The Federal Food, Drug, and Cosmetic Act authorizes the Food and Drug Administration(FDA) to regulate products as "drugs" or "devices" whenthey are "intended to affect the structure or any function of the body."21 U.S.C. 321(g)(1)(C) and (h)(3). FDA has found that the nicotine containedin tobacco products is a highly addictive substance that causes significantmood-altering effects, and that tobacco products are intended by tobaccomanufacturers to have substantial effects on the structure and functioningof the human body, including satisfying a user's addiction and acting asa sedative, stimulant, and appetite suppressant. The question presentedis whether, given FDA's findings, tobacco products are subject to regulationunder the Act as "drugs" and "devices."

PARTIES TO THE PROCEEDING
The petitioners are: Food and Drug Administration, and Jane E. Henney, Commissionerof Food and Drugs.
The respondents are: Brown and Williamson Tobacco Corp.; Lorillard TobaccoCompany; Philip Morris, Incorporated; RJ Reynolds Tobacco Company; CoyneBeahm, Incorporated; National Association of Convenience Stores; ACME Retail,Incorporated; United States Tobacco Company; Conwood Company, LP; NationalTobacco Company, LP; Pinkerton Tobacco Company; Swisher International, Incorporated;Central Carolina Grocers, Incorporated; J.T. Davenport, Incorporated; NorthCarolina Tobacco Distributors Committee, Incorporated; The American AdvertisingFederation; American Association of Advertising Agencies; Association ofNational Advertisers, Incorporated; Magazine Publishers of America; theOutdoor Advertising Association of America, Incorporated; and Point of PurchaseAdvertising Institute.




In the Supreme Court of the United States
OCTOBER TERM, 1998

No. 98-1152
FOOD AND DRUG ADMINISTRATION, ET AL., PETITIONERS,

v.

BROWN AND WILLIAMSON TOBACCO CORP., ET AL.

ON PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

The Solicitor General, on behalf of the Food and Drug Administration, etal., respectfully petitions for a writ of certiorari to review the judgmentof the United States Court of Appeals for the Fourth Circuit in this case.
OPINIONS BELOW

The opinion of the court of appeals (App. 1a-75a)1 is reported at 153 F.3d155. The opinion of the district court (App. 76a-136a) is reported at 966F. Supp. 1374.

The judgment of the court of appeals was entered on August 14, 1998. A petitionfor rehearing was denied on November 10, 1998. App. 137a-146a. The jurisdictionof this Court is invoked under 28 U.S.C. 1254(1).
STATUTORY AND REGULATORY PROVISIONS INVOLVED
The relevant provisions of the Federal Food, Drug, and Cosmetic Act andthe tobacco product regulations are reproduced in the appendix to this petition.App. 148a-163a.

1. This case concerns the authority of the Secretary of Health and HumanServices, through the Food and Drug Administration (FDA), to regulate cigarettesand smokeless tobacco (tobacco products) as "drugs" and "devices"under the Federal Food, Drug, and Cosmetic Act (Act), ch. 675, 52 Stat.1040, 21 U.S.C. 301 et seq. Before that Act was passed in 1938, the PureFood and Drug Act defined a "drug" to include "any substanceor mixture of substances intended to be used for the cure, mitigation, orprevention of disease of either man or other animals." Pure Food andDrug Act of 1906, ch. 3915, § 6, 24 Stat. 769. In the 1938 Act, Congressexpanded the definition of "drug" to include "articles (otherthan food) intended to affect the structure or any function of the bodyof man or other animals." § 201, 52 Stat. 1041; see 21 U.S.C.321(g)(1)(c). Congress also authorized FDA to regulate "device[s]."§ 201, 52 Stat. 1041. The term "device" is now defined tomean, inter alia, "an instrument, apparatus, implement, machine, contrivance,implant, in vitro reagent, or other similar or related article, includingany component, part, or accessory, * * * intended to affect the structureor any function of the body of man or other animals." 21 U.S.C. 321(h).In expanding the operative definitions in 1938, "Congress fully intendedthat the Act's coverage be as broad as its literal language indicates-andequally clearly, broader than any strict medical definition might otherwiseallow." United States v. Bacto-Unidisk, 394 U.S. 784, 798 (1969).
The Act recognizes that certain products may constitute "a combinationof a drug, device, or biological product." 21 U.S.C. 353(g)(1). FDAmay regulate drug/device combination products using its drug authorities,device authorities, or both. 61 Fed. Reg. 44,396, 44,400-44,403 (1996) (explainingthe basis for that conclusion).
The Act delegates broad authority to FDA to regulate "drugs" and"devices" for the purpose of protecting the public health. Ofparticular relevance here, FDA "may by regulation require that a devicebe restricted to sale, distribution, or use * * * upon such * * * conditionsas [FDA] may prescribe in such regulation, if, because of its potentialityfor harmful effect or the collateral measures necessary to its use, [FDA]determines that there cannot otherwise be reasonable assurance of its safetyand effectiveness." 21 U.S.C. 360j(e)(1). In making findings with respectto safety and effectiveness, FDA "weigh[s] any probable benefit tohealth from the use of the device against any probable risk of injury orillness from such use." 21 U.S.C. 360c(a)(2)(C); see 21 C.F.R. 860.7(d)(1);61 Fed. Reg. at 44,412-44,413.

