FDA Gives First Greenlight to E-Cig

The first electronic nicotine delivery system (ENDS) has passed the FDA’s premarket approval process, showing reduced harm compared with traditional tobacco products, the agency announced Tuesday.

R.J. Reynolds Vapor Company gained approval for its Vuse Solo device and affiliated tobacco-flavored cartridges while at the same time receiving rejection notices for 10 other applications for flavored products. While FDA refused to specify the rejected products for commercial confidentiality reasons, it said an application for menthol-flavored Vuse Solo products are still under review.

FDA faced a court-ordered deadline last month to respond to vape manufacturers’ applications for their products to stay on the market but missed it for Reynolds and the other two top market leaders’ applications.

Congress gave the FDA authority in 2009 to oversee such products by “deeming” e-cigarettes and other non-traditional nicotine delivery systems as tobacco products under the agency’s oversight and subject to marketing restrictions, which it did in 2016.

Manufacturers were to submit applications with evidence that these ENDS would be “appropriate for the protection of public health,” both in terms of youth use and for traditional cigarette cessation overall, so that the FDA could review them by Sept. 9, 2021 under its Premarket Tobacco Product Application (PMTA) pathway.

The newly approved Vuse Solo product had proven in a study that it exposed users to fewer harmful and potentially harmful aerosols than traditional combusted cigarettes and proved to have less toxic aerosols in nonclinical studies as well.

“The 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,” said Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, in a statement.

One key concern with e-cigarettes has been use among youth, and FDA noted that Vuse was cited by 10% of vaping high school students as their usual brand in the 2021 National Youth Tobacco Survey.

While taking that data “very seriously” when reviewing these products for approval, the FDA cited evidence that youth were less likely to start vaping with tobacco-flavored products and then switch to traditional cigarettes — health advocates have called fruit, candy, or mint flavors a driver of teen use and addiction.

“These data reinforce the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption,” the agency’s press release noted.

The agency has said it will review sweet and fruity flavored e-cigarette applications on an individual basis without blanket rules for the industry, as the Wall Street Journal reported.

FDA said it will also continue monitoring marketing and use by young people. If there’s evidence that the products cause people, especially youth, to initiate using tobacco, authorization could be withdrawn.

“While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or ‘FDA approved,'” the agency cautioned. “All tobacco products are harmful and addictive and those who do not use tobacco products should not start.”