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FDA Authorizes JUUL2 E-Cigarette Products for Marketing

The U.S. Food and Drug Administration authorized the marketing of three new e-cigarette products through the premarket tobacco product application pathway. The authorized products are part of the JUUL2 e-cigarette system made by JUUL Labs, which is 35% owned by Altria (M), and include a tobacco-flavored pod, a menthol-flavored pod, and the JUUL2 device. As part of its thorough scientific review of new tobacco products, the FDA considers the risks and benefits to the U.S. population as a whole - including the benefits to adults who currently use tobacco products and switch to a potentially lower-risk product, as well as the risks posed to youth and non-users of tobacco products. To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks. The FDA's review of data in the application found that a substantial proportion of adults who smoke completely switched away from combustible cigarettes to the authorized JUUL2 products, with the menthol-flavored pod having a higher rate of complete switching compared to the tobacco-flavored pod. Specifically, 19.9 to 34.6% of those using the tobacco-flavored pod and 28.4 to 49.3% of those using the menthol-flavored pod stopped smoking cigarettes entirely at six weeks. Those who completely switched to the authorized products were exposed to lower levels of harmful chemicals than they would have been had they continued smoking cigarettes. The FDA determined that the added benefit to adults who smoke cigarettes is sufficient to outweigh the risks of the menthol-flavored product, including youth appeal. Other publicly traded companies in the space include British American Tobacco (BTI), Imperial Brands (IMBBY) and Philip Morris (PM).