2. In response to petitions filed by public health organ-izations requestingthat FDA regulate tobacco products, FDA conducted an extensive investigation,issued a proposed rule and jurisdictional analysis, and invited public comment.60 Fed. Reg. 41,314 (1995). In August 1996, FDA determined that tobaccoproducts are "drugs" and "devices" under the Act and,accordingly, issued regulations directed to those products. 61 Fed. Reg.at 44,396-44,397.
FDA based its determination that tobacco products are "drugs"and "devices" on two key findings. First, based on extensive scientificdocumentation, FDA found that the nicotine in tobacco products "affectsthe structure or any function of the body" because it causes and sustainsaddiction, and acts as a sedative, stimulant, and appetite suppressant.61 Fed. Reg. at 44,630, 44,664-44,685. Second, FDA found that those effectsare clearly "intended" by the manufacturers of tobacco products.Id. at 44,630, 44,686-45,204, 45,227, 45,233-45,236. The evidence beforethe agency included much material that was only recently uncovered throughFDA's investigation, congressional hearings, and disclosures by tobaccocompany officials and employees.
a. In finding that nicotine affects the structure and function of the body,FDA relied on scientific evidence showing that the nicotine in tobacco productsproduces chemical reactions in the brain that motivate repeated, compulsiveuse and create dependence in the user. 61 Fed. Reg. at 44,666. In particular,nicotine directly affects a part of the brain known as the mesolimbic system,which rewards the repeated consumption of certain pleasurable substances.By increasing the activity of the neurotransmitter dopamine within thatsystem, nicotine causes the compulsive drug-seeking behavior of drug addiction.Id. at 44,700. In some cases, nicotine in tobacco products acts as a sedative,while in other cases, it acts as a stimulant. Ibid. Clinical and animalstudies also indicate that nicotine can cause weight loss. Ibid. FDA foundthat those effects on the structure and function of the body are quintessentiallydrug-like, identical to those FDA has found in other products that it regulatesunder the Act, including stimulants, tranquilizers, appetite suppressants,nicotine replacement products, and narcotics used to treat addiction (e.g.,methadone). Id. at 44,632, 44,666-44,670.
b. FDA based its conclusion that nicotine's effects on the structure andfunction of the body are "intended" by manufacturers on findingsthat: (1) a reasonable manufacturer could foresee that consumers will usetobacco products to satisfy their nicotine addiction; (2) consumers usetobacco products because they are addicted to them and because they wantto obtain their mood-altering effects; (3) manufacturers know that consumersuse tobacco products primarily for those reasons; and (4) manufacturershave carefully engineered tobacco products to deliver pharmacologicallyactive doses of nicotine. 61 Fed. Reg. at 44,630, 44,686-45,204, 45,227,45,233-45,236.
FDA pointed to extensive, recently-discovered evidence that supports eachof those findings. For example, internal industry memoranda from the early1970s show that R.J. Reynolds scientists regarded nicotine as a "potent"and "habit-forming" drug, considered cigarettes to be "avehicle for delivery of nicotine," and conceived of the tobacco industryitself as "a specialized, highly ritualized and stylized segment ofthe pharmaceutical industry." 61 Fed. Reg. at 44,867. R.J. Reynoldsresearchers also recognized in the 1970s that "[t]he confirmed userof tobacco products is primarily seeking the physiological 'satisfaction'derived from nicotine," id. at 44,868, and that "[w]ithout anyquestion, the desire to smoke is based on the effect of nicotine on thebody," id. at 44,871. That knowledge was communicated to the highestlevels of the tobacco companies; as early as 1969, Philip Morris's vicepresident for research and development notified his board of directors that"the ultimate explanation for the perpetuated cigaret[te] habit residesin the pharmacological effect of smoke upon the body of the smoker."Id. at 44,856.
FDA also found evidence that "[m]anufacturers of commercially marketedcigarettes commonly manipulate nicotine deliveries to provide remarkablyprecise, pharmacologically active doses of nicotine to consumers."61 Fed. Reg. at 44,951. Such manufacturers use "nicotine-rich tobaccoblends in low-tar cigarettes," "filtration and ventilation technologiesthat selectively remove more tar [than nicotine] from smoke," and "chemicaladditives that increase the percentage of 'free' nicotine in cigarette smoke."Ibid. FDA found evidence that smokeless tobacco manufacturers also manipulatenicotine deliveries. Id. at 45,108. FDA quoted company documents revealingthat senior industry officials and researchers expressly conceived of cigarettesand smokeless tobacco as "a dispenser for a dose unit of nicotine,"id. at 44,856, "a vehicle for delivery of nicotine, designed to deliverthe nicotine in a generally acceptable and attractive form," id. at44,868, and the "means of providing nicotine dose in a metered fashion,"id. at 44,890.
c. Based on the record evidence, FDA concluded that the nicotine in tobaccoproducts is a "drug," 61 Fed. Reg. at 45,207, that tobacco productscontain "device components" for the delivery of that drug, andthat cigarettes and smokeless tobacco are "combination products."Id. at 45,208-45,216.

