Sottera, Inc. v. Food & Drug Administration

INC., SOTTERA, doing business NJOY, Appellee

v. ADMINISTRATION, DRUG

FOOD al., Appellants.

et

No. 10-5032. Appeals,

United States Court of Columbia Circuit.

District Sept.

Argued 7, 2010.

Decided Dec. Banc En Denied Jan.

Rehearing

Gregory argued G. Garre the cause for Sottera, appellee Inc. With him on the Bress, brief were Richard P. John R. Man- thei, and Jessica E. Phillips.

Deborah M. Shelton and Christopher M. Loveland were on the brief for amici curi- ae Pennsylvania, Smokefree et al. in sup- port of appellee.

Daniel Popeo, J. Samp, Richard A. Co- Klasmeier, leen E. and Rebecca K. Wood were on the brief for amicus curiae Wash- ington Legal Foundation in support ap- pellee.

Before: GARLAND and KAVANAUGH, Judges, Circuit WILLIAMS, Senior Circuit Judge. Opinion for the by Court filed Senior Judge Circuit WILLIAMS.

Opinion concurring in judgment filed Judge Circuit GARLAND. WILLIAMS, Senior Circuit Judge: Sottera, Inc., which does business as NJOY, is an importer and distributor of cigarettes” “electronic or “e-cigarettes,” a product that enables users to inhale vapor- ized nicotine. question before us is whether has authorized the Food Klein, Alisa B. Attorney, Depart- U.S. (“FDA”) and Drug Administration regu- Justice, ment of argued ap- the cause for late e-cigarettes under the drug/device pellants. With her on the briefs were provisions Food, of the Federal Drug, and Machen, Jr., Ronald C. Attorney, (“FDCA”), Cosmetic Act Mark Chaifetz, B. Stern and Samantha L. seq., et or under the Family Smoking Pre-

Attorneys, Ralph Tyler, Counsel, S. Chief vention and Tobacco Control Act of 2009 Department United States of Health and (the Act”), “Tobacco Pub.L. Services, Human Eric M. Blumberg, Dep- Stat. 1776. We think statutes, uty Counsel, Chief Schifter, and Karen E. properly in light read Cutini, Associate Chief Counsel. Drake S. Court’s decision FDA v. Brown & Wil-

Attorney, Justice, U.S. Department en- liamson, an appearance. tered (2000), L.Ed.2d locate the un- William B. Schultz was on the brief for der the Tobacco Act.

amici curiae American Academy of Pedia- trics, et al. in support of appellants. injunction. preliminary battery-pow- request cigarettes are

Electronic at 7. Op. at Mem. Compl. users to inhale that allow ered smoke, fire, ash, or without vapor nicotine Everywhere argued and NJOY Smoking Compl. at 2. NJOY carbon monoxide. ciga- FDA can that the ciga- like traditional Designed to look a rettes, them, market they propose to as rette, consists three e-cigarette each Act, claiming the Tobacco cartridge, the atomizer the nicotine parts: in & opinion the Court’s element, battery and heating and the or drug/device foreclosed FDCA Williamson cartridge serves plastic The electronics. market- jurisdiction over liquid nico- and contains mouthpiece as the therapeutic effect. ed without claims of tine, water, glycerol. and glycol, propylene agreed granted and the The district court vaporizes liquid atomizer Id. at 5. The pending, injunction. appeal this was Wfliile nicotine, electronics battery and and Smoking Everywhere voluntarily dis- air and monitor flow. the atomizer power FDA, complaint against missed its inhales, the user electronics Id. When the leaving appellee. as the sole See NJOY and the atomiz- the air flow activate detect at 4. NJOY Br. and the er; liquid vaporized, nicotine is deciding grant whether to When vapor.

user inhales the Id. injunction, preliminary a a district court e- imported has and distributed familiar NJOY must consider four factors: 2, “(1) 4. Id. at has a plaintiff since whether substantial merits; (2) e-cigarette in each de- of success on the liquid nicotine likelihood plants, irreparable injury Decl. of suffer plaintiff from natural tobacco would rived (3) 2, injunction granted; an and NJOY claims were an Leadbeater John injunction substantially injure and would other its is marketed labeled (4) grant of an parties; than interested pleasure,” rather as “smoking injunction public inter smoking product. would further cessation therapeutic or Ass’n, Inc. Dairy Coop. est.” Ark. v. U.S. of John Lead- Compl. NJOY Decl. (D.C.Cir. Dep’t Agric., 573 F.3d 15, 2009 the FDA April at 2. On beater 2009) Labs., Shalala, Inc. v. (citing Serono e- shipment that a NJOY’s ordered (D.C.Cir.1998)). 158 F.3d 1317-18 entry into the United cigarettes be denied weighing of the district court’s We review States, e-cigarettes ap- asserting that the abuse of these factors under an discretion misbranded, adulterated, or peared be standard, review of law de questions but drug-device combinations un- unapproved Id.; also Davis v. Pension Ben novo. see 20, 2009 Notice of April the FDCA. der Guaranty Corp., F.3d FDA Action. efit (D.C.Cir .2009). importer in April Also another Smoking Every- e-cigarettes, distributor FDA has authori- Under

