Authored By: Arent Fox
James R. Ravitz
Practice Group Leader
Emily M. Leongini
Court Upholds FDA’s Authority to Regulate E-Cigarettes
On July 21, the US District Court for the District of Columbia upheld FDA’s authority to regulate e-cigarettes and other electronic nicotine delivery systems (“ENDS”) as though they are tobacco, even though these products do not actually contain tobacco. The decision responded to consolidated cases brought by Nicopure Labs LLC, a manufacturer of e-cigarette devices and liquid nicotine, and by the trade group Right To Be Smoke-Free Coalition, which challenged certain aspects of the agency’s 2016 so-called “Deeming Rule.”
The Tobacco Control Act and FDA’s Deeming Rule
After the US Supreme Court decided in 2000 that FDA lacked the authority to regulate tobacco products as pharmaceuticals or medical devices, Congress enacted the Family Smoking Prevention and Tobacco Control Act (the “Tobacco Control Act” or “TCA”) in 2009 to give FDA explicit authority to regulate tobacco products. The Tobacco Control Act defines “tobacco products” broadly as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” With the passage of the TCA, the manufacture, distribution, and marketing of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco (including components, parts, and accessories of these products) fell within FDA’s regulatory jurisdiction.
The TCA also authorized FDA to “deem,” through regulation, other products as “tobacco products,” and therefore subject to FDA regulation. Last year, FDA did just that, deeming e-cigarettes, e-liquids, and ENDS, among other products, to be “tobacco products.” With the finalization of the Deeming Rule in 2016, these new tobacco products became subject to certain restrictions, including a prohibition on the sale to minors, a requirement for warning labels and, subject to some exceptions, pre-market review by the FDA before they can be lawfully marketed. It was the scope of this “Deeming Rule” that was at issue in the case decided in late July.
Nicopure Labs’ Challenge and the Court’s Response
Challengers of FDA’s regulation of e-cigarettes and other ENDS claimed that by extending the Tobacco Control Act to cover e-cigarettes, the FDA overreached its regulatory authority and, among other things, violated the First and Fourteenth Amendments, the Administrative Procedures Act, and the Regulatory Flexibility Act.
Because the DC Circuit had previously recognized FDA’s authority to regulate e-cigarettes as a tobacco product in 2011, the plaintiffs did not dispute FDA’s ability to regulate e-cigarettes generally. Instead they challenged the FDA’s authority to reach “modular ENDS”—refillable e-cigarettes that users can fill with an e-liquid of their choice. The plaintiffs reasoning was that FDA cannot properly regulate such devices and e-liquids that do not contain nicotine or any other tobacco derivatives, because they are not “made or derived from tobacco.”
The DC District Court sided with the FDA, holding that the agency reasonably interpreted the Tobacco Control Act when it declared that refillable e-cigarettes and nicotine-free e-liquids can be treated as “tobacco products.” The court concluded that the refillable e-cigarettes and even nicotine-free e-liquids could be fairly characterized as tobacco product “components” because they can reasonably be expected to be used with nicotine-containing fluid.
What Does this Ruling Mean for the Vape (and Cannabis) Industry?
If this decision stands despite the possibility for an appeal, e-cigarettes, e-liquids, and other recently-deemed tobacco products cannot be legally sold as of August 8, 2018 unless they undergo FDA premarket review. However, just days after the decision, FDA announced plans to issue a “new enforcement policy” that may extend the compliance date for manufacturers of newly deemed non-combustible products, like ENDS, until August 8, 2022. In this announcement, the agency also referenced plans to propose regulations outlining the scope of information that will be required to support such premarket approval, as well as guidance documents describing how the agency will review applications for premarket approval for ENDS.
Future agency rulemaking and guidance notwithstanding, the Nicopure Labs decision may also impact the ever-expanding cannabis industry. A variety of vaporizing devices, many of which are similar to those at issue in the case, have become popular in states with legalized or decriminalized cannabis. Although the Deeming Rule focuses on tobacco and nicotine products and does not appear to contemplate cannabis, at least in theory, the rule could apply indirectly to cannabis vaping products because of the dual-use nature of many of these products. For example, refillable e-cigarettes like those at issue in the case could potentially also be used with vaping liquids derived from cannabis and manufacturers of components and parts of ENDS that are sold or distributed separately for consumer use (e.g., cartridges, atomizers, flavorings, programmable software) may be subject to FDA’s product authorities if they can “reasonably be expected to be” used for human consumption of tobacco.
Although the Deeming Rule, now affirmed by the DC District Court, does not appear to immediately impact vaping of cannabis, it could provide FDA necessary authority in the event the agency takes a more active role in regulating marijuana, for example, if marijuana were rescheduled or if the executive branch begins to take a more aggressive approach to enforcing its federal prohibition, industry and the general public can benefit from clear, consistent, and reasonable regulations. Manufacturers of ENDS and ENDS parts and components–whether intended for use with nicotine, cannabis derivatives, or both–should actively monitor the agency’s evolving policies in this space and consider submitting comments to FDA when the agency’s proposals could impact their products and businesses.
Arent Fox’s Food, Drug, Medical Device & Agriculture and Cannabis groups will continue to monitor developments in FDA regulation of the e-cigarette and cannabis industries. If you have any questions, please contact James Ravitz, Emily Leongini, or the Arent Fox professional who usually handles your matters.