MAIN	cases	docket	decisions	orders	briefs	rules	guides	calendar
No. 98-1152: FDA v. Brown and Williamson Tobacco Corp.

No. 98-1152

In the Supreme Court of the United States

OCTOBER TERM, 1998



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



REPLY BRIEF FOR THE PETITIONERS



SETH P. WAXMAN
Solicitor General
Counsel of Record
Department of Justice
Washington, D.C. 20530-0001
(202) 514-2217



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



REPLY BRIEF FOR THE PETITIONERS



A. The Food and Drug Administration seeks certiorari in this case becausethe court below incorrectly resolved an issue of exceptional public importance.That issue is whether FDA has authority to regulate tobacco products underthe Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 301 et seq., givenFDA's findings that the nicotine in tobacco products is intended by manufacturersto have substantial effects on the structure and function of the human body,including sustaining a user's addiction and acting as a sedative, stimulant,and appetite suppressant.
In recognition of the overriding public importance of that issue, 39 Stateshave joined a brief as amici curiae urging the court to grant FDA's petition.The States agree that review is warranted because the case is of "enormouspublic importance"; the decision below "misapplies important,well-settled principles of administrative law"; and the decision "fundamentallymisconstrues the relationship between the States and the federal government."States' Br. 2, 3-4.
Respondents do not deny the importance of the question presented. Instead,they argue that the question is of such exceptional public importance thatonly Congress should resolve it. Congress, however, has already given FDAauthority under the Act to regulate "drug[s]" and "device[s]."21 U.S.C. 321(g)(1) (C) and (h)(3). And, after the most important rule-makingin its history, FDA has determined that tobacco products are subject toregulation as both. The question whether FDA's determination falls withinthe authority that Congress has already conferred on it is uniquely onefor the courts, not for Congress.
Respondents also argue that the decision of the court of appeals is correct.We address below respondents' attempts to defend the decision below. Beforewe do, however, we note that the decision whether to grant certiorari doesnot depend on how the question presented ultimately should be resolved.For purposes of granting certiorari, it is only necessary to conclude thatthe court below resolved "an important question of federal law thathas not been, but should be, settled by this Court." Sup. Ct. R. 10(c).That standard is plainly satisfied here. The question whether FDA has authorityto regulate the product that is the leading cause of preventable death inthe United States, 61 Fed. Reg. 44,398 (1996), should not be left to a singleregional court of appeals. A question of such momentous importance shouldbe finally resolved by this Court.
B. Respondents contend (see, e.g., Br. in Opp. 21-23) that the decisionbelow is correct because, in their view, Congress unambiguously made clearthat tobacco products as customarily marketed are not "drug[s]"or "device[s]" within the meaning of the Act. That argument cannotbe reconciled with (i) the Act's controlling definitions of "drug"and "device," which define those terms to include products thatare "intended to affect the structure or any function of the body,"21 U.S.C. 321(g)(1)(C) and (h)(3); (ii) FDA's detailed findings that thenicotine in tobacco products is intended by tobacco manufacturers to havesignificant effects on the structure and function of the body, includingsatisfying a user's addiction, and acting as a sedative, stimulant, andappetite suppressant; (iii) the absence of any exemption for tobacco productsfrom the controlling definitions of "drug" and "device,"in contrast to the Act's express exemption of tobacco products from thedefinition of "dietary supplement," 21 U.S.C. 321(ff)(1); and(iv) the similarity between tobacco products and other products indisputablysubject to FDA regulation under the Act.
1. Because the language of the "drug" and "device" definitions,when applied to FDA's findings, provides such compelling support for FDA'sdetermination that tobacco products are covered by the Act, it is not surprisingthat respondents in their 28-page opposition never once quote the controllingdefinitions. Nor is it surprising that respondents never once directly confrontFDA's specific findings about the effects of nicotine on the structure andfunction of the human body intended by tobacco manufacturers. The forceof the controlling definitions and FDA's findings does not dissipate, however,simply because respondents refuse to acknowledge them. As we explain inour petition (at 16-18), they constitute the key to a correct decision inthis case.
At the very least, the Act's definitions, when applied to FDA's findings,completely undermine respondents' argument that the present case can beresolved in their favor at step one of the analysis set forth in ChevronU.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).Given those definitions and findings, it simply is not possible to concludethat Congress specifically addressed the question and clearly denied FDAauthority to regulate tobacco products. And, once it is accepted that thepresent case must be resolved at step two of Chevron, the result is clear.FDA reasonably determined that tobacco products are subject to regulationunder the Act.

