The U.S. Food and Drug Administration on Thursday announced a finalized policy that it says will prioritize enforcement “against certain unauthorized flavored e-cigarette products” that appeal to children, including those with fruit or mint flavors. Tobacco- and menthol-flavored products, which studies have shown to be less popular with youth, are not subject to the crackdown.
Companies must cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes within 30 days. Companies that fail to comply will be subject to FDA sanction.
In a news release announcing its plan, the FDA noted more than 5 million U.S. middle and high school students reported using e-cigarettes within the past 30 days and about 1.6 million reported using on 20 or more days within the past 30-day period, per statistics from the 2019 National Youth Tobacco Survey.
HHS Secretary Alex Azar said youth use of e-cigarettes is an epidemic of substance use that has risen at an unprecedented rate in the U.S.
“By prioritizing enforcement against 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,” Azar said in a statement.
The enforcement against e-cigarette flavors that are particularly appealing to children is part of a broader effort by the federal government to curb nicotine intake by young people, as recently signed legislation pushed the minimum age for purchasing tobacco to 21.
The FDA said it will continue to monitor e-cigarette usage patterns and that if tobacco- and menthol-flavored products rise in popularity with youth, additional enforcement steps could be taken.
FDA also announced Thursday that for all products not currently subject to its crackdown, manufacturers still must “take adequate measures to prevent youth access,” including:
- Implementing adequate programs to monitor retailer compliance with age verification and sales restrictions, with appropriate penalties for retailers who do not comply
- Using adequate age verification to prevent underage access to its website and Internet-based sales
FDA said it will also prioritize enforcement against products that are targeted to youth or likely to promote usage by youth.