3. a. Having concluded that tobacco products fall within its regulatoryauthority, FDA determined that such regulation is consistent with the agency'smission to protect the public health because of the serious threat to publichealth caused by tobacco use. 61 Fed. Reg. at 44,398. The evidence in FDA'srulemaking record shows that tobacco use is the largest cause of preventabledeath in the United States; more than 400,000 deaths result each year fromillnesses such as cancer, respiratory illnesses, and heart disease thatare caused by tobacco use. Tobacco alone kills more Americans annually thanAIDS, alcohol, car accidents, homicides, suicides, illegal drugs, and firescombined. The average tobacco user loses 15 years of his or her life. Id.at 44,571.
FDA found that tobacco use is a "pediatric disease," 61 Fed. Reg.at 44,421, because most people who use tobacco as adults began smoking regularlyduring childhood, and childhood initiation leads to addiction. Nearly allfirst use of tobacco occurs before high school graduation. If adolescentscan be kept tobacco-free, most will never start using tobacco. Id. at 44,399,44,421. Efforts to prevent childhood tobacco use, however, have not beensuccessful thus far. Every year, approximately one million children andadolescents begin to smoke, id. at 44,398, 44,568, and the rate of youthtobacco use is increasing, id. at 44,399. Tragically, one of every threeyoung people who become regular smokers will eventually die prematurelyfrom a tobacco-related disease. Id. at 44,399, 44,568.
b. Because of the evidence that most tobacco-related addiction begins inchildhood, FDA directed its initial regulatory efforts to reducing the useof tobacco products by young people. It adopted access restrictions that:(1) prohibit the sale of cigarettes and smokeless tobacco products to personsunder age 18; (2) require retailers to check the identification of personsunder age 27; and (3) prohibit vending machine sales and self-service displaysof cigarettes and smokeless tobacco except in adult-only locations. 61 Fed.Reg. at 44,616-44,617.
Based on evidence that "cigarette and smokeless tobacco advertisingplays a material role in the decision of children and adolescents underthe age of 18 to engage in tobacco use," 61 Fed. Reg. at 44,489, andinternal company documents that show the industry's intent "to attractyoung smokers and so-called presmokers" through advertising, id. at44,480, FDA also concluded that advertising restrictions are necessary tocomplement the access restrictions. Id. at 44,406-44,407 ("The effectivenessof the restrictions on youth access would be substantially diminished ifthe manufacturers were free to entice children and adolescents to circumventthe access restrictions."). FDA's advertising restrictions include:(1) a requirement that advertisements appear in black-and-white, text-onlyformat, except in adult publications and adult-only facilities; (2) a banon outdoor advertising within 1000 feet of schools and public playgrounds;(3) a prohibition on the sale or distribution by tobacco companies and distributorsof hats, t-shirts, and other non-tobacco products, such as promotional items,that bear a tobacco product brand name or logo; and (4) a prohibition onsponsoring athletic, cultural, or other events in a tobacco brand name.Id. at 44,617-44,618.
In adopting the complementary access and advertising restrictions, FDA invokedits authority under 21 U.S.C. 360j(e) to place conditions on the sale, distribution,and use of a device if FDA determines that "there cannot otherwisebe reasonable assurance of its safety and effectiveness." FDA reliedon that authority because tobacco products are "combination products"for which FDA has discretion to use its drug authorities, its device authorities,or both. 61 Fed. Reg. at 44,400-44,403.
c. FDA considered, but rejected, a ban on the sale of tobacco products toadults. FDA noted that, because of illnesses caused by cigarettes and smokelesstobacco, those products are "unsafe, as that term is conventionallyunderstood." 61 Fed. Reg. at 44,412. But FDA further noted that, asreflected in the Act and judicial decisions construing it, the determinationwhether there is a "reasonable assurance of safety" within themeaning of the Act "involves consideration of not only the risks presentedby a product but also any of the countervailing effects of use of that product,including the consequences of not permitting the product to be marketed."Id. at 44,412-44,413. For several reasons, FDA concluded that, with respectto adults, "the sudden withdrawal from the market of products to whichso many millions of people are addicted would be dangerous." Id. at44,413. First, "there could be significant health risks to many ofthese individuals." Ibid. Second, the health care system could be "overwhelmedby the treatment demands that these people would create, and it is unlikelythat the pharmaceuticals available could successfully treat the withdrawalsymptoms of many tobacco users." Ibid. Third, because of the strengthof the addiction, and the difficulty of quitting, "a black market andsmuggling would develop to supply smokers with these products," andthe black market products would likely "be even more dangerous thanthose currently marketed, in that they could contain even higher levelsof tar, nicotine, and toxic additives." Ibid.

4. Respondents (tobacco companies, advertisers, and retailers) brought suitin the United States District Court for the Middle District of North Carolina,challenging the validity of FDA's regulations. Respondents moved for summaryjudgment, arguing that: (1) Congress has withheld from FDA any authorityto regulate cigarettes and smokeless tobacco, as marketed by respondents;(2) the Act does not authorize FDA to regulate advertising of cigarettesand smokeless tobacco; and (3) the restrictions that FDA placed on advertisingand promotion of cigarettes and smokeless tobacco violate the First Amendment.For purposes of its summary judgment motion, respondents accepted as truethe facts found by FDA concerning the effects of tobacco products on thehuman body, and the intent of the manufacturers to cause those effects.App. 76a-78a.
The district court denied summary judgment to respondents on the issue ofwhether tobacco products are covered by the Act and the validity of theaccess regulations, but granted their motion with respect to the advertisingregulations. App. 76a-136a. The district court first held that FDA had lawfullyconcluded that tobacco products are subject to regulation under the Actas "drugs" and "devices." Id. at 80a-126a. The courtrejected respondents' contention that the Act applies only to products thathave a medical purpose. The court noted (id. at 102a-103a & n.13) thatthe Act separately covers products intended for use "in the diagnosis,cure, mitigation, treatment, or prevention of disease," 21 U.S.C. 321(g)(1)(B)and (h)(2); and it explained that, because the definitions on which theFDA relied expressly include all products intended to affect the "structureor any function of the human body," the "plain language"of the Act does not limit its reach to only those drugs and devices thathave a medical purpose. See App. 113a-116a.
The district court also held that FDA had properly determined that tobaccoproducts are "intended" to affect the structure or function ofthe human body within the meaning of the Act. App. 104a-113a. The courtrejected respondents' contention that FDA's general regulations interpretingand implementing the Act's "intended use" standard limit evidenceof intended use to explicit representations by manufacturers concerningthe therapeutic or other effects of the product. The court pointed out thatthe regulations provide as well for consideration of consumer use and amanufacturer's knowledge of such use. See id. at 109a-110a & n.15 (quoting21 C.F.R. 201.128 and 21 C.F.R. 801.4). In addition, the district courtnoted that a number of courts, as well as the House Report on the MedicalDevice Amendments of 1976 (see H.R. Rep. No. 853, 94th Cong., 2d Sess. 14(1976)), had stated that FDA could rely on evidence other than manufacturers'representations, such as evidence of consumer use. Id. at 107a-108a, 110-112a.
Because it found that cigarettes and smokeless tobacco fall within the Act'sdefinitions of "drug" and "device," the district courtconcluded that those products would be excluded from the Act's coverageonly if respondents established that "Congress has expressed its clearintent to withhold from FDA jurisdiction to regulate tobacco products insome place other than the text of the [Act]." App. 81a. The court foundno such clear intent. Id. at 80a-101a. In particular, it rejected respondents'contention that other statutes enacted after 1938, including the FederalCigarette Labeling and Advertising Act, 15 U.S.C. 1331 et seq., establisha congressional intent to withhold jurisdiction from FDA to regulate tobaccoproducts. App. 92a-101a. The court similarly rejected respondents' contentionthat FDA's prior decisions not to regulate most tobacco products and statementsto Congress that tobacco products were not covered by the Act unless manufacturersmade therapeutic claims for them showed that Congress had withheld jurisdiction.The court explained that FDA was entitled to revisit the question in lightof the new evidence concerning the addictive and other effects of tobaccoproducts and the intended use of tobacco products to achieve those effects.Id. at 84a-92a.
After concluding that FDA had properly exercised jurisdiction over tobaccoproducts, the district court held that FDA had authority under 21 U.S.C.360j(e) to issue restrictions on access by minors to tobacco products. Ittherefore upheld the regulations' access restrictions. App. at 133a. Decliningto reach the First Amendment issue (id. at 134a n.33), the district courtruled, however, that FDA's advertising restrictions are not authorized bythe provision of the Act allowing FDA to impose conditions on the "sale,distribution, or use" of "devices." Id. at 127a-133a. Thedistrict court certified all of its rulings for interlocutory appeal, id.at 135a-136a, and the court of appeals accepted that certification, id.at 11a.2

