FDA Greenlights the First E-Cigarette Products for Sale

Less than two months after delaying the decision to permit JUUL to remain on the market, the U.S. Food & Drug Administration has authorized the first e-cigarette on the market. Despite JUUL’s popularity in the vape space, the approved e-cigarette is not manufactured by JUUL Labs.

On Oct. 12, the FDA authorized the marketing of three products in the e-cigarette division of tobacco giant RJ Reynolds, which owns the Camel, Natural American Spirit and Newport, Pall Mall and Kent cigarette brands. The approval was granted for the Vuse Solo electronic nicotine delivery system (ENDS) unit.

After a successful lawsuit by anti-tobacco groups forced the agency to speed up its review, a federal judge set a deadline of Sept. 9 for the FDA to rule on market approval for JUUL and dozens of other companies.

But the agency, after hinting that it would favor JUUL and a handful of other companies, announced it was delaying the decision, angering anti-vaping groups.

To be approved, vape companies must prove that their products benefit the public by getting people to quit smoking or reduce their consumption of combustible cigarettes. In addition, vape companies must show that their products are not marketed or appealing to people under 21 years of age.

Vuse Solo is the first ENDS product to receive FDA authorization out of more than 6.5 million products from approximately 500 companies that submitted an application for market approval, according to an Associated Press report.

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, said in an FDA press release that the authorizations “are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation.”

Zeller continued, “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.”

Several medical experts have expressed dismay with the FDA’s authorization.

According to Healthline.com, a statement provided by Anne Marie Hummel, associate executive director for advocacy and government affairs at the American Association for Respiratory Care, called the FDA decision “extremely disappointing given the harmful effect of tobacco use and its relationship to chronic respiratory disease.”

Dr. Sanjivan Singh Kohli, a pulmonary and critical care medicine physician at Providence Mission Hospital in California, told Healthline, “Any way you’re getting it, the use of nicotine has a lot of negative effects on the cardiovascular system.”




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