On Thursday, September 10, 2009, an ad-hoc group of electronic cigarette users, calling themselves the Alliance of Electronic Smokers, filed an amicus brief in the litigation against the FDA by two electronic cigarette suppliers.
Here is the information regarding their brief:
MOTION OF ALLIANCE OF ELECTRONIC SMOKERS FOR LEAVE TO PARTICIPATE AND FILE BRIEF AS AMICUS CURIAE
The Alliance of Electronic Smokers (AES), as an interested nonparty, respectfully moves the Court for leave to participate and file a brief as amicus curiae in this litigation in support of Plaintiff’s and Intervenor-Plaintiffs’ Motions for Preliminary Injunction.
As set forth in greater detail in the accompanying Brief of Amicus Curiae, AES is an ad hoc group consisting of current consumers of electronic cigarettes (e-cigarettes) that would like to preserve their current choice of tobacco products – a right that is being eliminated by the efforts of the U.S. Food and Drug Administration (FDA) improperly to exert regulatory authority over e-cigarettes. AES and its members are concerned that their right to choose a preferred vehicle for smoking pleasure could be infringed based on the outcome of the present case. Accordingly, AES and its members have significant interests in the outcome of this litigation. Moreover, AES believes that its perspective would be helpful to the Court in evaluating the merits of this matter. In particular, AES responds to points raised in the submissions by Action on Smoking and Health (ASH), which this court has granted permission to appear as amicus curiae. AES is including as Exhibit A hereto its proposed amicus brief with this motion.
Because the proposed brief responds to points raised in ASH’s previous submissions in this matter, AES believes its participation will not prejudice any party. Pursuant to Local Rule 7(m), undersigned counsel has conferred by telephone with counsel for the Plaintiff and Intervenor Plaintiff, and they do not oppose this Motion. Also, AES conferred with counsel for Defendants regarding their consent and, as of the time of this filing, was still waiting for a response.
BRIEF OF AMICUS CURAE
ALLIANCE OF ELECTRONIC SMOKERS
The Alliance of Electronic Smokers is an ad hoc group of adult smokers who use and enjoy electronic cigarettes (“e-cigarettes”) for recreational purposes and wish to continue to do so. E-cigarettes have been available to smokers since 2007 and, until recently, the U.S. Food and Drug Administration (“FDA”) had made no effort to restrict their use. We wish to bring several points to the Court’s attention, and to comment on various issues raised by amicus Action on Smoking and Health (“ASH”) in its recent filings:
I. THE NEW TOBACCO ACT
If FDA wishes to regulate e-cigarettes, it now has an avenue to do so—through the Family Smoking Prevention and Tobacco Control Act (“FSPTCA”), Public Law No: 111-31, H.R. 1256, 111th. Cong. (2009). FDA acknowledges that e-cigarettes would fit the statutory definition of a “tobacco product” under the FSPTCA. See Defendants’ Supplemental Brief In Opposition to Plaintiff’s and Intervenor’s Motions For A Preliminary Injunction, filed July 10, 2009, at 5 n.3. The FSPTCA reflects a legislative compromise. The Act allows FDA to regulate many elements of the production, labeling and advertising of “tobacco products,” while ensuring that nicotine cannot be banned for recreational use. FSPTCA Section 907(d)(3) (the Secretary may not “requir[e] the reduction of nicotine yields of a tobacco product to zero.”). Under section 901(b), FDA could regulate (but not ban) e-cigarettes following notice and comment rulemaking. Indeed, there is no statutory or other legal reason why FDA could not issue a notice promptly and complete this type of rulemaking in a matter of months.1
Congress recognized expressly in the FSPTCA that FDA did not previously have drug jurisdiction over tobacco products. FSPTCA, Sec. 2(7) & (12), Sec. 3 (1-7). The term “tobacco products” in the FSPTCA reflects the holding from the Supreme Court’s decision in FDA v. Brown & Williamson. 529 U.S. 120, 131, 158-59 (2000). In that case, the Supreme Court held that “Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products.” 529 U.S. at 126. Just as it has in this case, the FDA argued in Brown &Williamson that tobacco products were within its drug jurisdiction because they are intended “to deliver the pharmacological effects of satisfying addiction, stimulation and tranquilization. . . .” 529 U.S. at 131. But the fact that tobacco products deliver nicotine with stimulative pharmacological effects did not convince the Supreme Court that FDA had jurisdiction to regulate tobacco as a drug as customarily marketed for tobacco pleasure. Id. at 158-59. Indeed, the Supreme Court only noted one possible exception to its conclusion that FDA lacked drug jurisdiction over tobacco products – “with respect to the well-established exception of when the manufacturer makes express claims of therapeutic benefit.” Id. at 158-59 (emphasis supplied). As the Plaintiff and Plaintiff-Intervenor have argued in this litigation, there are no such claims of “therapeutic benefit” in the record in this case; nothing in the record shows such products were offered to help smokers them quit smoking (i.e. for smoking cessation) or for any other medical purpose.
