WHITE OAK, Md. – The Food and Drug Administration (FDA) finalized its enforcement policy Thursday that essentially bans certain unauthorized flavored e-cigarette products that appeal to children, including fruit and mint flavors.
Under the policy, companies are forbidden from manufacturing, distributing and selling all flavored cartridge-based e-cigarette products, except for tobacco and menthol flavors.
If businesses fail to comply with the FDA’s policy within 30 days, officials say they “risk FDA enforcement actions.”
The enforcement of the new policy comes amid epidemic levels of youth use of e-cigarettes and the popularity of certain products among children.
“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally,” said HHS Secretary Alex Azar.
The 2019 National Youth Tobacco Survey (NYTS) shows that more than 5 million U.S. middle and high school students are current e-cigarette users (having used within the last 30 days) – with a majority reporting cartridge-based products as their usual brand.
By not prioritizing enforcement against other flavored products in the same way as flavored cartridge-based products, the FDA has attempted to balance the public health concerns related to youth use with considerations regarding addicted adult cigarette smokers who may try to use electronic nicotine delivery system (ENDS) products to transition away from combustible tobacco products.
“Because of the relatively low numbers of youth using both menthol- and tobacco-flavored, cartridge-based ENDS products, these products are not among the current enforcement priorities,” wrote the FDA. “However, should the FDA become aware of an increase of youth using any other flavored products (both cartridge-based or otherwise), the agency will take additional steps to address youth use of those products if necessary.”
For all other products, including menthol-, tobacco-, and non-flavored ENDS products, the FDA says it will also prioritize enforcement where the manufacturer fails to take adequate measures to prevent youth access.
“For example, the FDA will consider whether the manufacturer has implemented adequate programs to monitor retailer compliance with age-verification and sales restrictions or if it has established and enforced penalties against retailers that fail to comply with those programs,” wrote the FDA. “The agency also will consider whether the manufacturer uses adequate age-verification technology (or requires that retailers who sell its products use such technology) to prevent underage access to its website and to prevent underage sales through the internet.”
In a press release, the FDA made note that its enforcement priorities are not an outright “ban” on flavored or cartridge-based ENDS.
"The FDA has already accepted and begun review of several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act. Manufacturers that wish to market any ENDS product – including flavored e-cigarettes or e-liquids – are required by law to submit an application to the FDA that demonstrates that the product meets the applicable standard in the law, such as whether the product is appropriate for the protection of the public health. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale."