Lead Opinion
Opinion for the Court filed by Senior Circuit Judge WILLIAMS.
Opinion concurring in the judgment filed by Circuit Judge GARLAND.
Sottera, Inc., which does business as NJOY, is an importer and distributor of “electronic cigarettes” or “e-cigarettes,” a product that enables users to inhale vaporized nicotine. The question before us is whether Congress has authorized the Food and Drug Administration (“FDA”) to regulate e-cigarettes under the drug/device provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 351 et seq., or under the Family Smoking Prevention and Tobacco Control Act of 2009 (the “Tobacco Act”), Pub.L. 111-31, 123 Stat. 1776. We think that the statutes, properly read in light of the Supreme Court’s decision in FDA v. Brown & Williamson,
NJOY has imported and distributed e-cigarettes since 2007. Id. at 2, 4. The liquid nicotine in each e-cigarette is derived from natural tobacco plants, Decl. of John Leadbeater at 2, and NJOY claims that its product is marketed and labeled for “smoking pleasure,” rather than as a therapeutic or smoking cessation product. NJOY Compl. at 2; Decl. of John Lead-beater at 2. On April 15, 2009 the FDA ordered that a shipment of NJOY’s e-cigarettes be denied entry into the United States, asserting that the e-cigarettes appeared to be adulterated, misbranded, or unapproved drug-device combinations under the FDCA. April 20, 2009 Notice of FDA Action.
Also in April 2009, another importer and distributor of e-cigarettes, Smoking Everywhere, Inc., sought a preliminary injunction barring the FDA and various officials from denying their products entry into the United States and from regulating e-cigarettes under the drug/device provisions of the FDCA. Smoking Everywhere Compl. at 1-2, 7. NJOY joined as an intervenorplaintiff and filed its own complaint and request for a preliminary injunction. NJOY Compl. at 3; Mem. Op. at 7.
Smoking Everywhere and NJOY argued that the FDA can regulate electronic cigarettes, as they propose to market them, only under the Tobacco Act, claiming that the Supreme Court’s opinion in Brown & Williamson foreclosed FDCA drug/device jurisdiction over tobacco products marketed without claims of therapeutic effect. The district court agreed and granted the injunction. Wfliile this appeal was pending, Smoking Everywhere voluntarily dismissed its complaint against the FDA, leaving NJOY as the sole appellee. See NJOY Br. at 4.
When deciding whether to grant a preliminary injunction, a district court must consider four familiar factors: whether “(1) the plaintiff has a substantial likelihood of success on the merits; (2) the plaintiff would suffer irreparable injury were an injunction not granted; (3) an injunction would substantially injure other interested parties; and (4) the grant of an injunction would further the public interest.” Ark. Dairy Coop. Ass’n, Inc. v. U.S. Dep’t of Agric.,
Under the FDCA, the FDA has authority to regulate articles that are “drugs,” “devices,” or drug/device combinations. 21 U.S.C. § 321(g)(1) defines drugs to include
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than*894 food) intended to affect the structure or any function of the body of man or other animals.
21 U.S.C. § 321(g)(1)(B) & (C). The statute defines devices similarly, see 21 U.S.C. § 321(h)(2) & (3); products that are “combination[s] of a drug, device, or biological product” are regulated as combination products, see 21 U.S.C. § 353(g)(1).
Until 1996, the FDA had never attempted to regulate tobacco products under the FDCA (with one exception, irrelevant for reasons discussed below) unless they were sold for therapeutic uses, that is, for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” under § 321(g)(1)(B). Cf. Action on Smoking and Health v. Harris,
In FDA v. Brown & Williamson, the Supreme Court rejected the FDA’s claimed FDCA authority to regulate tobacco products as customarily marketed. Looking to the FDCA’s “overall regulatory scheme,” the “tobacco-specific legislation” enacted since the FDCA, and the FDA’s own frequently asserted position, it held that Congress had “ratified ... the FDA’s plain and resolute position that the FDCA gives the agency no authority to regulate tobacco products as customarily marketed.”
To fill the regulatory gap identified in Brown & Williamson, Congress in 2009 passed the Tobacco Act, Pub.L. No. 111—31, 123 Stat. 1776, 21 U.S.C. §§ 387 et seq., providing the FDA with authority to regulate tobacco products. The act defines tobacco products so as to include all consumption products derived from tobacco except articles that qualify as drugs, devices, or drug-device combinations under the FDCA:
(rr)(l) The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product
(2) The term “tobacco product” does not mean an article that is a drug under [the FDCA’s drug provision], a device under [the FDCA’s device provision], or a combination product described in [the FDCA’s combination product provision],
21 U.S.C. § 321(rr).
The Tobacco Act itself states that it does not “affect, expand, or limit” the FDA’s jurisdiction to regulate products under the drug/device provisions of the FDCA, 21 U.S.C. § 387a(c)(1), and the district court and parties themselves appear to agree that the Tobacco Act did not expand the category of drugs, devices, and combination products subject to FDCA jurisdiction in the wake of Brown & Williamson. See Mem. Op. 9 n. 4. The question before us, therefore, is whether the FDA can regulate electronic cigarettes under the FDCA’s drug/device provisions or whether it can regulate them only under the Tobacco Act’s provisions.