2. FDA's judgment does not, however, rest only on the application of theplain language of the Act to FDA's thoroughly documented findings that thenicotine in tobacco products is intended by tobacco manufacturers to sustainaddiction and act as a sedative, stimulant, and appetite suppressant. FDAalso relied on the similarity of tobacco products to other products thatare covered by the Act, including tranquilizers (such as Valium), stimulants(such as NoDoz), weight-loss products (such as Dexatrim), narcotics usedto treat addiction (such as methadone), and nicotine replacement products(such as nicotine inhalers).
Respondents attempt (Br. in Opp. 13) to distinguish those products on theground that they are marketed with therapeutic claims, while tobacco productsare marketed only to provide smoking pleasure. That distinction, however,finds no support in the text of the Act or in its public health purposes.The text of the Act makes "intended" effect, not "marketclaims," the decisive factor. 21 U.S.C. 321(g)(1)(C) and (h)(3). Coverageof tobacco products therefore does not depend on whether a manufacturerexpressly represents that tobacco products satisfy an addictive need oract as a sedative, stimulant, or appetite suppressant. While such claimswould be sufficient to establish intended effect, they are not the onlybases for such a finding. When, as here, manufacturers know that most consumersuse tobacco products to satisfy addiction and to obtain other physiologicaleffects, and manufacturers engineer their products to deliver the amountof nicotine necessary to sustain addiction, an intended effect on the structureand function of the body is equally apparent. Tobacco manufacturers maynot escape regulation by relying on a euphemistic market claim that cigarettesare intended for smoking pleasure.1
From a public health perspective, no other result could be justified. Therisks to the public health and the appropriateness of regulation under theAct exist regardless of whether the intended effect is established throughmarket claims or by other evidence. Under respondents' view, FDA would nothave been able to regulate "caine," an imitation cocaine productthat was marketed as incense, or "khat," an imported stimulantthat was sold without any market claim. 61 Fed. Reg. at 45,167 (explainingthat those products were regulated because they were found to have intendedeffects on the body based on, inter alia, widespread consumer use of theproducts for their physiological effects). Indeed, if respondents were correctin their understanding of the Act, the marketers of nicotine inhalers couldescape FDA regulation as long as they eliminated any therapeutic claimsand marketed their products as providing "breathing pleasure."FDA correctly rejected such an approach as inconsistent with the text ofthe Act and its public health purposes.

