Food & Drug Administration v. Brown & Williamson Tobacco Corp.

v. BROWN ADMINISTRATION DRUG AND et al. FOOD CORP. TOBACCO al. & WILLIAMSON et 21, 2000 March 1, 1999 December Argued No. 98-1152. Decided O’Connor, J., delivered the opinion of the Court, in which Rehnquist, J.,C. and Scalia, Kennedy, and Thomas, JJ., joined. Breyer, J., filed a dissenting opinion, in which Stevens,' Souter, and Ginsburg, JJ., joined, post, p. 161. Solicitor General Waxman argued the cause petition- for ers. With him on the briefs were Acting Assistant Attor- ney Ogden, General Deputy Solicitor General Kneedler, Deputy Assistant Attorney General Schultz, Irving L. Gorn- stein, Eugene Douglas Letter, Thirolf Gerald C.Kell, Chris- and Schifter, E. Porter, Karen Jane Margaret Kohl, N.

tine Kaeding. J. Patricia respondents. for cause argued Cooper M.

Richard Reynolds Tobacco J. respondent R. for on the brief himWith W. Bert Krulwich, S. Andrew Umin. M. was Steven Co. a filed L. Robinson Michael Kirby, and W. Rein, Thomas Corp. Tobacco Williamson respondent Brown & for brief States United respondents brief for filed Larry Sitton B. re for a brief filed MacLeod C. William al. etCo. Tobacco et al. Stores of Convenience Association spondents National Richman, Rich Levine, N. Jr., Arthur Grossi, T Peter Jeff respond for a brief Dym filed Herbert Merrill, and A. ard et al.* Inc. Philip Morris ents of Min State for filed were reversal curiae urging amici of * Briefs S. Minnesota, James of Hatch, General Attorney Mike by et al.

nesota Reme, At by and General, Louise H. Attorney Alexander, Assistant M. Botelho Bruce as follows: States respective for their General torneys Arkansas, Bill Pryor of Arizona, Mark of Napolitano Janet Alaska, of of Blumenthal Rickard Colorado, of Salazar Ken California, of Lockyer Hawaii, I. of Anzai Earl Florida, of Butterworth Connecticut, Robert A. of Modisett A. Illinois, Jeffrey Ryan of E. James Idaho, G. Alan Lance of Kansas, Andrew Stovall of J. Iowa, Carla J. of Indiana, Thomas Miller Reilly F. Thomas Jr., Curran, Maryland, of Joseph Maine, J. Ketterer of of Mis Moore Mike Michigan, of Granholm M. Massachusetts, of Jennifer Montana, of P. Mazurek Joseph Missouri, of NixonW. Jeremiah sissippi, Hamp Newof McLaughlin T. Philip Nevada, of Papa Del Sue Frankie New of A. Madrid Patricia Farmer, Jr., of New Jersey, J. John shire, Dakota, North of Heitkamp Heidi York, New Spitzer of Eliot Mexico, Oklahoma, of Edmondson Drew W. A. Ohio, of Montgomery D. Betty Sheldon Pennsylvania, Fisher of D. Michael Oregon, Hardy Myers of Cornyn Dakota, John South of Island, Mark Barnett of Rhode Whitehouse Vermont, Christine H. Sorrell of Utah, William of Texas, Jan Graham Jr., Virginia, McGraw, West V. Darrell Washington, Gregoire 0. Action for Wyoming; Woodhouse Gay Wisconsin, Doyle E. James Scheg; E. Kathleen III F. by John Health Banzhaf Smoking and Brooks, R. David E. Russell Inc., Society, Cancer the American for Dalton; American J. Westland, and William W. Charles Gelfand, delivered opinion Justice O'Connor of the Court. case involves one of the most troubling public health problems facing our Nation today: the prema- thousands of ture deaths that occur year each because of tobacco use. In 1996,the Food Drug (FDA), Administration after having expressly disavowed such authority since inception, its jurisdiction asserted products. See 61 Fed. Reg. 44619-45318. The FDA concluded that nicotine is a “drug” within the meaning of the Food, Drug, and Cos- (FDCA metic Act Act), 52 Stat. 1040, as amended, 21 U. S. C. 301 et seq., and cigarettes and smokeless to- bacco are products” “combination that deliver nicotine to -the body. 61 Reg. Fed. (1996). Pursuant to this author- ity, it promulgated regulations intended to reduce tobacco consumption among children and adolescents. Id., at 44615- 44618. The agency believed that, because most tobacco begin consumers their use before reaching age of 18, curbing tobacco use by minors could substantially reduce prevalence of addiction in generations future and thus the incidence of tobacco-related death and disease. Id., at 44398-44399. Regardless of how serious problem an administrative agency seeks to address, however, it may not exercise its authority “in a manner that is inconsistent with the adminis trative structure that Congress enacted into law.” ETSI Pipeline Project v. Missouri, 484 U. (1988). S. 495, 517 And although agencies are generally entitled to deference in the interpretation of statutes they administer, reviewing “court, as well as agency, give must effect to the unam- College of Chest Physicians by Raymond D. Cotton; and for Citizen, Public Ine., 'et al. by Allison M. Zieve, Alan B. Morrison, and David C. Vladeck. urging affirmance were filed for the Pacific Legal Foundation by Anne M. Hayes and M. Reed Hopper; for the Product Lia- bility Advisory Council, Inc., by Kenneth S. Geller; and for the Washington Legal Foundation et al. by Daniel Topeo J. and Richard A. Samp.

126 A.S.U. Chevron Congress.” of expressed intent biguously U. S. Inc., 467 Council, Resources Inc. v. Natural Defense (1984). we believe case, In this 837, 842-843 jurisdiction asserting from the FDA precluded clearly has authority is inconsistent products. Such regulate to tobacco FDCA’s in the expressed Congress has the intent with legisla- tobacco-specific in the scheme regulatory overall light In FDCA. the subsequent to enacted it has tion that jurisdiction of assertion FDA’s the intent, this clear of impermissible.

I designee of Secre- as grants FDA, The FDCA authority (HHS), to Services tary and Human of Health 21 See “devices.” “drugs” and items, among other regulate, III). Act The (1994 Supp. §§ ed. and 321(g)-(h), 393 U. C.S. food) (other intended than defines, to “articles “drug” include 21 body.” any function or structure to affect the “an as part, “device,” §321(g)(1)(C). It defines C. U. S. contrivance,... machine,, implement, apparatus, instrument, component, any including article, or related similar or other the struc- affect to ... intended accessory, which is part, or 321(h). § also Act The body.” any or function ture “combi- so-called authority to grants FDA the drug, of a a combination which “constitute products,” nation has FDA The 353(g)(1). product.” biological device, regu- to discretion giving it the provision as construed this both. or as devices, drugs, as products late combination (1996). Reg. 44400 Fed. rule proposed published FDA August 1995, On tobacco and smokeless cigarettes concerning sale The Reg. 41314-41787. Fed. and adolescents. children sale, distribu- on the restrictions several rule, included which designed was products, of tobacco advertisement tion, and availability and attractiveness reduce the period comment public A 41314. Id., at young people. sub- 700,000 over received during which followed, missions, more than any “at other time in its history other subject.” 61 Reg. (1996). Fed.

28, 1996, the FDA issued a final rule entitled “Regulations Restricting the Sale and Distribution Ciga- rettes and Smokeless Tobacco to Protect Children and Ado- lescents.” Id., at 44396. The FDA determined that nico- tine ais “drug” and cigarettes and smokeless tobacco “drug are delivery devices,” and therefore jurisdiction it had under the FDCA regulate products tobacco as customarily marketed —that is, without manufacturer claims of therapeu- tic benefit. Id., at 44397,44402. First, the FDA found that tobacco “‘affect the structure function of ” the body’ because nicotine significant “has pharmacological effects.” Id., at 44631. Specifically, nicotine psy- “exerts choactive, or mood-altering, effects on the brain” that cause and sustain addiction, have both tranquilizing and stimulat- n ing effects, and control weight. Id., at 44631-44632. Sec- ond, the FDA determined that these effects were “intended” under the FDCA they because “are widely so known and foreseeable that [they] may be deemed to have been intended by the manufacturers,” id., at 44687;consumers use tobacco products “predominantly or nearly exclusively” to obtain these effects, id., at 44807;and the statements, research, and actions of manufacturers revealed they that “have ‘designed’ cigarettes provide pharmacologically active doses of nico- tine to consumers,” id., at 44849. Finally, the agency con- cluded cigarettes that and smokeless tobacco are “combina- products” tion because, in addition to containing nicotine, they include device components that deliver a controlled amount of nicotine to the body, id., at 45208-45216. jurisdictional question, the FDA next explained the policy justifications regulations, its detail- ing deleterious health effects associated with tobacco use. It found that tobacco consumption was “the single leading cause preventable death in the United States.” Id., at 44398. According to the “[m]ore FDA, than 400,000 illnesses, such tobacco-related year from each die

people Ibid. disease.” heart illnesses, and respiratory cancer, reduce way to only that determined agency also The to re- mortality was and illness of tobacco-related amount accomplished be goal that could a addiction, the level duce starting to from adolescents children only by preventing 82% that found FDA The Id., at 44398-44399. tobacco. use age of before cigarette first their had smokers adult smokers regular already become half had than and more were children that also found It age. Id., at 44398. by that prevalence age, younger smoke beginning to similar increased, and recently smoking had youth Id., at tobacco. to smokeless respect with problems existed if “the accordingly concluded The 44398-44399. use begin who adolescents children number can illness diminished, tobacco-related substantially be can any- suggest data because reduced correspondingly be or adolescence smoking in childhood begin does not who one Id., 44399. begin.” at unlikely to ever is regulations promulgated findings, the on these Based acces- labeling, and promotion, products’ concerning tobacco 44615-44618. id., at and adolescents. sibility to children or cigarettes sale of prohibit regulations access The retail- require 18; than younger persons to tobacco smokeless pur- age all photo identification verify through ers cigarettes sale prohibit the 27; younger than chasers of free prohibit distribution 20; than quantities smaller displays and through self-service prohibit sales samples; Id., adult-only locations. except vending machines any require regulations promotion The 44616-44617. text-only for- black-and-white, appear in a advertising print almost read appears in which it publication mat unless advertising within prohibit outdoor adults; exclusively by prohibit the school; or playground public any feet of 1,000 T-shirts items, such promotional distribution prohibit name; and brand manufacturer’s bearing the hats, manufacturer from sponsoring any athletic, musical, artistic, or other social or cultural using event its brand name. Id., at 44617-44618. The labeling regulation requires that the statement, “A Nicotine-Delivery Device for Persons 18 or appear Older,” on all product tobacco packages. Id., at 44617. PDA promulgated regulations these pursuant to its authority regulate "restricted devices.” See 21 U. S. C. §360j(e). The § PDA construed 353(g)(1) as giving it the discretion to products” “combination using the Act’s drug authorities, device authorities, or both, depending on public “how the goals health of the act can be best accom- plished.” 61 Reg. Fed. (1996). Given greater flexibility in the FDCA for the regulation of devices, the FDA determined that “the device provide authorities most appropriate basis for regulating cigarettes and smoke- less tobacco.” Id., at 44404. Under 21 U. S. C. 360j(e),the agency may “require that a device be restricted to dis- sale, tribution, or use ... upon such other [the conditions as FDA] may prescribe in regulation, such if, because of potential- its ity for harmful effect or the collateral necessary measures its [the use, FDA] determines that there cannot otherwise be reasonable assurance of its safety and effectiveness.” The FDA reasoned that its regulations fell within au- thority granted by §360j(e) because they related to the sale or distribution of and were necessary providing a reasonable assurance of safety. 61 Fed. Reg. (1996). 44405-44407

Respondents, a group of tobacco manufacturers, retailers, and advertisers, filed suit in United States District Court for Middle District of North Carolina challenging the regula- tions. See Coyne Beahm, Inc. v. FDA, 966 F. Supp. (1997). They moved for summary judgment on grounds the that the FDA jurisdiction lacked to regulate prod- tobacco ucts as customarily regulations marketed, the exceeded the FDA’s authority under 21 U. S. §360j(e), C. and the advertís- Second Amendment. First the violated restrictions

ing Summary Judgment for Motion Plaintiffs’ in Brief Support (CA4), 97-1604 in No. in 3 Ree. (MDNC), in 2.-95CV0059I No. Motion Plaintiffs’ in Support Brief 40; Third Tab No. 3in (MDNC), 2:95CV00591 in No. Judgment Summary for District Court The 42. No. (CA4), Tab in 97-1604 No. Rec. it in part. and denied motion part respondents’ granted au- FDCA the held that court The 1400. at 966 F. Supp., as custom- tobacco products FDA to the thorizes labeling regu- and access FDA’s and that marketed arily agency’s that it found also but are permissible, lations its author- exceed restrictions advertising promotion im- court The Id., stayed at 1380-1400. under 360j(e). ity (except it valid found regulations of the plementation minors) and to of tobacco products sale on the prohibition Id., interlocutory appeal. immediate order for its certified at 1400-1401. reversed, Circuit Fourth Court Appeals

The FDA jurisdiction not has granted that Congress holding (1998). Ex- F. 3d products. tobacco to regulate that concluded whole, the court aas the FDCA amining a number create would of tobacco products FDA’s regulation Id., at 162-167. Various provi- inconsistencies. of internal determine to the agency Act require sions allowed be sold it can “safe" before product regulated rulemaking its the FDA found market, yet remain “un- “dangerous” are proceeding would apparently Id., at 164-167. Thus, the FDA safe.” found clearly the court a result tobacco products, ban have Ibid. This apparent intent. to congressional contrary concluded, demonstrates Appeals Court anomaly, to regu- authority the FDA intend give not did evi- found Id., also court The 167. late tobacco. Im- this conclusion. confirms FDCA to the external dence 1995 that before stated consistently portantly, enacted has tobacco, and Congress over lacked jurisdiction several tobaeco-speeificstatutes fully cognizant of the FDA’s position. See id., at 168-176. In fact, the court reasoned, Congress has considered rejected many bills that would given have the agency authority. such See id., at 170-171. This, along with the absence of any by intent the enacting Congress in 1938 to subject products tobacco regulation to under the FDCA, demonstrates intended to withhold such authority from the FDA. Id., at 167-176. Having resolved jurisdictional question against agency, the Court of Appeals did not address whether the regulations exceed the FDA’s authority under 21 U. S. C. §360j(e) or violate the First Amendment. See 153 F. 3d, at 176, n. 29. granted

We parties’ federal petition for certiorari, 526 U. S. (1999), to determine whether the FDA has author- ity under the arily marketed. regulate FDCA to products tobacco as custom-

