definition 'drug' vendors drug." 27-28. contended "long aware vendor," "Congress disturb interpretation," "acquiesced limits cigarettes." 23, 27, 23. expansion, job F.2d, 243. 1980, commence proceedings 50-51. "[i]nsofar relate attached filters section 201(h) [21 321(h)]." 67. 49 Assistant Brandt being major cancer," "major disease" "unfavorable outcomes." 19-20. "well-established dependence, 20. maintained something itself, nor seeking authority." 74. Senate, addictiveness, Department's assumed responsibility Act: 772 56 50 Against backdrop, four incrementally expanded Amendments, 175 290aa seq.), "addictive tobacco" recommendations appropriate. 2200, modifying prescribed warning. Notably, debate Hawkins "[u]nder exempted 130 26953 1986 (CSTHEA), 4401 Like CSTHEA Act], package 4406(a)). 51 1988, summarizing abundant scientific literature demonstrating "[c]igarettes forms addicting," "nicotine psychoactive" "causes withdrawal usually accompanies abstinence." "pharmacologic behavioral processes cocaine." 15. year, Young doesn't look like possible [tobacco] smoking, I think, Rural Development, Related Agencies Appropriations 1989: Appropriations, 100th 409 hearing, Counsel "what fairly law purpose," themselves concept ordinarily 410. Between 1987 1989, 3294, (1987); 1494, 101st (1989); 769, before, proposals. 1992, 300x creates incentives retail Taken together, rely failure act-its consideration rejection authority-in simple inaction purportedly represents acquiescence contrary, creating doing hazards persistently substance respect, supervision substantial component III), imposing health-related U. S §§1334(a), 4406(a). 53 previous Bob Jones Univ. 461 574 "[i]t conceivable Congress-and setting, Member Congress-was abundantly what going on." 600-601. affirmatively relying focused belief result, 54 takes change 26-29, fact sharp break prior Certainly, charged administering "carved stone." 863; Smiley Citibank (South Dakota), N. A., 735, 742 Motor Vehicle Mfrs. Assn. State Farm Mut. Automobile Ins. 463 ample latitude 'adapt policies changing circumstances.' (quoting Permian Basin Area Rate Cases, 390 747, 784 (1968)). consistency reason: unwavering 1914. crucial, bolsters understood 55 argues inference drawn "critically ambivalent." Post, 22. disagree. series crafted assertions oversight area. inference-that ratify jurisdiction-is unmistakable. alternatively merely traditional largely perceived inability 'intent' requirement." 30. fair unconditional. 242 Edwards) ("[R]egulation "[a]ny intent"); 74 Brandt) itself"); ("Congress cigarettes"); (because interpretation"). equivocal, well-established exception Rankin) ("The claims"); vendors"); 67 ("Insofar jurisdiction"). resolute gives C 57 Deference administers Judicial Review Questions Law Policy, Admin. Rev. 363, 370 (1986) legal one. upon, answered, questions, interstitial matters answer course daily administration"). 58 1914, 35-36; Reply Owing society, history. better worse, squarely 59 Our 218 (1994), instructive. "modify" §203(b) 1934. gave "modify requirement" possessed voluntary mandatory requirement distance carriers file rates. 225. FCC's construction, slightest doubt" question. 228. reasoning apt here, entirely, substantially, rate-regulated discretion-and achieve subtle permission 'modify' rate-filing requirements." MCI, confident strained Act-a scheme-but ignore implication clear, 62 seriousness sought address. amply demonstrated adolescents, perhaps threat "important, controversial" 31, '[i]n anxiety effectuate public, stop.' ... Bacto&nbhyph;Unidisk, 800 Cases Jam 340 593, 600 (1951)). reasons, 63 ordered. 64 whom Ginsburg join, dissenting. 65 ." Unlike majority, fit language. 66 interpretation, majority nowhere denies following salient points. (including cigarettes) fall definition, literally. mood-stabilizing interaction chemical cells system. Both alike know of, desire, chemically induced result. Hence, affect" body's "structure" "function," literal words. purpose-the health-supports inclusion scope. 798 liberal [its] overriding (emphasis added)). Unregulated [to] 44398 kill "than AIDS, added). 