CASAA Call to Action: The SFATA (The Smoke Free Alternatives Trade Association) approach to the FDA Vaping regulations is unique and well worth a read. It is basically a “legal” approach and strongly implies that SFATA plans to sue the FDA at the appropriate time. The letter includes signatures of two attorneys (Counsel of record) for SFATA. These partner attorneys work for Venable LLP, one of the most highly regarded law firms in the nation. With over 600 attorneys, a century of existence, and an expertise in this very issue of regulatory authority and overreach. In a nut shell, these are very high powered attorneys who specialize in law suits against regulatory authorities.
A few exstracts:
“The Courts have been vigilant in policing FDA’s unfounded assertions of jurisdiction.
The proposed Deeming Regulation is a fraught attempt by FDA to assert jurisdiction in the absence of Congressional authorization. Similar attempts have failed in the past and have been struck down by the courts. For example, the Supreme Court rejected FDA’s attempt to regulate nicotine as a “drug” and cigarettes and smokeless tobacco as “devices” in FDA v. Brown & Williamson Tobacco Corporation.1 Likewise, in Sottera Inc. v. FDA, the court rejected FDA’s attempt to regulate e-cigarettes, holding that unless an e-cigarette is marketed for therapeutic purposes, FDA may not regulate them as drugs/devices or combination products.2 Brown & Williamson and Sottera foreshadow the outcome here if FDA adopts the Proposed Rule more-or-less “as is” with respect to e-cigarettes: FDA can expect the courts to yet again reject the Agency’s attempt to assert jurisdiction which Congress failed to grant.
Beyond losing on jurisdictional grounds, the courts have taken a highly skeptical view overall of FDA’s tobacco regulatory activities. In R.J. Reynolds Tobacco Co. v. Food and Drug Administration, for example, the court invalidated the final regulation requiring graphic warning labels.3 Very recently, in Lorillard v. Food and Drug Administration, tobacco companies won a court ruling that certain members of the Tobacco Product Scientific Advisory Committee were impermissibly conflicted due to their anti-smoking connections.”
“Absent therapeutic claims, FDA does not have authority to regulate e-cigarettes.
FDA does not have jurisdiction over electronic cigarettes absent therapeutic claims, and Sottera is not to the contrary. It is a severe misreading of the holding of Sottera to conclude that the court there held that FDA has jurisdiction over e-cigarettes as tobacco products. That question was not presented in the case. When Sottera was litigated and decided, FDA had not (and to this day has not) regulated e-cigarettes as tobacco products. Thus, the question presented in Sottera was not whether e-cigarettes are tobacco products, but whether they were, as FD then asserted, “drugs” or “devices.”5 The court rejected FDA’s position, noting that FDA itself frequently expressed the view that “cigarettes are beyond the scope of the [Food, Drug, and Cosmetic Act (“FDCA”)] absent health claims establishing a therapeutic intent on behalf of the manufacturer or vendor.”6 The court found it dispositive that, in enacting several statutes on tobacco regulation, “Congress has 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.”7
The Deeming Regulation, as proposed, purports to address the “jurisdictional lines established by Sottera” by deeming e-cigarettes tobacco products subject to the Act. However, as explained below, e-cigarettes do not meet the definition of a “tobacco product,” as defined in Section 201 (rr) of the Food Drug and Cosmetic Act (FDCA), as amended by the Tobacco Act.8 Consequently, FDA has no authority to regulate them as such. Moreover, e-cigarettes are not intended for use as smoking cessation products, nor are they used as such by a vast majority of e-cigarette consumers. Rather, they are a technology product for those who seek the unique, recreational vapor experience e-cigarettes provide adult consumers.”
“E-cigarettes are not a “tobacco product,” as defined by the Act.
FDCA § 201 (rr) defines “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.” The Proposed Rule would “deem products meeting the statutory definition of ‘tobacco product,’ except accessories of a proposed deemed tobacco product” to be subject to the Act.9 FDA interprets “tobacco products” to broadly cover a diverse range of currently marketed products such as “certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco” as well as future products not currently marketed.10 “FDA envisions that there could be tobacco products developed in the future that provide nicotine delivery (e.g, via dermal or buccal absorption), similar to currently marketed medicinal nicotine products, but which are not marketed for therapeutic purposes. Such products would be ‘tobacco products’ and subject to FDA’s chapter IX authorities should the deeming rule be finalized.”11 Therefore, FDA apparently acknowledges certain jurisdictional limits emphasized by Sottera while ignoring the primary limit imposed by the statute – the definition of “tobacco product,” i.e. “made or derived from tobacco.” In fact, e-cigarettes contain no solid tobacco; the only possible nexus that FDA could assert to deem e-cigarettes tobacco products, as defined, is that certain e-cigarettes contain varying levels of nicotine, and certain types of nicotine are derived from tobacco. That is a far too thin – and far too exception ridden – basis upon which to base jurisdiction, particularly where, as here, the consequence of finding jurisdiction is the imposition of an unintended crushing regulatory burden.”
I am not an attorney however, it has always been my position that the FDA is not and never will be the appropriate agency to regulate Vaping. This letter makes that point abundantly clear and clearly establishes a legal framework to SUE the FDA. I vigorously encourage all Vaping business to join SFATA. Unfortunately, a significant number of Vaping merchants have not chosen to due this. A quick glance at the SFATA membership list shows only about 211 members. In my mind this is not only deplorable but short sited. I’m proud to say that I have advertised SFATA on our sidebar since the day this site launched.