For the first time, the FDA has authorized a modern pod-based vaping product used with high-strength nicotine salt refills. The agency today issued marketing granted orders for the NJOY Ace device and three refill pods, allowing them to be legally sold in the U.S.
The decision is important because, until now, the FDA has only allowed the sale of older, less-effective—and less-popular—vaping devices. The Ace authorization indicates the federal regulator is not opposed in principle to high-strength products that use nicotine salt e-liquid.
The vaping products authorized previously are the Vuse Solo (and refill cartridges), and the Logic Power and Logic Pro (and refills). None of those products offer the effective vapor and nicotine delivery of modern pod-based devices and refills like the NJOY Ace.
The products authorized today are:
As with previous PMTA decisions, the FDA only authorized tobacco-flavored refills. The agency says NJOY’s two menthol-flavored refills remain under review, and the FDA issued Marketing Denial Orders (MDOs) for the other NJOY Ace pod flavors—Blueberry and Watermelon Twist—that had been submitted for review.
NJOY’s inability to convince the FDA to authorize its non-tobacco flavors doesn’t bode well for the future of any fruit- or dessert-flavored vape approvals. NJOY is better equipped and funded than any of the thousands of small manufacturers that sell flavored e-liquids, and presumably NJOY’s applications included extensive research on the benefits their flavors offer for adult vapers.
No vape products sold in flavors other than tobacco and menthol have been authorized by the FDA. In August 2021—a year after the September 2020 Premarket Tobacco Application (PMTA) submission deadline—the agency announced tough new criteria would be applied to products sold in other flavors, and began issuing cookie-cutter MDOs for flavored vape products. Dozens of small manufacturers have challenged the FDA’s marketing denials in court or through the agency’s appeal process.
Last week, a federal judge ordered the FDA to provide progress reports on PMTAs submitted by the top 10 vaping brands sold primarily in convenience stores. The first FDA status report on those products is due April 29—this Friday.
NJOY is a major vape brand that would have been on that list. The two most popular vapes sold in the c-store/gas station market are British American Tobacco’s Vuse Alto and Juul Labs’ JUUL. Both remain in FDA review, but FDA sources have told Wall Street Journal reporter Jennifer Maloney that decisions on those products will come soon.