68 Despite language (both support come authority), nonetheless reads excluding reasons: 69 (1) "fit" (like outright, concedes remedy, ante, 19-20; 70 (2) which, viewed together demonstrate 33-34. my view, neither propositions valid. significantly alternatives. infra, 14-21. tell it. 21-26; cf. Modernization 1997, 111 2380 note 321 III)) (statute "shall" "be whether" product"). 72 bulk follows explain latter conclusions. short, indicia meaning-language purpose-along (described briefly Part I) sufficient statute-specific arguments companies (discussed II) erroneous assumptions and, thus, defeat jurisdiction-supporting thrust inferences draws persuasive, (as just easily infer all. changed mind insignificant IV establishes) reasons justified. V, accountability attach alleviate concern ought decision. contained "drug": "[1] medicines preparations Pharmacopoeia National Formulary [2] mixture cure, mitigation, prevention §6, 769. 75 added third here: 76 "(3) articles 675, §201(g), 1041 321(g)(1)(C)). 77 "device." §201(h), 321(h)). mentioned, strongly projurisdiction statute. 1-2. 78 offers support. drafted language, expand significantly. 1944 73d 15-16 (1933), reprinted Legislative History 107-108 (1979) Leg. Hist.). purpose" "make alleged treatments diseased conditions." 108. While drafters "slenderizing" "antifat remedies," "admittedly inclusive, wide definition." 107. deliberately, "all preparations, added); 2800 516 (1934), Hist. then-FDA Walter Campbell acknowledging "[t]his 'drugs' all-inclusive"). studying experts written purposefully discretionary powers J. O'Reilly, §6.01, 6-1 (2d 1995) O'Reilly), regarded constitution" "establish[es] principles" "permit[s] parameters" "implement efficient controls devised." Hutt, Philosophy Regulation Cosm. 177, 178-179 (1973) too, said 80 "historical expansion creation parallel show coverage indicates-and equally clearly, broader strict allow." 798. 81 surprise President needed wisely-a New Deal Gray Powell, 314 402, 411-412 (1941) (Congress "could legislated specifically" field promise informed, equitable" determination). around granting transportation communication. Civil Aeronautics 601, §401(d)(1), 987 (Civil Board airlines confines "public convenience necessity" standard); Carrier 1935, 498, §204(a)(1), 546 (Interstate requirements" trucking); 1934, 652, §201(a), 1070 (Federal (FCC) radio, television, interest" standard). suddenly hesitated established implies? 82 Nor surprising expected. inherent seemed bring proving changes makers "function." Or, back then, assuming proof, popular 105 (1997) (in 1930's "Americans love --"). proved prerequisites, courts authorized. Southwestern Cable 157, 172 (1968) (reading authorizing cable systems noting 1934 foreseen development of" advanced communications systems). all, narrowly phrased 774-777 (statutory "transportation" natural gas includes "prices" producers); Phillips Petroleum Co. Wisconsin, 347 672, 677-684 (1954) (independent producer Gas exemption gathering production facilities). pursue further, favor present view. contention: broad, enough turn arguments. 85 possibly mean literally say. example, implant, vitro reagent, article 321(h). literally, everything air conditioners thermal pajamas. argue avoid "device" confined defined. 8-9. 86 right winter underwear. agree accept limitation. thing, cramped (third "clearly, definition"); 108 (definition covers conditions"). another, companies' restriction superfluous. 321(g)(1)(A), (g)(1)(B) (covering pharmacology compendia diagnosis, treatment, disease"). 87 Most supplies different, suitable, limitation: agent. affects "does primary body," dependent metabolized achievement purposes." §321(h) One readily "drug," falls definition. hypothesize pajamas recognize ingredient, meets test. oversimplify, enters blood carries immediately brain. 44698-44699 (1966). then binds receptors surface cells, setting reactions alter one's mood feelings sedation stimulation. 44699, 44739. increases nicotinic brain's surface, alters normal electrical activity. stimulates transmission "rewards" pleasurable sensations (dopamine), causing addiction. 