For the first time, health officials with the Food and Drug Administration (FDA) have authorized a set of electronic cigarettes through the Premarket Tobacco Application (PMTA) process. This marketing authorization means that these select products can now be legally sold in the U.S.
FDA marketing authorization is not the same as FDA approval, and the FDA emphasized that these products are still unsafe. Since their 2007 introduction onto the market as tools to help smokers quit, vapes have seen very little government testing or oversight. Lobbying by big vaping companies has stalled the FDA's efforts to regulate these tobacco products.
"Today's authorizations are an important step toward ensuring all new tobacco products undergo the FDA's robust, scientific premarket evaluation," Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products, said in a statement.
The authorization covers specific R.J. Reynolds (NASDAQ: REYN) (RJR) vaping products, including the Vuse Solo and its tobacco-flavored e-liquid pods. Vuse is the second most popular vape brand in the U.S. after Juul and makes up roughly a third of the market. RJR also sells Newport, Camel, and other popular combustible cigarettes.
The authorization was contingent upon the manufacturer's ability to prove that its e-cigarettes "could benefit addicted adult smokers who switch to these products", either by significantly reducing or completely ending the users' "exposure to harmful chemicals" compared to the use of combustible cigarettes.
"We must remain vigilant with this authorization and we will monitor the marketing of the products," Zeller continued. "We will take action as appropriate, including withdrawing the authorization."
Companies can lose authorization if it's proven that their products are being used by consumers who didn't use tobacco previously, including young people. In September, the FDA rejected similar applications for authorization due to the possible interest in the applicants' products amongst teen users.
Companies can also lose authorization if they fail to meet any requirements set by regulators. These requirements include proving that the electronic product is less harmful than traditional cigarettes.
While the FDA authorization covered a number of Vuse Solo products, the agency rejected 10 products submitted under the brand. The names of these products are not being released by the agency. If retailers have stock of any Vuse Solo products not covered in the FDA order, the FDA recommends they contact RJR.
"These products... may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement," the statement reads. "The agency is still evaluating the company's application for menthol-flavored products under the Vuse Solo brand."
A 2021 study on teen vaping conducted by the FDA and the Centers for Disease Control and Prevention (CDC) showed that more than 10% of youth e-cigarette users reported using Vuse products. Puff Bar was the most popular brand amongst young users, accounting for 26.1% of youth e-cigarette smokers.
The FDA defended its decision to authorize Vuse despite its relative popularity by arguing that teen vape users aren't likely to switch to cigarettes, and most teen users start with sweet flavors not covered by the authorization. The authorization also strictly limits where and when Vuse is allowed to advertise and may be withdrawn if teen vaping increases significantly.
The FDA called on vape manufacturers to submit PMTAs for all products by September 2020. Since then, the agency has reportedly responded to 98% of applications, including the rejection of more than a million products. However, decisions remain to be made on some of the biggest manufacturers, including Juul.