FDA approves fruit-flavored vapes

The Food and Drug Administration (FDA) authorized fruit-flavored vaping products for the first time.

• Why it’s important: Flavored products are particularly appealing to young people, who are also more susceptible to the addiction and other risks associated with nicotine. While the goal is to help adults who smoke cigarettes quit, these vaping products may not sufficiently help achieve that goal, while introducing nicotine to some young people who would not otherwise use the substance.

The details:

• The authorizations allow the sale of Glas blueberry and mango vaping pods, as well as two menthol-flavored products, to adults 21+.
• FDA said a “rigorous, scientific review” found that “device access restriction” technology combined with FDA’s restrictions around marketing would “effectively mitigate the ability of youth to use the product.”
• Users of Glas e-cigarettes are required to verify their age and identity with government-issued ID and to pair the device to a phone using Bluetooth. Following verification, the device will not operate if separated from the phone, and the app conducts random biometric check-ins to periodically confirm the registered user is the one using the device. FDA said that Glas demonstrated that most adults successfully completed age verification and found the instructions and age-verification software easy to understand and activate, while young people could not.
• FDA is requiring Glas to “carefully target” advertising to people 21+. The company must also track, measure, and report to FDA the effectiveness of its youth prevention measures and provide analyses of the demographics of the audiences reached by its advertising, marketing, and promotional activities.

The bigger picture: The approval marks a major shift, and there are concerns that the process was political rather than driven by the science only.

• FDA for years worked to regulate flavored vapes, rejecting more than 1 million fruit-, candy-, and dessert-flavored products. In March, FDA released draft guidance suggesting it was open to approving flavors like coffee, mint, and cinnamon. But it said that vapes with fruit, candy, and dessert-like flavors “pose a substantial public health risk.”
• FDA Commissioner Makary initially opposed authorizing the products, despite career staff signing off on the authorization, as his office was concerned about the impact on public health. But the White House urged him to greenlight the products.

Read more: FDA authorizes fruit-flavored vapes for the first time; In a first, FDA authorizes fruit-flavored vapes for adults; Why the FDA is authorizing fruit-flavored vapes