FDA Authorizes Unpopular Vuse Vibe and Ciro Devices

Menthol-flavored Vice and Ciro refills remain under review, while the FDA wrestles with how to handle menthol vapes in light of its plan to ban menthol cigarettes. The agency issued Marketing Denial Orders (MDOs) for other Vuse flavors, as it has for previously authorized vape products. The FDA hasn’t authorized any products in flavors other than tobacco. Last August, the agency announced a new standard for flavored products—nearly a year after the deadline for submitting PMTAs.

The FDA has still not acted on Premarket Tobacco Applications (PMTAs) submitted by RAI for the Vuse Alto, a pod-based device nearly as popular as Juul Labs’ JUUL. Combined, the Alto and JUUL currently make up about 70 percent of the convenience store/gas station segment of the vape product market.

The FDA has been ordered by a federal judge to produce status reports on its progress reviewing PMTAs for the most popular brands of vaping products, including Vuse. The first report is due next Monday, and there had been some speculation that the agency would announce decisions on some of the best-selling products before that deadline. The Vuse Vibe and Ciro, however, are not popular products.

The FDA has not authorized any products from small independent manufacturers, most of whom have received boilerplate MDOs, and have been forced out of business or are challenging the agency in court.

American Vapor Manufacturers Association (AVM) President Amanda Wheeler said in a statement that “small and mid-sized businesses are being willfully strangled out of the market by FDA’s neo-prohibition policy.”