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Judge Rules FDA Has No Authority Over E Cigarettes

Federal Judge: FDA Has No Authority Over Electronic Cigarettes

January 14, 2010 1:06 pm

Judge Leon has ruled in the Smoking Everywhere and Njoy lawsuit against the FDA. He found that the electronic cigarette suppliers “are substantially likely to succeed on the merits and are likely to suffer irreparable harm if I do not return the parties to the status quo ante, their respective motions for preliminary injunction are GRANTED pending a final disposition of this case.”

Judge Leon goes on to say, “This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA.”

This means the FDA can not legally stop the importation of electronic cigarettes in to the United States by Smoking Everywhere or NJoy. Here is the full text of the Judge’s opinion:

———————–

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

SMOKING EVERYWHERE, INC.,

Plaintiff,

and

SOTTERA, INC., d/b/a NJOY,

Intervenor-Plaintiff,

Civil Case No. 09-771 (RJL)

U.S. FOOD AND DRUG

ADMINISTRA TION, et aI.,

Defendants.

MEMORANDUM OPINION (January H,2010) [# 2 and 24]

Plaintiff, Smoking Everywhere, Inc. (“Smoking Everywhere”), and intervenor-plaintiff, Sottera, Inc., which does business as “NJOY” (“NJOY”) (collectively, “plaintiffs”), are distributors of a product known as “electronic cigarettes” or “E¬cigarettes.” They claim that inbound shipments of their products from overseas manufacturers have been denied entry into the United States, or have otherwise been detained, by order of the Food and Drug Administration (“FDA”) on the ground that

electronic cigarettes are an unapproved drug-device combination under the Food, Drug,

and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq. Plaintiffs seek a preliminary

Department of Health and Human Services and Secretary Kathleen Sebelius (collectively,

“FDA”),1 enjoining FDA from regulating electronic cigarettes as a drug-device

combination and from denying entry of those products into the United States. As such,

this case raises for the first time the issue of whether FDA has the authority under the

FDCA to regulate electronic cigarettes as a drug-device combination. For the following

reasons, the Court concludes that it does not and therefore GRANTS plaintiffs’ motions.

FACTUAL BACKGROUND

I. Electronic Cigarettes

Smoking Everywhere describes “electronic cigarettes” as “an alternative to traditional smoked tobacco products” that is “designed to replicate the adult experience of

smoking without combustion or the use of cancerous by-products.” (Smoking

Everywhere Complaint [# 1] at ,-r 8). They function by vaporizing a liquid nicotine

mixture that is derived naturally from tobacco plants. (Id.). Once the nicotine mixture is

vaporized, the user inhales the vapor in much the same way that a traditional smoker

would inhale tobacco smoke, except “without the fire, flame, tar, carbon monoxide,

I Among the original named defendants in this suit were Joshua M. Sharfstein, Acting Commissioner of the FDA, and Charles E. Johnson, Acting Secretary ofHealth and Human Services. Pursuant to Federal Rule of Civil Procedure 25(d), if a public officer named as a party to an action in his official capacity ceases to hold office, the Court will automatically substitute that officer’s successor. In this case, Joshua Sharfstein and Charles Johnson no longer serve as the acting heads oftheir respective agencies. Accordingly, the Court removes them as defendants in this lawsuit.

known cancerous substances, ash, stub, or smell found in traditional cigarettes.” (Id). Electronic cigarettes have three basic components that are designed to resemble an actual cigarette: the cartridge, the heating element (also known as the atomizer), and electronics plus a battery. (Jd. at ~ 9). The cartridge, a plastic container that holds a mixture of propylene glycol and liquid nicotine, serves as the mouthpiece of the electronic cigarette. (Id). The heating element vaporizes the liquid nicotine mixture, and the electronics power the heating element and monitor the air flow. (Jd). When a user inhales from the cartridge, the electronics detect the flow of air and then activate the heating element, which vaporizes the nicotine mixture. (Jd. at ~ 10). The vapor, which the user inhales, contains a flavor that simulates the taste and feel of tobacco. (Jd.). Simply stated, the electronic cigarette is designed to look and to be used just like a traditional cigarette.

