Washington – The US Food and Drug Administration announced Tuesday that it has authorized the marketing of e-cigarettes for a single manufacturer, making it a first for the agency.
FDA directs RJ Reynolds Vapor Company to market its Vuss Solo Closed Electronic Nicotine Delivery System (ENDS) device as well as tobacco flavored e-liquid pods, specifically Vuss Solo Power Unit, Vuss Replacement Cartridge Original 4.8% G1 and Vuss Gave the permission to. Replacement Cartridge Original 4.8% G2.
“Today’s authorization is an important step toward ensuring that all new tobacco products pass the FDA’s robust, scientific pre-market evaluation,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The manufacturer’s data demonstrates that its tobacco-flavored products may benefit addictive adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – from exposure to harmful chemicals. by reducing it.”
“We must be 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 such individuals. who had not previously used a tobacco product, including youth,” Zeller said.
RJ Reynolds Vapor Company was able to obtain permission through the FDA’s Premarket Tobacco Product Application, or PMTA. In the application process, manufacturers must demonstrate their products protecting public health.
The FDA found that people who participated in a study using Vuse products were “exposure to less harmful and potentially harmful components (HPHCs) from aerosols than users of combustible cigarettes.” The results of the study also showed that the aerosols of the Vuce products were significantly less toxic than those of combustible cigarettes.
One prerequisite is that RJ Reynolds Vapor Company aims to reduce youth exposure and access to its e-cigarettes. FDA Officials Said They Accept 2021 National Youth Tobacco Survey Which found that about 10% of high school students use Vuse e-cigarettes. But officials said the greater benefit is the number of adults who will eventually stop or reduce smoking combustible cigarettes because of e-cigarettes. He also said it is less likely that minors who smoke e-cigarettes will switch to combustible cigarettes or other high-risk products.
FDA officials reiterate that all tobacco products are harmful.
“Today’s action allows tobacco products to be sold in the US, but does not necessarily mean that these products are safe or ‘FDA approved’,” the agency said. “All tobacco products are harmful and addictive and people who do not use tobacco products should not start.”
This story was reported from Los Angeles.