The FDA at one point argues that its decision to regulate electronic cigarettes under the FDCA’s drug/device provisions
In Brown & Williamson the Supreme Court addressed the FDA’s regulation of cigarettes and smokeless tobacco products under the FDCA. It began by noting that the FDCA seeks to ensure that the FDA will approve products only if they are safe and effective for their intended use.
Clearly that could not be the case, the Court reasoned. After all, Congress had declared, in a provision of the U.S. Code then in force, that tobacco was “one of the greatest basic industries of the United States,” id. at 137,
For our purposes, the central question is whether Brown & Williamson’s reading of the FDA’s authority under the drug/device provisions of the FDCA applies only to tobacco products for which Congress has passed specific regulatory statutes or whether it extends to all tobacco products as customarily marketed. The FDA argues that Brown & Williamson takes a statute-specific approach, excluding the FDA from regulating only those tobacco products that at the time of Brown & Williamson had been the subject of specific federal legislation. FDA Br. at 14. Though Brown & Williamson is not crystal clear, we think the better reading is that the FDA lacks FDCA drug/device authority to regulate all tobacco products marketed without claims of therapeutic effect, i.e., as customarily marketed.
Brown & Williamson’s focus was not on the particular products that the six statutes cover or even on the six statutes themselves; at no point did it quote the precise language in which the six statutes identified covered products. Rather, Brown & Williamson considered the context of each statute to show that Congress was actively thinking about “the tobacco
Brown & Williamson concentrated overwhelmingly on the unifying theme of historic FDA policy towards tobacco products — -a policy that it saw as undifferentiated except with regard to the presence or absence of claims of therapeutic effect. See, e.g., id. at 145,
Moreover, discussing the record before Congress in the period when it passed these six statutes, Brown & Williamson noted that Congress knew of both “the adverse health consequences of tobacco use” and of “nicotine’s pharmacological effects.” Id. at 138,
In this light, Brown & Williamson interprets the six statutes not as a particular carve-out from the FDCA for cigarettes and smokeless tobacco (plus any additional products covered in the six statutes, which the FDA briefs make no effort to itemize), but rather as “a distinct regulatory scheme to address the problem of tobacco and health” — one that Congress intended would “preclude! ] any role for the FDA” with respect to “tobacco absent claims of therapeutic benefit by the manufacturer.” Id. In doing so, Congress also “persistently acted to preclude a meaningful role for any administrative agency in making policy on the subject of tobacco and health.” Id. at 156,
Reflecting on the history and structure of tobacco regulation, Brown & Williamson concluded,
Congress has affirmatively acted to address the issue of tobacco and health, relying on the representations of the FDA that it had no authority to regulate tobacco. It has created a distinct scheme to regulate the sale of tobacco products, focused on labeling and advertising, and premised on the belief that the FDA lacks such jurisdiction under*897 the FDCA. As a result, Congress’ tobacco-specific statutes preclude the FDA from regulating tobacco products as customarily marketed.
Id. at 156,
Brovm & Williamson therefore did not preclude the FDA from regulating only those products for which Congress had passed specific statutes. Rather, it recognized that Congress had consciously developed a statutory scheme for tobacco and health that distinguished tobacco products as customarily marketed from ones marketed for therapeutic purposes. “Thus, what Congress ratified was the FDA’s plain and resolute position that the FDCA gives the agency no authority to regulate tobacco products as customarily marketed.” Id. at 159,
At oral argument the FDA observed with some justice that the regulatory scheme before the Court in Brovm & Williamson addressed only cigarettes and smokeless tobacco; it would have us infer that the Court used the incessantly repeated phrase “tobacco products” as a shorthand, confined to the products before the Court (supplemented by whatever additional products were reached by the six statutes). We find no evidence of any such restrictive intent; certainly the Court did not use the familiar economizing form: “cigarettes and smokeless tobacco (‘tobacco products’).”