II The FDA’s jurisdiction assertion of tobacco products is founded on its conclusions that nicotine is a “drug” and that cigarettes and smokeless tobacco are “drug delivery devices.” Again, the FDA found that prod- tobacco ucts are “intended” to deliver pharmacological effects of satisfying addiction, stimulation and tranquilization, weight control because those effects are foreseeable reasonable manufacturer, consumers use products to obtain those effects, and tobacco manufacturers have de- signed their produce those effects. Reg. Fed. (1996). 44632-44633 As an initial matter, respondents take issue with the FDA’s reading of “intended,” arguing that it is a term of art that refers exclusively to claims made manufacturer or vendor about the product. See Brief for Respondent Brown & Williamson Corp. Tobacco 6. That is, product a is not drug or device under the FDCA unless the manufacturer or vendor makes some express claim concern- ing product’s therapeutic benefits. See id., at 6-7. We assuming, because however, question, this resolve not

need struc- the to affect “intended be product can a arguendo, that therapeutic of claims body” absent the of or function ture contra- jurisdiction claim FDA’s benefit, the or medical Congress. of intent clear the venes ana for framework appropriate is the issue A threshold authority to of assertion lyzing FDA’s the administrative an involves case this products. Because administers, our statute of a agency’s construction Re v. Natural Inc.A. U.S. by Chevron governed analysis is (1984). Under 467 U. S. Inc., Council, sources Defense Con “whether ask first must reviewing court Chevron, a issue.” question at precise spoken directly gress has anat inquiry is so, the done has If Id., 842. at ex unambiguously effect to give “must court end; the also United see 848; Id., at Congress.” of pressed intent Holly (1999); 380, 392 S. Co.,526 Apparel U. Haggar v. States (1996). Con ifBut 392, 398 U. S. NLRB, 517 v. Corp. Farms reviewing a question, specifically addressed gress has not statute of agency’s construction respect the must court Aguirre-Aguirre, v. INS permissible. See is long as it so 452, 45 S. Robbins, 519 U. (1999); v. Auer 415, 526 S. U. responsi “[t]he justified (1997). because deference Such policy choices such of assessing the wisdom bilities pub competing views struggle between resolving 866, and supra, at Chevron, ones,” judicial not lic interest are ever- familiarity with greater agency’s because subjects surrounding changing and circumstances facts (1991). 173, 187 Sullivan, 500 S. U. v. Rust regulated, see ad specifically Congress has determining whether In not reviewing court should issue, a question dressed statutory provision particular a examining confine itself words ambiguity certain meaning The in isolation. —of —or in context. placed when only may evident become phrases (1994)(“Ambiguity 115, 118 U. S. Gardner, 513 v. Brown statutory but possibilities not of definitional is a creature context”). It is a “fundamental canon of statutory construc tion that the words of a statute must be read in their context and with a view to place their in the overall statutory scheme.” Davis v. Michigan Dept. Treasury, 489 U. S. (1989). 803, 809 A court must therefore interpret the stat ute “as symmetrical and coherent regulatory scheme,” v. Alloyd Co.,513 Gustafson U. S. (1995), 561, 569 and “fit, if possible, parts all into an harmonious whole,” FTC v. Mandel Brothers, Inc., 359 (1959). U. S. 385, 389 Similarly, the meaning of one statute may be affected other partic Acts, ularly where Congress spoken has subsequently and more specifically to the topic at hand. See United States v. Estate Romani, 523 U. S. (1998); 530-531 United States v. Fausto, 484 U. (1988). S. 439, 453 In addition, we must be guided to degree by common sense as to the manner in which Congress is likely delegate a policy decision of such economic political and magnitude to an administrative agency. Cf. MCI Telecommunications Corp. v. American Telephone & Telegraph Co., (1994). 512 U. S. 218, 231 principles in mind, we find that has directly spoken to the issue here precluded and the FDA’s jurisdiction to regulate products.

A Viewing the FDCA as a whole, it is evident that one of the Act’s objectives core is to ensure any product regulated by the FDA is “safe” and “effective” for its intended use. § 21 U. 393(b)(2)(1994 S. C. Ill) ed., Supp. (defining the FDA’s mission); More Information for Better Patient Care: Hearing before Senate Committee on Labor and Human Resources, 104th Cong., 2d (1996) (statement Sess., 83 of FDA Deputy Schultz) (“A Comm’r precept fundamental of drug and regulation device in this country is prod- that these ucts proven must be safe and effective they before can be sold”). This essential purpose pervades the FDCA. For instance, § 21 U. 393(b)(2)(1994 S. C. Ill) ed., Supp. defines public the “protecting] include “[mission” to FDA’s

the effective” and safe drugs are ensuring . . . health safety and the assurance is reasonable “there and The use.” human for intended of devices effectiveness drug, with any new approval of premarket requires FDCA “shall FDA states exceptions, and limited some a new application” approve the refusing to issue, order an purpose. intended for its effective and safe drug not if it is approval after (4)-(5). discovers 355(d)(1) (2), FDA If §§ — notice due “shall, after ineffective, it or drug is unsafe that a ap withdraw applicant, hearing to the opportunity 355(e)(1) (3). Act §§ The C. drug. 21 U. S. — proval” of the three one of into classify all devices FDA requires the also category the 360c(b)(1). which Regardless § categories. assurance “reasonable abe must there chooses, FDA C.S. 21 U. device.” effectiveness safety and Ill); Fed. (1994 Supp. (C) (B), 360e(a)(1)(A)(i), ed. §§ provision device” (1996). “restricted Even Reg. 44412 regulations promulgated pursuant to which conditions place agency to here authorizes issue can “there when specifically of a device distribution or sale effec safety and of its assurance reasonable be otherwise not re generally Act Thus, 360j(e). U. S. C. tiveness.” drug marketing of prevent FDA quires physical or inflicting death for “potential where device therapeutic benefit.” possibility by the injury not offset (1979). S. 442 U. v. Rutherford, States United exhaustively quite rulemaking proceeding, In its “danger- unsafe,” are products “tobacco that documented illness.” suffering from great pain and “cause ous,” consumption (1996). that It found Reg. Fed. risks,” and “extraordinary health presents products tobacco preventable leading cause single is the use “tobacco stated It 44398. Id., at States.” in the United death tobacco- from year each die people 400,000 “[m]ore than illnesses, and respiratory cancer, illnesses, such related heart disease, often suffering long painful deaths,” and “[tjobacco alone kills more people year each in the United States than acquired immunodeficiency syndrome (AIDS), car accidents, alcohol, illegal homicides, drugs, sui- cides, and fires, combined.” Ibid. Indeed, the FDA charae- .terized smoking pediatric as “a disease,” id., at 44421, be- cause “one out of every three young people who become regular smokers . . . will die prematurely as a result,” id., at 44399. These findings logically imply that, if products tobacco were “devices” under the FDCA, the FDA required would be to remove them from the market. Consider, first, provisions

FDCA’s concerning the misbranding of drugs or devices. The Act prohibits “[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.” 21 §331(a). U. S. C. light In of the findings, FDA’s two distinct FDCA provisions would cigarettes render and smokeless to- bacco misbranded devices. First, §352(j) drug deems a device “[i]f misbranded it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” The FDA’s findings make clear prod- tobacco ucts are “dangerous to health” when used in the pre- manner scribed. Second, drug or device is misbranded under “[u]nless Act its labeling bears . . . adequate directions for use ... in such manner and form, as are necessary for protection of users,” except where such directions are “not necessary protection public health.” §352(f)(1). Given the FDA’s conclusions concerning the health consequences of tobacco use, there are no directions that could adequately protect consumers. That is, there are no directions that could make products safe for ob- taining their intended effects. Thus, were tobacco within the FDA’sjurisdiction, the Act would deem them mis- branded devices that could not be introduced into interstate Act ad- contention, the Contrary the dissent’s to

commerce. device the evident is- it discretion once no remedial mits is misbranded. devices place all to FDA requires the FDCA

Second, the See classifications. of three one into regulates it classification device’s a 360c(b)(l). agency § relies The necessary regulation degree of control determining the safety and of assurance is “a reasonable there ensure that (1996). has FDA The Reg. 44412 61 Fed. effectiveness.” regulations Instead, the products. classify yet tobacco the which controls,” “general so-called represent here issue classification. impose in advance agency to entitles Act no prescribes FDCA Although the id., at 44404-44405. See stated has the FDA classification, for device deadline rulemaking” as a future products “in classify will tobacco find FDA’s Given 44412. Id., at Act. required use, tobacco consequences the health ings regarding tobacco smokeless cigarettes and place agency have would Act’s of the application after because, even III in Class unrea potential “presen[t] they would controls, available 360c(a)(l)(C). §C. 21 S. injury.” U. or illness risk of sonable subject to be would devices, tobacco III As Class C. U. S. process. approval premarket the FDCA’s §360e; Ill); S. (1994 C. 21 U. 360c(a)(1)(C) Supp. § ed., FDA (1996). provisions, these Under Reg. 44412 Fed. pre- for application an approving prohibited from would be assurance showing of reasonable “a approval without market pre of use the conditions is safe under such device labeling proposed suggested in recommended, scribed, FDA’s 360e(d)(2)(A). view In C. S. 21 U. thereof.” use, the effects health regarding conclusions reasonable such finding any no basis agency have would statu its fulfilled safety. Thus, once assurance allow not it could products, classify tobacco obligation to tory be marketed. them to

The FDCA’s misbranding and device classification provi- sions therefore make evident that were the FDA regulate cigarettes and smokeless tobacco, the Act would require the agency to ban them. In fact, based on provisions, these FDA itself has previously taken the position that if tobacco products were within its jurisdiction, “they would have to be removed from the market because would be impossi- ble prove they were safe for their us[e].” intended Pub- lic Cigarette Health Amendments of 1971: Hearings before the Commerce Subcommittee on S. 1454,92d Cong., 2d Sess., (hereinafter (1972) (statement Hearings) of FDA Comm’r Edwards). Charles See also Cigarette Labeling and Advertising: Hearings before the House Committee on Interstate and Foreign Commerce, 88th Cong., 2d Sess., 18 (1964) (hereinafter (statement 1964 Hearings) Dept, Health, Education, and (HEW) Welfare Secretary Anthony Celebrezze that proposed amendments to the FDCA that would given have jurisdiction the FDA over “smoking prod- uct[s]” “might well completely outlaw at cigarettes”). least the removal of tobacco products from the market. provision A of the United States Code currently in force states that “[t]he marketing of to- bacco constitutes one of greatest basic industries of the United States with ramifying activities which directly affect interstate and foreign commerce at every point, and stable conditions therein are necessary general welfare.” 7 §1311(a). U. S. C. More importantly, Congress has directly problem addressed of tobacco and health through legisla- tion on six occasions since 1965. See Federal Cigarette La- beling and Advertising Act (FCLAA), Pub. L. 89-92, 79 Stat. 282; Public Cigarette Health Smoking Act of 1969, Pub. L. 91-222, 84 Stat. 87; Alcohol Drug Abuse Amendments of 1983, Pub. L. 98-24, 97 Stat. 175; Comprehensive Smoking Education Act, Pub. L. 98-474, 98 Stat. 2200;Comprehensive Smokeless Tobacco Health Education Act of 1986, Pub. L. 99-252, 100 Stat. 30; Alcohol, Drug Abuse, and Mental 102-321, L. Act, Pub. Reorganization Administration

Health statutes, these Congress enacted When 394. 202,106 Stat. well were use consequences health the adverse g., e. See, effects. pharmacological nicotine’s known, as were Surgeon U. Welfare, S. Education, Dept, Health, U. S. 25-40, Health Smoking and Committee, Advisory General’s Report) (hereinafter Surgeon General’s (1964) 69-75 coro- lung cancer, smoking causes cigarette (concluding that emphysema, and bronchitis chronic and disease, nary artery includ- effects, pharmacological has various nicotine and that suppression); appetite tranquilization, and stimulation, ing Health Services, Public Human and Dept, Health of S.U. 7-12 Smoking for Women Consequences Service, Health cancer, lung chronic mortality for (1980) rates (finding that increased are coronary disease heart lung and disease, during smoking smokers, and and men both women ef- health adverse significant with pregnancy is associated Dept, child); U. S. newborn and unborn fetus on the fects Why Service, Health Public Services, Human of Health and Ed- Smoking (1983), Prevention in Cigarettes People Smoke the Subcommittee 1824before Hearings H. R. on Act, ucation on Committee House Environment and the Health (1983) Sess., 32-37 Cong., 1st Commerce, 98th Energy and smoking is (stating that Hearings) (hereinafter 1983 House our dependence drug example of widespread “the most chemistry of “affect that--cigarettes country,” and and Human Health Dept, of S. system”); U. brain and nervous Consequences Health Service, The Health Services, Public (herein- (1988) 145-239 6-9, Smoking: Addiction Nicotine to- (concluding that Report) Surgeon General’s after 1988 way heroin same addicting much the products are bacco addic- causes drug is the nicotine cocaine, and ordering short stopped tion). well Nonetheless, labeling and regulated generally it has Instead, ban. providing expressly products, of tobacco advertisement national “commerce Congress that policy is the economy may protected be .. . to the maximum extent con- sistent with” consumers “be[ing] adequately informed about any adverse health effects.” 15 U. S. C. 1331. Congress’ decisions labeling and advertising and to adopt express policy of protecting “commerce and the national economy ... to the maximum extent” reveal its intent that products tobacco remain on the market. Indeed, the collec- premise tive of these statutes is that cigarettes and smoke- less tobacco will continue to be sold in the United States. A ban of products tobacco by the FDA would therefore plainly contradict congressional policy.