3. Because the nicotine in tobacco products falls within the core of FDA'sregulatory authority, respondents are also mistaken in asserting (Br. inOpp. 26) that FDA's interpretation of the Act would expand its applicationto products such as thermal pajamas and air conditioners. Those examplesraise the question whether it would be reasonable to rely on the plain languageof a definition when it leads to an application that is far removed fromthe ordinary understanding of the term that is being defined. See Gustafsonv. Alloyd Co., 513 U.S. 561, 574-576 (1995). This case, however, does notraise that question. In ordinary usage, no one would say that thermal pajamasand air conditioners have drug-like effects. By contrast, as internal industrydocuments in the record make clear, manufacturers of tobacco products havelong characterized the nicotine in tobacco products as having such effects,while denying such effects publicly. See Pet. 5.
C. 1. Respondents' remaining efforts to avoid the force of the controllingdefinitions and FDA's findings are also unpersuasive. For example, respondentsattempt (Br. in Opp. 9-12) to draw support for their position from FDA'srefusals in 1977 and in 1980 to regulate tobacco products as "drug[s]"or "device[s]." But an agency is always free to change its interpretationof a statute or its position on an issue, Rust v. Sullivan, 500 U.S. 173,186-187 (1991); Chevron, 467 U.S. at 863-864, as long as it provides a reasonableexplanation for the change. FDA satisfied that obligation by explainingthe circumstances that led to its change in position.
First, while no major health organization had determined that nicotine wasan addictive drug before 1980, by 1994 every leading scientific panel ororganization had concluded that nicotine "is addictive or dependence-producing."61 Fed. Reg. at 45,228. Second, since 1980 scientific evidence has shownthat as many as 92% of all smokers and 75% of smokeless tobacco users areaddicted; and slightly less than three-quarters of all cigarette smokersand more than one-half of all smokeless tobacco consumers use those productsas a sedative. Id. at 45,233-45,234. In contrast, before 1980 evidence regardingthe proportion of users who were addicted was extremely limited, and theevidence was insufficient to conclude that tobacco products were consumedprimarily for their pharmacological effects. Id. at 45,234-45,235. Third,recently released internal industry documents show that tobacco manufacturershave long known that consumers use tobacco products primarily to sustainaddiction and for their other pharmacological effects, and that manufacturershave engineered their products to deliver active doses of nicotine. Id.at 45,235-45,236. Almost none of that evidence was publicly available in1980. Id. at 45,237. FDA's change in position was therefore "basedon an overwhelming body of new evidence that ha[d] become available sinceFDA last considered this issue." Ibid.2
Respondents contend (Br. in Opp. 13) that FDA's 1977 and 1980 decisionswere not based on the absence of the evidence discussed above, but on acategorical view that tobacco products are not covered by the Act absentspecific health claims. Respondents have misread those decisions.
In its 1977 decision rejecting a petition filed by Action on Smoking &Health (ASH) to regulate cigarettes based on ASH's assertions concerninghow consumers use them, FDA stated that "FDA can assert jurisdictionover cigarettes containing nicotine (or nicotine separately) when a jurisdictionalbasis for doing so exists, e.g., health claims made by the vendors."Letter from Donald Kennedy, FDA Commissioner, to John F. Banzhaf, III, ASHExecutive Director 1 (Dec. 5, 1977). In its brief defending the decision,the government explained that FDA had concluded that cigarettes could notbe regulated as drugs "in the absence of health claims by the manufacturersor vendors or other evidence of the manufacturers' or vendors' intent toaffect the bodily structure or function." Appellees C.A. Br. at 14,Action on Smoking & Health v. Harris, No. 79-1397 (emphasis added).And, in affirming FDA's decision, the D.C. Circuit stated that "wedo not read [FDA's decision] to mean either that the Commissioner will neverconsider evidence of consumer intent on this question or that he simplyignored the evidence presented to him in this petition." Action onSmoking & Health v. Harris, 655 F.2d 236, 239 (1980). Instead, the petitionfailed because ASH had failed to "meet the high standard establishedin cases where the statutory 'intent' is derived from consumer use alone."Ibid.
Similarly, in rejecting ASH's second petition in 1980, FDA stated:
ASH asserts that objective evidence other than manufacturers' claims canbe material to a determination of intended use under the statutory definition.* * * We agree. * * * [E]vidence of consumer use can be one element of objectiveevidence to be weighed in determining if the intended purpose of a productsubjects it to regulation under the Act. ASH has not established that consumersuse attached cigarette filters * * * to the extent necessary to allow FDAto impute the requisite intended uses to manufacturers or vendors.
Letter from Jere E. Goyan, FDA Commissioner, to John F. Banzhaf, III, ASHExecutive Director 8-9 (Nov. 25, 1980). In light of the above, we do notunderstand how respondents can assert (Br. in Opp. 13) that "[n]oneof FDA's statements disavowing jurisdiction relied on * * * lack of evidence."

