FDA Ignores Congress, Leaves Kids at Risk by Failing to Clear the Market of Unauthorized Synthetic Nicotine Products
Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids
July 14, 2022
WASHINGTON, D.C. – In March, Congress passed a new law that set a deadline of July 13, 2022, for manufacturers of synthetic nicotine products – including many e-cigarettes popular with kids – to obtain marketing authorization from the FDA in order to keep their products on the market. All unauthorized synthetic nicotine products are now illegal and by law must be removed from the market now, not at some undetermined date in the future.
It is unacceptable that this deadline came and went on Wednesday with the FDA taking only minimal action to enforce a law the FDA itself sought from Congress. The FDA issued its first two warning letters to manufacturers of synthetic nicotine products that failed to even file marketing applications. However, the FDA also said it is processing applications for approximately one million other products submitted by more than 200 manufacturers, but it took no action to remove any of these unauthorized products from the market despite the clear language of the law. Every one of these synthetic nicotine products is now illegal, and by law, it is now illegal to sell them. The FDA should act immediately to remove these products from the market while reviewing the applications. The FDA must also clear the market of any products that failed to submit marketing applications by the May 14, 2022, deadline for doing so.
The FDA’s failure to fully enforce the law and clear all unauthorized products from the market is unacceptable. It ignores explicit deadlines set by Congress and puts America’s kids at risk.
Additional Information
In March, Congress passed a new law enabling the FDA to regulate synthetic nicotine products as tobacco products and setting explicit deadlines for manufacturers to apply to the FDA and obtain marketing authorization to keep their products on the market. This law was in response to e-cigarette manufacturers’ growing use of synthetic nicotine – nicotine that is made in a lab, rather than derived from tobacco – to evade FDA regulation and keep selling flavored products that attract and addict kids. The most blatant example is Puff Bar, which is the most popular e-cigarette brand among kids and sells synthetic nicotine products with kid-friendly flavors like Banana Ice and Cool Mint. In 2021, 27% of middle and high school e-cigarette users reported Puff Bar as their usual brand, according to the 2021 National Youth Tobacco Survey. Other manufacturers have followed the Puff Bar playbook and switched to using synthetic nicotine, especially manufacturers of disposable e-cigarettes that are popular with kids. Disposables are used by 54% of all youth e-cigarette users.
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. In addition, 44% of high school e-cigarette users report frequent or daily use, a strong sign they are becoming addicted to the nicotine-loaded products on the market today.