FDA apparently recognized this dilemma and con- cluded, somewhat ironically, that are ac- tually “safe” within the meaning of the promul- FDCA. In gating its regulations, the agency conceded that “tobacco products are unsafe, as that term is conventionally under- stood.” 61 Fed. Reg. (1996). Nonetheless, the FDA reasoned that, in determining whether a device is safe under Act, the it must consider “not only the presented risks by a product but also any of the countervailing effects of use of product, that including the consequences of not permitting product the to be marketed.” Id., at 44412-44413. Apply- ing this standard, the FDA found that, because of the high level of addiction among tobacco a users, ban likely would be “dangerous.” Id., at 44413. In particular, current tobacco users could suffer from extreme withdrawal, the health care system and available pharmaceuticals might not be able to meet treatment demands of those suffering from with- drawal, and a black market offering cigarettes even more dangerous than those currently sold legally likely would de- velop. Ibid. The FDA therefore concluded that, “while taking cigarettes and smokeless tobacco off the market could prevent some people from becoming addicted and reduce death and disease for others, the record does not establish that such a ban is the appropriate public health response under the act.” Id., at 44398. factors “these asserts, that PDA be, as the may well

It scheme regulatory developing a when be considered must prod- these for result public health the best that achieves leaving that judgment FDA’s the But Id., 44413. at ucts.” in achiev- effective “is more the market products tobacco for substitute nois ibid., ban,” a goals than ing public health FDCA’s by the required safety determinations specific the Act the provisions Several provisions. operative various safe product determine itself require the FDA ther- probable product’s is, That by consumers. as used United harm. outweigh risk its must apeutic benefits (“[T]he Commissioner S., U. Rutherford, v. States therapeu- expected drug safe when a generally considers use”). contrast, In by its entailed the risk gain justifies tic agency, with allow safety would conception of FDA’s requires FDCA provision of respect each “dangerousness,” “safety” or product’s agency to determine admin- alternative effects aggregate health compare inquiry. different qualitatively is a This actions. istrative be would bana has concluded the FDA although Thus, are not concluded it has “dangerous,” Act. throughout the is used term “safe” as that fac those 360c(a)(2), specifies which C. U. S. Consider safety determining may consider the FDA tors that classification, purposes a device effectiveness all For approval. premarket standards, performance “rea a be at least must FDA, there regulated devices de of the effectiveness safety and of the assurance sonable (1994 (C) (B), ed. §§360c(a)(l)(A)(i), 21 U.S.C. vice.” See (1996). 21 U. S. C. Title III); Reg. 44412 61 Fed. Supp. and 360c(a)(2) § provides be to are device aof safety and effectiveness

“the determined— use whose persons “(A) respect to the with intended, or represented device “(B) respect with to the conditions of prescribed, use recommended, or suggested in the labeling of the de- vice, and

“(C) weighing any probable benefit to health from the use of the against device any probable risk of injury or illness from such use.” A straightforward reading provision of this dictates that the

FDA must weigh probable therapeutic benefits of the device to the against consumer probable risk of injury. Applied to products, tobacco the inquiry is whether their purported satisfying addiction, stimulation benefits— and sedation, weight outweigh the risks to health control— from their use. To accommodate the FDA’s conception of safety, however, one must read “any probable benefit to health” to include the benefit public to health stemming from adult consumers’ continued use of products, even though the reduction of tobacco use is the raison d’etre of regulations. In other words, the FDA is forced to con- tend that very evil it seeks to combat is a “benefit to health.” implausible. This is

The FDA’s conception of safety is also incompatible with the FDCA’s misbranding provision. Again, §352(j) pro- vides that a product is “misbranded” if “it is dangerous health when used in the dosage or manner, with the fre- quency or duration prescribed, recommended, or suggested in the labeling thereof.” According to the FDA’s under- standing, a product would be “dangerous to health,” therefore misbranded under 352(j), comparison when, in leaving product on market, a ban produce would not “adverse health consequences” in aggregate. Quite simply, these are inquiries. different Although banning particular product might be detrimental public health in aggregate, the product could still “dangerous be to health” when used as directed. Section 352(j) focuses on dangers to the con- sumer from use of product, not stemming those from the agency’s remedial measures. dis- the FDA and by the analogy made

Consequently, the various treatment in drugs the used highly toxic to sent (1996); Reg. 44413 61 Fed. unpersuasive. See is cancers J.). “dangerous” Although (opinion of post, at 177 Breyer, meaning the within safe drugs are sense, these some benefits therapeutic patients, for because, certain the Act cannot drugs Accordingly, such risk of harm. outweigh the under health” “dangerous to described properly be products. tobacco 352( for true is not j). same The U. S. C. cigarettes detail, great has documented FDA theAs any obtaining means unsafe are an tobacco smokeless effect. pharmacological “the that means conclusion our that contends The dissent drugs 'dangerous’ outright ban requires the

FDCA reading “perverse” is a this and that post, devices,” or our misunderstands This 174, 180. post, at statute, clearly may FDCA, with FDA, consistent holding. The banning them. without products “dangerous” many dangers under poses drug device every or virtually Indeed, is conclude may not do the FDA What conditions. certain therapeu- safely for used be drug cannot device that product that time, allow same yet, at purpose and tic incompatible with regulation is Such market. on the remain drug or every ensuring that objective core the FDCA’s effective. is safe device Con- is clear whole, as a

Considering the FDCA FDA’s from to exclude gress intended is FDCA precept of A fundamental jurisdiction. not banned—must by the FDA—but regulated any product Act provisions Various its intended use. be safe product using safety of to the refers that this make clear ramifica- public health effects, not intended its to obtain FDA. by the actions administrative alternative tions of a reasonable there must determine is, the FDA That outweigh benefits therapeutic product’s assurance According stand- to this consumer. to the harm the risk of ard, the FDA has concluded that, although products tobacco might be effective in delivering certain pharmacological ef- fects, they are “unsafe” and “dangerous” when used for these purposes. Consequently, if products tobacco were within the FDA’s jurisdiction, the Act would require the FDA to remove them from the market entirely. But a ban would contradict Congress’ clear intent as expressed in its more recent, tobacco-specificlegislation. The inescapable conclu- sion is that there is no room for products within the FDCA’s regulatory scheme. If they cannot be used safely for any therapeutic purpose, yet they cannot be banned, they simply do not fit.

B In determining whether Congress spoken has directly to the FDA’s authority to regulate tobacco, we must also con sider greater detail the tobacco-specific legislation that Congress has enacted over past years. At the time a statute is may enacted, it have a range plausible of meanings. Over time, however, subsequent acts can shape or focus those meanings. The judicial “classic task of reconciling many laws enacted over time, and getting them to ‘make sense’ in combination, necessarily assumes that implica tions of a statute may be by altered the implications of a later statute.” United States v. Fausto, 484 U. S., at 453. This is particularly so where the scope of the earlier statute is broad but the subsequent statutes more specifically ad dress topic at hand. As we recognized recently United States v. Estate Romani, specific “a policy embod ied in a later federal statute should control our construction of the [earlier] statute, even though ha[s] not been ex pressly amended.” 523 S., U. at 530-531. enacted separate six pieces of legislation since 1965addressing problem of tobacco use and human health. See supra, at 137-138. Those statutes, among things, other require that health warnings appear on all packaging and in print all and outdoor advertisements, see advertisement 4402; 1331,1333, prohibit §§ S.U. C. commu- electronic medium through “any

tobacco Communica- Federal to regulation nication” subject 4402(f); §§1335, require (FCC), see Commission tions to Congress three years every to report of HHS Secretary property “the addictive concerning findings on research receipt States’ 290aa-2(b)(2); and make §C.S. tobacco,” U. 42. making on their contingent block grants of certain federal distributor retailer, manufacturer, “for any it unlawful to any such product distribute any to sell or tobacco products 300x-26(a)(l). of 18,” the age under individual the acted against has statute, Congress each In adopting statements repeated consistent and FDA’s of the backdrop tobacco to regulate FDCA under the authority it lacked manufacturer. the benefit by of therapeutic claims absent and after over this period, occasions on several fact, In pharmaco- nicotine’s use and of tobacco health consequences considered known, Congress well become had effects logical such have granted that would bills and rejected evident it is circumstances, these Under jurisdiction. ratified effectively have statutes tobacco-specific Congress’ under lacks that it jurisdiction position FDA’s long-held has tobacco products. to the FDCA the problem address scheme distinct regulatory created con- scheme, as presently health, and and of tobacco FDA. for the role structed, precludes released General 1964, Surgeon On January Health. and Smoking Committee Advisory of the report effects health deleterious That documented report “that part, in relevant detail, concluding, smoking great mortality substantially contributes smoking cigarette rate.” death overall diseases and from certain specific identified also It 31. Report General’s 1964 Surgeon “stimulation,” including nicotine, effects of pharmacological Id., 74- of appetite.” “suppression and “tranquilization,” Trade Federal release, the report’s after days 75. Seven (FTC) Commission issued a notice of proposed rulemaking, see 29 Reg. Fed. (1964), 530-532 and in June 1964,the FTC promulgated a final rule requiring cigarette manufacturers “to disclose, clearly and prominently, in all advertising on every pack, box, carton or other container . . . ciga- rette smoking is dangerous to health may cause death from cancer and other diseases,” id., at 8325. The rule was to become effective January 1, 1965,but, on a request from Congress, the FTC postponed enforcement for six months. See Cipollone v. Liggett Group, Inc., 505 U. S. 504, 513-514 (1992). In response to Surgeon General’sreport and the FTC’s

proposed rule, Congress convened hearings to consider legis- lation addressing “the tobacco problem.” 1964 Hearings 1. During those deliberations, FDA representatives testified before Congress that the agency jurisdiction lacked under the FDCA to regulate products. Surgeon General Terry was asked during hearings in 1964whether HEW had the “authority to brand or label the packages cigarettes to control the advertising there.” Id., at 56. The Surgeon General stated that “we do not have such authority in exist- ing laws governing the ... Food and Drug Administration.” Ibid. Similarly, FDA Deputy Commissioner Rankin testi-' fied in 1965 “[t]he Food and Drug Administration has no jurisdiction under the Food, Drug, and Cosmetic Act over tobacco, unless it bears drug claims.” Cigarette Labeling and Advertising Hearings —1965: on H. R. 2248 before the House Committee on Interstate and Foreign Commerce, 89th Cong., (hereinafter 1st Sess., 193 1965 Hearings). See also Letter to Directors of Bureaus, Divisions and Directors of Districts from FDA Bureau of (May Enforcement 24,1963), in 1972 Hearings (“[Tjobacco 240 for marketed chewing or smoking without accompanying therapeutic claims, does not meet the definitions in the Drug, Food, and Cosmetic Act for food, drug, device or eosmetic”). In fact, HEW Secretary Celebrezze urged Congress not to amend the FDCA to cover

146 the in findings of in because, light products” “smoking com- well might a such “provision report, General’s

Surgeon contrary be would This at least cigarettes. outlaw pletely of light the in what, or intended understand, what, we accept- be amendment, would 18th the with our experience 18. Hearings 1964 people.” American able with consistent was of jurisdiction disavowal The FDA’s inception. the agency’s since taken it had the position to regulate authority asserted it never concedes, the FDA As it promul- until marketed customarily tobacco products for Petition- Brief See here. at issue the regulations gated on Smok- (FDA) in Action Brief Appellee see also 37; ers 9 1980), in (CADC Harris, 655 F. 236 2d ing Health and v. 73 (“In the 14-15 4,No. pp. Tab (CA4), 97-1604 in No. Rec. Act, Drug and Food of original enactment since years the modern of the promulgation since 41 years and in- repeatedly has Act, the and Cosmetic Food, Drug, the scope Congress that cigarettes beyond are formed intent therapeutic establishing claims health absent statute vendor”). the manufacturer behalf Congress’ with consistent also was position The FDA’s Act’s Before the FDCA. it enacted when intent specific Bureau agency, FDA’s predecessor 1938, adoption to regulate authority lacked that it announced Chemistry, 1906, ofAct and Drug Food Pure under tobacco products thera- with marketed were they unless 768, Stat. 3915,34 eh. Bureau of Agriculture, U. S. Dept, See claims. peutic Announcements Regulatory and Service Chemistry, of Chief 13, Opinion ¶ (Feb. Announcements 1914) (Apr. and considered 1929, Congress In L. Alsberg). C. Bureau of June Act Drugs Food amend “[t]o a bill rejected tobacco its provisions 30, 1906, extending also Sess., 1. 1st 71st Cong., S. products.” And, as Smoot). (remarks of Sen. (1929) Rec. Cong. the FDCA the text is no evidence there admits, considered even Congress history its legislative the applicability of the Act to products. See Brief for Petitioners 22, n. 4. Given the economic political and significance of the tobacco industry at the time, it is ex tremely unlikely Congress could have intended place tobacco within the ambit of the FDCA absent discussion of the matter. Of course, whether the Congress that enacted the FDCA specifically intended the Act to cover to bacco is not determinative; “it is ultimately pro visions of our laws rather than the principal concerns of our legislators by which we are governed.” Oncale v. Sun downer Services, Inc., Offshore 523 U. S. (1998); 75, 79 see also TVA v. Hill, 437 U. S. (1978) (“It 153, 185 is not for us to speculate, much less act, on whether Congress would have altered its stance had specific events of this case been anticipated”). Nonetheless, this intent is certainly relevant to understanding the basis for the FDA’s representations to Congress and the background against which Congress enacted subsequent tobacco-specificlegislation. enacting the FCLAA in considered rejected several proposals give the FDA

the authority to regulate tobacco. In April 1963, Repre- sentative Udall introduced a “[t]o bill amend the Federal Drug, Food, and Cosmetic Act so as to make that applica- Act ble to products.” smoking H. R. 5973,88th Cong., 1st Sess., 1. Two months later, Senator Moss introduced an identical bill in the Senate. S. 1682, 88th Cong., 1st (1963). Sess. In discussing his proposal on the Senate floor, Senator Moss explained that “this amendment simply places smoking prod- ucts under FDA jurisdiction, along with drugs, foods, cosmetics.” 109 Cong. Rec. (1963). In December 1963, Representative Rhodes introduced another bill would have amended “by FDCA striking out ‘food,drug, device, or cosmetic, place each where it appears therein and inserting in lieu thereof 'food, drug, device, cosmetic, or smoking product.’” H. R. 9512, 88th Cong., §3 1st Sess., (1963). And in January 1965,five months before passage of

148 a bill to again introduced Representative Udall FCLAA, smoking applicable to Act “to make the FDCA

amend of None Sess., 1. Cong., 1st 89th 2248, R.H. products.” law. proposals became these subject tobacco to 1965 ultimately in decided

Congress of scheme regulatory extensive the less to products program Federal “comprehensive a created FCLAA, which respect advertising with labeling cigarette and to deal with L. Pub. health.” smoking and any relationship between to regula- any rejected § The FCLAA 282. 2, 79 Stat. 89-92, warning, “Caution: required the it advertising, but of tion to Health,” to Your Hazardous May Be Smoking Cigarette In 283. §4, 79 Stat. Id., packages. cigarette all appear on stated Policy,” “Declaration the FCLAA’s “the ensuring that goals of objective balance was to its smoking cigarette adequately informed may public be and “commerce protecting and to health” may hazardous be §2, Id., extent.” economy to maximum ... the national §1331). (codified C. U. at 15 S. 282 79 Stat. grant the to proposals Congress reject the only did Not reg- any other pre-empted explicitly jurisdiction, but FDA relating smok- to labeling: “No statement cigarette ulation of by... this required statement than health, other ing and L. Pub. package.” cigarette required on be Act, shall label- product regulation of §5(a), The 283. Stat. 89-92, itas both FDCA, aspect integral is an ing, however, cur- requirements labeling today. The 1965 and in existed essentially identical are which FDCA, imposed rently regulate the to require the in those force safety consum- protect the drugs devices labeling (1964 §352 ed. C. §352; 21 U. S. Ü.S.C. ers. all requires IV). Act earlier, discussed Supp. As neces- are use ... for “adequate directions bear products 352(f)(1); § C. 21 U. S. users,” protection sary pro- (1964 ed.); 352(f)(1) requires that all § S. C. U. pathological those use against warnings “adequate. vide conditions byor children where its may use dangerous be health,” § 21 U. S. C. 352(f)(2); 21 U. 352(f)(2) S. (1964 C. ed.); and deems product “[i]f misbranded it is dangerous to health when used in the dosage or manner, or with the fre quency or duration prescribed, recommended, or suggested in the labeling thereof,” 21 § U. S. C. 352(j); 21 U. S. C. (1964 352(j) ed.). In this sense, the FCLAA was—and re incompatible with FDA regulation mains— of prod ucts. This is not to say that the FCLAA’s pre-emption pro by vision itself necessarily foreclosed jurisdiction. Cipollone v. Liggett Group, Inc., 505 S.,U. at 518-519. But it is an important factor in assessing whether Congress ratified the agency’s position is, —that whether Congress adopted a regulatory approach to problem of tobacco and health that contemplated role, no for the FDA. Further, the FCLAA evidences Congress’ intent pre- any clude administrative agency from exercising significant policymaking authority on the subject of smoking and health. In addition to prohibiting any additional requirements for cigarette labeling, the provided FCLAA “[n]o statement relating to smoking and health shall be required in the ad- vertising any cigarettes the packages of which are labeled in conformity with the provisions of this Act.” Pub. L. 89- §5(b), 92, 79 Stat. 283. Thus, in reaction to the FTC’s at- tempt to regulate cigarette labeling and advertising, Con- gress enacted a statute reserving exclusive control over both subjects to itself.

