CLEVELAND — At a GetGo gas station close to a highway entrance in suburban Ohio, a brightly lit sign alerts customers to four new flavors of Vuse Pro vapes, now available in peach, berry, watermelon, and fresh mint.
These products from Reynolds American are already for sale in Ohio and select other states, even though they haven’t been authorized by the Food and Drug Administration. But the FDA effectively invited companies to start breaking the rules when it softened its enforcement guidance in May, according to some critics, setting the stage for what they say is likely to be a new wave of illegal fruit-flavored e-cigarettes.
“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,” said Mitch Zeller, a former head of the FDA’s Center for Tobacco Products.
The decision to move ahead with new products in the absence of FDA authorization could spur other big manufacturers frustrated with the agency’s decisions and timelines to do the same, said Cristine Delnevo, director of the Rutgers Institute for Nicotine and Tobacco Studies. (Tobacco giant Altria sued the FDA over the timeliness of its review process last week.) “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,” Delnevo said via email.
