FDA Finds Certain Electronic Cigarette Products “Appropriate For The Protection Of Public Health” But Not “FDA Approved” | Faegre Drinker Biddle & Reath LLP


On October 12, 2021, the United States Food and Drug Administration (“FDA”) issued orders authorizing RJ Reynolds (RJR) Vapor Company to market three of its electronic nicotine delivery system (ENDS) products – the Vuse Solo ENDS electronic cigarette and accompanying tobacco flavored pods. In issuing the orders, the FDA found “that the marketing of these products is appropriate for the protection of public health.” However, the FDA also said its orders do not mean that “these products are safe or” FDA approved. ” See FDA Approves Commercial Electronic Cigarette Products, Marking Agency’s First Such Authorization | FDA.

Although ENDS products, such as electronic cigarettes, have been on the market since the mid-2000s, this is the first time that the FDA has allowed specific ENDS products to be marketed via the tobacco product application route before. marketing.

As a backdrop, in 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (the “Act”) which granted the FDA the power to regulate the manufacture, distribution and marketing of cigarettes, tobacco and tobacco. cigarettes, roll-your-own tobacco and smokeless tobacco products. It also gave the FDA the power to issue regulations “considering” that other products that meet the legal definition of a “tobacco product” are subject to the law. On May 10, 2016, the FDA issued a “rule of presumption” that made ENDS products, which include electronic cigarettes and vape pens, “tobacco products” subject to FDA regulatory controls. As such, ENDS products have only been subject to FDA regulatory authority since 2016.

The 2016 “presumption rule” required manufacturers of electronic cigarettes and other ENDS products to apply for and obtain pre-market authorization before introducing new products into interstate commerce for commercial distribution. Typically, pre-market review takes place before a product is on the market; however, since many ENDS products were already on the market in 2016, the pre-market approval process was an afterthought. Manufacturers of products that were in the market as of August 8, 2016 were required to submit their applications by September 9, 2020. As of September 9, 2020, the FDA has received millions of applications and as of September 9, 2021, the FDA has taken action on approximately 93 % of requests submitted on time.

The FDA is closely examining these applications given the growing concern about the use of ENDS by young people. The FDA said that “[s]Since 2014, electronic cigarettes have been the most common tobacco product used by young Americans “and that the use of these products by young people is dangerous because these” products contain nicotine, which is highly addictive and can be harmful. to adolescent brain development.[,]” ; further away, “[u]singing nicotine as a teenager may also increase the risk of future addiction to other drugs. See The use of electronic cigarettes by young people remains a serious public health problem in the context of the COVID-19 pandemic | FDA.

In this context, the FDA’s conclusion that the marketing of the three RJR Vapor Company products “is appropriate for the protection of public health” is somewhat surprising. Ultimately, the FDA’s decision was based on its conclusion that “[t]The manufacturer’s data shows that 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.

When it comes to protecting young people, the key to the FDA’s decision was whether the products were flavored with tobacco. The FDA noted that “[e]existing evidence consistently indicates that the use of tobacco-flavored ENDS is less common compared to non-tobacco-flavored ENDS in young people. ” See Technical Project Manager PMTA Review. Besides, “[t]The data also suggests that most youth and young adults who use ENDS start with flavors such as fruit, candy, or mint, not tobacco flavors. Notably, although the FDA granted marketing orders for the three Vuse products from RJR Vapor Company, it also issued 10 refusal-to-market orders for the flavored Vuse ENDS products.

Another crucial part of the FDA’s decision was the issuance of “strict marketing restrictions for the company, including digital advertising restrictions as well as radio and television advertising restrictions, to reduce the potential for exposure of young people to tobacco advertising for these products ”.

It will be interesting to see which additional ENDS products the FDA allows for sale through the pre-market approval process. To obtain such authorization, manufacturers will have to demonstrate that their product is suitable for the protection of public health. This analysis requires a consideration of the risks and benefits for the population as a whole, including users and non-users of tobacco products. Given concerns about the use of ENDS by young people, it appears that manufacturers will face an uphill battle to establish that the benefits of their products outweigh the potential risks to young people.

About Margaret Shaw

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