The first half of 2022 has seen a fair amount of FDA and government action advancing tobacco control. This update summarizes key details about the FDA’s activity and possible next steps in the ongoing effort to strengthen public health and implement robust federal regulations on commercial tobacco and related products.

The FDA’s Long-Awaited Proposed Rules for Menthol Cigarettes and Flavored Cigars

On April 28, 2022, the FDA announced its proposed rules for prohibiting menthol in cigarettes and prohibiting flavors in cigars. The agency has dragged its heels on prohibiting menthol in cigarettes for years, ever since the Family Smoking Prevention and Tobacco Control Act was passed in 2009.  At that time, Congress asked the FDA to explore whether a ban on the sale of menthol-flavored cigarettes would advance public health (even as, through the Tobacco Control Act, Congress banned the sale of all other flavored cigarettes). The 2013 Citizen Petition filed by the Public Health Law Center called on the FDA to ban menthol in cigarettes, and although the agency announced it would look into developing a rule, it still took nine years and a lawsuit led by the African American Tobacco Control Leadership Council for them to do so. At last, however, the FDA has put forth its proposed rules which, as written, would both protect and advance public health.

While this is a positive development, it is only the beginning. The FDA received nearly 250,000 public comments on its proposed rules banning menthol and flavored cigars, and should the FDA finalize either or both of the proposed rules, the tobacco industry is likely to file legal challenges immediately. These challenges could result in stays on the rules, which would prevent them from taking effect until legal proceedings have concluded – a process that could take years. The FDA’s authority to issue the rules is well established and the agency is likely to prevail in any litigation; however, the date these rules will take effect is still uncertain. The FDA’s action on menthol and flavored cigars should be greeted as catalyzing opportunities for advocates at the state, local, Tribal, and territorial levels to push for complementary prohibitions that can be in place sooner.

Congress Expressly Authorizes the FDA to Regulate Synthetic Nicotine

Largely due to the implementation of premarket review for e-cigarettes, products purportedly consisting of synthetic nicotine are now on the market.  Until recently, the FDA’s authority to regulate nicotine in tobacco products was limited to tobacco-derived nicotine. Then, in March 2022, Congress closed the loophole that manufacturers were exploiting. The new law allows the FDA to regulate nicotine regardless of the source. Several state and local jurisdictions have already passed laws like this but having a federal framework in place allows for a more comprehensive approach.

Despite this promising measure, the FDA has yet to take significant enforcement actions against companies still selling unauthorized synthetic nicotine products. Tribal, state, local, and territorial governments can and should move forward to implement their own laws where necessary and ensure that synthetic nicotine is included in their tobacco control efforts.

E-Cigarette Marketing Review Ongoing, with Several Notable Updates

In September 2021 we reported on the FDA’s struggles and delays in processing and reviewing the millions of premarket tobacco product applications (PMTA)s it received related to e-cigarettes. The FDA is still reviewing applications, even after dismissing millions of submissions, and it has issued several key decisions since September 2021.

Juul receives a marketing denial order. The FDA recently issued a marketing denial order (MDO) to e-cigarette manufacturer Juul Labs. Juul, a product that has become synonymous with e-cigarette use, is one of the most popular brands among youth and adults and significantly contributed to the youth vaping epidemic. The FDA did not consider Juul’s application to be adequate with respect to the toxicological profile of its products. The agency also noted that Juul’s marketing strategy had included minors and Juul’s devices were readily used with third-party e-liquid pods.

Juul sued and received a court-ordered stay on the MDO pending review, and the FDA imposed its own stay on its order so it could reevaluate the “unique” scientific issues pertinent to Juul and Juul products. The FDA is unlikely to reverse its prior decision and it is more likely working on bolstering evidence to support the MDO.

Over 50 companies appeal their MDOs, with two courts of appeal deciding in the FDA’s favor. Expectedly, several manufacturers that received MDOs appealed the FDA’s decisions. Arguments raised by these companies included claims that the FDA did not have authority to make such decisions and that the agency acted arbitrarily and capriciously.

Two recent decisions have the potential to impact other MDO cases under review.  On July 18, 2022, the 5th Circuit denied the petition for review filed by an e-cigarette liquid manufacturer, Wages and White Lion. Then, on July 26, 2022, the D.C. Court of Appeals denied the petition for review of another e-liquid manufacturer, Prohibition Juice Co., and others. Both courts rejected outright the argument that the FDA lacks authority to issue MDOs to e-cigarette manufacturers and determined that the FDA’s analysis of the products they reviewed comports to a rational and reasonable process known to the petitioners when they submitted their PMTAs – and so, cannot be considered arbitrary and capricious. That two separate appellate courts reached the same conclusion bodes well for the FDA’s decision-making process.

In contrast, the 11th Circuit panel found that the FDA did act arbitrarily and capriciously when it did not review the marketing and sales plans that several manufacturers had submitted in their PMTAs. The majority determined that the FDA stated such details were important factors and that excluding them from their analysis was not a “harmless error,” juxtaposing the rulings from other courts. The majority remanded the case back to the FDA, though it is likely (indeed, the majority suggests and the dissent considers necessary) that the FDA will simply review the materials and deny again the manufacturers’ applications.

The FDA authorizes marketing for some products. The FDA has granted market authorization to a handful of select products: RJ Reynolds’ Vuse Solo, Vibe, and Ciro; U.S. Smokeless Tobacco’s VERVE (an Altria company); Logic Technology’s Vapeleaf, Pro, and Power (a JTI company); and NJOY Daily and Ace. None of these products are particularly popular with American consumers, and VERVE was no longer being produced when the FDA authorized it for sale. The FDA rested its rationale for authorization on whether these products were likely to aid current users of combustible products to switch to e-cigarettes, while being unlikely to attract youth and non-users. FDA authorization allows these products to be lawfully marketed, although as noted by the multiple court-issued stays – along with the FDA’s spotty and slow enforcement – unauthorized products are likely to remain on shelves for some time.

By Neil Sircar, Staff Attorney
August 25, 2022