where, injunc- Inc., preliminary sought “drugs,” are ty articles that FDA and various officials barring tion “devices,” drug/device combinations. or entry denying their into drugs § defines to include 321(g)(1) U.S.C. regulating e-ciga- and from States United (B) in diag- use drug/device provisions of intended for articles rettes treatment, nosis, cure, or Everywhere Compl. mitigation, Smoking FDCA. man or other prevention of disease joined intervenor- (C) (other animals; articles than complaint and filed own plaintiff food) intended to affect the structure market- body of man or other any function of the ed.” 529 120 S.Ct. 1291. animals. fill To gap identified (C). § & The stat- 321(g)(1)(B) U.S.C. Williamson, Brown & similarly, ute defines devices see U.S.C. passed the Tobacco No. 111— Pub.L. 321(h)(2) (3); that are “com- §§ 123 Stat. seq., 387 et device, biological of a drug, bination[s] providing the FDA with to regu product” regulated are as combination products. late tobacco The act defines products, 353(g)(1). see U.S.C. so as to all con include 1996, attempt the FDA had

Until never sumption products derived from tobacco regulate ed to under the except qualify drugs, articles that as de (with exception, vices, FDCA one irrelevant for or drug-device combinations under below) they reasons discussed unless were the FDCA: uses, is, therapeutic sold for for use (rr)(l) product” The term “tobacco treatment, “diagnosis, cure, mitigation, any means product made derived or prevention disease” under from tobacco that is for human intended § 321(g)(1)(B). Smoking Action on Cf. consumption, including any component, Harris, and Health v. 655 F.2d 236 part, accessory of a product (D.C.Cir.1980). year, But in that changed long-held position, promulgat (2) The term product” “tobacco does not ing regulations affecting tobacco products mean an article is a under drug [the marketed, customarily i.e., as ones sold drug provision], FDCA’s a device under Regula without claims. See provision], [the FDCA’s device or a com- Restricting tions the Sale and Distribution bination product in [the described of Cigarettes and Smokeless Tobacco to FDCA’s combination provision], Adolescents, Children Protect 61 Fed. 321(rr). § 21 U.S.C. 1996). 44,396 28, Reg. (Aug. agency The Tobacco Act itself states that does is a drug asserted nicotine that affects “affect, expand, or limit” the FDA’s the structure or function of body under jurisdiction regulate products § 321(g)(1)(C) cigarettes drug/device provisions FDCA, 21 drug/de smokeless tobacco were therefore 387a(c)(1), and the district court falling vice combinations under the FDA’s parties appear agree themselves regulatory purview, therapeu even absent expand Tobacco Act did not 44,397, tic claims. See Fed.Reg. devices, category drugs, 44,400. and combina products subject tion jurisdiction Williamson, In FDA v. in the wake of Brown & Williamson. See Supreme rejected Op. us, Mem. 9 n. 4. The question before claimed FDCA to regulate tobac- therefore, can regu whether FDA co products marketed. cigarettes late electronic under Looking to the “overall regulatory FDCA’s drug/device provisions FDCA’s or whether scheme,” “tobacco-specific legislation” it can them under the Tobac enacted since the and the FDA’s provisions. co Act’s frequently own position, asserted it held ... point had “ratified the FDA’s The FDA argues at one that its plain and resolute position the FDCA to regulate decision gives agency drug/device provisions FDCA’s Smoking Pub.L. deference. See sive Education 98- to Chevron is entitled 474, 2200; Chevron, U.S.A., Comprehensive Smoke- v. Res. 98 Stat. Inc. Nat. Def. Council, Inc., less Tobacco Health Education Act of S.Ct. U.S. 30; Alcohol, (1984). Pub.L. 100 Stat. Br. at L.Ed.2d 694 Abuse, Drug and Mental Health Adminis- does not turn on in fact the case But Reorganization Act, tration Pub.L. 102- statutory Rath- interpretation. matters Finally, citing Stat. 394. er, Tobacco argues, FDA itself its decision MCI Telecommunications authority