FDA clears e-cigarettes for sale, citing effects on smoking cessation
The authorization includes strict marketing restrictions for manufacturers, including restrictions on digital, radio and television advertising, to reduce the potential for exposure of young people.
As part of the first-of-its-kind approval, FDA officials authorized 3 new tobacco products to be marketed through the Pre-Market Tobacco Product Application (PMTA) route.
According to an FDA press release, the administration has issued marketing orders for the closed-end Vuse Solo device and its 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 approvals are an important step in ensuring that all new tobacco products pass the FDA’s pre-market scientific assessment,” said Mitch Zeller, JD, director of the Center for Tobacco Products at the FDA, in the press release. “The manufacturer’s data shows that 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.”
Within the framework of the PMTA chain, manufacturers must demonstrate that the marketing of the new tobacco product would be appropriate for the protection of public health. Newly approved products met this standard, according to the press release because, among several important considerations, the reviewers determined that study participants who used only authorized products were exposed to fewer harmful and potentially harmful aerosol constituents. compared to users of burnt cigarettes.
In addition, the toxicological evaluation revealed that the aerosols of authorized products are significantly less toxic than burnt cigarettes based on the comparisons of available data and the results of non-clinical studies. The FDA has also looked at the risks and benefits for the general population, including young people. The agency said it had determined that the potential benefits for smokers who completely or drastically change their cigarette consumption would outweigh the risk to young people, provided the applicant meets post-market requirements to reduce youth exposure and access to products.
The press release noted that the 2021 National Youth Tobacco Survey found that about 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 unflavored ENDS products, young people are less likely to start using tobacco-flavored ENDS and then switch to higher risk products, such as burnt cigarettes.
Research also suggests that most youth and young adults who use ENDS start with flavors such as fruit, candy, or mint, not tobacco flavors. This reinforces the FDA’s decision to only allow tobacco flavored products because they are less appealing to young people.
The clearance includes strict marketing restrictions for the company, including restrictions on digital, radio and television advertising, to reduce the potential for exposure of young people to tobacco advertising. The company is also required to regularly report product market information to the FDA, including current and completed consumer studies, advertisements, sales data, and current and new user information.
In addition to these approvals, the FDA also denied marketing applications for ENDS flavored products submitted under the Vuse Solo brand, although the FDA did not disclose specific flavored products due to potential issues of confidential business information. These products are not expected to enter interstate commerce and should be taken off the market if they are already available, according to the press release.
The FDA clears electronic cigarette products for sale, marking the agency’s first-of-its-kind clearance. Press 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