5. a. In a 2-1 decision, a panel of the Fourth Circuit reversed, App. 1a-75a,holding that "FDA lacks jurisdiction to regulate tobacco products"and that "all of the FDA's August 28, 1996 regulations of tobacco productsare thus invalid," id. at 11a-12a. The panel majority disagreed withthe district court's framing of the issue as whether, in light of the broaddefinition of "drug" and "device," Congress nonethelessintended to withhold from FDA jurisdiction to regulate tobacco products.Id. at 15a. Rather, the majority viewed the relevant question as "whetherCongress intended to give the FDA jurisdiction over tobacco products ascustomarily marketed." Id. at 14a.3 The majority noted that, underChevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S.837 (1984), "the court, as well as the agency, must give effect tothe unambiguously expressed intent of Congress," and that "onlyif the intent of Congress is ambiguous [do] we defer to a permissible interpretationby the agency." App. 15a-16a. The majority also stated that "[a]precondition to deference under Chevron is a congressional delegation ofadministrative authority," id. at 16a (quoting Adams Fruit Co. v. Barrett,494 U.S. 638, 649 (1990)), so that "no deference is due the FDA's constructionof the Act unless it is acting within the bounds of its congressionally-establishedauthority," ibid. The majority believed that a particularly searchinginquiry was necessary because FDA was "attempting to expand the scopeof its jurisdiction." Id. at 16a-17a.
To ascertain Congress's intent, the majority looked first to the Act's definitionsand concluded that the plain meaning of those provisions "may appearto support the government's position that tobacco products fit within theAct's definitions of drugs or devices." App. 19a. The majority concluded,however, that FDA could not rely on the definitional provisions, because,in its view, tobacco products do not fit into the overall regulatory schemecreated by Congress. Id. at 22a.
The majority concluded that, under the provision of the Act upon which FDAhad relied in issuing its regulations, 21 U.S.C. 360j(e), FDA has a responsibilityto determine that there is a reasonable assurance of safety of a productthat it declines to ban completely from the market. App. 22a. Because FDAhad found tobacco products to be dangerous, the majority concluded, "FDAcannot comply with the terms of the very statutory provision it has chosenas its basis for regulation." Id. at 23a. For substantially the samereason, the majority concluded that FDA's regulatory approach failed tosatisfy several other provisions of the Act. Id. at 23a-30a. The majorityconcluded that "FDA's need to maneuver around the obstacles createdby the operative provisions of the Act reflects congressional intent notto include tobacco products within the scope of the FDA's authority."Id. at 29a-30a.
The majority also examined what it termed "extrinsic evidence"of congressional intent. App. 31a-52a. First, the majority concluded, onthe basis of its review of various statements by FDA, see id. at 31a-37a,that "[f]rom 1914 until the present rulemaking attempt, the FDA hadconsistently stated that tobacco products were outside the scope of itsjurisdiction." Id. at 31a. The majority next concluded that Congress'sfailure to enact bills that would have given FDA authority over tobaccoproducts "provide[s] strong evidence of congressional intent that it,and not the FDA, controls the regulation of tobacco products." Id.at 39a. And, it concluded that four tobacco-specific statutes enacted since1964 provide "corroborating evidence" that Congress did not intendthe FDA's original jurisdictional grant to include "tobacco products."Id. at 40a; see generally id. at 39a-52a.
b. Judge Hall dissented. App. 55a-75a. He concluded that "[t]obaccoproducts fit comfortably into the [Act's] definitions of 'drug' and 'device,'"and, even if the "search for legislative intent [is expanded] beyondthe words of the statute, the evidence falls far short of demonstratingthat Congress intended to deny or withdraw jurisdiction over tobacco fromthe FDA." Id. at 55a. He noted that "[t]he majority devote[d]approximately three paragraphs to the words that form the heart of the FDA'sjurisdictional claim" and essentially "conced[ed] that tobaccoproducts fit the [Act's] 'literal' definition of drug." Id. at 56a.
Judge Hall rejected the majority's view that, since FDA has a mandate toprevent the marketing of a drug found to be unsafe and tobacco productsare unsafe, the regulations at issue must be inconsistent with that mandate,because they do not ban the continued sale of tobacco products to adults.App. 60a-61a. He concluded that "[h]ow the FDA has chosen to regulatetobacco has no bearing on the question of whether that agency has the authorityto regulate it at all. * * * It is no argument to say that the FDA can donothing because it could have done more." Ibid.
Judge Hall also concluded that "[t]he majority starts off on the wrongfoot when it asks 'whether Congress intended to delegate jurisdiction overtobacco products to the FDA,'" because "Congress did not 'intend'that any particular product be included." App. 62a. Rather, "[t]heoperative congressional intent * * * was simply to confer broad discretionarypowers on the FDA to regulate 'drugs' and 'devices'" through definitionsthat were "written broadly enough to accommodate both new productsand evolving knowledge about existing ones." Id. at 63a.
Judge Hall similarly disagreed with the majority's reliance on FDA's priordecisions and statements regarding the regulation of tobacco products. App.63a. He pointed out that "an agency can change its view of what actionis possible or necessary, particularly when new facts come to light."Id. at 64a. Here, he explained, FDA had a strong basis for changing itsposition because of new evidence that "nicotine is extremely addictiveand that a large majority of tobacco users use the product to satisfy thataddiction," and, even more important, because of new evidence that"manufacturers design their products to sustain such addiction."Id. at 65a. Finally, Judge Hall concluded that the tobacco-specific statutescited by the majority address narrow subjects and fall far short of showingthat Congress intended to prevent FDA from exercising jurisdiction overtobacco products. Id. at 65a-70a.4
The Fourth Circuit denied FDA's petition for rehearing. App. 137a-146a.Judge Hall would have granted panel rehearing, and Judges Michael, Motz,and Murnaghan would have granted rehearing en banc. Id. at 145a-146a. Fouractive judges were disqualified from the case. Id. at 146a.

