FDA Targets Vape Products Marketed to Children

Saying underage use of e-cigarettes has reached “epidemic levels”, the U.S. Food and Drug Administration last week issued a policy stepping-up enforcement against specific, unauthorized flavored e-cigarette products including fruit and mint flavors designed to appeal to kids. 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 FDA enforcement. And what does that mean to local shops selling these products? Follow federal law, sell to customers age 21 or older. When in doubt, check I.D.

According to the FDA, among middle and high school students, over 5 million were current users of e-cigarettes in 2019 and almost 1 million were using e-cigarettes daily. A survey in 2014 reported 81 percent of youth e-cigarette users cited appealing flavors as their primary reason for use. Back in 2016 all e-cigarettes and other ENDS products became subject to FDA’s tobacco authorities. Electronic nicotine delivery systems (ENDS, and more commonly known as vapes) are described as noncombustible tobacco products, which use a liquid that’s heated to create an aerosol, or vapor, that the user inhales. Such liquids may contain nicotine, as well as flavorings, propylene glycol, vegetable glycerin, and other ingredients.

E-cigarettes and ENDS products on the market at that time needed FDFA authorization to be legally marketed, but the agency deferred enforcement of the premarket authorization requirements. To date, no ENDS products have been authorized by FDA — meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in FDA’s discretion. Beginning 30 days from the publication of the notice of availability of this guidance in the Federal Register, 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:

• 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 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 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. Additional data from another federal survey further underscore that youth are particularly attracted to e-cigarette flavors such as fruit and mint, much more so than tobacco or menthol flavored e-cigarettes. 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. In particular, evidence shows that youth exposure to nicotine can adversely affect the developing adolescent brain and that, compared with non-users, youth who use e-cigarettes are more likely to try conventional cigarettes in the future.
Parents: do you know the terminology (vaping, JUULing, mods), or have you been told that vaping is less dangerous or less addictive than smoking tobacco? Read more and get facts from the Centers for Disease Control at cdc.gov/tobacco Or check out hopkinsmedicine.org and search keywords “5-truths-you-need-to-know-about-vaping”


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