“The FDA issued marketing granted orders to RJ Reynolds (RJR) Vapour Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavoured e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8 per cent G1, and Vuse Replacement Cartridge Original 4.8 per cent G2,” said the agency in a statement.
In September, the agency had rejected more than 946,000 flavoured electronic nicotine delivery systems (ENDS) products, such as e-cigarettes and e-liquids, prohibiting them from being marketed or sold due to lack of sufficient evidence on health benefits.
The new approval marks the first set of ENDS products ever to be authorised by the FDA.
“The manufacturer’s data demonstrates its tobacco-flavoured 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,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.
The agency will, however, “monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements. We will take action as appropriate, including withdrawing the authorization”, Zeller added.
Moreover, the agency found that study participants who used only the authorised products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes.
“The authorised products’ aerosols are significantly less toxic than combusted cigarettes based on available data,” the FDA said.
“The FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth,” it added.
The FDA has been investigating, for more than a year, whether the e-cigarettes were a benefit or a danger to public health. The agency had received applications for approval of some 6.5 million products.
“The importance of the FDA authorising a vaping product as ‘appropriate for the protection of public health’ should not be understated,” Gregory Conley, president of the American Vaping Association, an industry group, was quoted as saying to the New York Times.
“Now that the FDA has acted, we are hopeful that adult consumers and health communicators will begin to understand the harm reduction benefits offered by these and other smoke-free products,” he added.
The FDA said it is also working on its plan to eliminate menthol cigarettes from the market, a prospect the tobacco industry is vigorously lobbying against.
Source: IANS
