FDA Approves First E-Cigarette for Tobacco Cessation Use
In the first authorization of its kind, the U.S. Food and Drug Administration (FDA) this week announced it has authorized the marketing of three new electronic nicotine delivery systems (ENDS) products through the FDA’s Premarket Tobacco Product Application (PMTA) pathway.
The FDA granted marketing approvals to R.J. Reynolds Vapor Company for its Vuse Solo ENDS device and accompanying tobacco-flavored e-liquid pods. According to the FDA, R.J. Reynolds Vapor Company submitted data to the FDA demonstrating that marketing of these products is appropriate for the protection of public health, allowing these products to be legally sold in the U.S.
Under the PMTA pathway, manufacturers must demonstrate to the FDA that, among other things, marketing of the new products will be appropriate for the protection of public health. The products approved this week were found to meet this standard after the FDA determined study participants who only used the authorized products were exposed to fewer harmful and potentially harmful constituents from aerosols compared to users of combustible cigarettes. Further, the FDA assessed the likelihood of the use of the product by young people with the agency determining that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.
In addition to the authorizations, the FDA issued 10 marketing denial orders for flavored ENDS products submitted under the Vuse Solo brand by R.J. Reynolds as the products were found to not be appropriate for the protection of public health. These products may not be sold in the U.S.
For the authorized products, the manufacturer must comply with strict marketing restrictions, including digital advertising restrictions and radio and television advertising restrictions, to reduce the potential for youth exposure to tobacco advertising. The company must also report regularly to the FDA with information regarding the products on the market, including ongoing and completed consumer research, advertising, marketing pans, sales data, information on current and new users, manufacturing changes, and adverse experiences.
Additional information from the FDA is available here.