The U.S. Food and Drug Administration (FDA) continues to move through the premarket tobacco product applications under its review. On July 17, 2025, the FDA authorized Juul’s e-cigarette and flavor pods for sale in the U.S.. The flavor pods authorized for sale  include Virginia tobacco flavor in 3 percent and 5 percent nicotine concentrations and menthol flavor in the same concentrations.

This development is concerning, despite the FDA’s claims that these authorizations meet appropriate requirements for the protection of public health standard. In its marketing granted order for Juul products, the FDA redacted important information relevant to determining how Juul has met the FDA’s requirements. The FDA claims that its goal is to limit the use of tobacco products by young people, but when it authorizes a flavor like menthol, that claim is more difficult to believe.

Data related to how e-cigarettes help adult smokers quit is still forthcoming. Most of what is available shows a limited benefit from using e-cigarette products, and some research shows these products can in fact lead to continued use of both combustible and e-cigarette products.  Dual use is more likely to occur without a treatment intervention. In addition, researchers are still collecting data about the actual harm of e-cigarettes. Nicotine causes addiction, which is itself a public health issue. Nicotine can contribute to the development of cancer and be a factor in cardiovascular issues. E-cigarettes also contain other chemicals and metals that could cause potential future harm to users.

There is limited data on whether flavored products benefit users wishing to quit. Significant research, however, has found that the tobacco industry uses menthol flavor to hook people more quickly and deeply to nicotine. By authorizing menthol e-cigarettes, the direction the FDA wants to take regarding the protection of public health is unclear. When the FDA was considering banning the sale of menthol cigarettes and flavored cigars, it noted that these flavors made it harder for smokers to quit and were enticing to children. This recent decision to allow one of the most addictive flavors in both NJOY e-cigarettes and now Juul products does not appear to advance the protection of public health.

The FDA does warn Juul that its marketing order is subject to monitoring, particularly on the way it markets its products. The FDA states that Juul is not allowed to market to children and young people, and if it does, the FDA can rescind the marketing order. This is the same warning the FDA gave Zyn when it authorized Zyn’s flavored nicotine pouches.

Now that the FDA is emphasizing enforcement of foreign tobacco products, perhaps it will also ensure that domestic manufacturers and distributors abide by FDA rules. The FDA still has a responsibility under the Family Smoking Prevention and Tobacco Control Act to ensure that products it authorizes are appropriate for the protection of public health. Public health should be about everyone in the country and not only for what is best for users of tobacco products. The Tobacco Control Act gives ample jurisdiction to the FDA to regulate tobacco products of all types, and the FDA should exercise its ability to regulate and monitor tobacco products better to benefit the general public.

Esther Agbaje
Lead Staff Attorney
July 24, 2025