Source: http://www.vapordogs.com/news/2/federal-judge-rules-fda-has-no-authority-over-electronic-cigarettes.html
Timestamp: 2019-04-21 00:52:45+00:00

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reasons, the Court concludes that it does not and therefore GRANTS plaintiffs’ motions.
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.
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)).
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).
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.
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.
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.
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).
to prevent or alleviate nicotine withdrawal symptoms.” (FDA Opposition [# 14] at 21).
structure or function of the body or are intended for use in the mitigation of disease.
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).
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).
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.
tobacco product. (Id.). Put simply, this argument is bootstrapping run amuck.
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.
drug or device under the FDCA. This argument is too clever by half.
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).
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).
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).
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».
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.
nicotine addiction.” (AR DET 97-98, 100-01).
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.
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.
Plaintiffs contend that they will suffer irreparable harm because FDA has disallowed entry into the United States of their electronic cigarettes-their only product line-and will continue to do so. To constitute irreparable harm, the claimed injury “must be both certain and great; it must be actual and not theoretical.” Wisconsin Gas Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985). To say the least, the harm to plaintiffs in this case is anything but theoretical. FDA has refused admission of Smoking Everywhere’s electronic cigarette products and has ordered that they be exported or destroyed. In NJOY’s case, FDA has detained its inbound shipment of electronic cigarettes and, by all accounts, will continue to do so. FDA justifies its decision to detain or refuse entry to these products because the products are intended to provide the same drug effects on the structure and function of the body as cigarettes. Because the point of electronic cigarettes is to provide the same effects as regular cigarettes, there is little reason to believe that FDA will not exclude future shipments of plaintiffs’ products on the same basis.
Certainly, FDA now has jurisdiction to regulate tobacco products like electronic cigarettes in any manner it wishes consistent with the Tobacco Act and the APA.
that has only one product line.
preliminary injunctive relief is sufficiently grave to threaten plaintiffs’ very existence.
statute or regulation, whether or not such statute or regulation be valid,” as well as claims arising out of “interference with contract rights,” both of which would most likely apply in this case, are excluded from the FTCA’s general waiver of sovereign immunity for torts. 28 U.S.C. § 2680(a), (h). There being no apparent avenue for obtaining damages against FDA, any economic loss suffered by plaintiffs due to the detention or refused admission of their products can never be recovered and is therefore irreparable.
safety than traditional cigarettes, which are readily available to the public. Furthennore, now that FDA has regulatory power over electronic cigarettes through the Tobacco Act, any harm to the public interest or to third parties caused by an injunction that merely forbids FDA from regulating electronic cigarettes as a drug-device combination is greatly diminished. At best, therefore, the potential hann to the public interest or to other interested parties only marginally favors, ifat all, the denial of preliminary injunctive relief. To the extent the balance ofhanns and the public interest favor FDA, those factors are overcome nevertheless by the likelihood of success on the merits and the likelihood of irreparable hann, both of which strongly favor plaintiffs. Consequently, plaintiffs have, in my judgment, met their burden for establishing entitlement to a preliminary injunction.
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. Ironically, notwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable. I am mindful, however, that the purpose of preliminary injunctive relief is merely “preventative, or protective; it seeks to maintain the status quo pending a final detennination of the merits of the suit.” Wash. Metro. Area Transit Comm ‘n v. Holiday Tours, Inc., 559 F.2d 841, 844 (D.C. Cir. 1977). Because I have concluded that plaintiffs 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. An Order consistent with this opinion is attached herewith.
For better reading, you can download Judge Leon’s Ruling Against The FDA HERE.
On behalf of INSTEAD and all of our smoking customers who find the electronic cigarette a great alternative to tobacco cigarettes, thank you Judge Leon.
What does Judge Leon’s Ruling Against The FDA Mean For Electronic Cigarettes?
Many in the electronic cigarette industry believe that Judge Leon’s ruling against the FDA is the final word in the battle over the future of electronic cigarettes. That is not the case. It was, however, a legal opinion about the potential outcome of a trial regarding the classification of the electronic cigarette. Judge Leon gave opinions on the 3 arguments that the FDA was making to show electronic cigarettes are a drug delivery device and that they have a legal right to stop the importation.
The FDA argues that electronic cigarettes contain nicotine, a drug, and it effects the way the body works so it is a new drug.
The argument that the FDA is making here is the same one they made when they tried to classify tobacco cigarettes as a new drug. That didn’t work either.
The FDA argued that the sellers were making therapeutic claims, thereby making the electronic cigarette a new drug.
So, making health claims does not make a product a new drug. However, he did mention that making quit smoking claims or nicotine treatment claims DOES make the electronic cigarette a new drug. In this case, there was no evidence either company was making such claims.
Lastly, the FDA argued that stopping the importation of electronic cigarettes was for public health. A sad argument at best considering that electronic cigarettes are the alternative to a product that kills over 400,000 Americans each year.
Judge Leon found that this was “yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA”.
It means that the FDA can not legally stop the importation of electronic cigarettes by Smoking Everywhere or NJoy. It means Judge Leon believes that if this goes to trial, the e-cigarette suppliers will win. It means that Judge Leon believes the electronic cigarette is a reduced harm tobacco product, as outlined in the Tobacco Bill.
The FDA can continue to stop other companies shipments, but leave themselves open to future lawsuits. Without specific therapeutic claims (i.e. quit smoking and treating nicotine withdrawal claims), they have no basis to stop the products until such time as they do prove it is indeed a new drug or the electronic cigarette is legally classified as a tobacco product as Judge Leon suggests. What is interesting is that Judge Leon made no mention of the distinction between the zero nicotine e-liquid and that which contains nicotine. Without nicotine, the e-liquid contains no part of tobacco. And the batteries, chargers, atomizers, and cartridges contain no part of tobacco. So it appears that the only thing that could possibly be included in the definition of a “tobacco product” is e-liquid that contains nicotine. And this has not been settled either.

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