Vuse Becomes First E-Cigarette Product To Win FDA Marketing Approval

Following concerns about vaping addictions and health risks, FDA has rejected thousands of applications by the makers of e-cigarette products.

After rejecting thousands of marketing application submitted by the makers of e-cigarette products, federal health officials have issued the first authorization for Vuse Solo to continue selling certain tobacco-flavored products in the United States.

The U.S. Food and Drug Administration (FDA) has been requiring all new and existing nicotine based e-cigarette and vaping products go through a premarket tobacco product applications (PMTAs), as part of a continuing effort to curb the skyrocketing teen nicotine addiction rates caused by vaping in the United States.

The FDA has been using its oversight authority under 910 of the Federal Food, Drug, and Cosmetic Act to claim regulatory responsibility of all Electronic Nicotine Delivery Systems (ENDS), which includes e-cigarettes, vaping products, and all liquids used with the devices.

Under new rules, manufacturers are required to provide evidence that their vaping products benefit adult smokers enough to overcome the public health threat they represent to youth, as well as how they intended to prevent the lithium ion batteries from exploding by September this year.

The Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2 became the first products granted authority to remain on the market, after the agency issued a Premarket Tobacco Product Application (PMTA) marketing approval on October 12, which only applies to tobacco-flavored electronic cigarettes.

According to the FDA, the approved Vuse Solo products do not by any means encourage non-tobacco users to start. Rather, the FDA indicates the manufacturer demonstrated the tobacco-flavored products could benefit traditional combustible cigarette smokers who switch to these products by either completely or significantly reducing their nicotine consumption while also reducing their exposure to harmful chemicals.

While the FDA has authorized the manufacturer to continue selling the products on the market, the agency has imposed multiple marketing restrictions. Under the authorization, Vuse Solo will be required to follow strict guidelines on digital advertisements as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products. In addition, the agency refused to approve the marketing of a number of flavored Vuse products, but did not mention which ones.

Flavored vaping products have been strongly linked to underage use, according to both the FDA and independent researchers.

JUUL Decision Still Awaited

As the FDA continues to review thousands of applications, many consumers are awaiting the agency’s looming decision on whether JUUL pods are more of a health benefit or health threat.

The JUUL vape pens, which were introduced in 2015, are designed to look like USB drives, allowing teens to hide their vaping habit from parents and school officials. The pods were also sold in a variety of candy-like flavors intended to appeal to prior non-smokers, and the manufacturer targeted teens through social media and other efforts that failed to disclose the high levels of nicotine, which may cause life-long addiction problems.

Currently, more than 4,500 JUUL lawsuits are being pursued against the company by individuals, school districts and municipalities, each involving similar allegations that the e-cigarette manufacturer caused a new generation of teens and young adults to become addicted to nicotine by encouraging minors or prior non-smokers to use their vaping products.