Why is the FDA approving kid-friendly, fruit-flavored e-cigarettes?
Fruit-flavored e-cigarettes recently authorized by the Food and Drug Administration were not significantly better at helping smokers quit than tobacco-flavored e-cigarettes, according to a new memo that’s likely to stir more questions about the agency’s decision. The FDA last month gave its first OK to fruit-flavored vapes — essentially endorsing them as a less-harmful alternative to traditional cigarettes. The decision came despite the agency’s longstanding position that such flavors appeal to children and must show extra health benefits to warrant approval for adults. Health groups and Washington lawmakers quickly condemned the decision and have called for an explanation. A six-page FDA memo released this week provides more details about the agency’s rationale. In it, FDA regulators appear to sidestep previous statements about the risks of sweet vaping flavors while acknowledging shortcomings in the data submitted by vape manufacturer Glas Inc. To meet federal standards, companies must show that their products benefit public health. In practice, that means demonstrating that their vapes help adult smokers switch or quit cigarettes, while not attracting underage use by teens. Smokers who tried Glas vapes were much more likely to completely switch from cigarettes over the course of a three-month study, according to the memo. But the data did not show “statistically significant differences” between adults using the company’s mango and blueberry flavors and those using a tobacco-flavored e-cigarette. That means the new vapes failed to meet the same bar as a handful of other flavored products previously sanctioned by the FDA, including menthol-flavored vapes from Juul and NJOY. Those companies showed that adults who used menthol were significantly more likely to cut down or quit cigarettes compared with those vaping tobacco flavors. Elsewhere, FDA regulators explained that the Glas flavored vapes “did not have to demonstrate added adult benefit,” because yo