The Food and Drug Administration (FDA) issued an enforcement policy, effectively banning most flavors from unauthorized cartridge-based e-cigarettes until companies go through the premarket tobacco application (PMTA) process.
The FDA said that companies that do not cease to manufacture, distribute and sell the flavored cartridge-based e-cigarettes, excluding tobacco and menthol, in 30 days following the publication of the guidance risk enforcement actions.
The FDA will prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
“Coupled with the recently signed legislation increasing the minimum age of sale of tobacco to 21, we believe this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery,” said FDA Commissioner Stephen Hahn. “While we expect that responsible members of industry will comply with premarket requirements, we’re ready to take action against any unauthorized e-cigarette products as outlined in our priorities. We’ll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary.”
The FDA said the 2019 National Youth Tobacco Survey, conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, showed that more than 5 million U.S. middle and high school students have used e-cigarettes in the past 30 days, with a majority reporting cartridge-based products as their usual brand.
“These overall levels of youth e-cigarette use are particularly concerning because using e-cigarettes puts them at risk for nicotine addiction and other health consequences,” the FDA said.
Last week, the FDA officially changed the federal minimum age to purchase tobacco from 18 to 21, which applies to all tobacco products, including e-cigarettes and vaping cartridges. The provision came as part of a $1.4 trillion spending package signed by Trump on Dec. 20, which amended the Federal Food, Drug and Cosmetic Act.
On Dec. 31, during his New Year’s Eve party at Mar-a-Lago, Trump spoke about an upcoming ban of flavored e-cigarettes but said it might be temporary.
“Look, vaping can be good from the standpoint — you look at the e-cigarettes, you stop smoking,” he said. “If you can stop smoking, that’s a big advantage. So, we think we’re going to get it back on the market very, very quickly.”
Starting in May, all e-cigarettes will need to undergo FDA review. Under the premarket tobacco product applications (PMTA) pathway, manufacturers must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health.
“People have died from this, they died from vaping,” Trump said. “We think we understand why. But we’re doing a very exhaustive examination and hopefully everything will be back on the market very, very shortly.”