44700, 44721-44722. upshot stabilizes mood, suppresses appetite, tranquilizes, satisfies craving helped create-all metabolized. 89 physiology-and smoker psychology-helps why 75% "reduce[s] irritation," 41579 (1995); 73% (10- 22-year-olds) "relaxation," 44814 3% 70% want quit succeed, 44704. helps [makes them] feel better" situations involving negative mood." 44814. purposes, "function" substances. 44667 (FDA Valium, NoDoz, weight-loss products). loss kinds typically reviews controls. "food," suffice (and delivers drug-delivery "device") argument word "intended." art. 2. assert maker according companies, historically 91 "claimed"; uses ago "intent" shown "expressions," article." 6896 (1976) CFR 801.4 (1999)); ("objective intent" "article knowledge [of makers], offered used" purpose). wants, knows, 41527-41531 (1995) (describing topical hormones, sunscreens, fluoride, tanning lamps, thyroid food supplements, novelty condoms-all claims); §13.04, 13-15 ("Sometimes material 92 reverse kind answered interpretive unreasonable. effort former, tying technical called nothing either use" suggests (which shows intent) necessary. direct attention says applies-"food" "drug"-because, "through connection manufacturer] determine" "both." 361, 74th (1935), 696. 93 "objective Agnew 165 36, (1897) (intent encompasses act). acknowledge drug-like circumstance, i.e., claim, retains (say, aspirin calamine lotion), speaks 94 satisfy interpreted place, weight-reducing properties-and historical portend expectations. late 1920's, Company weight-conscious 'Reach Lucky sweet.' Ashes, 77-78. R J Reynolds (RJR) emphasized stability depicting pilot remarking 'It Takes Steady Nerves Fly Mail Night . That's Camels. plenty!' 86. RJR advertised quality instance 'You get Lift Camel,' Camels 'A Harmless Restoration Flow Body Energy.' 87. proof mildness beneficial effects) commonplace. (Brown Kool-brand mentholated tonic hot, tired throats"); 101, 131 (Phillip Morris "[r]ecognized laboratory tests conclusively advantage Phillip Morris"); (RJR proclaimed 'For Digestion's sake, Camels! mealtime pleasant-digestion stimulated-alkalinity increased' recent decades understand longer express-that stabilize sedate, stimulate, help suppress appetite. 95 refused publicly (until recently) induced, habit-forming, (Part 1): Environment, 103d 628 1994 (heads seven oath addictive" added)), gained solid, documentary produces metabolizing chemicals, wanted way. 96 tobacco-industry scientist '[s]moke optimized vehicle nicotine,' 'the dispenser smoke.' 44856 company executives '[t]hink pack storage day's supply nicotine-- Think dose unit [and] [t]hink puff nicotine.' (Philip Morris). researchers told superiors 99 'in levels, stimulant, depressant, tranquilizer, psychic energizer, reducer, anti-fatigue agent, energizer-- Therefore, may, compete variety types action.' 44669 (RJR). draft prepared Philip 101 'is physiologically active, nitrogen [similar to] quinine, atropine morphine. [And] [w]hile [other] physiology, influence.' 44668-44669. 102 1980 study 103 responsible individual's behaviour, motivation satisfaction smoker.' 44936 Williamson). 104 evidence, sufficiently "intend" "affect" reaches "inescapable conclusion" whole "simply fit" creates. Ante, majority's (such cigarettes); total cigarette-sale inappropriate. curious leads similarly "inescapable" opposite conclusion, namely, fails account pick remedy perverse causing, preventing, unnecessary whenever response. imagine circumstances. 107 Suppose, commonly used, mildly sleeping pill (or, say, contact lens), turned pose Suppose ban, turning potentially black-market substitute, draconian notice) wean gradually away safer Would remedy? think not. restrict permits product"-i.e., cigarette) contains nicotine)- 353(g)(1). discretion. "otherwise" assurance" "safety effectiveness," "sale, "such prescribe. §360j(e)(1) addresses (entitled "Banned devices") presents injury," "may"-not must-"initiate banned §360f(a) points subsections believes responses. 12-13. cited thing. true, contends, devices" classifications" "premarket approval." 