II. FDA’s PRIOR VIEWS ON BROWN & WILLIAMSON
Until recently, FDA agreed that the Brown & Williamson case precluded it from exercising drug jurisdiction over “tobacco products” offered for sale for non-therapeutic purposes, i.e. as customarily marketed for “tobacco pleasure.” Indeed, in 2003 FDA considered a citizen petition requesting that FDA classify as a drug a new non-cigarette “tobacco product” named “Ariva” – a tablet consisting of “cigalett” pieces of compressed powdered tobacco, mint flavoring and other ingredients.” Like e-cigarettes, Ariva’s labeling indicated that it would deliver nicotine to its users “When you can’t smoke,” and indicated that the product “contains nicotine, an addictive substance.” See Attachment A hereto, August 29, 2003, letter from John M. Taylor, III, Associate Commissioner for Regulatory Affairs, FDA, at 2 (emphasis added). The FDA concluded that it did not have drug jurisdiction over Ariva and explained very clearly that it viewed the Brown & Williamson decision to cover this new “tobacco product:”
The Court [in Brown & Williamson] concluded that FDA has no jurisdiction over “tobacco products as customarily marketed” because they simply do not fit within FDCA’s regulatory scheme. The Court recognized that “customarily marketed” tobacco products do not include products for which claims of therapeutic benefit, including “drug claims” or “health claims” are made.” . . . . FDA believes that, based on the information available to it at this time, it is precluded from asserting jurisdiction over Ariva as currently marketed because it is a “customarily marketed” tobacco product within the meaning of Brown & Williamson.
Id. at 2-3 (citations omitted and emphasis added).
III. RESPONSE TO ASH’S AMICUS ARGUMENTS
ASH has filed an amicus brief, and apparently has also sent the court a letter with a ten-page single spaced commentary on the August 17th hearing, dated August 24, 2009 (the “August 24 letter”). Notably, much of the amicus material is not relevant here or part of the administrative record compiled by FDA. For example, neither of the e-cigarette manufacturers acting as plaintiffs here have advertised or sell their products as delivery mechanisms for approved drugs with therapeutic effects, like Cialis or Viagra, as ASH’s August 24 letter misleadingly suggests. Similarly, ASH purports to identify certain other relevant products containing nicotine, but none are relevant here, because: (1) those products made specific claims about therapeutic purposes, (2) they predated the Supreme Court’s holding in Brown & Williamson; and/or (3) they were not ever the subject of a judicial challenge. Moreover, ASH failed to mention the one post-Brown & Williamson precedent that actually is relevant here – Ariva, as discussed above, another unconventional nicotine product for which FDA received citizen petitions requesting that it assert jurisdiction – a request that the FDA flatly rejected in 2003, finding that it lacked jurisdiction over “customarily marketed” tobacco products.
In addition, ASH cites Harris v. Action for Smoking & Health, 655 F.2d 236 (1980), a case it lost in the D.C. Circuit, to support its position that explicit manufacturer representations regarding drug claims are not necessary. To the contrary, however, in that case, the D.C. Court of Appeals actually affirmed the lower court’s holding that FDA’s refusal to assert jurisdiction over cigarettes as a “drug” was not arbitrary, capricious, or contrary to law.
Far from supporting ASH’s argument, Harris made clear that:
. . . the crux of FDA jurisdiction over drugs lay in manufacturers’ representations as revelatory of their intent . . . . Such an understanding has now been accepted as a matter of statutory interpretation.
655 F.2d 236, 238-39. And to the extent that manufacturer’s objectively manifested intent can be inferred, the D.C. Court of Appeals explained:
. . . consumers must use the product predominately and in fact nearly exclusively with the appropriate intent before the requisite statutory intent can be inferred.
655 F.2d at 240.2 That is certainly not the case here. There is no evidence to suggest that consumers have used e-cigarettes predominantly, much less nearly exclusively, for purposes of therapeutic benefit. Our choice to use e-cigarettes over traditional cigarettes is instead influenced by social stigmas and inconveniences associated with traditional smoking. But practical concerns are also important: the e-cigarette leaves no tar stains on the roof of our cars or in our homes, and does not leave our skin, breath, or clothes smelling like an ashtray. Also, we are able to “smoke” in places that traditional smoking is prohibited because second-hand smoke is not an issue. And the electronic cigarette gives the user the same smoking pleasure as traditional cigarettes, including by mimicking the physical activity of smoking.
E-cigarettes are very different from products offered to help smokers quit. The nicotine patch and gum for example are meant to gradually assist users to eliminate their nicotine addiction. Those products describe in detail how to eliminate nicotine addiction in multiple steps. E-cigarettes are not marketed for that purpose, and the product labeling does not include directions or any other statements concerning how to quit smoking.
There are other nontraditional nicotine products, such as “Snus” and dissolvable tobacco products such as Ariva, that have no purpose other than to deliver nicotine for recreation. By attempting to eliminate our access to the electronic cigarette, the FDA is depriving us of our right as consumers to make an informed choice to use vaporized nicotine products.
The Alliance of Electronic Smokers respectfully requests that the Court consider the consumer as an intelligent force and provide consumers the right to choose to use and enjoy electronic cigarettes, or personal vaporizers, as a choice. Accordingly, for the reasons set forth in this case by Plaintiff Smoking Everywhere, Inc. and Plaintiff-Intervenor Sottera Inc. d/b/a NJOY, and for the additional reasons set forth herein, we urge the Court to hold that FDA lacks the authority to interfere with that choice, and to grant the requested preliminary injunctions.
1. In contrast, it takes, on average, approximately eight years to obtain FDA approval of a drug, from the initiation of clinical trials through the FDA approval process. See Tufts Center for the Study of Drug Development, Outlook 2009, available at http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2009.pdf (last visited September 8, 2009). During this time, the unapproved drug cannot be marketed or sold.
2. ASH also cites U.S. v Travia, 180 F. Supp. 2d 115 (D.D.C.2001) for the proposition that a written label is not required to infer a seller’s intent. But Travia is readily distinguishable – there, undercover agents presented evidence of oral representations made to customers about the purpose of the product sold, and the case had no bearing at all on tobacco products.
For the pdf version click: Electronic Smokers Amicus Brief
Congrats to the Consumers who stood up for their rights to choose an alternative to a known killer! Every voice counts and every voice should be heard!