- The authorization permits the marketing of specific R.J. Reynolds Vapor Company products
- The products' benefits to adults smokers "outweigh the risk" to youths, the agency said
- This does not mean that the products are "FDA Approved," the agency clarified
The U.S. Food and Drug Administration (FDA) has permitted the marketing of specific e-cigarette products. This marks the first electronic nicotine delivery system (ENDS) authorization by the agency.
The agency announced permission to market e-cigarette products from R.J. Reynolds Vapor Company in a statement Tuesday. With the authorization of the Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1 and Vuse Replacement Cartridge Original 4.8% G2, the said products are now allowed to be sold in the U.S.
Data submitted by the company showed that marketing the products is "appropriate for the protection of public health," the agency said. Mitch Zeller, J.D., the director of the FDA's Center for Tobacco Products, further explained that the tobacco-flavored products could be helpful for "addicted" adult smokers who switch to using the products, whether completely or to reduce their cigarette use.
"Today's authorizations are an important step toward ensuring all new tobacco products undergo the FDA's robust, scientific premarket evaluation," Zeller said in the news release.
The FDA previously noted that it had already rejected the applications of over a million e-cigarettes and other related products, reported AP News. This is because of the products' appeal to younger people and even underage teens.
According to the agency, it considered the "risks and benefits" to the population, particularly to the youth. Based on its analysis of these specific products, the possible benefit to smokers who may switch to the products from using cigarettes "outweigh the risk to youth."
Furthermore, data showed that most of the young people who do try ENDS products tend to begin with flavors such as candy, fruit or mint, thus "reinforcing" the agency's choice to authorize the tobacco-flavored products since these are "less appealing to the youth."
"While today's action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or 'FDA approved,'" the FDA noted. "All tobacco products are harmful and addictive and those who do not use tobacco products should not start."
"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," Zeller noted. "We will take action as appropriate, including withdrawing the authorization."