The FDA announced on Tuesday that it had given approval to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8 percent G1, and Vuse Replacement Cartridge Original 4.8 percent G2.
The decision is part of the agency’s broader review of the vaping industry, following years of pressure from politicians and public health groups to regulate the segment as strictly as other tobacco products.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, J.D., 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.”
“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.”
FDA denies sales of 10 flavored products
The FDA said it had rejected the company permission to sell 10 flavored products but did not say what they were. The three authorized products are all tobacco flavored, and the FDA said they were less likely to appeal to adolescents, and more likely to be used by smokers to reduce their risk of harm.
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