Smoking Everywhere is a distributor that imports electronic cigarettes from overseas manufacturers. (Id at ~~ 7, 12). It derives all of its revenue from the importation and sale of electronic cigarettes, its sole product line. (Jd at ~ 12). Since its founding over a year ago, it has imported and sold more than 600,000 units. (Jd. at ~ 7). Smoking Everywhere markets its electronic cigarettes as an alternative to traditional cigarettes that delivers the same sensation as smoking. Its promotional materials state, for example: “[ e ]ach cartridge is equivalent to 20 traditional cigarettes”; “[t]he taste of the Smoking Everywhere cartridge resembles that of tobacco”; “Smoking Everywhere E¬Cigarette has been designed to look and feel like a traditional cigarette”; “[i]t looks like a

real cigarette, feels like a real cigarette and tastes like a real cigarette, yet it isn’t a real cigarette”; “Smoking Everywhere E-Cigarette … gives the users the feeling they get when they smok[e] real cigarette[s]“; “Smoking Everywhere E-Cigarette will provide smokers the same delight, physical and emotional feelings they get in smoking traditional cigarettes”; “[t]his is what the smoker gets, the nicotine hit that smokers crave”; and ‘” [e ]lectronic cigarette’ is a kind of non-flammable electronic cigarette with similar functions to those of a common cigarette which is to refresh smokers and satisfY their smoking addiction, thus making them happy and relaxed.” (Administrative Record of Detention and Refusal (“AR DET”) 28, 35, 39,41,49,51,56). Smoking Everywhere also markets its electronic cigarettes as a healthier alternative to traditional cigarettes. For example, customer testimonials on its website proclaim: “1 thought [E-cigarette] was a great alternative to help me stop smoking real cigarettes”; “I’ve been smoking real cigarettes for over 20 years and really wanted to stop because it was damaging my lungs . . . I’ve been using [E-cigarettes] for 3 weeks now and feel great”; and “[t]here is less health risk, and 1 can smoke anywhere and everywhere.” (AR DET 21). Smoking Everywhere’s promotional materials also state that E-cigarettes are “cheaper and healthier than real cigarettes,” that they offer “smokers a chance of smoking in a much healthier way,” and that “smokers still get their nicotine, but don’t get any harmful side effects of smoking traditional cigarettes.” (AR DET 39, 49).

distributing electronic cigarettes. (NJOY Complaint [#22] at,-r 1). Since it began selling electronic cigarettes in early 2007, NJOY has sold at least 135,000 units in the United States. (Id. at,-r 13). NJOY markets its electronic cigarettes only for “smoking pleasure” as an alternative to conventional cigarettes. (NJOY Complaint [#22] at,-r 1). It claims not to make therapeutic representations. (Id.). Indeed, NJOY labels its products with a disclaimer that states, for instance: “NJOY products are not a smoking cessation product and have not been tested as such.” (Declaration of John Leadbeater (“Leadbeater Decl.”) [#24-1] at,-r 9 (internal quotation marks omitted)).

II. The Refused Shipments

This action arises from FDA’s decision to detain multiple inbound shipments of electronic cigarettes belonging to Smoking Everywhere and NJOY. In the case of Smoking Everywhere, FDA issued a “hold” on two shipments that arrived at Los Angeles International Airport in late September 2008. (AR DET 59-60). On October 29, 2008, FDA issued notices of “Detention” on the ground that the shipments “appear to be adulterated, misbranded or otherwise in violation” of the FDCA. (AR DET 78-79, 80¬81). After an exchange of information about the shipments between FDA and Smoking Everywhere, FDA issued a “Correspondence” on December 23,2008, stating its conclusion that ”’Smoking Everywhere E-Cigarette’ and its component parts appear to be intended to affect the structure or function of the body, and to prevent, mitigate, or treat

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according to FDA, the product appears to be an unapproved drug-device combination

under the FDCA. (ld.). FDA reiterated this view in follow-up correspondence from a

compliance officer to a representative of Smoking Everywhere:

We believe that when originally offered for importation, this product was

explicitly labeled and promoted for “drug” use. In addition, … this product

is clearly intended for “drug” use by “the circumstances surrounding the

distribution of the article.” These circumstances include the product’s

conventional cigarette appearance; its design, formulation, and function to

deliver to the body through inhalation of a smoke-like aerosol (resembling

conventional cigarette smoke) various volatile chemical substances,

including nicotine, produced by the article; and how the product is intended

to be manipUlated and used like conventional cigarettes to affect the body’s

structures and functions and/or to treat/mitigate the symptoms of nicotine

addiction.

(AR DET 82). Based on this conclusion, FDA issued “Refusal ofAdmission” notices on

March 16,2009, for both shipments and directed that the “products must be exported or

destroyed under Customs supervision within 90 days.” (AR 102-04, 105-06).2

A short time later, FDA added electronic cigarettes manufactured by three Chinese

companies to Import Alert 66-41, a directive that authorizes FDA district offices to

“detain without physical examination any [u]napproved and/or misbranded drug listed in

the attachment.” (Administrative Record ofImport Alert 66-41 (“AR IA”) 3,85-86).