Subsequent tobacco-specific legislation followed a similar pattern. By the FCLAA’s own terms, prohibition on any cigarette additional labeling or advertising regulations relating to smoking and health was to expire July 1, 1969. § See 10,79 Stat. 284. In anticipation provision’s expi- ration, both FCC and the FTC proposed rules governing the advertisement cigarettes. See 34 Fed. Reg. 1959 (1969)(FCC proposed rule to “ban the broadcast of cigarette by commercials radio and television stations”); id., at 7917 on disclose manufacturers (FTC requiring rule proposed cigarette advertising “That print in all and packaging all from may cause death and dangerous health smoking is pulmonary bronchitis, disease, chronic coronary heart cancer, debating diseases’”)- After and other emphysema, regulation agencies administrative proper role Advertising— Labeling and Cigarette generally tobacco, see Interstate on House Committee Hearings before 1969: (1969), 2pt. Sess., Cong., 1st Commerce, 91st Foreign adver- cigarette banning FCLAA amended sub- communication' electronic any medium “on tisements Com- Communications Federal of the jurisdiction ject to the appear required to warning strengthening mission” Smoking Cigarette Health Public cigarette packages. Impor- §§ 88-89. Stat. 4, 6, 84 91-222, Pub. L. ofAct prohibition indefinitely the Congress tantly, extended smok- respect to labeling with cigarette regulation of other labeling reg- importance despite the (again ing health (codified 15at §5(a), FDCA). 88 84 Stat. the under ulation FTC 1334(a)). forbade expressly Moreover, it §C. U. S. July 1,1971, until rule pending on its taking action from its rule with proceed to FTC, if it decided required in advance months six least Congress at notify thereafter, As the 7(a), 89. Stat. 84 becoming effective. the rule’s originated the bill in which committee House of the chairman people— by body elected stated, “the —the legisla- in this involved policy determinations make must officials.” appointed up of agency made not some tion—and (remarks Staggers). (1970) Rep. Cong. 7920 Rec. 116 the au- transferred Congress had years later, after Four by Hazardous covered substances thority regulate Prod- (HSA) to the Consumer the FDA from Act Substances Health (CPSC), Public American Safety Commission ucts CPSC petitioned Moss, by Senator joined Association, tar. milligrams than yielding more cigarettes 236, 2dF. Harris, v. Smoking and Health Action on (CADC 1980); R. Kluger, Ashes to Ashes 375-376 (1996). After the CPSC determined that it lacked authority under the HSA to regulate cigarettes, a District Court held that the HSA did, in fact, grant CPSC such jurisdiction and ordered it to reexamine the petition. See American Public Health Association v. Consumer Product Safety Commission, [1972-1975 Transfer Binder] CCH Consumer Prod. Safety Guide 75,081 (DC ¶ 1975), vacated as moot, No. (CADC 75-1863 1976). Before the CPSC could take any action, however, Congress mooted the issue by adopting leg- islation that eliminated the agency’s authority to regulate “tobacco and tobacco products.” Consumer Product Safety Commission Improvements Act of 1976, Pub. L. 94-284, §3(c), 90 (codified Stat. 503 at 15 U. S. §C. 1261(f)(2)). Sena- tor Moss acknowledged that the “legislation, in effect, re- verse[d]” District Court’s decision, 121 Cong. Rec. 23563 (1975), and the FDA later observed that the episode was “particularly” “indicative of the policy Congress to limit the regulatory authority over cigarettes by Federal Agen- cies,” Letter to Action on Smoking and Health (ASH) Execu- tive Director Banzhaf from FDA Comm’r (Nov. Goyan 1980), App. 59. A separate statement in the Senate Report underscored that the legislation’s was purpose to “unmistak- ably reaffirm the clear mandate of the Congress that basic regulation of tobacco and tobacco products is governed legislation with dealing the subject,... and that any further regulation in this sensitive and complex area must be reserved for specific Congressional action.” S. Rep. No. 94-251, 43 (1975) p. (additional views of Sens. Hartke, Hollings, Ford, Stevens, and Beall).

Meanwhile, the FDA continued to maintain that it lacked jurisdiction under the FDCA to regulate tobacco products as customarily marketed. In 1972, FDA Commissioner Ed- wards testified before Congress that “cigarettes recom- mended for smoking pleasure are beyond the Federal Food, and Drug, Cosmetic Act.” 1972 239,242. Hearings He fur- Health Public the that FDA believed the that ther stated of regulation the that “demonstrates Smoking Act Cigarette “label- that and Congress,” of domain to be the cigarettes only take[n] be can step that ais banning cigarettes ing or incon- be would by FDA move Any such Congress. by the Ibid. intent.” congressional clear the with sistent that the requesting petition citizen filed ASH 1977, In grounds many of the same citing cigarettes, FDA Pe Citizen rulemaking here. the FDA’s motivated that 97-1604 1977), in No. Rec. (May 26, 77P-0185 tition, No. nicotine that asserted pp. ASH (CA4), 1-10. Tab No. on effects physiological strong had and highly addictive was con because “intended” were body; effects that those the ef those to obtain precisely products tobacco sumers use deaths premature of thousands causes fects; and that Commis petition, denying ASH’s annually. In Ibid. the Act interpretation “[t]he that Kennedy stated sioner drug anot cigarettes are that been consistently has by FDA to Letter vendors.” made are claims health unless 1977), App. 47. (Dec. 5, Banzhaf Director Executive ASH argued in the FDA litigation, proceeded matter After not are “cigarettes that Appeals Court its brief term of the statutory definition comprehended within or represent vendors objective evidence ‘drug’ absent Ap drug.” Brief as a be used their intend 2dF. Harris, 655 v. Smoking Health on pellee in Action (CA4), 4,No. Tab (CADC 1980), No. 97-1604 9 Rec. “long Congress had contended also The FDA 27-28. to be cigarettes consider not FDA does aware been health absence authority in the regulatory its within vendor,” manufacturer on behalf made claims disturb acted “Congress never has that, because in FDA’s “acquiesced it had interpretation,” agency’s regu authority to its statutory limits terpretation of Appeals The Court 23. n. 23,27, Id., at cigarettes.” late “[i]f statute concluding that position, FDA’s upheld the requires expansion, that is job of Congress.” Action on Smoking and Health v. Harris, 655 F. 2d, at 243. In 1980, the FDA also denied a request by ASH to commence rule- making proceedings to establish the agency’s jurisdiction regulate cigarettes as devices. See Letter to ASH Execu- tive Director Banzhaf from FDA (Nov. Goyan Comm’r 1980), App. 50-51. The agency stated “[i]nsofar rulemaking would relate cigarettes or attached filters as customarily marketed, we have concluded that FDA has no jurisdiction under 201(h) section [21 the Act U. S. C. §321(h)].” Id., at 67.

In 1983, Congress again considered legislation on the subject of smoking and health. HHS Assistant Secretary Brandt testified that, in addition to being major “a cause of cancer,” smoking is “major cause of heart disease” and other serious illnesses, and can result in “unfavorable preg- nancy outcomes.” 1983 House Hearings 19-20. He also stated that it was “well-established cigarette smok- ing is a drug dependence, and that smoking is addictive for many people.” Id., at 20. Nonetheless, Assistant Secre- tary Brandt maintained that “the issue regulation tobacco ... is something that Congress has reserved to itself, and we do not within the Department have the authority to regulate nor are we seeking such authority.” Id., at 74. He also testified before the Senate, stating despite that, the evi- dence of tobacco’s health effects and addictiveness, the De- partment’s view was that “Congress has assumed respon- sibility of regulating cigarettes.” . . . Smoking Prevention and Education Act: Hearings on S. 772 before the Senate Committee on Labor and Human Resources, 98th Cong., 1st (1983)(hereinafter Sess., 56 1983 Senate Hearings). Against this backdrop, Congress enacted three additional tobacco-specific statutes over the next years four that incre- mentally expanded its regulatory scheme for prod- ucts. In 1983, Congress adopted the Alcohol and Drug Abuse Amendments, Pub. L. 98-24, (codified 97 Stat. 175 Secretary of require the seq.), § which et 290aa S. C.

42 U. “addic- the on years every three Congress report to to HHS for recommendations to include and of tobacco” property tive yearA appropriate. may Secretary deem the that action Smoking Educa- Comprehensive Congress the enacted later, the amended 2200, which 98 Stat. 98-474, L. Act, Pub. tion warning. Nota- prescribed modifying the again by FCLAA Hawkins Senator floor, on the Senate during debate bly, because necessary part was argued the FCLAA that Congress Act, Cosmetic and Drug Food, “[u]nder the (1984). 26953 Cong. Rec. 130 products.” exempted tobacco Smoke- Comprehensive enacted inAnd (CSTHEA), Pub. 1986 Act of Education Health Tobacco less §4401 seq.), et (codified C. U. S. 15at 30 Stat. 99-252,100 L. of the provisions regulatory extended essentially which FCLAA, Like products. tobacco to smokeless FCLAA relating to the “[n]o statement provided that CSTHEA than other health, and tobacco of smokeless use any by required be Act], [the shall required statements smokeless aof ... package agency appear to Federal C. (codified 15 U. S. at §7(a), Stat. product.” tobacco Congress reserved 4406(a)). cigarettes, as with Thus, partic- is regulation that tobacco aspect smokeless an itself regulatory scheme. FDCA’s to important ularly report summa- released Surgeon General 1988, the In demonstrating that literature scientific rizing the abundant' addicting,” and are tobacco forms other “[cjigarettes and depend- physical “causes and psychoactive” is “nicotine that usually syndrome by a withdrawal characterized ence Surgeon General’s abstinence.” accompanies nicotine “pharma- concluded report further 14. The Report ad- determine processes cologic behavioral drugs addiction determine those similar diction are year, same In Id., 15. cocaine.” heroin such “it Congress that before Young stated Commissioner under [tobacco] possible like is look doesn’t Food, Drug and Cosmetic Act even though smoking, I think, has been widely recognized as being harmful to human health.” Rural Development, Agriculture, and Related Agencies Appropriations for 1989: Hearings before a Sub- committee of the House Committee on Appropriations, 100th Cong., 2d (1988). Sess., 409 At the same hearing, the FDA’s General Counsel testified that “what fairly important in FDA law is product whether a has a therapeutic purpose,” and “[cigarettes themselves are not used for a therapeutic purpose as that concept is ordinarily understood.” Id., at 410. Between 1987 and 1989, Congress considered three more bills that would have amended the grant FDCA to jurisdiction FDA regulate to products. tobacco See H. R. 3294, 100th Cong., 1st (1987); Sess. H. R. 1494,101st Cong., 1st (1989); Sess. S. 769, 101st Cong., (1989). 1st Sess. As before, Congress rejected proposals. In Congress instead adopted the Alcohol,Drug Abuse, and Mental Health Administration Reorganization Act, Pub. L. 102-321, §202, (codified 106 Stat. 394 at 42 U. S. C. 300x et seq.), which creates incentives for States regulate to the retail sale of products tobacco by making States’ receipt of certain block grants contingent on their prohibiting the sale of tobacco products to minors. together, Taken these actions by Congress over past years 35 preclude an interpretation of the grants FDCA that jurisdiction FDA regulate to products. tobacco We do rely

not on Congress’ failure to act—its consideration and rejection of bills that would given have FDA this author- ity reaching this —in conclusion. Indeed, is this not a case of simple inaction Congress that purportedly represents acquiescence its in an agency’s position. To the contrary, Congress has enacted several statutes addressing partic- ular subject of tobacco and health, creating a regula- distinct tory scheme cigarettes for and smokeless tobacco. In doing so, Congress has been aware of tobacco’shealth hazards and its pharmacological effects. It has also enacted legisla- this con- and repeatedly FDA background against the

tion FDCA under jurisdiction asserting lacks it sistently Fur- customarily marketed. tobacco meaning- preclude acted persistently Congress has ther, on making policy agency any administrative role ful substance Moreover, health. and tobacco subject of respect, important an inis, scheme regulatory Congress’ super- Although the jurisdiction. incompatible with is a health consumer protect labeling to product vision drugs and regulation FDA’s of the component substantial Ill), the (1994 Supp. §352 ed. C. U. S. devices, see any federal prohibit explicitly the CSTHEA FCLAA require- labeling any health-related imposing from agency see products, smokeless cigarettes ments 4406(a). 1334(a), §§ U.S.C. Congress’ clear circumstances, these Under FDA’s effectively ratified legislation has tobacco-specific regulate to- jurisdiction it lacks position previous S. 574 States, U. United v. Univ. Jones Bob inAs bacco. in this (1983), hardly conceivable “[i]t is —and abundantly not Congress of setting, Member —was Congress 600-601. Id., at on.” going what was of aware of tobacco issue the address affirmatively acted has had that FDA of the representations relying the on health, a distinct has created It regulate tobacco. authority to no focused products, tobacco regulate sale scheme belief on the premised advertising, and labeling result, As a FDCA. under jurisdiction such FDA lacks from preclude statutes tobacco-specific Congress’ customarily marketed. products regulating tobacco our discussion with issue takes Although dissent does conclusion our 186-189, post, position, change FDA’s jurisdiction assertion FDA’s rely fact on the not interpretation prior its sharp with break represents a aof interpretation agency’s initial Certainly, an FDCA. “carved not administering charged with it is statute in stone.” Chevron, 467 U. atS., 863;see also Smiley v. Cit (South ibank Dakota), A.,N. 517 U. (1996). S. 735, 742 As we recognized in Motor Vehicle Assn. United States, Mfrs. Inc. v. State Farm Mut. Automobile Ins. Co., 463 U. S. 29 (1983),agencies “must given be ample latitude to ‘adapt their rules and policies to the demands of changing circum stances.’” Id., at 42 (quoting Permian Basin Area Rate Cases, 390 U. S. (1968)). 747, 784 The consistency of the prior FDA’s position is significant in this case for a different reason: provides It important context to Congress’ enact ment of its tobacco-specific legislation. When the FDA re peatedly informed Congress that the FDCA does grant not it the authority to regulate products, tobacco its statements were consistent with the agency’sunwavering position since its inception, and with position predecessor its agency had first taken in 1914. Although not crucial, the consistency of the prior FDA’s position bolsters the conclu sion that when Congress created a distinct regulatory scheme addressing the subject of tobacco and health, it un derstood that the FDA is jurisdiction without to regulate tobacco and ratified that position.

