FDA Authorizes First E-cigarette Product

The FDA authorized the tobacco-flavored versions of RJ Reynolds e-cigarette brand Vuse while rejecting sweet flavored versions of the Vuse product. The FDA’s action on Vuse represents the first time the agency took action on an e-cigarette product that has a large share of the US e-cigarette market. While the FDA did reject Vuse flavored product applications, the agency has not made any decisions on menthol flavored Vuse products.   

“The ATS reiterates our long-held position – e-cigarettes are not ‘safe’ and the claims that e-cigarettes are a harm reduction tool remain unproven. All e-cigarettes have significant health risks including nicotine addiction and respiratory disease,” said ATS President Lynn Schnapp, MD, ATSF in respond to the FDA announcement. 

The ATS notes that the FDA has finally issued decisions on e-cigarette products that constitute a large share of the e-cigarette market. This is an important step by the FDA to finally rein in the U.S. e-cigarette marketplace.

The ATS is concerned that the agency has approved Vuse products with high nicotine concentration. The ATS appreciates that the FDA rejected RJR/Vuse application for flavored e-cigarette products, we note with concern that the agency has not yet rejected the Vuse application for menthol e-cigarette products. The presence of any flavored e-cigarette product poses an unacceptable risk to our nation’s youth. 

The ATS calls on the FDA to protect our nation’s youth by rejecting all flavored e-cigarette products, including menthol flavored e-cigarettes.