Over the last few weeks, the vapor industry plaintiffs and a number of supporters have filed briefs in an appeal of a decision upholding the FDA’s Deeming Regulations. On July 21, 2017, a federal district court rejected the industry plaintiffs’ challenge, and the case is now on appeal to the U.S. Court of Appeals for the D.C. Circuit.
In the plaintiffs’/appellants’ brief filed on February 12, Nicopure Labs and the Right to be Smoke-Free Coalition focus on the First Amendment free speech implications of the Tobacco Control Act’s Modified Risk Tobacco Product (“MRTP”) requirements and the FDA’s ban on free samples of electronic nicotine delivery systems (“ENDS”). The brief argues that the MRTP requirement violates the First Amendment because it prohibits truthful, non-misleading statements (for example, that ENDS do not produce smoke) without the FDA’s advance permission. The brief argues that the sampling ban violates the First Amendment by prohibiting expressive activity that allows consumers to make purchasing decisions.
The plaintiffs/appellants also argue that the FDA should have implemented a different premarket review regime for ENDS. The gist of the argument is that the Premarket Tobacco Application (“PMTA”) requirement for ENDS is irrational as compared to parallel requirements for cigarettes, where many products are exempt from premarket review requirements and other products can take advantage of the less onerous substantial equivalence pathway.
On February 20, several organizations and individuals filed amicus curiae briefs supporting the plaintiffs/appellants. Troutman Sanders represented a group of public health advocates and tobacco policy authorities, led by Clive Bates, in their amicus brief. The brief argues that, in fashioning the deeming regulations, the FDA failed to consider unintended consequences, including that over-regulation of ENDS will discourage consumers from switching to less risky alternatives.
A number of other amicus curiae, including the State of Iowa (led by Attorney General Tom Miller, an advocate for reasonable ENDS regulations), NJOY (an ENDS company), the Consumer Advocates for Smoke-Free Alternatives Association (“CASAA”) (an ENDS consumer advocacy organization) and the Washington Legal Foundation, also filed supporting briefs. The focus of these briefs is on the First Amendment issues raised by the plaintiffs pertaining to the MRTP provisions and the sampling ban. The State of Iowa asserted its interest in protecting the health of Iowa smokers, and faulted the FDA’s MRTP process for preventing product suppliers from marketing their products as safer alternatives to cigarettes. The State argued that ENDS companies should presumptively be permitted to say the following on their packaging: “THIS PRODUCT IS LESS HARMFUL THAN CIGARETTES BUT NOT AS SAFE AS NOT SMOKING OR VAPING AT ALL.” CASAA’s brief discussed the importance of sampling and flavors for consumers to receive information about ENDS and to transition to vaping.
The appeal is expected to be fully briefed by late April.