un- alter the FDA’s Act Co., AT Corp. v. & T Br. the FDCA. FDA der (1994), L.Ed.2d 182 respect Reply Br. at And “Congress Court noted that could not have that au- products, the breadth of delegate intended decision such thority governed by the economic and to an political significance in Brown & Williamson. Court’s decision cryptic in so fashion.” Brown & turn to that case. We therefore Williamson, 1291. the held that the So FDA’s In Brown & Williamson the jurisdiction claim of FDCA failed. regulation the FDA’s of Court addressed our products purposes, ques and smokeless tobacco For the central noting tion began by It that is whether Brown & Williamson’s under the FDCA. reading authority to ensure that the FDA of FDA’s the FDCA seeks only they drug/device provisions ap if are of the FDCA approve products will safe products plies only effective for their intended use. 529 which Congress specific regulatory has passed at 1291. Yet the FDA S.Ct. to all products had itself found that tobacco are statutes or whether extends tobac “unsafe,” great customarily “dangerous,” products and “cause co marketed. The suffering argues from Id. at FDA that pain illness.” Brown & Williamson (quoting Fed.Reg. statute-specific approach, takes a exclud 44,412). drug/de ing products regulating If tobacco were those of combinations under the time Brown vice subject have choice to ban & had been the of FDA would no but Williamson 135, 120 specific legislation. them. Id. at S.Ct. 1291. federal Br. at crys Though & Williamson case, Clearly that not be the could clear, we think the reading tal better all, Congress Court reasoned. After had drug/device the FDA lacks FDCA declared, provision of Code in the U.S. all force, of then tobacco was “one therapeutic claims marketed without of ef of greatest basic industries the United fect, i.e., marketed. States,” (quoting S.Ct. 1291 1311(a)), was passed and it had also Brown & Williamson’s focus not on that the separate relating particular products six statutes to tobacco six stat- 137-38, utes or on six since 1965. Id. 120 S.Ct. 1291. cover even statutes themselves; Cigarette point quote Labeling Federal and Ad- See 89-92, 282; vertising in which the six statutes precise language Pub.L. 79 Stat. Rather, Cigarette products. Act Smoking Public Health identified covered 91-222, 87; Alcohol the con- Pub.L. 84 Stat. Brown & Williamson considered that Congress Abuse Amendments of text of each statute show Drug actively thinking “the Comprehen- was about Pub.L. Stat. 145, 120 problem.” stating 529 U.S. at S.Ct. 1291. er the FDA jurisdic- statutes, situating In Bmm & Wil- tion was limited to tobacco bear- claims”). each adopting liamson ing “[i]n found “health statute, against Congress has acted Moreover, discussing record before backdrop of the FDA’s consistent and re- Congress period passed in the when it peated statements that it lacked statutes, these six Brown & Williamson under the FDCA to tobacco ab- noted knew of “the both therapeutic sent claims of benefit consequences adverse health of tobacco manufacturer.” Id. at 120 S.Ct. 1291. use” and of pharmacological “nicotine’s ef Brown & Williamson concentrated fects.” Id. at 120 S.Ct. 1291. None overwhelmingly unifying on the theme theless, rejected Congress “considered and FDA policy historic towards tobacco granted bills would have the FDA” policy ucts—-a that it saw as undifferentiat- jurisdiction products. over tobacco Id. at except regard presence ed to the absence of claims of effect. light, this Brown & Williamson inter- See, (“To- e.g., id. at 120 S.Ct. 1291 prets the particular six statutes not as a chewing bacco marketed for smoking carve-out from the FDCA for cigarettes claims, without accompanying therapeutic (plus any smokeless tobacco additional Food, does meet definitions statutes, covered the six which Drug, and ...” Cosmetic Act Let- (citing Bureaus, itemize), ter to briefs make no effort to Directors Divisions and of but rather “a regulatory Directors Districts from FDA Bureau of as distinct