2 Smoking Everywhere also alleges that another inbound shipment of its electronic cigarettes was detained at FDA’s request on April l3, 2009, at the Port of Miami in Miami, Florida (Smoking Everywhere Complaint [# 1] at ~ 28), but FDA reports that it has been unable to find any record of this shipment (FDA Opposition [#14] at 11).

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cigarette components manufactured by Shenzhen Kanger Technology Co. Ltd., Desonic Industrial, and Loong Totem Science & Technology as unapproved or misbranded drugs. (AR IA 85-86). NJOY claims, however, that even though the import alert only applies to the three named manufacturers, FDA’s publicly available Import Refusal Reports show that, from June 2008 to May 2009, FDA district offices have denied entry to more than thirty-five shipments of electronic cigarettes and their components from twenty other manufacturers. (NJOY Supp. Reply [#44] at 6; Declaration of David A. Becker in Support of Motion for Preliminary Injunction [#44-1, -2] at,-r,-r 3-4).

In NJOY’s case, an inbound shipment of its electronic cigarettes arrived in Phoenix, Arizona on April 15,2009. (NJOY Complaint [#22] at,-r 27, Ex. B). Five days later, FDA issued a notice of “Detention” on the ground that NJOY’s products “appear to be intended to both affect the structure or function of the body, and to prevent, mitigate, or treat the withdrawal symptoms of nicotine addiction.” (Jd. at,-r,-r 27-28, Ex. B). Arguing that FDA intends to deny entry to NJOY’s electronic cigarettes based on FDA’s conclusion (evident in Smoking Everywhere’s case) that electronic cigarettes are unapproved drug-device combinations under the FDCA, NJOY requested leave to intervene in this case, which the Court granted.

DISCUSSION

Plaintiffs seek a preliminary injunction barring FDA from refusing entry of their electronic cigarette products on the basis that those products are unapproved drug-device preliminary injunctive relief are, of course, well-known: (1) whether “the plaintiff has a

substantial likelihood of success on the merits”; (2) whether “the plaintiff would suffer

irreparable injury were an injunction not granted”; (3) whether “an injunction would

substantially injure other interested parties”; and (4) whether “the grant of an injunction

would further the public interest.” Ark. Dairy Co-op Ass ‘n, Inc. v. Us. Dep ‘t ofAgric.,

573 F.3d 815,821 (D.C. Cir. 2009). The party seeking a preliminary injunction need not

prevail on each factor. “Ifthe arguments for one factor are particularly strong, an

injunction may issue even if the arguments in other areas are rather weak.” CityFed Fin. Corp. v. Office ofThrift Supervision, 58 F.3d 738,747 (D.C. Cir. 1995). Having weighed the relevant factors, the Court concludes that plaintiffs have made a sufficient showing of success on the merits and irreparable harm to warrant preliminary injunctive relief.

I. Likelihood Of Success On The Merits

In FDA v. Brown & Williamson Tobacco Corp., the Supreme Court held that tobacco products, like traditional cigarettes, are not subject to FDA regulation as a drug or device. 529 U.S. 120, 160-61 (2000).3 Because electronic cigarettes, as marketed by

3 Because FDA had found that tobacco products were “unsafe” and “dangerous,” the Supreme Court reasoned “that were the FDA to regulate cigarettes and smokeless tobacco, the [FDCA] would require the agency to ban them.” Brown & Williamson Tobacco, 529 U.S. at 134-37. The Supreme Court noted, however, that a ban on tobacco products pursuant to the FDCA would contravene congressional intent because Congress “has foreclosed the removal of tobacco products from the market.” Id. at 137. Given that Congress had passed legislation specifically aimed at tobacco on six occasions since 1965, the Supreme Court inferred that “the collective premise of these statutes is that FDA cannot regulate their products. They further contend that Congress’s recent

enactment of the Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111¬

31, 123 Stat. 1776 (2009) (“Tobacco Act”), supports their argument.4 Under the Tobacco

Act, FDA may now regulate tobacco products, which the Act defines as “any product

made or derived from tobacco that is intended for human consumption,” 21 U.S.C. §

321(rr)(l), but it cannot regulate those products as it would a drug or device under the

cigarettes and smokeless tobacco will continue to be sold in the United States.” Id. at 137-39. To the extent that tobacco products are unsafe and yet cannot be banned, the Supreme Court concluded that “they simply do not fit” within the FDCA’s regulatory scheme. Id. at 143.

