FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products

On 26 August 2021, the US Food and Drugs Administration (FDA) announced a ban on the sale of more than 55 000 flavoured electronic cigarette products because they pose a health risk to young people. In Switzerland, all of these products are freely available without any control regarding their chemical content, without any government restriction on sales to minors and without any taxation.

As the FDA writes in a release, the agency imposed a distribution ban on certain electronic nicotine delivery systems (ENDS) on the grounds that they present a risk to public health among adolescents in the US. Given the public health threat presented by the well-documented, alarming use of flavoured ENDS among adolescents, the agency reviewed the applications subject to this action to determine whether there was sufficient scientific evidence of health benefits for adult smokers that would outweigh the risk to adolescents. In the absence of such evidence, the FDA issued a ban on distribution.

Out of the over 55,000 products of three applicants affected by the decision, those products that are not yet sold may not be put on the market, and those already on the market must be removed.

Applications for over 6,5 million flavoured products

In total, the FDA has received marketing applications from over 500 companies, concerning more than a staggering 6.5 million nicotine products. Although the agency has already issued other negative notices for some applications, this is the first set of bans for related products. The market leader Juul is not yet affected. However, applications for the remaining products are still under review. According to the release, the authority aims to shape the current market in such a way that all ENDS products available for sale are demonstrably "appropriate for the protection of public health".

Significant step

Although ENDS are often marketed as smoking cessation aids for adults, health experts have been sounding the alarm for years about a worrying rise in use among children and adolescents. In the US, e-cigarette sales increased by nearly 300% between November 2016 and August 2019, according to the US Centers for Disease Control and Prevention. Nearly 20% of high school students reported using e-cigarettes in 2020. Banning the sale of all flavoured tobacco or nicotine products - including flavoured e-cigarettes, menthol cigarettes and flavoured cigars - is critical to stopping the e-cigarette epidemic among youth and creating the first tobacco-free generation.

After all, the tobacco and nicotine industry has a long tradition of targeting children with flavoured products, and there is clear evidence that flavours play a key role in youth initiation and continued use of tobacco and nicotine products.

Additional links:

FDA press release: https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-applications-about-55000-flavored-e-cigarette-products-failing-provide-evidence

Article from CNN: https://edition.cnn.com/2021/08/26/health/fda-blocks-ecig-products/index.html

On the e-cigarette epidemic among youths: https://www.tobaccofreekids.org/what-we-do/us/flavored-tobacco-products