scheme 24, 1963))); (May problem Enforcement the of address tobacco and (“In years 120 S.Ct. 1291 the since the Congress health” —one that intended enactment original Drug Food and “preclude! any would role ] for the FDA” Act, years and in promul- the the since respect with to “tobacco absent claims of Food, gation of the modern Drug, and therapeutic benefit the manufacturer.” Cosmetic the FDA has repeatedly so, In doing Congress Id. also “persistent- Congress informed that are be- ly preclude acted to a meaningful role for yond the of scope the statute absent health any administrative agency making poli- establishing claims a therapeutic on intent subject on cy the of tobacco and health.” (cit- behalf of the manufacturer vendor” customarily Id. S.Ct. 1291. As (FDA) Brief ing Appellee in Action on marketed, products tobacco were to re- Harris, Smoking and Health v. 655 F.2d province Congress. main the of (D.C.Cir.1980))); id. at Reflecting history on the and structure (noting that predecessor the FDA’s regulation, of tobacco Brown & William- agency, Chemistry, the Bureau of stated it concluded, son authority regulate lacked Congress affirmatively has claims); absent acted to ad- therapeutic ucts id. at health, dress the issue of (quoting 120 S.Ct. 1291 tobacco and the FDA’s General relying defining representations Counsel as on the regulatory scope over products authority FDA that had therapeutic pur- regulate based on no pose); (citing id. at tobacco. It has created a distinct FDA Deputy scheme to stating Commissioner sale of tobacco jurisdiction products, was limited to on labeling focused and adver- claims”); products bearing “drug tising, premised id. at on the belief that 158, 120 (citing S.Ct. 1291 jurisdiction Commission- the FDA lacks such “any product made or de result, Congress’ tending to- aAs the FDCA. tobacco,” preclude rived statutes bacco-specific added). 321(rr)(1) (emphasis To be regulating tobacco FDA from sure, customarily align marketed. a as this definition could variety interpretations Brovm & 156, 120 Id. at scope (including the one Williamson’s therefore did not Brovm & Williamson here), reading our proffers but regulating FDA from preclude squarely range. within Congress had for which those Rather, it specific recog passed statutes. responds its treatment of consciously had devel nized that Cigarette Favor Smokeless tobacco and statutory scheme for oped reading Brovm & supports William distinguished tobacco health that Br. at think not. son. FDA 14-15. We from ones mar customarily marketed containing nico Favor was a small tube “Thus, therapeutic purposes. keted solution, user to inhale enabling tine the FDA’s Congress ratified was what Id. vapor without smoke. nicotine position plain resolute Though Cigarette was mar Smokeless gives claims, keted without market an unapproved Favor it was warned Id. S.Ct. 1291. ed.” drug. new Id. at 14-15. The FDA’s At FDA observed argument oral was, Favor howev claimed over justice with some er, challenged adjudicated in never the Court in Brovm & scheme before Wil- court. ad Nor Brovm Williamson only cigarettes and liamson addressed Cigarette, perhaps dress the Smokeless tobacco; us have infer smokeless would brought neither side before the because incessantly re- used the Court turn because individ (perhaps as a peated phrase products” “tobacco it). uals the case were unaware of litigating shorthand, products to the before confined Williamson, in argument In its Brovm & whatever (supplemented by the Court ad- that “the instances in FDA stated were reached the six products ditional that agency which the had found tobacco statutes). any find evidence such We products drugs were involved cases intent; certainly the Court did restrictive express market which there were claims economizing familiar form: not use the Br., therapeutic value.” Pet’rs’ FDA v. (‘tobac- “cigarettes and smokeless tobacco Williamson, Brown & products’).” co (2000) (No. 146 L.Ed.2d 98-1152), (empha 1999 WL at *37 wholly Tobacco Act is consis