4 Even though Congress did not enact the Tobacco Act until after the agency action under review in this case, it is significant because it reflects Congress’s understanding of the state of the law at the time of the agency action. Enacted against the backdrop of the Supreme Court’s decision in Brown & Williamson Tobacco, the Tobacco Act reflects Congress’s intent to confer FDA jurisdiction where it did not previously exist. One of the enumerated purposes of the Act is “to provide authority to the Food and Drug Administration to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act … , by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products.” Pub. L. No. 111-31, 123 Stat. at 1781. Thus, to the extent that a particular product satisfies the Tobacco Act’s definition of “tobacco product” and is exempt from regulation as a drug or device under the terms of the Act, the Court can assume that the product would have been exempt from FDA jurisdiction prior to passage of the Tobacco Act. Indeed, the Act itself provides that it is not intended to “affect, expand, or limit [FDA's] authority over (including the authority to determine whether products may be regulated), or the regulation of, products . . . that are not tobacco products under [the drug-device subchapter].” 21 U.S.c. § 387a(c)(l). The parties seem to agree that the Tobacco Act did not move the definitional line between tobacco products and drugs; they simply disagree about where the line is drawn. Undoubtedly, Congress’s passage of the Tobacco Act sheds considerable light on that issue.

cigarettes is naturally distilled from actual tobacco and is intended for human

consumption (FDA Supp. Br. [#41] at 5 n.3), plaintiffs assert that their electronic

cigarettes qualifY as a tobacco product and are therefore exempt from regulation as a

drug-device combination.

Not surprisingly, FDA contends that the Tobacco Act supports its argument that electronic cigarettes fall beyond the scope of Brown & Williamson Tobacco and, as a result, are subject to regulation under the FDCA as a drug-device combination. To make its case, FDA points to a provision of the Tobacco Act that excludes from the meaning of “tobacco product” any “article that is a drug under [21 U.S.C. § 321(g)(1)], a device under [21 U.S.C. § 321(h)], or a combination product described in [21 U.S.C. § 353(g)].” 21 U.S.c. § 321(rr)(2)-(3). FDA contends that the labeling and promotional materials for Smoking Everywhere’S products “represent and suggest that the product[s] will provide the same drug effects on the structure and function of the human body as cigarettes.” (FDA Supp. Br. [#41] at 5). Because of those effects, FDA claims that the electronic cigarettes marketed by Smoking Everywhere qualifY as a drug-device combination, which the FDCA defines as an article “intended to affect the structure or any function of the

5 The Tobacco Act provides that “[t]obacco products, including modified risk tobacco products … , shall be regulated by the [Secretary of Health and Human Services] under this subchapter and shall not be subject to the provisions of subchapter V of this chapter,” which pertains to the regulation of “drugs” and “devices.” 21 U.S.C. § 387a(a).

promotional materials suggest that its electronic cigarettes are intended to have a

therapeutic effect. According to FDA, “[t]he assertion that E-Cigarettes provide a

‘healthier way’ to obtain the effects of nicotine establishes that E-Cigarettes are intended

to prevent or alleviate nicotine withdrawal symptoms.” (FDA Opposition [# 14] at 21).

Consequently, FDA claims that Smoking Everywhere’s products also satisfy the FDCA’s

other definition of a drug-device combination as an article “intended for use in the

diagnosis, cure, mitigation, treatment, or prevention of disease.” 21 U.S.C. §

32l(g)(1)(B). Based on the totality of the labeling and promotional materials, FDA

contends that Smoking Everywhere’s electronic cigarettes either are intended to affect the

structure or function of the body or are intended for use in the mitigation of disease.

Thus, FDA concludes that those products fall well within the FDCA’s definition of a

drug-device combination and should be regulated as such.

6 The Court notes that the FDCA defines a “device” along the same lines as a “drug.” For instance, a “device” is defined as “an instrument, apparatus, … or other similar or related article, including any component, part, or accessory,” that is “intended for use in the diagnosis … cure, mitigation, treatment, or prevention of disease” or that is “intended to affect the structure or any function of the body.” 21 U.S.C. § 321 (h)(2)-(3). Unlike a drug, however, a device “does not achieve its primary intended purposes through chemical action within or on the body” and “is not dependent upon being metabolized for the achievement of its primary intended purposes.” Id. § 321 (h). Articles that “constitute a combination of a drug, device, or biological product” are regulated as combination products. Id. § 353(g). FDA understands this provision as giving it the discretion to regulate combination products as drugs, as devices, or as both. Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44,396, 44,400 (1996).

§ 701 et seq. The AP A requires a court to set aside final agency action that it finds to be

“arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law” or

“in excess of statutory jurisdiction, authority, or limitations, or short of statutory right.”