argues that the proper inference to be drawn from Congress’ tobacco-specific legislation is “criti- cally ambivalent.” Post, at 182. We disagree. In that se- ries of statutes, Congress crafted a specific legislative re- sponse to the problem of tobacco and health, and it did so with the understanding, based on repeated assertions by FDA, that the agency has no authority under the FDCA to products. tobacco Moreover, expressly pre-empted any regulation other of the labeling of products concerning their health consequences, though even oversight of labeling is central to the FDCA’s regulatory scheme. And in addressing the subject, Congress consist- ently evidenced its preclude intent to any federal agency from exercising significant policymaking authority in the area. Under these circumstances, we believe the appro-

158 ratify FDA’s Congress to intended inference—that priate unmistakable. jurisdiction position it lacks prior —is Congress’ if argues that, even alternatively The dissent ratify the fact, in legislation did, tobacco-specific subsequent contingent dis merely a position was position, that FDA’s contends the dissent Specifically, jurisdiction. of avowal on premised largely was view traditional “the FDA’s statutory ‘in necessary prove the inability to perceived a reading of fairA 189-190. Post, at requirement.” tent’ however, demonstrates 1995, prior to representations FDA’s essentially unconditional. was position agency’s (statement Ed of Comm’r 239, 242 Hearings g., e. 1972 See, of the domain wards) be is to cigarettes (“[Regulation of inconsist be would “[a]ny move Congress,” such and intent”); Hear House congressional the clear with ent (“[T]he Brandt) Secretary (statement of Assistant ings 74 something that ... of regulation of issue (statement Hearings 56 itself”); Senate to reserved has Brandt) assumed (“Congress has Secretary Assistant Appel Brief cigarettes”); regulating... responsibility 2d 655 F. Harris, Smoking Health v. in Action lee (CA4), 4,No. Tab (CADC 1980), No. 97-1604 Rec. disturb (because acted “Congress never has 27, 23 n. in the FDA’s “acquiesced it interpretation,” agency’s be position could agency’s extent terpretation”). To respect to only with was equivocal, it characterized makes manufacturer when exception of well-established g., 1965 Hear See, e. therapeutic benefit. express claims Rankin) (“The Food (statement Deputy Comm’r ings 193. Food, jurisdiction under no has Drug Administration drug bears unless tobacco, Drug, Act over and Cosmetic from Banzhaf Director claims”); Executive Letter ASH (“The (Dec. 1977), inter App. 47 Kennedy FDA Comm’r ciga consistently been has by FDA pretation the Act by the made are claims drug health unless are not rettes vendors”); from Banzhaf Director Executive ASH Letter (Nov. Goyan Comm’r 1980), (“Insofar id., at 67 rulemaking would relate to cigarettes or attached filters as customarily marketed, we have concluded that FDA has no jurisdiction”)- Thus, what Congress ratified was the FDA’s plain and position resolute that the gives FDCA the agency no authority regulate products tobacco as customarily marketed.

C Finally, our inquiry into whether Congress has directly spoken to precise question at issue shaped, is at least in some measure, the nature question of the presented. Deference under Chevron to an agency’s construction of a statute that it premised administers is theory that a statute’s ambiguity constitutes an implicit delegation from Congress to the agency to fill in the statutory gaps. See Chevron, supra, at 844. In extraordinary cases, however, may there be reason to hesitate before concluding that Con- gress has intended such an implicit delegation. Breyer, Cf. Judicial Review of Questions of Law and Policy, 38 Admin. L. (1986) Rev. (“A 363, 370 may court also ask whether the legal question is important an one. is likely more to have focused upon, and major answered, questions, while leaving interstitial matters to answer themselves in course of daily statute’s administration”). This hardly an ordinary case. Contrary to represen- its

tations to Congress since 1914, the FDA has now asserted jurisdiction an industry constituting significant portion of the American economy. In fact, the FDA con- tends that, were it to determine that tobacco pro- vide no “reasonable assurance safety,” it would have authority cigarettes ban and smokeless tobacco entirely. See Brief for Petitioners Reply 35-36; Brief for Petitioners 14. Owing to its unique place in American history and soci- ety, tobacco has unique its own political history. Congress, for better or for worse, has created a distinct regulatory scheme for products, squarely rejected proposals to acted repeatedly tobacco, over jurisdiction the FDA

give policy- significant exercising from agency to preclude the and history this Given area. the in authority making are asserted, we has FDA that the authority the of breadth construction expansive to the agency’s not defer to obliged to deny judgment consistent Congress’ to statute, but the this power. the Ameri- v. Corp. Telecommunications MCI decision Our in- is (1994), U. S. Co., Telegraph & can Telephone the construction the proper involved case That structive. of 1934. Act 208(b) the Communications §in “modify” term discre- it the Act gave the' because that, contended FCC The statute, the under imposed requirement” “modify to tion the voluntary render to authority the therefore it possessed carri- distance long that requirement mandatory otherwise con- FCC’s the rejected Id., at 225. We rates. their file ers had Congress that doubt” the slightest “not struction, finding reasoning In 228. Id., at to the question. directly spoken unlikely is highly “[i]t that concluded here, we more apt even of whether determination leave would Congress that rate- substantially, even entirely, be will industry an unlikely more even discretion —and to agency regulated as permis- device a subtle such through achieve would Id., 231. at requirements.” rate-filing ‘modify’ to sion have not could that Congress MCI, are confident we inAs and political economic of such a decision to delegate intended find To a fashion. cryptic in so to agency an significance products, tobacco to regulate authority has the FDA understand- strained extremely an adopt not only must one concept the Act —a throughout used it is “safety” ing also ignore scheme —but regulatory FDCA’s to central tobacco- subsequent Congress’ implication plain based clear, therefore is It legislation. specific to- subsequent scheme overall regulatory FDCA’s spoken directly has bacco legislation, question at issue precluded the FDA from regulating products.

[*] ^{[*] [*]} By no means question do we the seriousness of prob lem that the FDA has sought to address. The agency has amply demonstrated that tobacco use, particularly among children and poses adolescents, perhaps single sig most nificant threat public health in the United States. None theless, no matter how “important, conspicuous, and contro versial” the issue, and regardless of how likely public to hold the Executive Branch politically post, accountable, 190,an administrative agency’spower pub in the lic interest must always grounded be grant a valid of au “ thority from Congress. ‘[i]n And our anxiety to effectuate congressional the purpose of protecting public, we must take care not to extend the scope of the beyond statute point where Congress indicated it stop.’” would United States v. Article Drug . . . of Bacto-Unidisk, 394 U. S. (1969) 800 (quoting 62 Cases Jam v. United States, of 340 U. S. 593, (1951)). 600 Reading the FDCA as a whole, as well as conjunction in with Congress’ subsequent tobacco- specific legislation, it is plain that Congress has not given the FDA the authority that it seeks to exercise here. For these reasons, the judgment of the Court of Appeals for the Fourth Circuit is affirmed.

It is so ordered. Justice Breyer, with whom Justice Stevens, Justice Souter, and Ginsburg Justice join, dissenting. The Food and Drug (FDA) Administration has the author- ity to (other “articles food) than intended to af- fect structure function of body . . .”. Fed- eral Drug, Food, and Cosmetic (FDCA), Act 21 U. S. C. §321(g)(1)(C). Unlike the majority, I believe that tobacco products fit within this statutory language. denies majority nowhere interpretation, In its own (in- products First, tobacco points. salient

following two statutory this scope within cigarettes) fall cluding mood- their Cigarettes literally. achieve definition, read chemical of the interaction through the stabilizing effects Both system. nervous central of the cells and nicotine de- of, and know alike smokers and cigarette manufacturers are cigarettes Hence, result. chemically induced sire, “function,” body’s “structure” affect” “intended words. of these sense the literal protection purpose basic statute’s Second, the —the cigarettes within inclusion supports the public health — Drug . . Bacto- . Article v. States scope. United its given (1969) (FDCA to be “is 784, 798 U. S. Unidisk, pur- overriding [its] with consistent construction liberal added)). Un- (emphasis public health” protect pose to [to] “[mjore people 400,000 than causes use regulated tobacco cancer, illnesses, such year from tobacco-related each die Reg. Fed. disease.” heart illnesses, and respiratory people more kill (1996). Indeed, accidents, car , . ... . . AIDS year every “than country this com- fires, suicides, drugs, illegal homicides, alcohol, added). Ibid, (emphasis bined.” purpose general language and literal FDCA’s Despite the cigarettes finding that (both FDA’s support which majority nonethe- authority), the statutory its within come two excluding tobacco statute less reads reasons: basic because

(1) “fit” the case does not the FDCA dangerous prohibit requires the the statute outright, (like cigarettes) or devices drugs ciga- sale of banning the simply agency concedes 189-141;and remedy, at ante, proper anot rettes which, when statutes, (2) other has enacted Congress denying history of long FDA’s light viewed tobacco-related jurisdiction and considered together with Congress’ failure explicitly to grant the agency tobacco-specific authority, demonstrate that did not intend for the FDA to exercise jurisdiction over tobacco, ante, at 155-156.

In my view, neither of these propositions is valid. Rather, the FDCA does not significantly limit the FDA’s remedial alternatives. See infra, at 174-181. And the later statutes do not tell the FDA it cannot exercise jurisdiction, but sim- ply leave FDA jurisdictional law where Congress it. found See infra, at 181-186; cf. Food and Drug Administration Modernization Act of 1997, 111 Stat. (codified at note fol- lowing U. §321 S. C. (1994 ed., Ill)) (statute Supp. “shall” not “be construed to affect the question of whether” the FDA “has any authority to regulate any tobacco product”).

opinion that follows will explain the basis for these latter conclusions. In short, I believe that most important indicia of statutory meaning language and — purpose along with the — FDCA’s legislative (de- history scribed briefly I) Part are sufficient to establish that FDA has authority regulate tobacco. The statute-specific arguments against jurisdiction that the tobacco companies and majority rely (discussed upon in Part II) are based on erroneous assumptions and, thus, do not defeat jurisdiction-supporting thrust of the FDCA’s language and purpose. The inferences that the majority draws from later legislative history are not persuasive, (as since I point out in Part III) one can just as easily infer from the later laws that Congress did not intend to affect the FDA’s tobacco-related authority all. And the fact the FDA its changed mind about the scope of its own jurisdiction is legally insig- nificant (as because Part IV establishes) the agency’s reasons for changing course are fully justified. Finally, as I explain in Part V, the degree of accountability that likely will attach to the FDA’s action in this case should alleviate any concern

164 ought agency, administrative an than rather Congress, decision. regulatory important this

to make H-t con- Act Drug and Food Pure federal the 1938, Before “drug”: definitions jurisdictional two only tained “[1] and United ease.” be ^[2] medicines used States any ofAct for substance Pharmacopoeia June and preparations cure, mitigation, 30, or 1906, mixture or National ch. of substances 3915, or prevention recognized §6, 34 Formulary... Stat. intended 769. dis- the here: relevant definition, a third added 1938, Congress In affect food) intended (other than “(3) articles June ofAct ....” body function structure 21 at (codified 1041 Stat. 52 § 675, 201(g), ch. 1938, 321(g)(1)(C)). § S. C. U. “device.” ato respect definition similar a added also

It 321(h)). § U.S.C. at (codified Stat. 201(h), See defini- third language literal mentioned, I have As support strongly both purpose general FDCAs and the tion supra, at See statute. of the reading a projurisdiction 161-162. The support. further offers history statute’s The before testified and language, new drafted jurisdic- FDCA’s expand would definition the third before S. on Hearings significantly. scope tional Commerce, 73d Committee Senate of the Subcommittee FDA, Legislative 1in (1933), reprinted 15-16 Sess., 2d Cong., Its Act Cosmetic Food, Drug, Federal of the History Hist.). In- Leg. (hereinafter (1979) 107-108 Amendments “make pos- towas definition of the new deed, purpose” “[t]he been have many products a great the regulation sible treatments to be be alleged cannot the market found on fo- drafters Id., While 108. conditions.” diseased jurisdiction need to give upon cused specifically over “slenderizing” products such as “antifat remedies,” ibid., they were aware that, in doing they so, had created what was “admittedly an inclusive, a wide definition,” id., at 107. And that broad language was included deliberately, so jurisdiction could be had over “all substances and prep- arations, other than food, and all devices intended to affect the structure or any function of body Ibid, . (em- . . phasis added); see also Hearings on S. 2800before the Senate Committee on Commerce, 78d Cong., 2d Sess., 516 (1934), reprinted in 2 Leg. (statement Hist. 519 of then-FDA Chief Walter Campbell acknowledging “[t]his definition of ‘drugs’ all-inclusive”).