A divided court of appeals has ruled that FDA has no authority to regulatetobacco products, and it has invalidated the most important public healthand safety rulemaking that FDA has conducted in the past fifty years. Thepanel reached that conclusion notwithstanding FDA's thoroughly documentedfindings, based on extensive evidence in the record, that the nicotine intobacco products is intended to cause substantial effects on the human body,including satisfying a user's addiction and acting as a sedative, stimulant,and appetite suppressant.
The panel's ruling is based on a fundamentally flawed approach to the interpretationof the Federal Food, Drug, and Cosmetic Act, and it drifts far afield fromthe kind of analysis of administrative action required by this Court's decisionin Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S.837 (1984). Unless reversed by this Court, the panel's ruling will deprivethe public of an unparalleled opportunity to prevent millions of childrenfrom beginning a highly addictive habit that often leads to premature death.FDA regulations currently in effect, but invalidated by the court of appeals,are already restricting youth access to tobacco products. The public healthsuffers in a substantial way as each month passes and FDA's other tobaccoproduct regulations relating to access and advertising remain blocked bycourt order. The recent agreement between five tobacco companies and 46States settling financial claims by the States to compensate them for thehealth-care costs of tobacco use (see note 9, infra), does not diminishthe public health significance of FDA's regulatory program. To the contrary,it vividly confirms the serious public health consequences of tobacco use.Review by this Court is therefore warranted to resolve the question whether,given FDA's thoroughly documented findings about the intended pharmacologicaleffects of tobacco products on the human body, tobacco products are "drugs"and "devices" covered by the Act.
A. The panel majority in this case held that "FDA lacks jurisdictionto regulate tobacco products." App. 11a-12a. Under that ruling, unlesstobacco manufacturers market their products with "specific therapeuticclaims such as weight loss," id. at 15a n.9, FDA is completely withoutauthority over such products. The panel's holding is based on a seriousmisreading of the Act and a fundamental misapplication of basic administrativelaw principles.
1. The Act sets forth a standard for whether a product is subject to regulationas a "drug." That standard is uniformly applicable to all productsnot expressly exempted. It provides that the term "drug" not onlyincludes "articles intended for use in the diagnosis, cure, mitigation,treatment, or prevention of disease," but also includes, inter alia,"articles (other than food) intended to affect the structure or anyfunction of the body of man or other animals." 21 U.S.C. 321(g)(1).The Act similarly sets forth a standard for whether a product is a "device"that is uniformly applicable to all products not expressly exempted. TheAct provides that a "device" is, inter alia, "an instrument,apparatus, implement, machine, contrivance, implant, in vitro reagent, orother similar or related article, * * * intended to affect the structureor any function of the body of man or other animals * * * and which is notdependent upon being metabolized for the achievement of its primary intendedpurposes." 21 U.S.C. 321(h).
This Court has held that "Congress fully intended that the Act's coveragebe as broad as its literal language indicates- and equally clearly, broaderthan any strict medical definition might otherwise allow." United Statesv. Bacto-Unidisk, 394 U.S. 784, 798 (1969). Moreover, while the Act specificallyexcludes certain products from particular product categories-soap is excludedfrom the definition of "cosmetic," 21 U.S.C. 321(i), and tobaccoitself is excluded from the definition of "dietary supplement,"21 U.S.C. 321(ff)(1)-the Act does not exclude tobacco products from thedefinition of "drug" or "device." Thus, tobacco products,like all other products containing nicotine, are subject to regulation underthe Act if they are "intended to affect the structure or any functionof the body." 21 U.S.C. 321(g)(1) and (h).
Applying that statutory standard, FDA concluded that tobacco products fallwithin the statutory standards for both "drug" and "device."FDA's conclusion is based on an overwhelming factual record showing that:(1) the nicotine in tobacco products causes and sustains addiction, andacts as a sedative, stimulant, and appetite suppressant; (2) most personswho use tobacco products do so in order to achieve those effects; (3) tobaccomanufacturers know that consumers use their products for those purposes;and (4) tobacco manufacturers design their products to deliver pharmacologicallyactive doses of nicotine. Given that evidence, FDA reasonably concludedthat tobacco products are "intended" to "affect the structureor any function of the body" and are, therefore, subject to regulationunder the Act. 21 U.S.C. 321(g)(1) and (h).
Indeed, it is difficult to see how FDA could have come to a different conclusionbased on the record before it. As FDA pointed out, in light of its findings,tobacco products cannot be distinguished meaningfully from other productsthat FDA regulates, such as stimulants, tranquilizers, appetite suppressants,nicotine replacement products, and narcotics used to treat addiction. 61Fed. Reg. at 44,632, 44,666-44,670.
It is not necessary for present purposes, however, for the Court to decidewhether the text of the Act, as applied to the evidence in the rulemakingrecord, compels the conclusion that tobacco products are "drugs"and "devices" subject to regulation under the Act. Congress assignedto FDA the responsibility to implement the statutory scheme by determiningwhich products satisfy the statutory standards in light of the evidencepertaining to each particular product. Accordingly, FDA's interpretationand application of the complex statutory framework at issue in this caselies at the very core of agency action that is entitled to deference underChevron, 467 U.S. at 842-845. That means that "a court may not substituteits own construction of a statutory provision for a reasonable interpretationmade by the administrator of an agency." Id. at 844. At the very least,in view of FDA's thoroughly documented findings, FDA reached the "reasonable"conclusion that tobacco products fall within the coverage of the Act. Thepanel majority was therefore required by Chevron to defer to FDA's conclusion.5