Jd. § 706(2)(A), (CV Because plaintiffs invite the Court to review FDA’s construction

7 There is some question about whether FDA’s decision to detain NJOY’s shipment without a “Refusal of Admission” notice is a final agency action. (See FDA Supp. Br. [#41] at 9). NJOY contends that because further resort to the administrative process would be futile, it need not fully exhaust its administrative remedies. I agree. Exhaustion does not apply where it “would be futile because of certainty of an adverse decision.” James v. Us. Dep’t a/Health & Human Servs., 824 F.2d 1132,1138 (D.C. Cir. 1987) (internal quotation marks and emphasis omitted). “Resort to administrative remedies is ‘futile’ and adverse action certain,” if the agency “has evidenced a strong position on the issue together with an unwillingness to reconsider.” Jd. at 1139. FDA has taken the sweeping position in this litigation that if an electronic cigarette product claims to “provide the same drug effects on the structure or function of the human body as cigarettes,” then that product meets the definition of a drug or device under the FDCA. (FDA Supp. Br. [#41] at 5). On that basis, FDA denied entry to Smoking Everywhere’S electronic cigarettes because, for instance, they claimed to “provide smokers the same delight, physical and emotional feelings” as traditional cigarettes. (AR DET 49). NJOY’s product makes a similar claim. For example, NJOY markets its electronic cigarettes as providing “all the pleasures of smoking without all the problems.” (Leadbeater Decl. [#24-1] at Ex. A). It is unlikely that an electronic cigarette manufacturer or distributor could market its product in any other way given that electronic cigarettes are made to replicate the effects of regular cigarettes. An FDA official suggested as much when he advised a representative of Smoking Everywhere that FDA did not believe Smoking Everywhere’s product could be “relabeled to make it anything other than an article which … appears to be a drug-device combination.” (AR DET 82). Given FDA’s refusal to allow entry of Smoking Everywhere’s products, given its unwavering position in this litigation (even after passage of the Tobacco Act), and given the manner in which NJOY has marketed its electronic cigarettes, there is no reason to believe that FDA would treat NJOY’s products any differently than Smoking Everywhere’S products. Indeed, as NJOY points out, FDA has already refused entry to as many as thirty-five shipments of electronic cigarettes from twenty manufacturers. (NJOY Supp. Reply [#44] at 6). Accordingly, the Court concludes that exhaustion would be

Natural Res. De! Council, Inc., 467 U.S. 837 (1984). See Brown & Williamson Tobacco,

529 U.S. at 132 (stating that Chevron is the appropriate framework for analyzing FDA’s

claim of authority to regulate tobacco products). 8 Chevron deference is appropriate in

this case because FDA’s interpretation and application ofthe relevant statutory provisions

forms the basis of its decision to detain or to refuse entry ofplaintiffs’ products and thus

carries the force of law. See Citizens Exposing Truth About Casinos v. Kempthorne, 492

futile and that NJOY’s claims, like Smoking Everywhere’s, are now properly before the

Court.

8 Even more boldly, FDA also argues that its import decisions are committed to agency discretion and thus are not subject to any judicial review. Judicial review is not permitted under the APA where “agency action is committed to agency discretion by law.” 5 U.S.C. § 701(a)(2). FDA contends that the authority to refuse imports is committed to its discretion by 21 U.S.C. § 381(a)(3), which authorizes FDA to refuse admission of a drug or device if it “appears” from examination or “otherwise” that the drug or device is “adulterated, misbranded, or in violation of section 355.” For FDA, Congress’s use of the term “appears” is dispositive. By authorizing FDA to refuse admission to any product that “appears” misbranded or adulterated, “Congress empowered the agency to exercise its discretion in a broad and flexible manner.” (FDA Opposition [#14] at 29). FDA’s argument goes much too far. Agency action is committed to agency discretion by law only where “the statute is drawn so that a court would have no meaningful standard against which to judge the agency’s exercise of discretion.” Heckler v. Chaney, 470 U.S. 821, 830 (1985) (emphasis added). Here, there is such a standard: whether the article under inspection is “adulterated, misbranded, or in violation of section 355.” 21 U.S.C. § 381(a)(3). The statute’s use ofthe term “appears” affords the agency, at best, some degree of deference in close cases, but it certainly does not permit the agency unfettered discretion to refuse an article that obviously is beyond the scope of the FDCA. Furthermore, the issue in this case is not whether a particular drug appears adulterated or misbranded, but whether a particular product is even a drug subject to the FDCA. FDA might well be entitled to Chevron deference on this threshold legal question, but it is certainly not entitled to unreviewable discretion.

absence of formal rulemaking or adjudication, where an agency action has the force of law).

The first step in the Chevron analysis requires a reviewing court to inquire “whether Congress has directly spoken to the precise question at issue.” Chevron, 467

U.S. at 842. If so, the court must give effect to Congress’s “unambiguously expressed intent.” Id. at 843. If, however, Congress has not spoken unambiguously, the court must defer to the agency’s construction of the statute so long as that construction is “permissible.” Id.

