Nicopure Labs, LLC, maker of Halo and eVo vapor products, filed a lawsuit against the FDA over the deeming regulation in 2016, on First Amendment, jurisdictional and administrative procedural grounds. Last year, a federal district court ruled in favor of the FDA, but Nicopure announced its intention to appeal. This month, Nicopure — now joined by a coalition of organizations as co-plaintiff — filed an opening brief in the appeal.
Details about the legal theory underlying the case can be found in a recent post by the attorneys representing the coalition of organizations and an analysis at the time of the initial verdict by legal scholar Jonathan H. Adler.
This week, the leading American tobacco harm reduction organization, CASAA (The Consumer Advocates for Smoke-free Alternatives Association), filed an amicus brief in support of Nicopure. (An amicus brief is a legal filing by someone who is not a party in a case, which presents factual or legal claims to the court, usually to support one side in a case. Several others have also been filed in support of Nicopure.) CASAA’s filing argues that as a membership organization and consumer representative with extensive knowledge of the interests and preferences of their membership, they offer a unique perspective.
CASAA’s brief provides facts about the importance of flavors to vapers and smokers who are considering switching. It also underscores the need for accurate information. Both of these relate to First Amendment claims in the lawsuit.
FDA rules forbid merchants from communicating generally-accepted science (e.g., “vaping is less harmful than smoking”) or even simple and indisputable facts (e.g., “there is no smoke”). Merchants cannot even provide some simple product information (e.g., “this product contains no diacetyl”). The lawsuit makes the rather compelling point that forbidding such accurate communication is a violation of free speech rights. CASAA explains the crucial role of vape shops in providing such information to potential customers. They argue that the lack of such information interferes with smoking cessation. They make a good case that while this is technically a speech rights issue, its real importance is as a violation of consumers’ rights. (The CASAA brief is about matters of fact rather than law; presumably this position is an appeal to natural law rather than statute.)
The lawsuit argues that prohibiting vape shops from offering free flavor sampling is also a First Amendment violation. This is, to say the least, a rather more difficult case to make for reasons explained by Adler. It is also possible that this aspect of the case does not matter because, as previously reported, the FDA issued a guidance that forbids sampling only in venues accessible by minors. Vape shops that sensibly maintain an adults-only policy are thus apparently exempt, though the FDA could choose to “clarify” that this is not the case at any time. Regardless of the legal situation, CASAA offers a compelling explanation about why flavor exploration in general, and free samples in particular, are useful for keeping vaping an attractive alternative to smoking.
The brief draws on CASAA’s knowledge about its membership, including its 2015 member survey and its testimonials collection. Based on these, CASAA notes the wide variety of flavor preferences among consumers, as well as the variety that many vapers seek, which support the value of being able to sample. They note that a majority of their members credit interesting flavors with transitioning them fully from smoking. [Disclosure: The author of this article was the primary author of that survey and analyzed and reported its results, and conceived of and oversaw the creation of the testimonials collection.]
Opinions about the prospects for this lawsuit stopping some of the damage caused by the FDA deeming range from “quixotic” to “best hope.” CASAA’s Executive Director, Alex Clark, offers a take that goes a different direction: “Like most lawsuits, the greatest value is in raising public awareness.” He argues that there is value in debating these points in an official record. Policy questions — whether imposing these rules is good for society — are unfortunately not central to the technical arguments of this lawsuit. The importance of flavor sampling for smoking cessation, let alone the importance of flavors more generally, is not going to change a court’s interpretation of the First Amendment. The court is extremely unlikely to convert the human right to health-affecting information into a legal right. But such arguments might influence future administrative or legislative decisions.
Clark declined to offer a predictions about the outcome of the case, instead noting, “Regardless of the outcome, the original complaint and this appeal serves to strengthen the foundation for making changes to the underlying statute in the future.”