After studying the FDCA’s history, experts have written that the statute “is a purposefully broad delegation of discre- tionary powers by Congress,” 1 O’Reilly, J. Food and Drug Administration (2d §6.01, p. 6-1 1995) (hereinafter ed. O’Reilly),and that, in a sense, the FDCA “must regarded be as a constitution” that “establishes] general principles” and “permit[s] implementation within parameters” broad so that the FDA can “implement these objectives through the most effective and efficient controls that can be devised.” Hutt, Philosophy of Regulation Under the Federal Drug Food, Cosmetic Act, 28 Drug Food Cosm. L. J. (1973) 177, 178-179 (emphasis added). This Court, too, has said that “historical expansion of drug, definition of and the

creation parallel of a concept of devices, clearly show... that Congress fully intended that the Act’s coverage be as broad as its literal language indicates—and equally clearly, broader than strict medical might definition otherwise allow.” Bacto-Unidisk, 394 U. S., at 798. Congress That grant would FDA such jurisdic- broad tional authority should surprise no one. In 1938,the Presi- dent and much of Congress believed that federal administra- tive agencies needed broad authority and would exercise that authority wisely view embodied in —a much Second New 411-412 U. S. Powell, v. Cf. Gray

Deal legislation. de- but specifically” have “could (1941) legislated (Congress whose experience to those function “to delegate cided more informed, of better promise field gave ain particular time same around determination). Thus, equitable” FDCA, language the relevant that it added even agencies administrative other laws granting enacted transporta- Nation’s of much the to regulate broader powers ofAct Aeronautics e. Civil See, g., and communication. tion Aeronautics (Civil 987 52 Stat. 401(d)(1), § 601, 1938, ch. of general highly confines within airlines to regulate Board Carrier standard); Motor necessity” and convenience “public (Interstate Com- 546 204(a)(1), 49 Stat. § 498, ch. 1935, ofAct requirements” “reasonable to establish Commission merce 201(a), 652, 1934, ch. ofAct Communications for trucking); (FCC) Commission (Federal Communications 48 Stat. even confines television, within later radio, to regulate would standard). Why interest” broader “public to delegate to hesitated have suddenly Deal Congress New discre- all FDA an agency so well established rele- reading that a straightforward authority tionary implies? language vant statutory statutory delegation a such is it surprising

Nor of juris- assertion to an many years lead after could power expected. not have might the 1938 legislators diction that a broad nature the very inherent a Such possibility unlikely seemed well have In it may delegation. within manufacturers cigarette ever bring FDA would cigarettes proving statutory FDCA’s language makers and in the body changes chemical produce body’s affect to chemically their product “intended” have then, may back Or, “function.” “structure” such proof, assuming that, even unlikely seemed so popular to regulate discretion its exercise would actually (in the (1997) Ashes Ashes R. Kluger, product. ...”). smoking with love were in “Americans 1930’s But it should not have seemed unlikely that, assuming the FDA decided to regulate proved particular juris dictional prerequisites, the courts would rule juris such a dictional assertion fully authorized. Cf. United States v. Southwestern Cable Co., 392 U. S. (1968) 157, 172 (reading Communications Act of 1934 as authorizing jurisdic FCC tion to regulate systems cable while noting that “Congress could not in 1934 have foreseen the development of” ad vanced systems). communications After all, this Court has read more narrowly phrased statutes grant might what have seemed even more unlikely assertions of agency juris diction. e.g., See, Permian Basin Area Rate Cases, 390 U. S. (1968) 747, 774-777 (statutory authority in terstate “transportation” of gas natural includes authority to regulate “prices” charged by field producers); Phillips Petro leum Co. v. Wisconsin, 347 U. S. (1954) (inde 672, 677-684 pendent gas producer subject to regulation despite Natural Gas Act’s express exemption of gathering production facilities). I shall pursue not general these matters further, for nei ther the companies nor the majority denies that the FDCA’s literal language, its general purpose, and particular its legis lative history favor the present FDA’s jurisdictional view. they Rather, have made several specific arguments in sup port of one basic contention: Even if the statutory delegation is broad, is not broad enough to include tobacco. I now those arguments. turn to each of II

A The tobacco companies contend that FDCA’s words cannot possibly be read to mean what they literally say. The statute defines “device,” for example, as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article ... intended to affect the structure or any function of the body ...21 might in- literally, definition 321(h). this Taken

U. S. C. paja- thermal air conditioners from room everything clude result, the a such that, avoid argue companies The mas. to medical be confined should “drug” “device” or meaning of for Brief narrowly defined. products, therapeutic or 8-9. Co. Tobacco States United Respondent the statute right that be may well companies The under winter conditioners air room cover not read be pro accept their must we agree that not I do But wear. reading cramped thing, a such one For posed limitation. lan statutory purpose of established contravenes (third defini S., at Bacto-Unidisk, 394 U. guage. See definition”); medical strict than “clearly, broader tion can “that (definition covers Leg. Hist. conditions”). diseased for treatments alleged to be be not render would restriction companies’ another, For C.S. 21 U. superfluous. See “drug” definitions two other leading (covering articles (g)(1)(B) §§321(g)(1)(A), for use “intended and those compendia pharmacology prevention treatment, mitigation, cure, diagnosis, disease”). supplies language itself statute’s importantly,

Most be a “drug” must that a limitation: suitable, more different, states definition “device” FDCA’s agent. The chemical body or function structure affects which an article intended primary its not achieve only if it “does is a “device” body,” and . the .. within action through chemical purposes achieve- being metabolized upon dependent “is not 321(h) (emphasis § . purposes.” primary intended its ment of at language that this from added). readily infer can One purpose primary its achieve does that least an article depend- body within action through chemical oth- that it “drug,” provided is a being metabolized upon ent And “drug” definition. scope of the within falls erwise or thermal air conditioners hypothesize about not one need pajamas to recognize chemical nicotine, an impor- tant tobacco ingredient, meets this test. Although I now oversimplify, FDA has determined

that once nicotine enters the body, the blood carries it almost to immediately the brain. See 61 Fed. Reg. 44698-44699 (1966). Nicotine then binds to receptors on the surface of brain cells, off a setting series of chemical reactions alter one’s mood and produce feelings of sedation and stimu- lation. See id., at 44699,44739. Nicotine also increases the number of nicotinic receptors on the brain’s surface, and al- ters its normal electrical activity. See id., at 44739. And nicotine stimulates the transmission of a natural chemical that “rewards” the with body pleasurable sensations (dopa- mine), causing nicotine addiction. See id., at 44700, 44721- 44722. The upshot is that nicotine stabilizes mood, sup- presses appetite, tranquilizes, and satisfies a physical craving that nicotine itself has helped create —all through chemical action within the body after being metabolized. This physiology not simply —and smoker psychology— helps explain as why many 75% of adult smokers be- lieve that smoking “reduce[s] nervous irritation,” 60 Fed. Reg. (1995); why 73% of (10- young people to 22-year- olds) who begin smoking say do they so for “relaxation,” Fed. Reg. 44814 (1996); and why less than 3% of smokers succeed in quitting each year, although 70% want to quit, id., at 44704. That chemistry also helps explain the Surgeon General’s findings smokers believe “smoking [makes them] feel better” and smoke more “in situations involving negative mood.” Id., at 44814. And, for present purposes, that chemistry demonstrates that nicotine affects the “struc- ture” and “function” of the body ain manner that is quite simi- lar to the effects of other regulated substances. See id., (FDA regulates Valium, NoDoz, weight-loss products). Indeed, addiction, sedation, stimulation, and weight loss are precisely the kinds of product effects that the FDA typically reviews and controls. And, since the nicotine in cigarettes

170 establish suffice effects its chemical “food,” is not

plainly ait delivers that (and the cigarette a “drug” is as that it the FDCA. “device”) purpose for drug-delivery B fo- argument definitional principal companies’ The C.S. 21 U. See “intended.” word statutory cuses upon this in “intended” that say The companies §321(g)(1)(C). & Brown Respondent for Brief See art. terma context statutory that assert 2. They Corp. Tobacco Williamson made has maker the product’s means that “intended” word have will its product effect express claim about an the companies, Indeed, according Ibid. the body. make manufacturers that cigarette inability prove FDA’s said has historically that agency why is precisely such claims id., tobacco. to regulate statutory power it lacked the at 19-20. “claimed”; word not use however, does FDCA,

The issued long ago FDA And “intended.” the word uses not shown be can “intent” the relevant say regulations cir- also “by but “expressions,” a manufacturer’s only by 41 of the article.” the distribution surrounding cumstances see (1999)); §801.4 CFR (codified at 21 (1976) Fed. 6896 Reg. if shown intent” (1976) (“objective 6896 Reg. also Fed. makers], offered its [of the knowledge is, with “article the absence even Thus, purpose). used” a particular af- has regulated claims, the of express knows, wants, and manufacturer if the the body fect e.g., Reg. Fed. See, use so product. consumers of topical regulation (1995) agency’s (describing 41527-41581 thyroid lamps, fluoride, tanning sunscreens, hormones, without marketed condoms —all novelty food supplements, (“Some- 13-15 13.04, at O’Reilly see also claims); express ...”). it a drug makes the material nature the very times this interpretation an agency reverse ordinarily Courts interpretive answered clearly has if kind only question or if the agency’s interpretation is unreasonable. Chevron U.S. A. Inc. v. Natural Resources Council, Defense Inc., 467 U. S. 837, (1984). 842-843 companies, The in an effort to argue point former, to language in the legisla tive history tying the word “intended” to a technical concept called “intended use.” But nothing in Congress’ discussion either of “intended” or “intended use” suggests that an ex press (which claim intent) shows is always often necessary. Indeed, the primary statement to which the companies direct our says attention only that a manufacturer can determine what kind of regulation applies or “drug” —“food” because, — “through his representations in connection with its [the sale, manufacturer] can determine” whether an article is to be used as a “food,”as a “drug,” or as “both.” Rep. S. No. 361, 74th Cong., 1st Sess., 4 (1935),reprinted in Leg. Hist. 696. Nor is the FDA’s “objective intent” interpretation unrea sonable. It falls well within the established scope of the ordinary meaning of the word “intended.” Agnew v. United States, 165 (1897) U. (intent S. 36, 53 encompasses the known consequences act). of an And the companies ac knowledge that the FDA can a drug-like substance in the ordinary circumstance, i. e., where the manufacturer makes an express claim, so it is not unreasonable to conclude that the agency retains power such where product’s a effects on the body are so well known (say, like those aspirin calamine lotion), that there is no need for express represen tations because the product speaks for itself.

The companies also cannot deny that the evidence of their intent is sufficient to satisfy the statutory word “intended” as FDA long has interpreted it. In the place, first there was once a time when they actually did make express ad- vertising claims regarding tobacco’s mood-stabilizing weight-reducing properties representations historical —and portend can present expectations. In the late 1920’s,for example, the American Tobacco Company urged weight- conscious smokers to ‘“Reach for a Lucky instead of a ” The advertise- 77-78. Ashes, at Kluger, Ashes sweet.’ stability (RJR) mood emphasized Reynolds J of R ments “ Steady Nerves ‘It remarking that Takes pilot depicting why Camels. I smoke That’s Night.... Ply at the Mail advertised also Id., 86. RJR plenty!’” I smoke And stating one instance cigarettes, stimulating quality “ ” Camels another, that and, Camel,’ awith get a Lift ‘You “ Body of Natural of the Flow Restoration ‘A Harmless are ” proof mild- of medical claims And Id., at 87. Energy.’ effects) commonplace. were (and once beneficial other ness Kool- (Brown advertised Williamson & at 9E g., id., e. See, hot, tired “a tonic cigarettes mentholated brand that contended (Philip Morris throats”); 101, 131 id., at “ conclusively proven have laboratory tests ‘[r]ecognized (RJR pro- Morris’”); 88 id., at [sic] Phillip advantage of . . Camels . sake, smoke Camels! Digestion’s “‘For claimed is stimulated —al- pleasant digestion more mealtime make — cigarette ”). decades Although in recent kalinity increased’ claims health express making stopped have manufacturers what understand come advertising, have consumers their through express longer need to no companies —that stimulate, sedate, mood, cigarettes stabilize action chemical appetite. suppress help and to acknowl- companies refused though the

Second, even the nicotine (until recently) very only publicly edge effects, habit-forming, induced, chemically and cigarettes has 1): (Part Hearings Products of Tobacco g., Regulation e. see, Environ- on Health Subcommittee House before (hereinafter (1994) Cong., Sess., 2d ment, 103d companies testified (heads major tobacco of seven Hearings) (em- addictive” not “nicotine is they believed oath under solid, gained access recently added)), has phasis manufacturers cigarette proving that documentary evidence effects within these produces long known have they chemicals, metabolizing of through the body long have wanted products their produce those effects in way. this For example, in 1972, a tobacco-industry scientist ex- “ plained ‘[sjmoke beyond question optimized most vehicle of nicotine,’” and “‘the cigarette is the opti- most mized dispenser of smoke.’” 61 Fed. Reg. (1996). (emphasis deleted). That same urged scientist company executives to “ ‘[tjhink of the cigarette pack as storage a container for day’s supply of nicotine. . . . Think of cigarette a dispenser for a dose [tjhink unit of [and] nicotine of a

puff of smoke as the vehicle of nicotine.’” Ibid. (Philip Morris) (emphasis deleted).

That year, same other tobacco industry researchers told their superiors that

“ ‘in different situations and at different dose levels, nic- otine appears to act aas depressant, stimulant, tranquil- psychic izer, energizer, appetite reducer, anti-fatigue agent, or energizer. . . . Therefore, [tobacco] products may, in a sense, compete with a variety of other ” with certain types drug action.’ (RJR) Id., at 44669 (emphasis deleted). A draft report prepared by authorities at Philip Morris said that nicotine

“‘is a physiologically active, nitrogen containing sub- [similar stance to] quinine, cocaine, atropine and mor- phine. [wjhile [And] each of these [other] substances can be used to affect human physiology, nicotine has a particularly broad range of influence.’” Id., at 44668-44669.