The relevant statutory provisions, particularly the Tobacco Act’s amendments to the FDCA, hardly constitute the kind of direct statement by Congress that would satisfy the first step of the Chevron analysis. Thus, the real issue under Chevron is whether FDA’s position is a “permissible”-that is, reasonable-construction or application of those provisions. For the following reasons, I believe it is not.

A. Structure Or Function Claims

FDA says that the electronic cigarettes marketed by plaintiffs are a drug-device combination and should therefore be excluded from the Tobacco Act’s definition of “tobacco product” because the labeling and promotional materials “represent and suggest that the product will provide the same drug effects as cigarettes.” (FDA Opposition [# 14] at 19). Because plaintiffs’ electronic cigarettes are to be used, like conventional cigarettes, as a means for delivering nicotine and because consumers and scientists widely electronic cigarettes are intended to affect the structure or function of the body, (FDA

Supp. Br. [#41] at 5). As a result, they qualifY as a drug-device combination, not as a

tobacco product. (Id.). Put simply, this argument is bootstrapping run amuck.

That electronic cigarettes are devices for delivering nicotine and are intended to

have the same effect on the structure and function of the body as cigarettes is hardly a

basis for classifYing electronic cigarettes as a drug-device combination, thereby excluding

them from the definition of “tobacco product.” If it were, then traditional cigarettes

would be excluded as well. Indeed, any tobacco product containing nicotine and claiming

to have some pharmacological effect would be excluded. Because this result would

effectively dismantle the existing regulatory wall Congress erected between tobacco

products and drug-device combinations, I can easily infer that Congress did not intend

tobacco products to be drugs merely because they deliver nicotine.9

9 Another provision of the Tobacco Act supports this inference as well. If Congress intended that FDA regulate tobacco products as drugs merely because they deliver nicotine, then it is certainly possible, ifnot likely, that FDA would have to ban those products as unsafe if the manufacturer intended that they be used, like traditional cigarettes, solely for the enjoyment of their pharmacological effects. Approval of a new drug is contingent on clinical tests that show the drug to be safe and effective for its intended use. 21 U.S.C. § 355(b)(1), (d). FDA acknowledges, and the administrative record shows, that nicotine causes addiction, which is a harmful disease. (See, e.g., Administrative Record of Nicotine Background (“AR NIC”) 23, 49-50, 66). Congress has also issued findings that “[n]icotine is an addictive drug” and that “[t]obacco dependence is a chronic disease.” Pub. L. No. 111-31, 123 Stat. at 1777, 1779. At high doses, nicotine exposure can even be fatal. (AR NIC 54). Nevertheless, whatever health implications nicotine might have, the Tobacco Act expressly forbids FDA from “requiring the reduction of nicotine yields ofa tobacco product to zero.” 21 U.S.C. §

Not surprisingly, FDA does not contend that traditional tobacco products like cigarettes are drug-device combinations. FDA accepts, as it must, that those products are exempt from such regulation by the Supreme Court’s decision in Brown & Williamson Tobacco. Instead, FDA contends that only non-traditional tobacco products can be drug-device combinations. According to FDA, by excluding drugs or devices from the Tobacco Act’s definition of “tobacco product,” Congress merely “confirmed its intention that tobacco-containing products that [were] subject to FDA’s pre-existing jurisdiction are still subject to that jurisdiction.” (FDA Supp. Br. [#41] at 3 (emphasis added)). I disagree.

FDA attempts to avoid the full implications of its rationale for treating electronic cigarettes as drug-device combinations by limiting the meaning of “tobacco product” (at least as applied to products containing nicotine) to those specific products at issue in Brown & Williamson Tobacco. In that case, the Supreme Court acknowledged that if FDA classified traditional tobacco products, like cigarettes, as drugs or devices under the FDCA, it would have to ban those products as unsafe for their intended use. Brown & Williamson Tobacco, 529 U.S. at 134-37. To do so, however, would run afoul of congressional intent as revealed in subsequent tobacco-specific legislation-such as the Federal Cigarette Labeling and Advertising Act (“FLCAA”), Pub. L. No. 89-92, 79 Stat.

387g(d)(3 )(B). It is apparent, therefore, that Congress did not intend tobacco products delivering nicotine for recreational use to be classified as a drug-device combination and thus subject to a potential ban on nicotine yields.

(“CSTHEA”), Pub. L. No. 99-252, 100 Stat. 3D-which regulates certain tobacco

products but does not ban them. ld. at 137-39. The FLCAA applies only to “cigarettes”

and “little cigars,” 15 U.S.C. § 1331 et seq.,10 and the CSTHEA applies to “smokeless

tobacco” products, 15 U.S.c. 4401 et seq. II Because neither act encompasses electronic

cigarettes, FDA contends that those products, at least as they are marketed by plaintiffs,

are beyond the scope of Brown & Williamson Tobacco and are therefore regulable as a

drug or device under the FDCA. This argument is too clever by half.

