FDA Orders E-Cigarette Manufacturers to Remove Flavored Products from Market

In a move that has been anticipated for months, the U.S. Food and Drug Administration issued a press release this week announcing a new enforcement policy that applies to unauthorized flavored cartridge-based e-cigarette products that appeal to children. The announcement comes amid increasing concerns about e-cigarette manufacturers enticing children with candy-like flavors and targeting teens, young adults and prior non-smokers with aggressive marketing tactics previously used by the tobacco industry to attract underage users. According to the FDA’s new flavored e-cigarette policy, e-cigarette manufacturers have 30 days to cease the manufacture, distribution and sale of certain unauthorized flavored cartridge-based e-cigarette products that appeal to underage users, including fruit and mint flavored products.

Youth E-Cigarette Use an Epidemic in the U.S.

“Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration today issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors,” the FDA news release states. Flavored cartridge-based e-cigarettes are a type of electronic nicotine delivery systems (ENDS) product featuring a cartridge or pod that holds a nicotine-containing liquid that becomes aerosolized when the product is used. These e-liquid cartridges deliver a potent dose of nicotine without the harsh flavor or smell associated with combustible cigarettes. This smoother nicotine experience, paired with the fruity flavors many e-cigarettes come in, are what make e-cigarettes like JUUL vape pens so popular among youth.

The primary objective of this new FDA policy is to limit children’s access to e-cigarette products that are easy to use, easily concealable and available in flavors that are extremely appealing to underage users, including fruit and mint flavors. “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,” says FDA Commissioner Stephen M. Hahn, M.D. The FDA expects e-cigarette manufacturers to comply with the new policy banning the manufacture, distribution and sale of flavored e-cigarette products other than tobacco or menthol. However, the agency is prepared to take regulatory action against any companies that fail to do so.

E-Cigarettes as Addictive as Combustible Cigarettes

E-cigarette manufacturers like JUUL Labs continue to claim that their products provide a safer alternative to combustible cigarettes and can help current smokers quit smoking cigarettes. However, new research shows that JUUL vape pens have the same flavor and addictive profile as Marlboro cigarettes. And even if e-cigarettes do offer a potential smoking cessation benefit for cigarette smokers, there is a growing body of evidence suggesting that the devices are attracting youth who have never used cigarettes at an even higher rate. “The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes,” states Department of Health and Human Services (HHS) Secretary Alex Azar in the FDA’s press release. “By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth.”

E-Cigarette Use Among U.S. Students

This new e-cigarette enforcement policy comes as the 2019 National Youth Tobacco Survey, a study on e-cigarette use in the United States, shows that more than five million middle and high school students in the U.S. are current e-cigarette users, with a majority of users reporting cartridge-based products as their preferred type of e-cigarette product. Another study from November 2019 warns that adolescent e-cigarette use has increase dramatically since 2016 and that young e-cigarette users are particularly attracted to flavors like fruit and mint, significantly more so than tobacco or menthol flavors. According to this new e-cigarette policy, beginning 30 days from the date the release was published, the agency will prioritize enforcement against illegally marketed electronic nicotine delivery systems by focusing on the following types of e-cigarette products:

• 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.

The growing rate of e-cigarette use among teens and young adults is particularly alarming because, in addition to the potential health risks associated with e-cigarettes, youths who use e-cigarettes are at risk for nicotine addiction and are also more likely to try conventional cigarettes in the future.