2. The court of appeals' holding that FDA lacks authority to regulate tobaccoproducts, notwithstanding the plain statutory text and compelling factualrecord before FDA, rests on a series of legal errors. Those errors fallinto three categories.
a. First, the panel started with the wrong question when it asked "whetherCongress intended to give the FDA jurisdiction over tobacco products."App. 15a. As Judge Hall noted in dissent, "Congress did not 'intend'that any particular product be included." Id. at 62a. Instead, it enactedgeneral definitions of "drug" and "device" so that FDA-applying its accumulated scientific and administrative expertise to bothnewly developed products and expanded medical knowledge concerning existingproducts-could decide whether a particular product is subject to regulationbased on the evidence before it. Id. at 62a-63a. Accordingly, the relevantquestion in this case is not whether Congress intended to delegate authorityto FDA over tobacco products in particular or in the abstract, but whetherCongress intended to delegate authority to FDA to regulate tobacco products(along with any other products not expressly exempted) in the event thatFDA found that they are "intended to affect the structure or any functionof the body." 21 U.S.C. 321(g)(1) and (h). The answer to that questionis clearly yes, since that is the standard that Congress established, andCongress did not exempt tobacco products from review under that standard.
Once the question is correctly posed, moreover, it is evident that the courtof appeals seriously erred in basing its conclusion that FDA lacks jurisdictionover tobacco products on (i) its own view that the Act lacks regulatoryprovisions that are appropriate for tobacco products, (ii) unenacted billsproposed after 1938 that would have given FDA authority to regulate tobaccoproducts, and (iii) tobacco-specific laws enacted since 1964 that addressdifferent issues. Those materials do not provide a principled basis on whichto hold that Congress intended to prevent FDA from regulating tobacco productsaltogether should it find, based on compelling evidence of the sort beforeFDA in 1996, that tobacco products are intended to affect the structureor any function of the body.6
b. Second, the court of appeals' decision rests on fundamental misconceptionsconcerning Chevron deference. The court of appeals stated that "[a]precondition to deference under Chevron is a congressional delegation ofadministrative authority," App. 16a (quoting Adams Fruit Co. v. Barrett,494 U.S. 638, 649 (1990)), so that "no deference is due the FDA's constructionof the Act unless it is acting within the bounds of its congressionally-establishedauthority," App. 16a. That statement implies that, before applyingthe analysis required by Chevron to the question whether FDA has authorityover tobacco products, a court must first determine independently whetherCongress has delegated to FDA the authority to regulate tobacco products.That approach is circular and would drain Chevron of any meaning. The holdingin Adams Fruit, that a precondition to deference under Chevron is a "congressionaldelegation of administrative authority," simply means that Congressmust have delegated authority to the agency to enforce the statutory provisionwhose meaning is at issue. Adams Fruit, 494 U.S. at 650; Chevron, 467 U.S.at 842-845. Here, Congress has clearly delegated authority to FDA to enforceprovisions of the Act that depend on the meaning of the terms "drug"and "device." FDA therefore is unquestionably entitled to Chevrondeference on the meaning and scope of those terms.
Adams Fruit, on which the majority below relied, addressed a completelydifferent situation. The question in that case was whether state workers'compensation laws bar private rights of action under the Migrant and SeasonalAgricultural Worker Protection Act, 29 U.S.C. 1801 et seq. The Court declinedto give deference to a regulation of the Department of Labor on that questionbecause the private right of action was administered by the courts and notby the Department of Labor. The Court explained that, because Congress hadestablished "an enforcement scheme independent of the Executive andprovided aggrieved farmworkers with direct recourse to federal court wheretheir rights under the statute are violated[,] * * * it would be inappropriateto consult executive interpretations * * * to resolve ambiguities surroundingthe scope of [the] judicially enforceable remedy." 494 U.S. at 650.Since the question presented here involves the scope of FDA's authorityunder the very law Congress directed it to administer, Adams Fruit is inappositehere.
The court of appeals' analysis of the issue under Chevron was also affectedby its characterization of FDA's action as "attempting to expand thescope of its jurisdiction." App. 16a. As long as an agency is reasonablyinterpreting a provision it enforces, however, Chevron deference applies.It is simply not relevant whether the agency's proposed interpretation canbe said to affect its jurisdiction. Commodity Futures Trading Comm'n v.Schor, 478 U.S. 833, 844-845 (1986); NLRB v. City Disposal Sys., Inc., 465U.S. 822, 830 n.7 (1984); see also Mississippi Power & Light Co. v.Mississippi ex rel. Moore, 487 U.S. 354, 380-382 (1988) (Scalia, J., concurring)(collecting cases). A contrary rule of interpretation would be unworkable,for Chevron deference would then be rendered of little or no force wheneverFDA sought to regulate any of the vast range of food and drug products thatare introduced each year.