FDA’s interpretation of “tobacco product” is not reasonable when considered in the context of the entire Tobacco Act. For instance, one provision of the Act specifically prohibits FDA from “banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products.” 21 U.S.C. § 387g(d)(3)(A). Yet another provision prohibits FDA from “requiring the reduction of nicotine yields of a tobacco product to zero.” 21 U.S.c. § 387g(d)(3)(B). That Congress would single-out “traditional” products for specific

10 The FLCAA defines “cigarette” as “any roll of tobacco wrapped in paper or in any substance not containing tobacco” or “any roll of tobacco wrapped in any substance containing tobacco which … is likely to be offered to … consumers as a cigarette.” 15

U.S.C. § 1332(1). It defines “little cigar” as “any roll of tobacco wrapped in leaf tobacco or any substance containing tobacco … and as to which one thousand units weigh not more than three pounds.” Id. § 1332(7).

II The CSTHEA defines “smokeless tobacco” as “any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity.” 21 U.S.C. § 387(18).

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eliminate nicotine yields suggests that Congress understood the term to encompass more than traditional tobacco products and that Congress intended to permit nicotine use, whether from unforeseen, non-traditional sources (like electronic cigarettes) or from well¬established, traditional sources (like regular cigarettes).

More importantly, it is apparent from Congress’s broad definition of “tobacco product” that it intended the Tobacco Act’s regulatory scheme to cover far more than the fixed array of traditional tobacco products at issue in Brown & Williamson Tobacco. Both the FLCAA and the CSTHEA only apply to “cigarettes,” “little cigars,” and “smokeless tobacco,” which Congress defined with considerable specificity, yet the Tobacco Act applies to “tobacco products,” which Congress defined expansively as “any product made or derived from tobacco that is intended for human consumption.” 21

U.S.C. § 321(rr)(l). Furthermore, Congress made clear that FDA’s new jurisdiction over tobacco products applies, not only “to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco,” but “to any other tobacco products” as well. Id. § 387a(b). Simply put, the Court cannot accept that Congress defined “tobacco product” in this manner when it knew all along that the only tobacco products beyond FDA’s drug¬device jurisdiction were the traditional products governed by the FLCAA and CSTHEA (with the possible exception of any nicotine-free tobacco products).

This conclusion is particularly warranted given that the line FDA attempts to draw between traditional tobacco products and non-traditional tobacco products is based on a reasoning ofthat case is limited to the traditional tobacco products covered by the FLCAA and CSTHEA. This reading of the case is defective, however, because it ignores that the Supreme Court understood Congress’s enactment of that tobacco-specific legislation, not as a narrow exception to the FDCA, but as a ratification of “the FDA’s long-held position that it lacks jurisdiction under the FDCA to regulate tobacco products.” Brown & Williamson Tobacco, 529 U.S. at 144. Because Congress was acting “against the backdrop of the FDA’s consistent and repeated statements that it lacked authority under the FDCA to regulate tobacco absent claims oftherapeutic benefit by the manufacturer,” id. (emphasis added), the Supreme Court had little choice but to conclude that Congress had “effectively ratified” FDA’s position that it lacked authority over tobacco products as “customarily marketed,” id. at 156. Thus, the line drawn by the Supreme Court was not between traditional and non-traditional tobacco products, as FDA suggests, but between tobacco products as customarily marketed and those that claim therapeutic benefits.12 Against this backdrop, the Tobacco Act reflects Congress’s intent

12 Although the Supreme Court noted that it was not deciding the larger question of whether any product could be classified as a drug or device absent claims of therapeutic or medical benefit, it made clear nevertheless that FDA’s assertion ofjurisdiction over customarily-marketed tobacco products contradicted Congress’s clear intent, Brown & Williamson Tobacco, 529 U.S. at 131-32, which the Supreme Court found to be based on FDA’s repeated representations that it lacked authority under the FDCA to regulate tobacco products “absent claims of therapeutic benefit by the manufacturer,” id. at 144¬

56. See also id. at 156 (“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.” (emphasis added».

products as customarily marketed. Congress enacted the Tobacco Act to confer FDA

jurisdiction over any tobacco product-whether traditional or not-that is sold for

customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in

effect, serves as an implicit acknowledgment by Congress that FDA’s jurisdiction over

drugs and devices does not, and never did, extend to tobacco products, like electronic

cigarettes, that are marketed in customary fashion for purely recreational purposes. 13

Furthermore, the Tobacco Act’s broad definition of “tobacco product” is also an implicit

admission by Congress that the existing tobacco-specific legislation, such as the FLCAA

and CSTHEA, failed to cover the full array of tobacco products that were beyond FDA’s

jurisdiction under the FDCA.