The added). fact, In sis one of FDA’s reading of Brovm & Wil tent with this arguments in was Brovm & Williamson the regula to liamson. Written address change its was “free identified, tory the case gap long position” provided as it reasoned reg FDA with provides Tobacco Act Id. *15 justification change. for the authority products over ulatory tobacco added). likely (emphasis And would therapeutic claims. requiring without con have true —but for the Court’s been authority un leaving Besides FDA’s ratified Congress had what clusion that drug/device provisions der undisturbed, as the invariable Court understood see 387a(c)(1), made with 321(rr)(2) products § of tobacco § act exclusion & therapeutic effect. ex- out claims of broadly defines consequen- regarding also offered a claims has its electronic namely, cigarettes. Op. Mem. at 25 n. Until argument, tialist understand- time, such the definitional line laid down in ing Brown Williamson this fashion & (as Brown severely any & Williamson we understand the FDA thwarted in leaves it) jurisdiction leaves the FDA without e-cigarettes rela- nudge effort toward (or over these tively the FDCA’s away healthful forms least merits, ones). drug/device provisions. On the relatively unhealthful Wheth- then, likely to succeed. consequentialist argument er such should any interpretation in our play role We also find that the court district questionable, but Brown Williamson in finding abuse discretion gives no matter. In fact the Tobacco Act tips the balance of harms toward NJOY. over authority broad harm, showing irreparable injury instance, products, including, for party great; must “be both certain and impose their restrictions on it must be actual theoretical.” sale, advertising promotion on the FERC, Co. v. Wisconsin Gas 758 F.2d 387f(d), § products, of such see 21 U.S.C. (D.C.Cir.1985). The FDA’s refusal to regulate the mode of manufacture of admit NJOY’s into United 387f(e), products, see id. and to obviously States the firm’s destroyed abili establish standards for products, ty the United States to cover its costs see id. To 387g. the extent that Con- purchase production e-cigarettes. gress believed & Williamson left The finding district court’s this loss insufficiently regulative environment irreparable would be injunction absent an cigarettes, tobacco, cigars, smokeless entirely appears Op. reasonable. Mem. products, and other tobacco it found the Regarding harm parties to third adequate remedy. Tobacco Act an interest, public to the the district court Together, Brown & Williamson and the observed that the FDA had cited no evi Tobacco Act establish that the FDA cannot dence to show that electronic regulate anyone. marketed tobacco harmed signifi Id. at 30. More products under the drug/device cantly, FDCA’s rightly the court found that provisions, can tobacco FDA has under the Tobacco Act therapeutic pur- marketed for cigarettes, enabling poses provisions, under those and that it it to mitigate perhaps extinguish any regulate can customarily public marketed tobacco harm to Id. health. at 31. Given products under the Tobacco Act. the likelihood NJOY’s on success the