The panel's holding in this case thus cannot be reconciled with a properapplication of Chevron. In light of FDA's findings concerning the intendedeffects of tobacco products, and the plain language of the only directlyrelevant provisions of the Act-the "drug" and "device"definitions- FDA acted reasonably in concluding that tobacco products aresubject to regulation under the Act.
c. Third, to the extent that the court of appeals concluded that Congressclearly intended to preclude FDA from regulating tobacco products, thatconclusion conflicts with the plain language of the controlling definitionsof "drug" and "device." It also ignores the absenceof any exemption from those definitions for tobacco products, an absencemade all the more telling by Congress's decision to enact an express exemptionfor tobacco from the Act's definition of "dietary supplement."See 21 U.S.C. 321(ff)(1). And, as we shall now explain, the panel's conclusionis also unsupported by the materials upon which it relied.
The panel concluded that, because FDA found tobacco products to be dangerous,it would be required by 21 U.S.C. 360j(e) to prohibit the sale of tobaccoproducts to adults as well as children if those products are covered bythe Act. App. 21a-23a. For that reason, the panel believed, FDA "cannotcomply with the terms of the very statutory provision it has chosen as itsbasis for regulation." Id. at 23a. The Act, however, does not requireFDA to consider only the risks of tobacco products. Instead, the Act andimplementing regulations authorize FDA to weigh the health risks of permittingcontinued sales of tobacco products to adults against the health risks ofprohibiting such sales. 61 Fed. Reg. at 44,412-44,413 (discussing 21 U.S.C.360c(a)(2)(C) and 21 C.F.R. 860.7(d)(1)). After engaging in that weighingprocess, FDA concluded that, with respect to adults, "[t]he suddenwithdrawal from the market of products to which so many millions of peopleare addicted would be dangerous." Id. at 44,413. That public healthpolicy conclusion was well-founded, and the panel majority should not havesecond-guessed it. As FDA found, prohibiting adult access to tobacco products"could [create] significant health risks" for persons addictedto such products. 61 Fed. Reg. at 44,413. The health care system could be"overwhelmed by the treatment demands that these people would create,and it is unlikely that the pharmaceuticals available could successfullytreat the withdrawal symptoms of many tobacco users." Ibid. Equallyimportant, because of the strength of nicotine addiction, and the difficultyof quitting, "a black market and smuggling would develop to supplysmokers with these products," and it is likely that those products"would be even more dangerous than those currently marketed, in thatthey could contain even higher levels of tar, nicotine, and toxic additives."Ibid. In deciding upon its regulatory approach, FDA properly took thoseserious health risks into account.
At the very least, FDA's regulatory approach under 21 U.S.C. 360j(e) isreasonable, and it therefore should have been sustained under Chevron. Butthe panel majority did not even consider the question of Chevron deferencewhen it rejected FDA's decision to allow continued sales to adults onceFDA concluded that tobacco products are subject to regulation under theAct. See App. 21a-22a. In any event, as Judge Hall pointed out in dissent,"[h]ow the FDA has chosen to regulate tobacco has no bearing on thequestion of whether that agency has the authority to regulate it at all[.]It is no argument to say that the FDA can do nothing because it could havedone more." Id. at 60a-61a (emphasis omitted).7
The panel majority also relied on prior statements by FDA that it did nothave jurisdiction to regulate tobacco products unless manufacturers madetherapeutic claims about the products' effect on the body. App. 32a-37a.That reliance was misplaced both as a matter of fact and as a matter oflaw. In the first place, the court of appeals was simply wrong in regardingthe 1996 regulations as an abrupt change from a consistent prior positionthat tobacco products would be subject to regulation under the Act onlyif manufacturers made express health or therapeutic claims in marketingthem. That notion is refuted by FDA's most recent rejection of a petitionto regulate tobacco products prior to 1996-the petition filed by Actionon Smoking and Health (ASH) in 1978. In response to ASH's request that FDAregulate filtered cigarettes as devices because they were intended to mitigatedisease, the Commissioner stated:
ASH asserts that objective evidence other than manufacturers' claims canbe material to a determination of intended use under the statutory definition* * *. We agree. However, * * * ASH has not established that consumers useattached cigarette filters * * * to the extent necessary to allow FDA toimpute the requisite intended uses to manufacturers or vendors.
Letter from FDA Commissioner Goyan to ASH Executive Director Banzhaf 8-9(Nov. 25, 1980) (reprinted in 61 Fed. Reg. at 45,224) (emphasis added).In addition, as Judge Hall explained, an agency is always free to changeits view on an issue, and that is particularly true "when new factscome to light." App. 64a. See Rust v. Sullivan, 500 U.S. 173, 186-187(1991) (recognizing legitimacy of agency change of position). Indeed, theDistrict of Columbia Circuit made that very point in sustaining FDA's denialof an earlier petition filed by ASH in 1977, making clear that FDA "isclearly free to revise its interpretations" if it "provide[s]a reasoned explanation for its action." Action on Smoking & Healthv. Harris, 655 F.2d 236, 242 n.10 (1980). Significantly, the D.C. Circuitalso made it clear that manufacturers' claims are not the only basis onwhich intended use of cigarettes could be established and that consumeruse of a product can be a relevant factor in determining its intended use.See id. at 239-240.8

