FDA references only three claims made in Smoking Everywhere's literature: (l) electronic cigarettes offer "smokers a chance of smoking in a much healthier way," (2) electronic cigarettes are "a great alternative to help ... stop smoking real cigarettes," and (3) "I've been smoking real cigarettes for over 20 years and really wanted to stop ... I've been using it for 3 weeks now and feel great." (ARDET 49,21; FDA Opposition [#14] at 21). The latter two claims are customer testimonials posted on the Smoking Everywhere website. None of these claims, on their face, suggests an objective intent to treat nicotine addiction and withdrawal. At best, these claims demonstrate that Smoking Everywhere markets its electronic cigarettes as an alternative-albeit a healthier alternative-to traditional cigarettes. 15 FDA does not point to any representation by Smoking Everywhere that its product is intended to help wean smokers off of nicotine. Nor does FDA identify any product labeling that includes instructions about how to overcome nicotine addiction using electronic cigarettes. The clear import of Smoking Everywhere's advertising is that it wants consumers to use its electronic cigarettes for the same recreational purposes and with the same frequency as traditional cigarettes. 16 Thus, FDA's finding that the electronic cigarettes marketed by Smoking Everywhere appear to be intended to prevent, mitigate, or treat nicotine addiction is simply not supported by substantial evidence in the administrative record.17
Nor does the fact that plaintiffs advertise their products as a healthier alternative to traditional smoking mean that electronic cigarettes quality as a drug-device combination under the FDCA. Smoking Everywhere advertises, for instance, that its product poses "less health risk." (AR DET 21). Along similar lines, NJOY markets its product as having "all the pleasures of smoking without all the problems." (Leadbeater Decl. [#24-1] at Ex. A). A product qualifies as a "drug" if it is "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." 21 U.S.C. § 321(g)(1)(B). The Court has already concluded based on the information before it that the electronic cigarettes marketed by plaintiffs are not intended for treating the disease of nicotine addiction. To the extent those products are marketed as providing the same experience as traditional cigarettes but without the negative health consequences associated with tar and smoke, they fall within the plain meaning of "modified risk tobacco product," which the Tobacco Act defines as any tobacco product "sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products." ld. § 387k(b)(1). To treat as a drug any tobacco product that merely claims to be a healthier alternative would effectively nullifY the provisions relating to modified risk tobacco products, which represent Congress's implicit acknowledgment that those products were outside of FDA's jurisdiction prior to the Tobacco Act. Moreover, it would create the absurd result that certain tobacco products-like low tar cigarettes or electronic cigarettes-would be exposed to the more onerous regulatory burdens for drugs and devices merely because they claim to be healthier alternatives to traditional tobacco products. Because the relevant statutory provisions do not compel this result, it is easy to conclude that Congress did not intend it.
In sum, absent substantial evidence of the manufacturer's objective intent that its electronic cigarettes affect the structure or function of the body in a way distinguishable from "customarily marketed" tobacco products or that its electronic cigarettes have the therapeutic purpose of treating nicotine withdrawal, there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette. Thus, the plaintiffs are substantially likely to succeed on their claim that FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.18
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15 To the extent that smoking cessation is a therapeutic claim distinct from the treatment of nicotine addiction and withdrawal, the Court is aware that the two customer testimonials referenced above suggest that electronic cigarettes are intended for smoking cessation, ifnot for treating nicotine dependence (as suggested by FDA). Given Smoking Everywhere's express disclaimer that its electronic cigarettes are not intended as a smoking cessation device, (AR DET 1), and given the overwhelming evidence in the record that its electronic cigarettes are intended merely as a recreational alternative to traditional cigarettes (and not necessarily as a therapeutic replacement for traditional cigarettes), the Court concludes that the two testimonials cited by FDA are not alone sufficient to support a finding that the product appears to be intended to help customers
quit smoking.
16 In this respect, Smoking Everywhere's electronic cigarettes are different from other nicotine products regulated by FDA that bear no similarity to traditional tobacco products and make express therapeutic claims. For instance, Nicotine Lollipops claim to help smokers quit "by suppressing the symptoms o/nicotine withdrawal" and by allowing "the individual to control the amount of nicotine taken based on the body's need at the time." (AR NIC 12 (emphasis added». Nicotine Lip Balm represents that it helps "relieve the craving for nicotine" and is "designed to help a person quit." (AR NIC 13 (emphasis added». Similarly, Nicotine Water claims that it is a "[m]ethod of delivering Nicotine to reduce use 0/ tobacco products" and is "more effective" than other products for treating addiction, like nicotine patches or gum. (AR NIC 20 (emphasis in original».
17 With respect to NJOY, FDA provides no factual basis at this point for the Court to conclude that NJOY's electronic cigarettes are intended to treat nicotine addiction or to facilitate smoking cessation. Indeed, NJOY represents that it has always labeled its products with a disclaimer stating that the products are not for smoking cessation. (Leadbeater Decl. [#24-1] at ~ 9). The Court is mindful that the factual record relating to NJOY is sparse. In the course of this litigation, FDA may produce evidence from an administrate record that NJOY's products in fact make therapeutic claims. Absent such evidence, however, FDA may not detain those products on that basis.
18 The Court takes no position on whether there is some other basis for FDA (or any other agency) to exclude electronic cigarettes from entry into the United States.