2. Respondents contend (Br. in Opp. 17) that Congress could not have intendedto give FDA authority to ban tobacco products. FDA, however, has not takenany steps to ban tobacco products. The regulatory actions at issue hereare FDA's prohibition on the sale of tobacco products to minors and certainaccess and advertising restrictions that are aimed at preventing circumventionof that prohibition. The question whether FDA has authority to ban the saleof tobacco products to adults is therefore not presented.
Respondents argue (Br. in Opp. 23-24) that, if tobacco products are coveredby the Act, FDA would necessarily have to ban their sale altogether. Fromthat premise, respondents contend that Congress could not have intendedfor FDA to have any authority over tobacco products. The premise of respondents'argument is simply incorrect. As we note in our petition, FDA determinedthat, even though tobacco products cause serious adverse health consequences,their sudden withdrawal "would be dangerous," both because thehealth care system "would be overwhelmed by * * * treatment demands,"and because of the likely development of black market tobacco products "evenmore dangerous than those currently marketed." 61 Fed. Reg. at 44,413.Based on those findings, FDA concluded that a ban on the sale of tobaccoproducts to adults is neither appropriate nor required under the Act. SeePet. 3, 8-9.
Since FDA is entitled to Chevron deference on its interpretation of theAct, FDA's conclusion that the Act does not require it to ban the sale oftobacco products to adults must be upheld unless Congress "directly"and "unambiguously" provided otherwise. 467 U.S. at 842, 843.Far from demonstrating such a clear and unambiguous congressional intent,respondents have not identified any language in the Act that removes FDA'sdiscretion to enforce the Act so as to avoid the harmful health consequencesof a total ban. Indeed, they do not even cite the provisions of the Actand regulations on which FDA reasonably relied in weighing the health risksof permitting continued sales of tobacco products to adults against thehealth risks of prohibiting such sales. See Pet. 23 (citing 21 U.S.C. 360c(a)(2)(C)and 21 C.F.R. 860.7(d)(1)).

3. Respondents' reliance (Br. in Opp. 8-9, 25-26) on certain tobacco-specificstatutes as evidence that FDA has no authority to regulate tobacco productsis similarly misplaced. Respondents' misreading of the Federal CigaretteLabeling and Advertising Act (FCLAA), Pub. L. No. 89-92, 79 Stat. 282, whichrequires certain warning labels on cigarettes, see 15 U.S.C. 1333, illustratesthe mistake in respondents' approach. FCLAA precludes FDA from requiringwarning labels different from those prescribed by that statute. See 15 U.S.C.1334(a) ("No statement relating to smoking and health, other than thestatement required by [Section 1333], shall be required on any cigarettepackage."). But the text of FCLAA does not limit FDA's authority toregulate tobacco products in any other way. In particular, it does not remotelysuggest that FDA lacks authority to prohibit the sale of cigarettes to minorsor to promulgate advertising restrictions designed to prevent circumventionof that prohibition. For that matter, FCLAA does not limit any authorityof FDA to ban tobacco products altogether, just as it does not limit theauthority of a State to do so. As the Court explained in Cipollone v. LiggettGroup, Inc., 505 U.S. 504, 518 (1992), FCLAA "merely prohibit[s] stateand federal rulemaking bodies from mandating particular cautionary statementson cigarette labels." FCLAA therefore provides no support for respondents'challenge to the regulatory program at issue here. Respondents' relianceon the other tobacco-specific statutes suffers from the same basic flaw.See Pet. 27.

4. Finally, respondents contend (Br. in Opp. 27-28) that FDA's regulationof tobacco products would impermissibly intrude on state authority to regulatetobacco products. Thirty-nine States, however, strongly disagree. As theStates explain in their amicus brief (at 4), "FDA regulation of tobaccoproducts is fully authorized by the FDCA and performs a critical functionin the comprehensive effort that is needed to address this important publichealth issue."
* * * * *
For the reasons discussed above as well as those set forth in our petition,it is respectfully submitted that the petition for a writ of certiorarishould be granted.

SETH P. WAXMAN
Solicitor General

APRIL 1999
1 Respondents refer (Br. in Opp. 25) to FDA's finding of intent as restingon the foreseeability of the effects of tobacco products. FDA's findingof intended effects, however, does not rest on foreseeability alone. Asnoted above, FDA also relied on evidence that tobacco manufacturers havelong known that consumers use tobacco products to sustain addiction andfor their other physiological effects, and on evidence that manufacturershave designed their products to produce the dosage of nicotine necessaryto sustain addiction, as well as evidence of actual consumer use for drug-likeeffects.
2 Because the evidence discussed above was not available in 1938, when theAct was passed, or in 1964, when the Surgeon General issued his report,respondents err in asserting that application of FDA's legal standard fordetermining coverage under the Act would have led FDA to conclude in 1938and 1964 that tobacco products were covered. Respondents' reliance (Br.in Opp. 24-25) on the Surgeon General's 1964 Report is particularly puzzlinggiven the report's (erroneous) conclusion that smoking is not addictive.