The regulation of e-cigarettes and other electronic nicotine delivery systems (“ENDS”) presents complex regulatory and scientific challenges. Two key federal agencies with product safety mandates and overlapping jurisdiction – the Consumer Product Safety Commission and the Food and Drug Administration – have turned their attention onto the specific area of e-cigarette battery-related fires and explosions in the last few months.
In August 2016, the Food and Drug Administration finalized its so-called Deeming Rule to bring e-cigarettes and ENDS, as well as their components and parts such as batteries, under its authority to regulate tobacco products. Under this newly granted authority to regulate e-cigarettes and ENDS, FDA held a public workshop in April on “Battery Safety Concerns in Electronic Nicotine Delivery Systems.” Through the workshop and also through other channels, FDA is seeking data and other information on explosions, fires, and overheating of e-cigarettes. FDA also has initiated a public safety campaign of “Tips to Help Avoid Vape Battery Explosions.”
The CPSC has focused its attention on general battery-related concerns with numerous product recalls of faulty lithium ion batteries in products ranging from laptops to the Samsung Galaxy Note 7 phone. Then, earlier this month, Firewood, a vaping supplier, participated in a voluntary recall under CPSC’s Fast Track Recall program of all Firewood 4 vaporizers sold on the company’s website Firewoodvapes.com. Firewood had received one report of an electrical short that caused the vaporizer battery to catch fire. No injuries were reported.
Both agencies have claimed some authority over these products. By recalling the Firewood 4 vaporizers, CPSC has exercised its authority over battery safety. Interestingly, though, the definition of consumer product in the Consumer Product Safety Act, written well before the advent of e-cigarettes, specifically excludes tobacco and tobacco products. 15 U.S.C. § 2052(a)(5). Yet the Final Deeming Rule gives FDA authority over all e-cigarettes and ENDS, as well as any components or parts of those covered products, including batteries. Indeed, just last month, the Deeming Rule survived its first court challenge to FDA’s exercise of jurisdiction over e-cigarettes. Nicopure Labs, LLC v. FDA, — F. Supp. 3d —-, No. 16-0878 (ABJ), 2017 WL 3130312 (D.D.C, July 21, 2017). The Court specifically stated that any challenge to the application of the Deeming Rule to the batteries or other parts of the e-cigarette “would be premature.” Id. at *11 n.15.
In its Deeming Rule and otherwise, FDA has made e-cigarette battery safety a priority. However, CPSC has shown it will assert its expertise in the area which is no surprise given the strong role it has taken in addressing battery overheating incidents in other products. It will be interesting to see how the jurisdictional overlap between the two agencies plays out.