And a 1980 study manufacturer’s stated that “ ‘the pharmacological response of smokers to nicotine is

believed to be responsible for an individual’s smoking degree the for motivation the providing

behaviour, ” Id., at smoker.’ the required satisfaction Williamson). (Brown & sufficiently than more has FDA the evidence, such With to their “intend” companies the that

established FDCA. meaning the body the within the “affect” C conclu- “inescapable the reaches nonetheless majority The aas of the structure FDCJA language and that sion” problem health public kind fit” “simply not do whole because, is That 143. Ante, at creates. that outright to ban FDA requires FDCA view, the majority’s yet, (such cigarettes); as drugs or devices “dangerous” ban cigarette-sale total an immediate that FDA concedes Ibid. inappropriate. is similarly with it leads because is argument curious This conclusion, opposite precisely “inescapable” force it must that but jurisdiction have does namely, fails argument importantly, More cigarettes. ban re- interpreted a statute fact account into take dan- a less dangerous over pick more a FDA to quiring the causing, rather statute, perverse be a remedy would gerous ban total a unnecessary whenever harm preventing, than at least can one And response. dangerous likely more circumstances. imagine such mildly addic- commonly used, example, Suppose, for lens), contact popular (or, kind say, a pill sleeping tive pose seri- out turned jurisdiction, the FDA’s plainly within further Suppose consumers. certain risks health ous im- an ignore would consumers addicted many of those dangerous more potentially turning ato ban, total mediate remedy (say, draconian a less substitute, while black-market safer away ato gradually notice) them wean adequate would impose FDA still the FDCA Would product. force the more dangerous remedy? For the following reasons, I think not. statute’s language does not restrict the FDA’s powers remedial in this way. The permits FDCA the FDA to regulate a product” “combination (such e., a—i. “device” as cigarette) a (such contains a “drug” nicotine)— under its “device” provisions. § 21 U. S. C. 353(g)(1). And the FDCA’s provisions “device” explicitly grant the FDA

wide remedial discretion. For example, where the FDA cannot “otherwise” obtain “reasonable assurance” of a de- vice’s “safety and effectiveness,” the agency may restrict regulation product’s a “sale, distribution, or upon use” “such . . . conditions as the Secretary may 'prescribe.” §360j(e)(1) (emphasis added). And the statutory section that most clearly addresses the power (entitled FDA’s to ban devices”) “Banned says that, where a presents device “an unreasonable and substantial risk of illness injury,” Secretary “may”—not must —“initiate a proceeding ... make such device a banned §360f(a) device.” (emphasis added). The points Court to other statutory subsections which require believes the FDA to ban a drug or entirely, device even where an outright ban risks more harm than other reg- ulatory responses. See ante, at 135-136. But the cited provisions do no such thing. It is true, as the majority con- tends, that “the FDCA requires the place FDA to all de- vices” in “one of three classifications” and that Class III de- vices require “premarket approval.” Ante, at 136. But it is not case that the place must cigarettes in Class HI because tobacco “presents itself potential unreasonable ” risk of illness or injury. 21 U. S. 360c(a)(l)(C). C. In fact, Class III applies only where regulation cannot otherwise “provide reasonable assurance of . . . §§360e(a) safety.” (1)(A),(B) (placing a device in Class I or Class II regu- when lation can provide assurance). Thus, the statute plainly allows the FDA to consider the relative, overall “safety” of the where alternatives, regulatory light of its a device safest e., the path, i. dangerous least the chosen FDA has assur- “reasonable a provide path, it can—and then does— the goodA statute. meaning of the “safety” within ance” safety for assurance a reasonable provides football helmet the dangerous. And still is sport itself if the player even “reasonable” a offers definition regulatory choice safest alternatives other where safety a world assurance dangerous. yet more are text statute’s entirely from clear it is not any event, In af- FDA require the categorization would III a Class devices, dangerous market from firmatively withdraw to widely distributed. already are which cigarettes, such as “unreasonable an (when presents 360f(a) § a device g., e. See, “may” Secretary injury,” the or of illness risk and substantial “pre- 360h(a) (when § a device device”); “a banned make it to harm of substantial risk unreasonable sents an “notification”); require “may” Secretary public health,” “unreasonable an creates 360h(b) (when § device defective a replace- “[rjepair, “may” order Secretary harm, the risk” of (point 18-29 at O’Reilly refund”); §18.08, 2cf. ment, or scientific “careful to allow approval” “premarket III Class exposed” it is “truly device new” of each review” “before added)). (emphasis users banning “misbranded” a requires Noting the FDCA §352(j), which C. 21 U. S. points also majority drug, dangerous “it is if “misbranded” drug or device a deems sug- recommended, or “prescribed, as used” health when addition, In ante, 135. labeling.” gested in the drug device or a 352(f)(1), calls which majority mentions adequate direc- . . labeling bears . “its unless “misbranded” of users.” protection necessary for “are tions use” determina- is not language “misbranding” this But Ibid. drug device to conclude permits tive, for “adequate” have it does to health” “dangerous is not directions regulated when so as to render it as harmless as possible. And surely the agency can determine that a sub- stance is (not comparatively “safe” “dangerous”) whenever it would be less dangerous to make the product (sub- available ject to regulatory requirements) than suddenly to withdraw it from the market. Any other interpretation risks substan- tial harm of the sort my that sleeping pill example illus- trates. See supra, at 174-175. And nothing in the statute prevents the agency from adopting a view “safety” that would avoid such harm. Indeed, the FDA already seems to have taken position this when permitting distribution of toxic drugs, such as poisons used for chemotherapy, that are dangerous for the user but are not “dangerous deemed to health” in the relevant sense. See 61 Reg. (1996). Fed. companies point to another statutory provi- sion says which that if a device “would cause serious, adverse health consequences or death, the Secretary shall issue” a cease distribution order. 21 U. §360h(e)(l) S. C. (emphasis added). But that word “shall” in this context cannot mean that the Secretary must resort to the recall remedy when- ever a device would have serious, adverse health effects. Rather, that language must mean that the Secretary “shall issue” a cease distribution order in compliance with the sec- procedural tion’s requirements the Secretary if chooses her discretion to use particular that subsection’s recall rem- edy. Otherwise, the subsection would trump and make meaningless the same provision section’s of other lesser rem- edies such as simple (which “notice” Secretary similarly can impose if, but only if, she finds that the “presents device an unreasonable risk of substantial harm to public”). § 360h(a)(l). And reading the statute to compel the FDA to “recall” every dangerous device likewise would conflict with that same subsection’s statement that the recall remedy “shall be in [the addition to other] provided” remedies in the statute. §360h(e)(3)(emphasis added). choose agency to permits then, language, statute’s The pro- overall purpose basic its with consistent

remedies —the public health. tection FDA require the not does FDCA reason second The is 175, at swpra, remedy, see dangerous more select contrary, the to the majority’s assertions despite the that, ef- health kinds among the distinguish not does statute assessing when account may take into agency fects permits the only statute insists Court safety. The benefits risks and health account into take agency ante, consumers, by individual as used “product itself’ consider- from prohibited thus, and, suffer many smokers lead smoking would ing that ban stronger, possibly buy or to symptoms withdrawal severe cigarettes market black dangerous, more —considerations of al- effects health aggregate “the majority calls FDCA But Ibid. actions.” administrative ternative compara- account to take FDA permits the expressly C. U. S. g., 21 e. See, manner. this precisely safety in tive pre- recal[l]” (no “risk of if recall 360h(e)(2)(B)(i)(II) device § 860h(a)(notifi- § recall); no than” risk greater health “a sents danger” greater a present “would notification “unless” cation notification”). “no such than between this context distinguish in one cannot Moreover, “ag- an by individual an incurred risk “specific” health a bottom, is, at risk relevant group. All to a risk gregate” prod- “the attaches risk relevant individual; all an risk sense in the “aggregate” is risk relevant all itself”; uct to deter- in order effects health aggregates agency unregulated smok- If consumer. to the individual risk mine peo- 1,000 group of typical a out of 4 individuals ing kill will a and if 1,000, 1 out kill smoking will regulated ple, if market) 2 out kill will (because black of the smoking ban group in each mean possibilities these three then 1,000; respec- average, die will individuals, on two one, and four, 4/1,000, is consumer individual to each the risk tively. And 1/1,000,and 2/1,000respectively. A “specific”risk to an indi- vidual consumer and “aggregate” risks are two sides of the same coin; each calls attention to the same set of facts. While may there be a theoretical distinction between risk of product itself and the risk related to presence or absence of an intervening (e. voluntary g., act the search replacement for a on the market), black the majority does not rely upon any such distinction, and the FDA’s history of regulating “replacement” drugs such as methadone shows that it has long likely taken actual alternative consumer be- havior into account. I concede that, as a logic, matter of one could consider the “safety”

FDA’s evaluation to be different from its choice of remedies. But to read the statute to forbid the agency from taking account of the realities of consumer behavior either in assessing safety or in choosing a remedy could increase the risks of doubling the risk of death to harm — each “indi- vidual user” my example above. Why would insist that the ignore such realities, even if the conse- quent harm would occur only unusually, say, where the FDA (a evaluates product a sleeping pill; cigarette; a contact lens) that is already on the market, potentially habit forming, or popular? I can find no satisfactory answer ques- this tion. And that, I imagine, why the statute says itself nothing any about of the distinctions that the Court has tried to draw. 21U. 360c(a)(2) S. C. (instructing FDA to de- termine safety and effectiveness of a “device” part weighing “any probable benefit to health . . against . probable risk injury of or illness ...” (emphasis added)). experience Third, against counsels overly an rigid inter-

pretation of the FDCA that is divorced from the statute’s overall health-protecting purposes. A different set of words, added to the FDCA in Delaney Amend- provides ment, that “no [food] additive shall be deemed to be safe if it is [after found appropriate tests] to induce cancer ingested when by man or §348(c)(3). animal.” The FDA food any ban to as requiring this language interpreted once in amount, appeared that the small how matter no additive, induce to found ever was additive that if food product any needed dose a large how matter animal, no cancer See cell. carcinogenic of a single the appearance induce view). agency’s (discussing (1977) 95-658, 7p. No. Rep. H. R. abso- was mandate ban statute’s the that believed FDA The use” of “safe a level establishing fromit and prevented lute out- use continued of benefits “the whether to judge or even interpretation— Id., This at 5. involved.” risks the weigh everything the ban required have could in principle which FDA the led actually teas mushrooms — herbal from this (1977), though Reg. Fed. see saccharine, ban ef- took never response regulatory controversial extremely renewed, continually has enacted, and because fect Label- Study Saccharin ban. the law postponing a g., Pub. 102- L. 1452; e. Stat. 3, 91 95-208, L. Pub. Act, ing 910. 105 Stat. VI, 142, Tit. be- language statutory the interpretation The Court’s lin- less even with conséquences Delaney-type us risks fore advances Court the view worse, Even reason. guistic purpose health-protecting overall FDCA’s undermines banning either dilemma strange FDA by placing doing or device drug dangerous a potentially completely conclu- its misunderstood have I that all. Saying nothing reg- clearly “may FDA maintains sion, majority them.” banning without ‘dangerous’ many ulate must ban— adds then Ante, at 142. itBut “can- or device drug otherwise than rather —a IIf Ibid. purpose.” therapeutic for any safely used not be majori- linchpin this because it is misunderstand, only Why must widely a unexplained. remains conclusion ty’s when the market from withdrawn be device unsafe but used many health threatens remedy that particular It response? regulatory another than more dangerous thus FDCA reads interpretation indeed, perverse is, require the ban of a device that has no “safe” thera- peutic purpose where a ban is the dangerous most remedial alternative.

my view, where linguistically permissible, we should interpret the FDCA in light of Congress’ overall desire to protect health. That purpose requires a flexible interpreta- tion that permits both the FDA to take into account the real- ities of human behavior and allows it, in appropriate cases, to choose from its arsenal of statutory remedies. A statute so interpreted easily “fit[s]” this, and other, drug- and device-related problems. health III In themajority’s view, laws enacted since require us deny jurisdiction, whatever the might FDCA mean in

their absence. But why? Do those laws contain language barring jurisdiction? The majority must concede that they do not. Do they provisions contain that are inconsist ent with the FDA’s exercise jurisdiction? With one exception, see infra, at 184-185, the majority points to no provision. such Do they repeal somehow the principles of (discussed law in Part II, supra) that otherwise would lead to the conclusion that the FDA jurisdiction has in this area? The companies themselves deny making any such claim. See Tr. of Arg. Oral 27 (denying reliance on doctrine of “par tial repeal”). Perhaps the later laws “shape” and “focus” what the meant a generation earlier. Ante, at 143. But this Court has warned against using views of a later Congress to construe a statute enacted many years before. See Pension Guaranty Corporation Benefit v. LTV Corp., “ 496 U. S. 633, 650 (later (1990) history is a ‘hazardous basis for inferring the intent of an earlier’ Congress” (quot ing United States v. Price, 361 U. S. (1960))). 304, 313 And, while the majority suggests that the subsequent history “controls] our construction” of the FDCA, see ante, at 143 (citation and quotation internal omitted), marks this Court “con- not are views subsequent that such held expressly has 4 87-88, n. 85, S.U. 390 States, United Haynes v.

trolling.” (such at 170 S., U. Co., 392 Cable (1968);accord, Southwestern “ ”); Sul- also see significance’ any, Very little, if have views (1990) J., 632 617, (Scalia, S.U. Finkelstein, 496 v. livan legislative subsequent on based (“Arguments concurring) ain even seriously, not taken not be history . should . . footnote”). majori the support not do later statutes the Regardless, Mem individual whatever because, is That

ty’s conclusion. the about assumed may have afte,r 1964 Congress bers embody not did they enacted laws jurisdiction, FDA’s au cannot one And assumption. jurisdiction” any “no such majority as intent, antijurisdiction tomatically an infer consistent (and similarly) both are later statutes does, for in namely, the desire, congressional different quite a with authority whatever interfering with without proceed tent Ciga g., e. See, possessed. may have otherwise FDA R. Hearings H. on Advertising Labeling and rette —1965: Interstate Committee House before et al. 2248 (herein (1965) 19 Sess., Cong., 1st 89th Commerce, Foreign pro (statement Rep. Fino Hearings) 1965 after As authority). agency “erode” not would legislation posed history legislative subsequent below, the I demonstrate (a) “rati either be read can for ambivalent, critically asor 158, ante, see assumption, no-jurisdiction fying]” a just where question (b) jurisdictional leaving ten “equally are inferences both the fact And found it. (cita supra, at Corp., Guaranty able,” Pension Benefit v. omitted); Johnson marks quotation internal tion 616, S. U. Cty., 480 Clara Agency, Santa Transportation majority from prevents dissenting), (1987) (Scalia, J., im antijurisdiction firm, statutes the later drawing from it needs. plication that provide Congress’ failure example, Consider, cireum- tobacco—a authority to express with stance that majority finds significant. See ante, at 147-148, 155. But cf. Southwestern Cable supra, Co., at (failed requests do not prove “did agency not already pos sess” authority). In fact, Congress both failed to grant ex press authority to the FDA when the FDA denied it had jurisdiction over tobacco and failed to take that authority expressly away when the later agency asserted jurisdiction. e.g., See, S. 1262,104th Cong., 1st Sess., §906 (1995) (failed bill seeking amend FDCA to say that “[njothing this Act or any other Act shall provide the with [FDA] au to thority regulate in any manner tobacco or tobacco prod ucts”); see also H. R. 516, 105th Cong., 1st §2 Sess., (1997) (similar); H. R. Res. 980, reprinted in 142 Cong. Rec. 5018 (1996) (Georgia legislators unsuccessfully requested Congress “rescind any action giving the FDA authority” over tobacco); H. R. 2283,104th 1st Cong., (1995) Sess. (failed bill “[t]o prohibit the [FDA] regulation of the sale or use of tobacco”); H. R. 2414, 104th 1st Cong., Sess., 2(a) § (1995) (similar). Consequently, the defeat of various different pro posed jurisdictional changes proves nothing. This history shows only that Congress could not muster the votes neces sary either to grant or to the deny FDA the relevant author ity. It neither favors nor disfavors the majority’s position.

