On February 12, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition[i] (the Appellants) filed their opening brief in the appeal of last year’s decision from the U.S. District Court for the District of Columbia, which ruled in favor of FDA in the first lawsuit challenging aspects of the Tobacco Control Act (TCA) and the Food and Drug Administration’s (FDA’s) Deeming Rule as they are being applied to the vapor industry. In the brief, the Appellants respectfully disagree with the lower court’s conclusions and believe that both the law and the facts compel a different result.
Specifically, Appellants argue that (1) the Modified Risk Tobacco Product (MRTP) provision of the TCA, as well as the ban on free samples of vapor products, violate the First Amendment of the U.S. Constitution, and (2) FDA was obligated to consider a less burdensome Premarket Tobacco Product Application (PMTA) process for vapor products while still protecting the public health. We summarize these issues in turn below, and you can download the full brief here.
1. Modified Risk Claims and Free Sample Ban
The MRTP provision in Section 911 of the TCA prohibits vapor companies from, among other things, representing without FDA authorization that their products: (i) present a lower risk of disease or is less harmful than another tobacco product; or (ii) contain a reduced level of, or is free from, a substance, or that exposure to a substance is reduced or eliminated. In other words, this means that vapor companies require explicit FDA approval to tell adult consumers, for example, that their products do not contain certain substances (“no diacetyl” or “no allergens”), that they are unlike more dangerous cigarettes because they have “no tar” or produce “no combusted smoke,” and they pose less health risk to individuals than smoking cigarettes (as FDA itself has publicly stated numerous times). Obtaining such MRTP authorization is an incredibly onerous and expensive process (which no company has been able to achieve yet) that requires applicants to demonstrate that their product will:
(i) significantly reduce harm and the risk of tobacco-related disease to individual users; and
(ii) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.
21 USC § 387k(g)(1). As to the latter “population effects” prong of the standard, applicants must establish not only the relative health risks of the subject product, but also the potential impact the product will have on overall tobacco use initiation and cessation. 21 USC § 387k(g)(4).
In reality, this imposes a prophylactic ban on MRTP claims and violates the First Amendment because it effectively prohibits truthful, non-misleading statements by vapor companies that convey information needed by adult consumers to make informed purchasing decisions and switch away from cigarettes to less risky vapor products. The First Amendment protects the rights of consumers in the marketplace to obtain product-related information so they can make educated decisions.
But vapor companies cannot make these claims without prior FDA approval and, in all likelihood, will never be able to because the Agency has never approved a claim under the stringent and cost prohibitive MRTP standard. As such, and as detailed in the brief, the MRTP process fails to meet the “intermediate scrutiny” standard required when the government regulates commercial speech. Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980).
Similarly, the free sample ban violates the First Amendment because it prohibits adult consumers from trying different vapor products and obtaining valuable information about a novel product category that will help them transition away from cigarettes. Sampling is an “expressive” act that is protected speech. As FDA conceded, sampling conveys information that allows consumers to make individualized choices and change their purchasing behavior. This is important where, as FDA also acknowledged, smokers may have a better chance of switching to vapor products if they can continually sample a variety of e-liquid flavors. Indeed, numerous consumer surveys and other data indicate that smokers rely heavily on flavor variability and the opportunity to try different e-liquids and devices when considering vaping as a substitute for deadly smoking. But, as set forth in the brief, neither Congress nor FDA demonstrated that the free sample ban survives intermediate scrutiny.
2. PMTA Process
Since the Deeming Rule took effect on August 8, 2016, the restrictions on vapor products have been even more onerous than combustible cigarettes, most of which are grandfathered and exempt from FDA’s premarket review requirements. While FDA’s announcement last year for a “comprehensive regulatory plan to shift trajectory of tobacco-related disease, death” acknowledged, among other things, the tobacco harm reduction potential of vapor products and extended the compliance policy deadline for PMTAs for pre-August 8, 2016 vapor products to August 8, 2022, the reality is that safety advances and innovation have been stifled, and the industry still faces effectively being banned in a few short years.
In this regard, it is critical to recognize that the TCA has an overarching goal of ensuring that adult smokers continue to have access to innovative, less risky tobacco products. Despite this, and even though the Agency acknowledged that forcing vapor products to complete a one-size-fits-all PMTA process would eliminate over 95% of manufacturers (along with product variety those companies supply), FDA failed to tailor the PMTA process to less risky vapor products. Indeed, to date FDA has only approved one PMTA (which was not for a vapor product) and, as provided in the brief, Deeming Rule commenters submitted compelling evidence showing the PMTA will be time and cost prohibitive. FDA was obligated, therefore, not just to extend the filing deadlines, but to consider a less burdensome PMTA process for vapor products (e.g., one that does not require long-term, clinical or epidemiological studies for each vapor product) while still protecting the public health.
FDA’s reply brief is due by April 18, 2018. We will keep you updated on the progress of the appeal.