12, 13. "present[s] applies "provide safety." §§360c(a)(1)(A), 360c(a)(1)(B) (placing assurance). allows relative, alternatives, chosen path, safest can-and does-provide good football helmet player sport dangerous. choice "reasonable" world alternatives 110 event, entirely categorization distributed. (when "unreasonable "may" device"); §360h(a) "notification"); §360h(b) defective risk" harm, "repair, replacement, refund"); §18.08, 18-38 (point "careful review" "truly new" "before exposed" Noting 352(j), "prescribed, labeling." 12. mentions §352(f)(1), calls "its users." "misbranding" determinative, "adequate" harmless possible. surely comparatively (not "dangerous") (subject requirements) sort illustrates. prevents seems poisons chemotherapy, user sense. 112 "would serious, issue" cease order. 360h(e)(1) resort recall compliance section's procedural chooses her subsection's remedy. Otherwise, subsection trump meaningless lesser remedies "notice" she finds public"). §360h(a)(1). compel "recall" likewise conflict other] provided" §360h(e)(3) 113 choose 114 second select distinguish insists "product itself" 17, considering severe symptoms buy stronger, cigarettes-considerations actions." comparative manner. 360h(e)(2)(B)(i)(II) (no "risk recal[l]" than" recall); (notification "unless" notification danger" "no notification"). 115 "specific" incurred "aggregate" group. All bottom, individual; attaches itself"; aggregates unregulated typical people, 1,000, market) 1,000; four, one, individuals, average, respectively. 4/1000, 1/1000, 2/1000 sides coin; set facts. theoretical distinction presence intervening (e.g., search replacement market), distinction, "replacement" methadone actual behavior account. concede logic, evaluation remedies. forbid realities increase harm-doubling "individual user" above. insist realities, consequent unusually, evaluates (a pill; cigarette; lens) habit forming, popular? satisfactory imagine, distinctions tried draw. (instructing --") 117 Third, counsels overly rigid divorced health-protecting 1958 Delaney Amendment, [food] additive [after tests] induce man animal." §348(c)(3). additive, small amount, appeared animal, large appearance carcinogenic cell. 95-658, (1977) (discussing view). absolute prevented "safe judge involved." 5. interpretation-which principle herbal teas mushrooms-actually led saccharine, 19996 (1977), took continually renewed, postponing Saccharin Study 95-203, §3, 1452; 102-142, Tit. VI, 910. Delaney-type linguistic reason. advances undermines placing strange Saying misunderstood maintains "may them." 19. adds ban-rather regulate-a "cannot purpose." misunderstand, linchpin unexplained. widely-used withdrawn threatens response? indeed, alternative. 119 linguistically desire flexible it, arsenal "fit[s]" this, other, drug- device-related problems. 120 whatever absence. why? Do contain barring jurisdiction? exception, somehow repeal II, supra) area? claim. Tr. Oral Arg. (denying reliance doctrine "partial repeal"). Perhaps "shape" "focus" meant generation earlier. warned construe before. Pension Benefit Guaranty Corporation LTV Corp., 496 633, 650 (1990) (later 'a inferring earlier' Congress" Price, 361 304, 313 (1960))). "control[s] construction" (citation quotation marks omitted), "controlling." Haynes 85, 87-88, (1968); accord, 170 'very little, any, significance' "); Sullivan Finkelstein, 617, 632 (Scalia, concurring) ("Arguments seriously, footnote."). Regardless, Members embody jurisdiction" assumption. automatically antijurisdiction does, similarly) interfering possessed. (1965) Fino "erode" authority). below, critically ambivalent, "ratif[ying]" no-jurisdiction assumption, 34, "equally tenable," omitted); Johnson Transportation Agency, Santa Clara Cty., 480 616, 672 (1987) dissenting), drawing firm, needs. 122 tobacco-a circumstance significant. 