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.
