FDA Must Enforce Congressionally… | Campaign for Tobacco-Free Kids
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FDA Must Enforce Congressionally Mandated Deadline and Remove Unauthorized Synthetic Nicotine Products From the Market After July 13

Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids
July 12, 2022

WASHINGTON, D.C. – In March, Congress passed a new law enabling the FDA to regulate synthetic nicotine products as tobacco products and setting explicit deadlines for FDA review of these products. Manufacturers of synthetic nicotine products had until May 14, 2022, to submit marketing applications to the FDA; if products did not receive marketing authorization by July 13, 2022, they would be illegal and must be removed from the market.

As we approach the July 13 deadline, the FDA has an obligation to enforce the law and clear the market of any synthetic nicotine products, including e-cigarettes, that have not obtained FDA authorization by that date. If the FDA allows unauthorized products to remain on the market, it will be directly contrary to the law passed by Congress and leave America’s kids at risk. There is no excuse for the FDA failing to act given the mandate and deadlines established by Congress.

The FDA’s record so far in enforcing this law is unacceptable. STAT News reported Friday that the FDA has not taken action to date against any synthetic nicotine manufacturer that didn’t submit an application by the May 14 deadline; nor would the FDA disclose how many applications were filed. The FDA also would not commit to taking enforcement action against products that do not receive marketing authorizations.

It would be outrageous if the FDA failed to enforce the law after Congress acted with urgency to address a growing threat to the health of our nation’s kids: E-cigarette manufacturers’ use of synthetic nicotine to evade FDA regulation and keep selling flavored products that attract and addict kids. In recent years, a growing number of e-cigarette makers have switched to using synthetic nicotine – nicotine that is made in a lab, rather than derived from tobacco – after the FDA acted against their flavored products made with tobacco-derived nicotine. 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 is 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.

Congress took a critical step to end this youth addiction crisis by authorizing the FDA to regulate synthetic nicotine products. The FDA has an obligation and responsibility to enforce the law.