Enforcement Against Unauthorized Flavored E-Cigarettes Appealing to Children Prioritized by FDA

This article was updated on January 6, 2020 at 4:40pm.

The FDA released a policy last week indicating prioritized enforcement against certain unauthorized flavored e-cigarette products that appeal to children, including fruit and mint flavors.

Under this policy, companies that do not cease manufacture, distribution, and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk enforcement actions by the federal agency.

“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 Alex Azar, secretary of the HHS, in a prepared statement.

The final guidance outlining the agency’s enforcement priorities for electronic nicotine delivery systems (ENDS), such as e-cigarettes and e-liquids, comes as the 2019 National Youth Tobacco Survey (NYTS) results on e-cigarette use show that more than 5 million middle and high school students in the United States are current e-cigarette users (having used within the last 30 days), with a majority reporting cartridge-based products as their usual brand.

“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. We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary,” said Azar in a prepared statement.

The NYTS survey, which is conducted annually by the FDA in conjunction with the CDC, also shows that of current youth e-cigarette users in 2019, approximately 1.6 million were using the product frequently, with nearly 1 million using e-cigarettes daily.

Beginning 30 days from the publication of the notice, the FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization, including:

• Any flavored, cartridge-based ENDS products (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 statement noted that the FDA’s enforcement priorities are not a ban on flavored or cartridge-based ENDS, and that the FDA has already accepted and begun review of several premarket applications for flavored ENDS products. The guidance also states that, after May 12, 2020, the FDA intends to also prioritize enforcement against any ENDS products that continue to be sold and for which the manufacturers have not submitted a premarket application.

“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. 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,” said FDA Commissioner Stephen M. Hahn, MD, in the statement.

Potential actions used to enforce the FDA’s policy were not addressed in the agency’s Jan. 2 statement. In recent years, the FDA has issued warning letters, and civil money penalties to companies in violation of vaping- and e-cigarette-related policies.

According to Stephanie Caccomo, a representative for the FDA, the federal agency's decisions are determined on a case-by-case basis. Depending on the situation, warning letters or enforcement actions may be pursued against the manufacturer, the retailer, or both.

REFERENCE

FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint [press release]. FDA website. Published January 2, 2020.https://www.fda.gov/news-events/press-announcements/fda-finalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes-appeal-children. Accessed January 6, 2020.