US FDA Issues Its First Vape Authorization to Vuse E-Cigarettes

The U.S. Food and Drug Administration announced Tuesday that it had approved e-cigarette products for the first time in history, approving R.J. Reynolds’ sale of three Vuse vape products.

“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.’ All tobacco products are harmful and addictive, and those who do not use tobacco products should not start,” FDA officials stated in a statement.

The FDA stated that it had refused the company’s request to sell ten flavored goods but did not specify which ones. The three allowed items are all flavored with tobacco, and the FDA determined that they are less likely to be used by teens and more likely to appeal to smokers to lower their risk of damage.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, Director of the FDA’s Center for Tobacco Products.

“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,” Zeller noted.

The Campaign for Tobacco-Free Kids, which campaigns for tobacco product eradication, was unimpressed.

“While it is a positive step that FDA denied applications for ten flavored Vuse e-cigarettes, it is concerning that a product that has three times the nicotine concentration as legally permitted in Canada, the U.K., and Europe was authorized. Vuse products with this level of nicotine leave our nation’s youth at an undue risk of addiction,” Matthew L. Myers, the group’s president, said in a statement.

The FDA stated that it would monitor the items’ marketing.

“We must remain vigilant with this authorization, and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization.”

The FDA’s action prohibits the items’ advertising on digital, radio, and television, the FDA stated.

“These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents from aerosols compared to users of combusted cigarettes,” the FDA stated.

For years, e-cigarette products have been allowed to remain on the market, although none have received FDA authorization.