"If the only reason why a major player like this is putting completely unauthorized and illegal products on the market is because of the FDA enforcement guidance, to me, it shows how wrongheaded that guidance is both as a public health matter, but also as a legal matter."
— Mitch Zeller, former director of the FDA's Center for Tobacco Products
"If major manufacturers conclude that compliance offers little advantage over introducing products first and dealing with regulatory consequences later, it could encourage broader noncompliance across the marketplace."
— Cristine Delnevo, director of the Rutgers Institute for Nicotine and Tobacco Studies
Zeller also warned about consumer confusion: with unauthorized fruit-flavored vapes from Reynolds sitting on shelves alongside both FDA-authorized products and illicit disposable vapes from foreign manufacturers, the marketplace becomes impossible for consumers to navigate. "How is the health-concerned adult cigarette smoker thinking of switching to e-cigarettes supposed to sort all this out?" he asked. "They're not going to go to FDA websites and look at the list of authorized products."
Delnevo offered a more nuanced view, noting that fruit-flavored vapes "aren't inherently good or bad." The question, she said, is "whether a specific product, marketed in a specific way, produces a net public health benefit at the population level." Her research at Rutgers suggests that the products with the greatest youth appeal are unauthorized vapes from foreign brands that "appear to have little interest in participating in FDA's pre-market review process."