Prior to the present proceeding, FDA simply did not have clear and compellingevidence that nicotine is extremely addictive, that consumers use tobaccoproducts because they are addicted to the products and want to obtain theirmood-altering and other effects, that manufacturers know that consumersuse tobacco products primarily for those reasons, and that manufacturershave deliberately and carefully engineered tobacco products to deliver pharmacologicallyactive doses of nicotine. 61 Fed. Reg. at 44,630, 44,686-45,204, 45,227,45,233-45,236; see also App. 65a. As Judge Hall noted, "[t]he administrativerecord in this case is a perfect illustration of why an agency's opportunityto adopt a new position should remain open." App. 65a.
The court of appeals also deemed it significant that Congress did not enactcertain proposed bills that would have specifically given FDA authorityto regulate tobacco products. App. 37a-40a. Failed legislative proposals,however, do not furnish a sound basis for determining the meaning of a priorstatute. Central Bank of Denver v. First Interstate Bank of Denver, 511U.S. 164, 187 (1994); United States v. Estate of Romani, 118 S. Ct. 1478,1487-1488 (1998); id. at 1488-1489 (Scalia, J., concurring in part and concurringin the judgment). The Constitution requires Congress to express its willthrough enacted bills, not through unenacted ones. INS v. Chadha, 462 U.S.919, 945-959 (1983). Congressional inaction also "lacks persuasivesignificance because several equally tenable inferences may be drawn fromsuch inaction, including the inference that the existing legislation alreadyincorporated the offered change." Central Bank, 511 U.S. at 187. Inany event, such post-enactment inaction in the Legislative Branch cannotundermine the respect owed an agency's reasonable interpretation of thestatute under Chevron. The court of appeals therefore erred in relying onunenacted bills here.
Finally, the panel majority relied on "tobacco-specific" legislation,such as the Federal Cigarette Labeling and Advertising Act (Labeling Act),15 U.S.C. 1331 et seq., the Comprehensive Smokeless Tobacco Health EducationAct of 1986, 15 U.S.C. 4401 et seq., and the Alcohol, Drug Abuse, and MentalHealth Administration Reorganization Act, Pub. L. No. 92-321, 106 Stat.394, 42 U.S.C. 300x-26. App. 40a-53a. Those Acts all address narrow issues,such as what warning labels must be put on tobacco products. See Cipollonev. Liggett Group, Inc., 505 U.S. 504, 518 (1992) (narrowly construing thepreemptive force of the Labeling Act). They do not come close to instructingFDA to refrain from any regulation of tobacco products even if it finds,based on compelling evidence of the sort before it in 1996, that tobaccoproducts are intended to affect the structure or any function of the body.The suggestion by the court below (App. 44a) that those Acts show that "Congresshas reserved for itself the regulation of tobacco products, rather thandelegating that regulation to the FDA," is perplexing. The only wayfor Congress to accomplish that result would be by passing a law that repealedFDA's authority under the Federal Food, Drug, and Cosmetic Act with respectto tobacco products. And even the panel majority did not suggest that the"tobacco-specific" laws it cited did that. Id. at 40a, 44a.
d. In sum, when the standard that Congress has selected for determiningwhether a product is a drug or a device is applied to the extensive evidencebefore FDA, it is clear that FDA acted reasonably in concluding that tobaccoproducts are subject to regulation under the Act as "drugs" and"devices." This Court should grant certiorari to review the panel'scontrary conclusion.
B. The question presented in this case is of urgent public importance. FDAhas determined that most persons who become addicted to tobacco productsbegin using those products when they are children, and youth tobacco usehas been on the rise. Every year, approximately one million children andadolescents begin to smoke, and one out of every three such persons willeventually die prematurely from a tobacco-related disease. 61 Fed. Reg.at 44,568. FDA's regulatory program is aimed at reversing that trend bypreventing minors from beginning to use tobacco products. Id. at 44,399.Specifically, FDA's program is designed "to ensure that children andadolescents are unable to have access to cigarettes and smokeless tobacco,"and "to prevent advertising by the manufacturers of cigarettes andsmokeless tobacco from undercutting the access restrictions." Id. at44,406. Unless this Court grants review, an unparalleled opportunity tocurb tobacco use by children and to reduce the disease and death associatedwith such use will be lost.
As much promise as the current regulatory program holds, the significanceof this case extends well beyond that particular program. The court of appealsnot only has invalidated the current program; it has held that FDA may notissue any regulations with respect to tobacco products as currently marketed.For example, even if FDA determined that a particular tobacco ingredientresulted in health hazards not previously known or associated with tobaccouse, or that a particular kind of filter would significantly reduce thehealth risks associated with cigarette use, FDA would lack authority totake action to mandate product modifications. Under the court of appeals'decision, FDA is powerless to adopt any measures designed to reduce thehealth risks associated with tobacco products as currently marketed, nomatter how efficacious such measures might be.
The public has a vital interest in obtaining a resolution by this Courtof the question whether FDA has authority to regulate tobacco products.The present case involves all major participants in the industry, includingmanufacturers, advertisers, and retailers; there will be no better vehiclefor resolving the issue. The parties below thoroughly canvassed the relevantlegal sources, and the three opinions below (the panel majority opinion,Judge Hall's dissent, and the district court opinion) fairly stake out thetwo sides.
FDA regards the question of statutory authority presented in this case asone of the most important questions it has faced since the enactment ofthe Federal Food, Drug, and Cosmetic Act in 1938. Because the court belowincorrectly resolved the issue, and because that issue is of overridingpublic importance, this Court's review is warranted.9