The U.S. Food and Drug Administration issued a guidance this month that signaled its willingness to authorize an array of flavored e-cigarettes. The agency need not do this and would be acting well within its authority in the Family Smoking Prevention and Tobacco Control Act if it continued to authorize only tobacco- and menthol-flavored e-cigarettes. The guidance also envisions a future in which the vaping industry surveils and collects personal information in potentially troubling ways.

In 2009, The Tobacco Control Act gave the FDA authority to regulate tobacco products, including the authority to conduct premarket review to determine whether to authorize such products for sale. The Tobacco Control Act originally only covered cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, but it empowered the FDA to deem other products to be tobacco products within the meaning of the Act as well. The agency exercised this authority in 2016, bringing several new types of products under its purview, including e-cigarettes.

The first e-cigarettes that the FDA authorized in 2021 were all tobacco flavored, though the agency also issued marketing granted orders for menthol-flavored products in 2024. The agency has issued such orders for 41 e-cigarette products to date, all of which are tobacco- or menthol-flavored. This is despite the FDA receiving millions of applications, most of which have been for flavors other than tobacco or menthol. Given the products that the agency has chosen to authorize thus far, the FDA has appeared hesitant to authorize e-cigarettes with flavors other than tobacco and menthol, likely because of the youth appeal of other flavors.

However, the agency has expressed some openness to other flavors of e-cigarettes. For instance, in his keynote address to the Food and Drug Law Institute’s Tobacco and Nicotine Products Regulation and Policy conference last October, the acting director of the FDA’s Center for Tobacco Products stated that proper age-gating technologies could facilitate the authorization of kiwi-strawberry-flavored e-cigarettes. The FDA also authorized several flavors of nicotine pouches last year, including cinnamon, coffee, citrus, and mint.

In the guidance published last week, the FDA elaborated on its position on flavored e-cigarettes as well as age-gating technologies. The agency differentiated between flavors that have higher and lower risks of youth appeal, concluding that it is well established that e-cigarettes flavored with fruit, candy, desserts, and other sweets have a high risk of youth appeal in comparison with flavors such as coffee, teas, menthol, mint, and spices. This sends an impression that the agency may be willing to authorize e-cigarettes with some range of flavors beyond tobacco and menthol.

The guidance also indicates that the FDA believes that device access restrictions could impact the agency’s willingness to authorize flavored e-cigarettes. Device access restrictions could include software or technologies that are part of the device, such as mechanisms for confirming age and identity using fingerprints or other biometric parameters. Further measures for making youth access less likely might include geo-fencing technologies that make the device inoperable at certain locations like playgrounds and schools. Though the guidance suggests that the FDA sees promise in these technologies, it is also clear that there is a lack of evidence about the extent to which e-cigarettes with device access restrictions can mitigate risks of youth appeal. The guidance concludes that such technologies may be one part of a comprehensive youth prevention strategy, but they would not on their own be sufficient to satisfy the high evidentiary burden for authorizing e-cigarettes with flavors like fruit, candy, and sweets.

In the end, this guidance raises some concerns. It contemplates a future in which the FDA authorizes e-cigarettes in many flavors, and with so-called "smart vapes" with features like touchscreens and phone connectivity already pervading the market, the FDA sees value in a turn to even smarter devices. Before embracing this future, the FDA should carefully consider whether such technologies truly protect youth or instead merely provide industry with a clearer pathway for expanding the market for flavored tobacco products.

Luke Haqq, Staff Attorney
March 17, 2026