On October 12, 2021, the U.S. Food and Drug Administration (“FDA”) issued orders granting R.J. Reynolds (RJR) Vapor Company approval to market three of its electronic nicotine delivery system (ENDS) products – the Vuse Solo ENDS e-cigarette and accompanying tobacco-flavored pods. In issuing the orders, FDA found “that the marketing of these products is appropriate for the protection of public health.” However, FDA also stated that its orders do not mean “these products are safe or ‘FDA approved.’” See FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency | FDA.
Although ENDS products, such as e-cigarettes, have been on the market since the mid-2000s, this is the first time FDA has authorized the marketing of specific ENDS products through the Premarket Tobacco Product Application pathway.
As background, in 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (the “Act”) which granted FDA the authority to regulate the manufacture, distribution, and marketing of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products. It also gave FDA the authority to issue regulations “deeming” other products that meet the statutory definition of a “tobacco product” to be subject to the Act. On May 10, 2016, FDA issued a “Deeming Rule” that rendered ENDS products, which include e-cigarettes and vape pens, “tobacco products” subject to FDA’s regulatory controls. As such, ENDS products have only been subject to FDA’s regulatory authority since 2016.
The 2016 “Deeming Rule” required that manufacturers of e-cigarettes and other ENDS products apply for and obtain premarket authorization before introducing new products into interstate commerce for commercial distribution. Generally, premarket review occurs before a product is on the market; however, given that many ENDS products already were on the market as of 2016, the Premarket Approval process occurred after the fact. Manufacturers of products that were on the market as of August 8, 2016, were required to submit their applications by September 9, 2020. As of September 9, 2020, FDA received millions of applications and as of September 9, 2021, FDA has taken action on about 93% of the timely submitted applications.
FDA is closely scrutinizing these applications given the growing concern regarding youth ENDS use. FDA has stated that “[s]ince 2014, e-cigarettes have been the most commonly used tobacco product among U.S. youth” and that youth use of these products is unsafe because these “products contain nicotine, which is highly addictive and can harm the developing adolescent brain[,]”; further, “[u]sing nicotine in adolescence may also increase risk for future addiction to other drugs.” See Youth E-cigarette Use Remains Serious Public Health Concern Amid COVID-19 Pandemic | FDA.
Against this backdrop, FDA’s finding that the marketing of RJR Vapor Company’s three products “is appropriate for the protection of public health” is somewhat surprising. Ultimately, FDA’s decision turned on its finding that “[t]he manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals.”
With respect to protecting youth, key to FDA’s decision was the fact that the products are tobacco-flavored. FDA noted that “[e]xisting evidence consistently indicates that use of tobacco-flavored ENDS is less common compared to non-tobacco-flavored ENDS among youth.” See Technical Project Lead Review of PMTA. Additionally, “[t]he data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors.” Notably, although FDA granted marketing orders for RJR Vapor Company’s three Vuse products, it also issued 10 marketing denial orders for flavored Vuse ENDS products.
Another crucial component of FDA’s decision was its issuance of “strict marketing restrictions on the company, including digital advertising restrictions as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products.”
It will be interesting to see what additional ENDS products FDA authorizes for sale through the premarket approval process. To obtain such authorization manufacturers will need to show that their product is appropriate for the protection of the public health. This analysis requires a review of the risks and benefits to the population as a whole, including users and nonusers of tobacco products. Given the concern regarding youth ENDS use it appears manufacturers will face an uphill battle in establishing the benefits of their products outweigh the potential risk to youth.