merits, irreparable harm the to NJOY’s business, unquestioned and the FDA’s To As to NJOY’s likelihood of success Act authority mitigate public bacco to any merits, on the the firm claims that its harm, the district court not abuse its cigarettes liquid electronic use a nicotine granting preliminary discretion in the in mixture from derived tobacco and that its junction. products are not for therapeutic marketed uses, Compl. 5; Decl. John noted, appears

Leadbeater at the FDA not to already As we have the FDA has Still, challenge either claim. authority regulate district to market- court noted that the factual record on products including e-ciga- ed tobacco — meager NJOY is may It rettes —under Tobacco Act. has establish that NJOY in regulate does fact make to therapeutically mar- Accordingly, in co. at least the absence of products under the FDCA’s keted tobacco And, contrary agency interpretation this entitled deci- drug/device provisions. deference, I products, to does to Chevron read the Tobacco is limited sion ability requiring regu- FDA’s Control Act as the FDA not affect the or any products cigarettes the “structure late like electronic un- products under other drugs and devices der that rather than under the prong defining FDCA. function” (h), as to the 321(g) in 21 U.S.C. I aside—

scope of which—tobacco course, in opinion. Of express we Williamson, Supreme In Brown & Congress prefers event Court held lacks under the FDCA’s regulate e-cigarettes products” “tobacco always drug/device provisions, can so drug/device provisions of un decree. are less those marketed with 158-59, of the district court is judgment therapeutic claims. 529 U.S. at face, its S.Ct. 1291. On the natural Affirmed. meaning product” term “tobacco is a chewing cigarettes tobac GARLAND, concurring Judge, Circuit —like Although co—that contains tobacco. it is the judgment: in liquid true that nicotine NJOY’s join my colleagues I Although is derived tobac case, of this I do so based on disposition co, it regard less natural to fact seems reasoning. I do not read FDA v. different plastic as sufficient transform NJOY’s Williamson, & contain cartridges no tobacco— —which (2000), 146 L.Ed.2d bar- product. into a tobacco As NJOY ac regulating FDA from “electronic ring the reading its to the coun knowledges, leads Food, Drug, cigarettes” syringe terintuitive conclusion that a filled (FDCA), Act et Cosmetic prod is a tobacco injectable with nicotine I seq., because do not believe the Tr. Argument uct Oral 40-41. as well. of the “tobac- Court intended use term all, many, although On occasions on to extend to do products” co used term The Tobacco Control which Brown Williamson not contain tobacco. coupled products,” 123 Stat. “tobacco Act of Pub.L. No. 1776, however, express reference to tobacco or to expressly extends an At plainly contain merely ucts that are “derived from” tobac- tobacco.1 See, 126, 127, products” e.g., cannot "be safe within mean- 529 U.S. at because, ing (using FDCA” the FDA has “[a]s the term “tobacco detail, cigarettes great products" in to the rule con- documented reference “cigarettes tobacco are unsafe means cerning sale of and smokeless smokeless effect”); tobacco”); (de- pharmacological obtaining any id. at 145, (describing the ciga- to S.Ct. 1291 FDA’s scribing that rule —which was limited 120 testimony requiring authority to that lacked rettes and smokeless tobacco —as testimony appear cigarette packages as that specified a on “all to- label that statement 134, regulate prod- packages”); jurisdiction to "tobacco product id. at lacked bacco ucts”); (citing, at (noting had found S.Ct. 1291 S.Ct. 1291 that had support proposition that the FDA products” to cause “tobacco-related “tobacco illnesses, cancer, regulate respiratory illness- never before "asserted such marketed,” es, products as that the FDA and heart disease”' —illnesses tobacco, nicotine); repeatedly in- that the "FDA has with not id. at fact associated cigarettes beyond (noting that are “tobacco formed 120 S.Ct. 1291 But point the Court state that the the most telling indication that the (or holding of Brown & regulating “nicotine” Williamson does was barred cigarettes extend to electronic that the is containing nicotine but not to- product a reasoning prod- bacco) apply Court’s does Thus, the most under FDCA. ucts that do not contain tobacco. straightforward reading of the “to- term for Court’s chief rationale prod- is as for products” bacco short-hand First, holding two premises. had Compare ucts that contain tobacco. that, “if Court determined (describing at S.Ct. 1291 U.S. ucts were ‘devices’ under congressional “creating several statutes as required FDA would be to remove them regulatory cigarettes a distinct scheme for from the market.” 529 U.S. at ”), tobacco with id. at and smokeless S.Ct. 1291. It reached this be- conclusion (describing 120 S.Ct. 1291 the same stat- may only approve cause the FDA a prod- “creating] utes as a distinct regulatory for marketing uct if it ”) products (emphases scheme for use, safe and effective for its intended added). “exhaustively the FDA had documented” reading This consistent the con products any are for unsafe text which the Court decided Brown & 133-35, pharmacological use. Id. at case, up Williamson. the Court Second, the Court found that challenge a held a 1996 FDA rule as Congress had “foreclosed removal of serting authority regulate the sale tobacco products from the market” cigarettes and smokeless tobacco under through “tobacco-specific legislation” 126-30, the FDCA. subsequent 120 S.Ct. passed to the FDCA. Id. at 137, 143, (citing Regulations Restricting Thus, 120 S.Ct. 1291. the Court Cigarettes they Sale and Distribution of concluded: “If cannot be safely used any therapeutic purpose, yet they Smokeless Tobacco to Protect Children banned, Adolescents, 44,396 they simply cannot be Fed.Reg. do not fit” (Aug. 1996)). within the FDCA’s scheme. Id. Because all of the 120 S.Ct. 1291. tobacco, issue in rule contained Court had no opine upon occasion to premise Neither pure holds true for nic- product, a like product otine tobacco-free electronic cigarettes, that does In not. First, delivers nicotine. unlike deed, although indistinguishable tobacco, containing which the FDA has from electronic had been intro “cancer, found to be associated with respi- years duced some ten earlier —the “Favor illnesses, ratory disease,” and heart Cigarette,” Smokeless of a which consisted

