An FDA memo reported no statistically significant difference between smokers using mango- and blueberry-flavored e-cigarettes and those using tobacco-flavored products. Photo credit: Rushay Booysen, Pexels.
A newly-released US Food and Drug Administration (FDA) memo has prompted debate over the agency's recent decision to authorize fruit-flavored e-cigarettes, after the document indicated the products did not outperform tobacco-flavored alternatives in helping adult smokers switch away from cigarettes.
Last month FDA authorized four electronic nicotine delivery system (ENDS) products from California-based Glas Inc, marking the agency's first authorization of non-tobacco and non-menthol vaping products in the US. The authorized products include mango- and blueberry-flavored offerings as well as menthol variants.
According to the FDA memo released this week, adult smokers who used Glas products showed higher rates of completely switching from cigarettes during a three-month study. However, regulators stated that data submitted by the company showed no statistically significant difference between smokers using the mango and blueberry products and those using a tobacco-flavored e-cigarette.
The finding contrasts with previous FDA authorizations for flavored vaping products. The agency noted that applications for menthol products from companies including Juul and NJOY demonstrated that adult users of menthol products were significantly more likely to reduce or stop cigarette smoking than users of tobacco-flavored products.
For years, FDA maintained that fruit- and dessert-flavored vaping products face a higher regulatory hurdle because of concerns that such flavors could appeal to underage users. Agency guidance has stated that manufacturers must provide strong evidence of additional benefits for adult smokers to justify authorization.
In the Glas decision, FDA reviewers concluded that the company’s products did not need to demonstrate added adult benefit because youth uptake appeared unlikely. Regulators cited the firm's age-verification system, which requires users to unlock devices through a smartphone application that verifies age before use.
The memo has drawn criticism from health organizations and lawmakers seeking greater transparency regarding the agency's rationale. Questions have also emerged about the document itself, which spans only six pages. Previous FDA reviews of vaping products have typically run much longer and included more detailed scientific information. The memo for Glas does not disclose key study details, including the number of participants involved.
The authorization represents a notable shift in FDA policy. Until May, the agency had authorized only tobacco- and menthol-flavored e-cigarettes through the premarket tobacco product application process. Following the Glas decision, FDA's list of authorized e-cigarette products expanded to 45 products.
FDA announced the authorization on May 5 after reviewing Glas's application through the PMTA pathway. The agency said the products met the legal standard requiring that marketing authorization be appropriate for the protection of public health.