The majority also mentions the speed with which Con- gress acted to take jurisdiction away from other agencies once tried they to assert it. See ante, at 145,149-151. But such a congressional response again proves nothing. On the one hand, the speedy reply might suggest that Congress somehow resented agency assertions of jurisdiction in an area it desired to reserve for itself —a consideration that sup- ports the majority. On the other hand, Congress’ quick re- action with respect to other agencies’ regulatory efforts con- trasts dramatically with its failure to enact any responsive (at law any speed) after the FDA asserted jurisdiction over tobacco more than three years ago. And that contrast sup- ports the opposite conclusion.

184 quite reveals statute post-1938 one least addition, at In majority infers. the than intent congressional

different Ill) (FDA (1994 Supp. ed., C.S. following U. note to construed be 1997)(law [not] “shall ofAct Modernization authority [FDA] has the whether question the affect “[sjuch authority, if product,” any tobacco the on effect [FDCA] as under exercised be any, shall enactment”). Consequently, [this] date day before all reconcile can interpretation only appears did inference subsequent statutes laws later its implicitly, or explicitly intend, either not jurisdictional FDA’s scope question answer 1997) (the 5, (Sept. Cong. S8860 Rec. authority. See nega- substantially interfere “not will Act Modernization authority”). any of tively affect to be appears also perspective historical majority’s The Labeling and Cigarette Federal language in shaped §1331 C. U. S. (FCLAA), 79 Stat. Advertising Act manu- requires FCLAA The ante, 148-149. seq. See et warn- etc., health packages, cigarette place facturers following: as the ings such Smoking WARNING: GENERAL’S

“SURGEON And Emphysema, Disease, Cancer, Heart Lung Causes 1333(a). § C. U. S. Pregnancy.” Complicate May which provision pre-emption express an has FCLAA The health, smoking and relating to “[n]o statement says that be re- Act], shall [this required statement than other 1334(a). pre- § This package.” cigarette any on quired requiring from FDA prohibits plainly emption clause relating to “statement other package” “any cigarette has contends one no but health,” smoking and Reg. g., 61 Fed. See, e. prohibition. by this abide failed prescriptions). regulatory (1996) (describing the other pre-emption FCLAA’s whether question Rather, provision does more. Does it forbid the FDA to at all?

This Court has already answered that question expressly and in negative. Cipollone v. Liggett Group, Inc., 505 U. S. 504 (1992). Cipollone held that the FCLAA’s pre- emption provision does not bar state or federal regulation outside the provision’s literal scope. Id., at 518. And it de- scribed the pre-emption provision as “merely prohibiting] state and federal rulemaking bodies from particu- mandating lar cautionary statements on cigarette labels ....” Ibid. with Congress’ in- tentions in regard to the pre-emption language. When Con- gress enacted the FCLAA, it focused upon the regulatory efforts of the Federal Trade Commission (FTC), not FDA. See 1965 Hearings 1-2. And the Public Health Cig- arette Act Smoking of 1969, Pub. L. 91-222, 7(c), 84 Stat. 89, expressly amended the FCLAA to provide that “[n]othing this Act shall be construed to affirm or deny the [FTC’s] holding that it has the authority issue trade regulation rules” for tobacco. See also H. R. Conf. Rep. No. 91-897, 7p. (1970) (statement of House (we Managers) have “no in- tention to resolve the question as to whether” the FTC could regulate tobacco in a different way); see also 116 Cong. Rec. 7921 (1970) (statement of Rep. Satterfield) (same). Why would one read the FCLAA’s pre-emption clause —a provi- sion that Congress intended to limit even in respect agency directly issue —so broadly that it would bar a dif- ferent from agency engaging any other cigarette regula- tion at all? The answer is that the Court need not, and should not, do so. And, inasmuch as the Court already has declined to view the FCLAA as pre-empting the entire field of tobacco regulation, I cannot accept that same law bars the FDA’s regulatory efforts here.

When the FCLAA’s narrow pre-emption provision is set aside, the majority’s conclusion that Congress clearly in- tended for its tobacco-related statutes to be the exclusive

186 ante, at health,” of problem “the

“response” to Notwithstanding the silence. legislative 157, based ad- has Congress itself legislators, by various voiced views au- tobacco-related the FDA’s issue the expressly dressed that was statement its said, I have and, as only thority once— question the affect to construed “be to not was statute the any tobacco regulate authority to [FDA] has the whether (1994 Supp. §321 ed., C. following S. 21 U. product.” Note of the all from drawn be to III). proper inference The Congress’ interprets that one then, is statutes, post-1965 statement. this consistently with legislative silence general IV majority the fact historical final the turn I now leg- subsequent interpretation its a factor views tobacco- its denials former history: FDA’s islative authority. related maintained expressly FDA early 1990’s,the Until seeks it now power that give it not did statute agrees majority The mind. changed its then It to assert. amake not does positions change of the FDA’s me with also see 156-157; ante, at legal difference. significant interpretation agency (“An initial S.,U. Chevron, Smiley Citibank v. stone”); accord, instantly carved is not (“[Cjhange (1996) 735, Dakota), S. U. A., 517 (South N. denials those labels Nevertheless, invalidating”). is not Con- about inference drawing an for context” “important change FDA’s view, my In 157. Ante, at gress’ intent. noth- does themselves, statutes subsequent policy,like the position. majority’s ing advance cigarettes, jurisdiction it denied When In so. was why that consistently stated not did cigarettes wrote example, FDA administrators particular, definitions—in FDCA satisfy relevant sell not did cigarette makers requirement “intent” —because claims.” “therapeutic accompanying product with their

187 Letter to Directors of Bureaus, Divisions and Directors of Districts from FDA Bureau of Enforcement (May 24,1963), in Public Health Cigarette Amendments of 1971: Hearings on S. 1454before the Consumer Subcommittee of the Senate Committee on Commerce, 92d Cong., 2d (1972) Sess., 240 (hereinafter FDA Letter). Enforcement And subsequent FDA Commissioners made roughly the same assertion. pointed One to the fact that the manufacturers only “recom- mended” cigarettes “for smoking pleasure.” Two others re- iterated the evidentiary need for “health claims.” Yet an- other stressed the importance of proving “intent,” adding “[w]e have not had sufficient evidence” of “intent with regard to nicotine.” See, respectively, (Comm’r id., at 239 Edwards); Letter of Dec. (Comm’r App. 5,1977, Kennedy); 1965 Hearings (Comm’r Rankin); 1994 Hearings 28 (Comm’r Kessler). Tobacco company counsel also testified that the FDA jurisdiction lacked jurisdiction because “de- pends on . . . intended use,” which in turn “depends, in general, on the claims and representations made manufacturer.” Health Consequences of Smoking: Nicotine Addiction, Hearing before the Subcommittee on Health and the Environment of the House Committee on Energy and Commerce, 100th Cong., 2d Sess., (1988) (testimony of Richard Cooper) (emphasis added).

agency statements occasionally referred to addi problems. tional Commissioner Kessler, for example, said that the “enormous social consequences” flowing from a deci sion to regulate tobacco counseled in favor of obtaining spe cific congressional “guidance.” 1994 Hearings 69; see also ante, at 153 (quoting statement of Health and Human Services Secretary Brandt to the effect that Congress wanted to make jurisdictional relevant decision). But a fair reading FDA’s denials suggests that the overwhelming problem was one of proving the requisite manufacturer intent. See Action on Smoking and Health v. Harris, 655 F. 2d 236, (CADC 1980) 238-239 (FDA “comments” reveal its “understand- lay drugs over jurisdiction crux “the ing” that revelatory of their as representations in manufacturers’ intent”). evi- obtained thing, the FDA one changed? For What despite necessary “intent” the prove sufficient

dence 172-174. supra, at See “claims.” specific absence the early the in available became first evidence, which This the that agency to demonstrate the permitted 1990’s, appetite-suppressing, achieved nicotine companies knew through chemical habituating effects mood-stabilizing, and compa- the when at time (not a means, even psychological) knowledge. denying such publicly nies were effects health adverse evidence Moreover, scientific serious- consensus 1980’s,a late until, in mounted, say con- not is That firm. became the matter ness phe- a new effects health smoking’s adverse cern about Counterblast, A New Higginson, e.g., See, nomenon. (1863) (characterizing tobacco Papers 179, Out-door “ ”). say, is to It class’ most active poison of narcotic ‘a began to evidence convincing epidemiological however, General’s Surgeon first century; mid-20th appear appeared effects health documenting the adverse Report establishing nic- Report Surgeon General’s 1964; stage, At each in 1988. appeared effects addictive otine’s controversy, di- subject of were the conclusions health only re- recently until time, over minishing somewhat —and consensus a wide there is clear that cently become it —has Reg. 44701-44706 Fed. problem. See the health about (1996). adminis- changed. Earlier policy

Finally, administration the rea- for jurisdiction to assert may hesitated have trations 186-187 supra, expressed. prior Commissioners sons administration current of the page. Commissioners and this regulatory attitude. different a simply took changing its from prevents Nothing in the law evidence mid-1990’s, By the such reasons. policy needed to prove objective intent —even without an express claim —had been found. The emerging scientific consensus about tobacco’s adverse, chemically induced, health effects may have convinced the agency that it should spend its re- sources on this important regulatory effort. As for the change of I administrations, agree with then-JusTiCE Rehn- QUIST’sstatement in a different case, where he wrote:

agency’s changed view . . . seems to be related to the election of a new President of a political different party. It is readily apparent that responsible mem bers of one administration may public consider resist ance and uncertainties to be more important than do their counterparts in previous administration. A change in administration brought about people casting their votes is a perfectly reasonable basis for an executive agency’s reappraisal of the costs and benefits of its programs and regulations. long As as the agency remains within the bounds by established Congress, it is entitled to assess administrative records and evaluate priorities light in of the philosophy of the administra tion.” Motor Vehicle Assn. Mfrs. United States, Inc. v. State Farm Mut. Automobile Ins. Co.,463 U. S. 29, 59 (1983)(concurring in part and dissenting part).

V One might nonetheless claim that, my even if interpreta- tion of the FDCA and later gets statutes the words right, it lacks a sense of their “music.” See Helvering v. Gregory, F. 2d (CA2 809, 810-811 1934)(L. J.) (“[T]he Hand, meaning of a [statute] may be more than that separate of words, as a melody is more than .”). notes . . Such a claim might rest on either of grounds. two First, one might claim despite that, legal FDA’s right to change its mind, its original played statements a critical part in the enactment of the later statutes and now should play a part critical in their interpretation. But the FDA’s inabil- perceived aon largely premised was view

traditional requirement. statutory “intent” necessary ity prove to statutory (“The basis Letter Enforcement g., e. See, jurisdiction FDA’s from tobacco the exclusion for smoking or chewing for marketed tobacco that the fact is meet not does claims, therapeutic accompanying without cosmetic”). The drug, device food, ... definitions X substance over jurisdiction assert cannot statement, “we if jurisdiction bar not would food,” aas is treated unless in- is is,X substance that later establishes agency of tobacco-related denials FDA’s The eaten. be, tended of statement kind sufficiently this resemble authority interpretive difference. critical make not they should interpreting when courts, might claim Second, one decision a cases close assume statutes, should Hearings consequences,” social “enormous with Con- democratically Members elected made be should agency administrators. by unelected than gress rather (1958) (assuming Con- 116, 129 S. 357 U. Dulles, v. Kent Cf. inter- rules make power to delegate want gress not did liberties). there If human of basic fering exercise with not I do however, interpretation, canon background such here. outcome it controls believe pol- reflects decision Insofar admin- which a decision administration, it icy of an support who officials elected politically those and istration, impor- very And will) (and responsibility. take must it, pub- attendant its here, as well taken decision of tance and it likely to aware be public is licity, means just Presidents, accountable. politically officials those hold In- public. by elected are Congress, like Members public only are President Vice and President deed, the believe not doI elects. Nation the entire whom officials magnitude this agency decision —one administrative an es- controversial—can conspicuous, important, that is any de- essential scrutiny that is public cape kind mocracy. And such a review will place take whether it is the Congress or the Executive Branch that makes the rele- vant decision. According to the only FDA, 2.5% of smokers successfully stop smoking year, each even though say 70% they want to quit and 34% actually make an attempt to do so. See 61

Fed. Reg. (1996) (citing Centers for Disease Control and Prevention, Cigarette Smoking Among Adults—United States, 1993;43 Morbidity and Mortality Weekly Report 929 (Dec. 1994)). The fact that only a handful of those who try quit smoking actually succeed illustrates a certain re- ality reality —the that the nicotine in cigarettes creates a powerful physiological addiction flowing from chemically in- duced changes in the brain. The FDA has found that the makers cigarettes “intend” these physical effects. Hence, nicotine is a “drug”; cigarette that delivers nicotine to the body is a “device”; and the FDCA’s language, read in light of its basic purpose, permits the FDA to assert the disease-preventing jurisdiction that the agency now claims. are so dangerous that the FDCA would require them (a to be banned result the majority believes Congress would not desired); have thus, it concludes that the FDA has no tobacco-related authority. I disagree that the statute require would cigarette ban. But even if I am wrong about the ban, the statute would only restrict the agency’s choice of remedies, not its jurisdiction. The majority also believes that subsequently enacted stat- utes deprive jurisdiction. FDA of But later say laws next to nothing about the FDA’s tobacco-related authority. Previous FDA jurisdiction disclaimers of may have helped form the legislative atmosphere out of which Congress’ own tobacco-specific statutes emerged. But a legislative atmos- phere is not a law, unless it is embodied in a statutory word phrase. And the relevant words phrases here reveal jurisdictional change the not intent an than

nothing more quo. status regulatory holds today Court upshot is that The authorize not does drugs devices unsafe aimed statute (a cigarette) (nicotine) a device drug aof regulation par- most, this than more Far unsafe. finds itself the Court life-threatening harms risks device drug and ticular majority’s rectify. The seeks regulation administrative set reasons And, for counterintuitive. conclusion it. require not does law that the believe I forth, I dissent. Consequently,

Case Details

Case Name: Food & Drug Administration v. Brown & Williamson Tobacco Corp.

Court Name: Supreme Court of the United States

Date Published: Mar 28, 2000

Citation: 529 U.S. 120

Docket Number: 98-1152

Court Abbreviation: SCOTUS