The Tobacco Act is wholly consistent with this reading of Brovm & Williamson. Written to address the regulatory gap that the case identified, the Tobacco Act provides the FDA with regulatory authority over tobacco products without requiring therapeutic claims. Besides leaving the FDA’s authority under the drug/device provisions of the FDCA undisturbed, see 21 U.S.C. § 321(rr)(2) & § 387a(c)(1), the act broadly defines tobacco products as extending to “any product made or derived from tobacco,” 21 U.S.C. § 321(rr)(1) (emphasis added). To be sure, this definition could align with a variety of interpretations of Brovm & Williamson’s scope (including the one FDA proffers here), but our reading is squarely within that range.
The FDA responds that its treatment of the Favor Smokeless Cigarette in 1987 supports its reading of Brovm & Williamson. FDA Br. at 14-15. We think not. Favor was a small tube containing a nicotine solution, enabling the user to inhale nicotine vapor without smoke. Id. at 14. Though the Smokeless Cigarette was marketed without therapeutic claims, the FDA warned Favor that it was an unapproved new drug. Id. at 14-15. The FDA’s claimed authority over Favor was, however, never challenged or adjudicated in court. Nor did Brovm & Williamson address the Smokeless Cigarette, perhaps because neither side brought it before the Court (perhaps in turn because the individuals litigating the case were unaware of it). In its argument in Brovm & Williamson, the FDA stated that “the only instances in which the agency had found that tobacco products were drugs involved cases in which there were express market claims of therapeutic value.” Pet’rs’ Br., FDA v. Brown & Williamson,
Together, Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under those provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act.
As to NJOY’s likelihood of success on the merits, the firm claims that its electronic cigarettes use a liquid nicotine mixture derived from tobacco and that its products are not marketed for therapeutic uses, NJOY Compl. at 5; Decl. of John Leadbeater at 2; the FDA appears not to challenge either claim. Still, the district court noted that the factual record on NJOY is meager and that the FDA may establish that NJOY does in fact make therapeutic claims regarding its electronic cigarettes. Mem. Op. at 25 n. 17. Until such time, the definitional line laid down in Brown & Williamson (as we understand it) leaves the FDA without jurisdiction over these products under the FDCA’s drug/device provisions. On the merits, then, NJOY is likely to succeed.
We also find that the district court did not abuse its discretion in finding that the balance of harms tips toward NJOY. In showing irreparable harm, the injury to the party must “be both certain and great; it must be actual and not theoretical.” Wisconsin Gas Co. v. FERC,
As we have already noted, the FDA has authority to regulate customarily marketed tobacco products — including e-cigarettes — under the Tobacco Act. It has authority to regulate therapeutically mar
The judgment of the district court is
Affirmed.
Concurrence Opinion
concurring in the judgment:
Although I join my colleagues in the disposition of this case, I do so based on different reasoning. I do not read FDA v. Brown & Williamson,
I
In Brown & Williamson, the Supreme Court held that the FDA lacks authority to regulate “tobacco products” under the drug/device provisions of the FDCA, unless those products are marketed with therapeutic claims.
On many, although not all, occasions on which Brown & Williamson used the term “tobacco products,” the Court coupled it with an express reference to tobacco or to products that plainly contain tobacco.
This reading is consistent with the context in which the Court decided Brown & Williamson. In that case, the Court upheld a challenge to a 1996 FDA rule asserting authority to regulate the sale of cigarettes and smokeless tobacco under the FDCA.
But the most telling indication that the holding of Brown & Williamson does not extend to electronic cigarettes is that the Court’s reasoning does not apply to products that do not contain tobacco. The Supreme Court’s chief rationale for its holding had two premises. First, the Court determined that, “if tobacco products were ‘devices’ under the FDCA, the FDA would be required to remove them from the market.”
Neither premise holds true for pure nicotine or for a tobacco-free product that delivers nicotine. First, unlike products containing tobacco, which the FDA has found to be associated with “cancer, respiratory illnesses, and heart disease,”
Second, the “tobacco-specific legislation” the Court found dispositive in Brovm & Williamson simply does not address products that deliver nicotine but contain no tobacco. As the Court explained, Congress had “directly addressed the problem of tobacco and health through legislation on six occasions since 1965.”
This “collective premise” does not extend to products, like electronic cigarettes, that contain only nicotine. None of the statutes the Court referenced regulate such products, and the statutory labeling requirements and advertising restrictions the Court cited do not apply to electronic cigarettes. See FDA Br. 10, 13-14. Nor can it be said that FDA regulation of a novel product like electronic cigarettes would threaten the health of the American tobacco industry. As NJOY avers, it “imports one hundred percent of its supply of E-cigarettes from overseas manufacturers, and, upon information and belief, there is no domestic manufacturer of E-cigarettes or their component parts.” NJOY Compl. ¶ 18 (J.A. 40).
Finally, the Brown & Williamson Court also noted that, “[i]n adopting each statute, Congress ... acted against the backdrop of the FDA’s consistent and repeated statements that it lacked authority under the FDCA to regulate tobacco absent claims of therapeutic benefit by the manufacturer.”
