FDA’s Decision To Block Sale of Popular Flavored E-Cigarettes Signals Stricter Tobacco Controls

The Food and Drug Administration (FDA) recently denied R.J. Reynolds’ applications to keep six flavored e-cigarette products under its Vuse Alto brand, including top-selling menthol, on the market.

The FDA has regulatory authority to evaluate whether new tobacco products meet specific public health standards. The agency denied Reynolds’ applications because they failed to meet the federal public health standard, which requires that the benefits for adult smokers outweigh the known risks to youth. Specifically, the menthol and mixed berry flavors did not demonstrate such benefits.

A study released by the Centers for Disease Control and Prevention underscores the nationwide scope of the vaping issue, revealing that 14.1% of high school students and 3.3% of middle school students used e-cigarettes in 2022. Among youth who used e-cigarettes, 84.9% used flavored e-cigarettes.

Our updated infographic for our 100 Arkansans initiative shows that the percentage of high school seniors in Arkansas who vaped nicotine at least once in the past 30 days remained virtually unchanged from 2020 to 2022 at about 17%.

To address youth vaping, ACHI has identified several policy options:

• Amend an Arkansas law that preempts local governments from enacting and enforcing regulations over the sale, distribution, and manufacture of e-cigarette products.
• Levy an excise tax on e-cigarettes that is no less than the tax on tobacco products and is based on nicotine amounts.
• Extend the Arkansas Clean Indoor Air Act to include e-cigarettes.
• Ban all flavored vaping liquids.
• Increase enforcement efforts to ensure retailers are complying with age restrictions for tobacco product purchases, including e-cigarettes.
• Prohibit e-cigarette advertising that targets youth.

The FDA’s decision is consistent with its responsibility to protect public health and its regulatory review standards for tobacco products. The agency not only is targeting menthol e-cigarettes but also is expected to extend its restrictions to all menthol cigarettes.

British American Tobacco, R.J. Reynolds’ parent company, is set to challenge the FDA’s decision, arguing it contradicts scientific evidence.