small tube containing an inhalable nicotine has not found nicotine or tobacco-free solution—there is no in Brown indication deliver nicotine are inherent- Williamson the Court ever had ly unsafe. contrary, To the the FDA has (The heard of it. FDA had au asserted approved several such marketed thority Favor notwith claims, with therapeutic determining that standing that was marketed without they satisfy safety require- the FDCA claims. Regulatory Letter ments that Brown & deter- Williamson from FDA to Advanced Tobacco Prods. products” mined “tobacco could not meet. (Feb. (J.A. 425-26)). 9, 1987) Inc. FDA 16 (noting See Br. that the FDA has scope claims”). of statute absent health

901 apply cited the Court do not electronic and transdermal gums nicotine approved 10, “it See FDA Br. 13-14. Nor Indeed, cigarettes. FDA states that patches). regulation of FDA a a manufacturer it be said that of possible be for can may well satisfy ... electronic product novel like cigarettes’ ‘electronic effectiveness, labeling of the and threaten the health American safety, FDCA’s would avers, approval.” industry. obtain FDA it “im- requirements and As NJOY supply of its ports percent Id. one hundred manufacturers, from overseas E-cigarettes Second, “tobacco-specific legislation” belief, and, upon information and there in Brovm & dispositive the Court found of E-cigarettes manufacturer no domestic prod does not address simply Williamson Compl. component parts.” their but contain nicotine ucts deliver (J.A. 40). ¶ 18 explained, As Con the Court tobacco. “directly problem addressed the had gress Finally, the & Williamson Court legislation through and health of tobacco that, statute, each adopting noted “[i]n also at since 1965.” 529 U.S. on six occasions against backdrop ... Congress acted im 137, Those statutes 120 S.Ct. 1291.2 repeated FDA’s consistent and advertising labeling requirements pose lacked under statements regulatory scheme that “create a distinct to regulate tobacco absent Id. cigarettes and smokeless tobacco.” by the manu- claims of benefit 143-44, 1291; 155, see at 120 id. at S.Ct. 144, 120 at facturer.” U.S. S.Ct. Moreover, 148-49, Con 1291. S.Ct. added). (emphasis “Under these circum- marketing of that “[t]he has declared gress concluded, stances,” the “it is evi- Court ba greatest constitutes one of the tobacco-specific Congress’ stat- dent States,” id. at the United industries of sic effectively ... ratified the utes (quoting jurisdiction it lacks position that long-held 1311(a)), “highly unlikely” that making the FDCA subjected have legislature would added). But (emphasis Id. ucts.” regime that could industry pre-1996 to which backdrop of statements down, entirely id. substantially shut state- referred did include the Court 160, 120 collective “[T]he at lacked over ments that statutes,” said, of these the Court premise nicotine, merely like which is cigarettes and smokeless is “that Rather, as the tobacco. derived in the United continue to be sold will clear, make the FDA’s citations Court’s Id. S.Ct. 1291. at States.” referred to its lack statements “tobacco,” id. jurisdiction either over ex- premise” does This “collective specific prod- or over 120 S.Ct. cigarettes, products, like tend tobacco, ciga- plainly like contain ucts nicotine. None of contain See, rettes, 145-46, 120 S.Ct. 1291. referenced statutes (citing labeling e.g., id. 120 S.Ct. statutory products, and such “[tjobacco marketed advertising restrictions statement requirements 2200; Act, 98-474, 98 Stat. cation Pub.L. following six statutes: Court listed 2. The Tobacco Health Advertising Comprehensive Smokeless Labeling Cigarette "Federal 99-252, 282; 89-92, Act Pub.L. (FCLAA), Stat. Education Act Pub.L. Abuse, Alcohol, 30; Drug and Mental Smoking Stat. Cigarette Act of Public Health 87; Reorganization 91-222, Drug Health Administration 84 Stat. Alcohol Pub.L. 102-321, 98-24, 106 Stat. 394.” 529 Pub.L. Pub.L. Abuse Amendments Smoking Edu- Comprehensive Stat. 387a(a). smoking Moreover, § accompanying without chewing U.S.C. unlike Williamson, claims, does not meet the defi- Brown & which used the food, drug, products” ... device or term “tobacco defining nitions cos- without FDCA). fact, it, in metic” And as the Tobacco Control Act includes a defi above, in noted 1987 the FDA had nition: “The term ‘tobacco product’ asserted means made or derived any product from materially indistinguishable from consumption.” electron- is intended for human 321(rr)(1) added). § cigarettes Ciga- ic Favor (emphasis Smokeless U.S.C. —the challenge. apparently without Because the nicotine NJOY’s electronic rette — cigarettes is “derived from” natural tobac sum, words, nothing In I see in the ¶ co, 1, it Compl. appears that the context, or rationale of Brown & William- may only pursuant it to the son supports interpreting that case as provisions of the Tobacco Control Act. barring regulating electron- ic the drug/device provi- conclusion, under disagrees The FDA with this Although agree sions of the FDCA. I contending with that the Tobacco Act Control my colleagues that these considerations do does not narrow the FDA’s preexisting reading Brown & justify not Williamson under support, the FDCA. In merely as a “carve-out from the FDCA for counsel cites another definitional tobacco,” cigarettes and smokeless Op. provision Act, of the Tobacco Control 896, they justify reading do it as a carve- which states that “[t]he term ‘tobacco out that contain product’ tobacco. does not mean article that is a (hold- See ..., U.S. at ..., S.Ct. 1291 drug device a combination ing Congress “preclude[ intended product” ] under the FDCA.

any 321(rr)(2). role for the FDA” respect view, § In pro- the FDA’s this “tobacco absent claims of therapeutic regulation bene- vision preserves for added)). fit” (emphasis any product “made or derived from Court had no opine reason to on the status Brown & Williamson did not tobacco” tobacco, of a product that contains no carve out of coverage. the FDCA’s And there indication the opinion that it because Brown & Williamson’s carve-out my meant to do so. colleagues’ opinion As did not nicotine-only products, extend to did, rests on the supposition that it I can- the agency maintains that such join their rationale. are necessarily products” “tobacco

within the meaning of the Tobacco Control II Act.3

But Brown & Williamson is not the 321(rr)(2) § end There is no doubt in- story. Congress passed a note ambiguity troduces into the anal- the Tobacco Control ysis. which that, states: But is a stretch to conclude products ... regulated “Tobacco shall just be having express used one statutory Secretary under this [Act] and shall subsection include “derived subject not be the provisions from” within [the the definition of “to- drug/device subchapter of the product,” 321(rr)(l), bacco FDCA].” FDA, 321(rr)(2) having Like nicotine-only products NJOY reads removed boundary leaving the between drug/device authority, from the FDCA’s drugs ucts and prior where was to the concludes that such are "tobacco passage of the Tobacco products" Control Act. Howev- under the Tobacco Control Act and er, because NJOY may reads Brown & regulated Williamson so not be FDCA.

