Congressional Agreement Will Stop E-Cigarette Makers from Using Synthetic Nicotine to Evade FDA Regulations that Protect Kids and Public Health

WASHINGTON, D.C. – The Campaign for Tobacco-Free Kids strongly supports the bipartisan legislative agreement in Congress to enable the FDA to regulate synthetic nicotine products as tobacco products, which is included in the omnibus appropriations bill. Synthetic nicotine poses a new and growing threat to the health of our nation’s kids. Congressional action is urgently needed to stop e-cigarette companies from using synthetic nicotine to blatantly evade FDA regulation and continue selling flavored e-cigarettes that are attracting and addicting kids. This agreement is an important victory for our nation’s kids and public health and should be swiftly enacted into law.

Current federal law (the 2009 Family Smoking Prevention and Tobacco Control Act) gives the FDA the authority to regulate tobacco products and defines a “tobacco product” as a product made or derived from tobacco. To evade FDA regulation, a growing number of e-cigarette manufacturers have switched to using synthetic nicotine – nicotine that is made in a lab rather than derived from tobacco – and are marketing these products with the kid-friendly flavors that fueled the youth e-cigarette epidemic in the first place. These efforts pose a serious threat to the FDA’s overall authority to protect kids and public health from e-cigarettes and other tobacco products. If left unaddressed, manufacturers of thousands of e-cigarettes – as well as other tobacco products – are likely to switch to synthetic nicotine to evade critical public health protections, including premarket review requirements for new tobacco products, the nationwide tobacco sale age of 21, and health warnings.

Critically, the legislation before Congress requires manufacturers of synthetic nicotine products to obtain FDA authorization to keep a product on the market, a process that requires demonstrating that the product is appropriate for the protection of public health. Within 120 days of enactment of the legislation, all products made with synthetic nicotine must have an FDA marketing order or they will be illegal and subject to FDA enforcement to take them off the market.

This new threat to kids has become all too real in recent years. In 2020, the FDA ordered Puff Bar to remove its flavored disposable e-cigarettes from the market because of their appeal to kids. In 2021, Puff Bar reentered the market as a synthetic nicotine product with kid-friendly flavors like Banana Ice and Cool Mint. Puff Bar products continue to be sold and are now the most popular e-cigarette brand among youth, with 27% of middle and high e-cigarette users reporting Puff Bar as their usual brand in 2021, according to the 2021 National Youth Tobacco Survey. Other manufacturers are following the Puff Bar playbook. Starting in fall 2021, after the FDA denied marketing applications for many flavored e-cigarettes because of their appeal to kids, some manufacturers reintroduced their products with claims that they had switched to synthetic nicotine. 

Youth e-cigarette use remains a serious public health problem in the United States, with over 2 million middle and high school students using e-cigarettes in 2021. Flavors have fueled this crisis as 85% of youth e-cigarette users report using flavored products. By stopping manufacturers from using synthetic nicotine to evade FDA regulation, Congress is taking a critical step to end this youth addiction crisis once and for all.