This conclusion does not mean that tobacco products can never be classified as a

drug or device in the absence of therapeutic claims. A case might arise, for instance,

13 Although FDA has in the past asserted jurisdiction over “Favor Smokeless Cigarettes” and “Nicogel Tobacco Hand Gel,” both of which purported to be recreational, non-therapeutic nicotine products (see AR NIC 1-11, 58-80), those actions were not judicially reviewed. In any event, FDA’s decision on smokeless cigarettes came before Brown & Williamson Tobacco and is not in step with the reasoning of that case, which was based in part on FDA’s representations to Congress that customarily-marketed tobacco products are not subject to FDA jurisdiction absent therapeutic claims. Furthermore, FDA predicated its decision to assert jurisdiction over Nicogel on the dissimilarity between that product and traditional tobacco products. (See AR NIC 68 (stating that Nicogel “cannot satisfY any of the sensory needs or desires associated with smoking”)). Other products cited by FDA-such as Nicotine Lollipops, Nicotine Lip Balm, and Nicotine Water-are not “customarily marketed” tobacco products because they too are dissimilar from traditional tobacco products, and more importantly, because they make express therapeutic claims. (See AR NrC 12-13,20).

the structure or function of the body that is different from nicotine. In that circumstance, the product might properly be classified as a drug or device because it is not a tobacco product as “customarily marketed.” But that is not the case here. FDA does not contend that the electronic cigarettes marketed by plaintiffs are intended to affect the structure or function of the body in any way materially different from traditional cigarettes. Indeed, by FDA’s own admission, Smoking Everywhere markets its product as providing “the same drug effects on the structure and function of the human body as cigarettes.” (FDA Supp. Bf. [#41] at 5). Likewise, NJOY markets its product as providing “all the pleasures of smoking.” (Leadbeater Decl. [#24-1] at Ex. A). Because plaintiffs sell their electronic cigarette products for customary recreational use, those products Gust like traditional cigarettes) are properly excluded from the meaning of drug or device under the FDCA.

B. Therapeutic Claims

FDA also contends that the electronic cigarettes marketed by Smoking Everywhere are drug-device combinations, not only because they contain nicotine and are intended to affect the structure or function of the body in the same way as traditional cigarettes, but because they are intended “to prevent or alleviate nicotine withdrawal symptoms.” (FDA Opposition [#14] at 21).14 According to FDA’s “Correspondence” issued on December

14 The Tobacco Act certainly contemplates that tobacco products marketed for the therapeutic purpose of treating nicotine addiction might constitute a drug-device combination excluded from the Tobacco Act’s definition of “tobacco product.” The Act specifically provides that products “intended to be used for the treatment of tobacco appear to be intended … to prevent, mitigate, or treat the withdrawal symptoms of

nicotine addiction.” (AR DET 97-98, 100-01).

Unfortunately for FDA, however, this finding is “unsupported by substantial evidence” in the record. See 5 U.S.C. § 706(2)(E). The “intended use” of a product is determined by “the objective intent of the persons legally responsible” for labeling the product. 21 C.F .R. § 201.128. Objective intent may be shown, for example, “by labeling claims, advertising matter, or oral or written statements” by the labeler. Id. It may also be shown “by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.” ld. Here, the overwhelming sum of Smoking Everywhere’s promotional material is aimed, not toward preventing, mitigating, or treating nicotine addiction and the effects of withdrawal, but toward encouraging nicotine use. Just a sampling of the promotional claims reveals, for instance, that Smoking Everywhere intends its electronic cigarettes to provide “the nicotine hit that smokers crave,” to “refresh smokers and satisfY their smoking addiction,” and to provide “the same pleasures of smoking a traditional cigarette.” (AR DET 51, 56). The brand name itself is evidence that the product is not intended to prevent, treat, or mitigate nicotine use and addiction but to promote “the

dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug Administration and is subject to the requirements of subchapter V of this chapter.” 21

U.S.C. § 387k(c).

offer low nicotine dosages, it offers high dosages as well. (AR DET 25, 28). It even offers its product in assorted flavors. (AR DET 28). Indeed, the overarching theme of the marketing campaign, from the pictures to the promotional claims, is that smoking electronic cigarettes is fun and exciting. One certainly does not get the impression from the advertising materials in the record that nicotine addiction is something that Smoking Everywhere intends its product to treat and cure. Moreover, there is little evidence in the record that Smoking Everywhere offers its product with the knowledge that any significant number of its customers will use electronic cigarettes to treat nicotine addiction, even though the product is not labeled or marketed that way.

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