903 2164, (2001), next, 150 292 am- 121 S.Ct. L.Ed.2d immediately employed then however, held them out Chevron to carve biguous subsection Rather, statutory for likely appropriate more deference is again. law,” 321(rr)(2) of Congress’ interpretations of “force id. expression an § is 229, 2164, 121 and ruled that an S.Ct. & Williamson’s preserve intent unlike, ex agency’s litigation a for holding product that even made briefs— regulations not warrant example, cigarette ample, tobacco—for —do —re- 19, device, deference, com- 238 n. 121 S.Ct. drug/device such drug, mains a Georgetown 2164. See also Bowen v. regulated can be bination that 204, 212-13, Hosp., 109 488 U.S. if it is marketed Univ. (declin (1988) 468, Hence, L.Ed.2d reading is S.Ct. 493 the better purposes. 321(rr)(2) ing “agen makes clear that accord Chevron deference simply litigating Legal Landmark cy positions”); from tobacco products made derived IRS, 1132, v. therapeutic pur- are marketed for Found. F.3d 1135-36 (D.C.Cir.2001) (denying within deference products” not “tobacco Chevron poses are interpretation “developed litigat Control to an meaning of the Tobacco ion”).4 subject regulation and are therefore of the drug/device provisions case, agency In this there pro is FDCA. nouncement that calls for Chevron defer course, briefs, circumstance, which of ence. Other than its do not

In the usual only expression of a of the FDA’s reading qualify, of the judge’s view “better” regarding agency is not view is statute administered agency’s barring “If a 2008 detention order necessarily dispositive. statute products. NJOY’s But that implementing agen importation if ambiguous, and reasonable, was passed Chevron order issued before cy’s construction Tobacco Act in 2009 and hence accept Control requires a federal court statute, at all. be even does construe “Chevron agency’s construction Mead, inapplicable here in agency’s ing light [the from what reading if the differs statutory court] the best must decide the best [itself] the court believes is reading” Legal of the Act. Landmark & Telecomm. interpretation.” Nat’l Cable Servs., Found., 267 And the best v. X 545 U.S. F.3d Ass’n Brand Internet 2688, full to the 967, 980, reading give is to effect Tobacco 125 S.Ct. 162 L.Ed.2d U.S.A., (2005) Chevron, prod of “tobacco Inc. v. Act’s definition (citing Control NRDC, 11, “any 837, 104 uct” as or derived from 843-44 & n. made 467 U.S. (1984)). tobacco,” 321(rr)(1), well L.Ed.2d 694 injunction Corp., 533 to its “[t]obacco States v. Mead U.S. United Mead, observes, still ron deference” under but entitled the Court has accord- 4. As interprets Auer agencies inter- to deference under "because briefs in which ed deference to scheme”); agencies’ see regulations. v. Rob- own pret own See Auer their Mead, bins, 121 S.Ct. 2164 also U.S. J., however, Court, (Scalia, (1997). dissenting) criticizing (noting and dis- L.Ed.2d distinction); Manning, Nonlegis interpretations John F. tinguishes agency between Rules, interpretations 72 Geo. regulations agency of stat- lative 943-44 L.Rev. Wash. Alaska, (2004) (observing that Mead narrowed Inc. v. Southeast Alas- utes. See Coeur - -, Council, range statutory interpretations ka Conservation deference, (2009) while leav are entitled to Chevron 174 L.Ed.2d 193 freestanding princi subject ing "intact but (finding interpretive "not the related memo deference). procedures ple” of Auer sufficiently to merit Chev- formal ... under that Act regulated” shall be subject provisions”

“shall not be 387a(a). 21 U.S.C.

Ill agen- the absence of authoritative that,

cy interpretation, I conclude unless a

product derived from tobacco is marketed

for therapeutic purposes, may provisions

Tobacco Accordingly, Control Act. be-

cause NJOY’s electronic are de- tobacco, join I my

rived from colleagues’

disposition. What result would be

were a contrary to offer statuto-

ry interpretation form of a regula-

tion, day I leave for the decides that step. take TATE, Appellant

Christine A.

v. COLUMBIA, Appellee.

DISTRICT OF

No. 09-7034.

United Court of Appeals, States

District of Columbia Circuit.

Argued Oct. Dec.

Decided

Case Details

Case Name: Sottera, Inc. v. Food & Drug Administration

Court Name: Court of Appeals for the D.C. Circuit

Date Published: Dec 7, 2010

Citation: 627 F.3d 891

Docket Number: 10-5032

Court Abbreviation: D.C. Cir.