24-25, 32-33. (failed requests "did possess" failed 1262, §906 "[n]othing [FDA] products"); 516, 105th §2 (similar); Res. 980, 142 5018 (Georgia unsuccessfully "rescind authority" tobacco); 2283, tobacco"); 2414, §2(a) (similar). proves nothing. muster votes favors disfavors 123 speed 26-29. hand, speedy reply resented desired reserve itself-a supports majority. quick agencies' efforts contrasts dramatically enact responsive (at speed) ago. contrast 124 post-1938 reveals infers. Note 1997) (law [not] product," "[s]uch exercised [FDCA] day date [this] enactment"). reconcile intend, implicitly, 143 S8860 (Sept. (the interfere negatively authority"). 125 perspective shaped 282, seq. 25-26. packages, etc., following: 126 "SURGEON GENERAL'S WARNING: Causes Lung Cancer, Heart Disease, Emphysema, Complicate Pregnancy." 1333(a). 127 pre-emption [this §1334(a). clause package" "statement abide prohibition. 44399 prescriptions). more. Does all? 128 negative. 504 bar state outside 518. "merely prohibit[ing] bodies mandating cautionary labels 129 intentions regard (FTC), §7(c), 89, affirm [FTC's] trade rules" Conf. 91-897, Managers) (we intention way); 7921 Satterfield) (same). clause-a issue-so broadly engaging so. inasmuch declined pre-empting entire bars narrow aside, "response" 35, silence. Notwithstanding voiced legislators, once-and, said, post-1965 interprets silence statement. history: former denials 132 Until early 1990's, assert. mind. agrees me positions difference. 34; 863 ("An instantly carved stone"); ("[C]hange invalidating"). Nevertheless, "important context" 34. policy, themselves, 133 administrators wrote definitions-in requirement-because "therapeutic 1454 Letter). Commissioners roughly assertion. pointed "recommended" pleasure." others reiterated evidentiary "health Yet stressed "intent," adding "[w]e evidence" "intent nicotine." respectively, (Comm'r Edwards); Dec. Kennedy); Rankin); Kessler). counsel "depends use," "depends, general, manufacturer." Addiction, 288 (testimony Richard Cooper) 134 Other occasionally referred Kessler, "enormous flowing counseled "guidance." 69; decision). overwhelming requisite 238-239 1980) "comments" "understanding" crux lay manufacturers' revelatory intent"). 135 changed? obtained "claims." 12-14. permitted knew achieved appetite-suppressing, mood-stabilizing, habituating psychological) means, knowledge. 136 mounted, until, 1980's, consensus firm. smoking's phenomenon. Higginson, Counterblast, Out-door Papers 179, 194 (1863) (characterizing narcotic poison class' convincing epidemiological began mid-20th century; documenting 1964; 1988. stage, controversy, diminishing recently-and recently-has problem. 44701-44706 137 administration changed. Earlier administrations expressed. attitude. 138 Nothing reasons. mid-1990's, intent-even claim-had found. emerging adverse, convinced spend resources effort. administrations, then-Justice Rehnquist's he wrote: 139 "The election party. members resistance uncertainties counterparts administration. brought casting perfectly executive reappraisal costs programs bounds assess records evaluate priorities philosophy administration." 29, (concurring part). V 140 gets right, "music." Helvering Gregory, 809, 810-811 (CA2 1934) (L. Hand, J.) [statute] melody notes rest grounds. 141 played critical play interpretation. requirement. exclusion X treated food" establishes eaten. resemble courts, assume close cases consequences," 69, democratically unelected administrators. Kent Dulles, 357 116, (1958) (assuming liberties). outcome Insofar reflects administration, officials will) responsibility. attendant publicity, accountable. Presidents, public. Vice elects. magnitude-one controversial-can escape scrutiny democracy. review 144 145 2.5% successfully stop 34% 44704 (citing Centers Disease Control Prevention, Among Adults-United 1993; Morbidity Mortality Weekly 929 1994)). handful try succeed illustrates reality-the reality powerful "drug"; "device"; disease-preventing 146 desired); concludes disagree am wrong remedies, 147 deprive Previous disclaimers form atmosphere emerged. law, phrase. status quo. 148 today holds aimed authorize (nicotine) unsafe. Far most, life-threatening rectify. counter-intuitive. forth, 149 dissent.

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