FDA’s Approval of Fruit-Flavored E-Cigarettes Sparks Debate

Recently, the Food and Drug Administration (FDA) approved fruit-flavored e-cigarettes, causing controversy. A new memo suggests these flavors are not much better at helping smokers quit than tobacco-flavored ones. This decision supports these products as less harmful than traditional cigarettes, despite concerns they appeal to children.

Health organizations and lawmakers criticized the decision, demanding clarification from the FDA. A six-page memo detailed the agency’s reasoning. It highlights how regulators navigate the challenge of sweet vaping flavors’ attractiveness to youths, and the poor data from Glas Inc., the manufacturer.

For federal approval, companies must prove their products benefit public health. This includes showing their vapes help smokers quit or switch from cigarettes without attracting teenagers. The memo states smokers using Glas vapes were more likely to switch fully from cigarettes over three months. However, no “statistically significant differences” appeared between those using fruit flavors and tobacco-flavored e-cigarettes.

This finding contrasts other e-cigarettes that met FDA standards, like menthol products from Juul and NJOY, which were shown to help adults quit more effectively than tobacco flavors. FDA explained Glas products did not need to prove additional adult benefits as likely underage use was limited by a required age-verifying app.

Despite this, FDA guidelines suggest fruit and dessert flavors must meet high standards for adult use due to risks to children. Tobacco-flavored products generally face fewer regulatory challenges.

The FDA memo’s unusual brevity is notable. Past memos on new vaping products are typically longer, like the 90-page document for Juul’s menthol e-cigarettes, including data from studies involving 50,000 people. The Glas document lacks essential details, such as smoker study numbers. This memo only appeared on the FDA’s site over a month post-approval, differing from typical immediate posts.

Congress members questioned the decision. Ten Democratic senators wrote to the FDA expressing concern and urging more information, calling the authorization “shortsighted and reckless.”

Glas’s application, including menthol and tobacco flavors, faced a convoluted path. Submitted in 2021, initial approvals in February were overridden by a senior official under then-FDA Commissioner Marty Makary. Approval for mango- and blueberry-flavored products came during Makary’s final week, amidst criticism and lobbying for relaxed regulations from the tobacco industry. Efforts to reach Glas for comment were unsuccessful.

The Associated Press reports with support from Howard Hughes Medical Institute’s Science Education and the Robert Wood Johnson Foundation. AP maintains full editorial control.