The authorization includes strict marketing restrictions on manufacturers, including restrictions on digital, radio, and television advertising, to reduce the potential for youth exposure.
In the first approval of its kind, officials with the FDA have authorized the marketing of 3 new tobacco products through the Premarket Tobacco Product Application (PMTA) pathway.
According to an FDA press release, the administration issued marketing granted orders to the Vuse Solo closed ENDS device and its accompanying tobacco-flavored e-liquid pods from RJ Reynolds Vapor Company. The company had submitted data to the FDA demonstrating that the marketing of these products is appropriate for the protection of public health.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, in the press release. “The manufacturer’s data demonstrate 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.”
Under the PMTA pathway, manufacturers must demonstrate that marketing of the new tobacco product would be appropriate to the protection of public health. According to the press release, the newly approved products met this standard because, among several important considerations, the evaluators determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents from aerosols compared to users of combusted cigarettes.
Furthermore, the toxicological assessment found that the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and the results of nonclinical studies. The FDA also considered the risks and benefits to the population as a whole, including youth. The agency said it determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.
The press release noted that the 2021 National Youth Tobacco Survey found that approximately 10% of high school students who currently use e-cigarettes named Vuse as their usual brand. Evidence has also shown that compared to users of non-flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS and then switch to higher-risk products, such as combusted cigarettes.
Research also suggests that most youth and young adults who use ENDS begin with flavors such as fruit, candy, or mint, and not tobacco flavors. This reinforces the FDA’s decision to authorize only the tobacco-flavored products because they are less appealing to youth.
The authorization includes strict marketing restrictions on the company, including restrictions on digital, radio, and television advertising, to reduce the potential for youth exposure to tobacco advertising. The company is also required to report regularly to the FDA with information about the products on the market, including ongoing and completed consumer research studies, advertising, sales data, and information on current and new users.
In addition to these approvals, the FDA also denied marketing applications for flavored ENDS products submitted under the Vuse Solo brand, although the FDA did not disclose the specific flavored products due to potential confidential commercial information issues. These products should not be introduced into interstate commerce and should be removed from the market if they are already available, according to the press release.
FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency. News release. FDA; October 12, 2021. Accessed October 13, 2021. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency
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