In sum, I see nothing in the words, context, or rationale of Brown & Williamson that supports interpreting that case as barring the FDA from regulating electronic cigarettes under the drug/device provisions of the FDCA. Although I agree with my colleagues that these considerations do not justify reading Brown & Williamson as merely a “carve-out from the FDCA for cigarettes and smokeless tobacco,” Op. at 896, they do justify reading it as a carve-out only for products that contain tobacco. See
II
But Brown & Williamson is not the end of the story. In 2009, Congress passed the Tobacco Control Act, which states: “Tobacco products ... shall be regulated by the Secretary under this [Act] and shall not be subject to the provisions of [the drug/device subchapter of the FDCA].” 21 U.S.C. § 387a(a). Moreover, unlike Brown & Williamson, which used the term “tobacco products” without defining it, the Tobacco Control Act includes a definition: “The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption.” 21 U.S.C. § 321(rr)(1) (emphasis added). Because the nicotine in NJOY’s electronic cigarettes is “derived from” natural tobacco, NJOY Compl. ¶ 1, it appears that the FDA may regulate it only pursuant to the provisions of the Tobacco Control Act.
The FDA disagrees with this conclusion, contending that the Tobacco Control Act does not narrow the FDA’s preexisting authority under the FDCA. In support, agency counsel cites another definitional provision of the Tobacco Control Act, which states that “[t]he term ‘tobacco product’ does not mean an article that is a drug ..., a device ..., or a combination product” under the FDCA. 21 U.S.C. § 321(rr)(2). In the FDA’s view, this provision preserves for regulation under the FDCA any product “made or derived from tobacco” that Brown & Williamson did not carve out of the FDCA’s coverage. And because Brown & Williamson’s carve-out did not extend to nicotine-only products, the agency maintains that such products are not necessarily “tobacco products” within the meaning of the Tobacco Control Act.
There is no doubt that § 321(rr)(2) introduces a note of ambiguity into the analysis. But it is a stretch to conclude that, having just used one express statutory subsection to include products “derived from” tobacco within the definition of “tobacco product,” § 321(rr)(l), Congress
In the usual circumstance, of course, a judge’s view of the “better” reading of a statute administered by an agency is not necessarily dispositive. “If a statute is ambiguous, and if the implementing agency’s construction is reasonable, Chevron requires a federal court to accept the agency’s construction of the statute, even if the agency’s reading differs from what the court believes is the best statutory interpretation.” Nat’l Cable & Telecomm. Ass’n v. Brand X Internet Servs.,
In this case, there is no agency pronouncement that calls for Chevron deference. Other than its briefs, which do not qualify, the only expression of the FDA’s view regarding electronic cigarettes is the agency’s 2008 detention order barring the importation of NJOY’s products. But that order was issued before Congress passed the Tobacco Control Act in 2009 and hence does not construe it at all. “Chevron being inapplicable here in light of Mead, [the court] must decide for [itself] the best reading” of the Act. Landmark Legal Found.,
Ill
In the absence of an authoritative agency interpretation, I conclude that, unless a product derived from tobacco is marketed for therapeutic purposes, the FDA may regulate it only under the provisions of the Tobacco Control Act. Accordingly, because NJOY’s electronic cigarettes are derived from tobacco, I join my colleagues’ disposition. What the result would be were the FDA to offer a contrary statutory interpretation in the form of a regulation, I leave for the day the agency decides to take that step.
Notes
. See, e.g.,
. The Court listed the following six statutes: "Federal Cigarette Labeling and Advertising Act (FCLAA), Pub.L. 89-92, 79 Stat. 282; Public Health Cigarette Smoking Act of 1969, Pub.L. 91-222, 84 Stat. 87; Alcohol and Drug Abuse Amendments of 1983, Pub.L. 98-24, 97 Stat. 175; Comprehensive Smoking Education Act, Pub.L. 98-474, 98 Stat. 2200; Comprehensive Smokeless Tobacco Health Education Act of 1986, Pub.L. 99-252, 100 Stat. 30; Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act, Pub.L. 102-321, § 202, 106 Stat. 394.”
. Like the FDA, NJOY reads § 321(rr)(2) as leaving the boundary between tobacco products and drugs where it was prior to the passage of the Tobacco Control Act. However, because NJOY reads Brown & Williamson as having removed nicotine-only products from the FDCA’s drug/device authority, it concludes that such products are "tobacco products" under the Tobacco Control Act and so may not be regulated under the FDCA.
. As the FDA observes, the Court has accorded deference to briefs in which agencies interpret their own regulations. See Auer v. Robbins,