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April 26, 2022

FDA Authorizes NJOY Ace, a High-Strength Pod Vape

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.

Ace is the first pod vape authorized by FDA

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:

  • NJOY Ace Device
  • NJOY Ace Pod Classic Tobacco 2.4% (or 24 mg/mL) nicotine
  • NJOY Ace Pod Classic Tobacco 5% (or 50 mg/mL) nicotine
  • NJOY Ace Pod Rich Tobacco 5% (or 50 mg/mL) nicotine

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.

Will Vuse and Juul be next?

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 say decisions on those products will come soon.

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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John Hastings
John Hastings
5 months ago

Ok benzoic acid got approved, pods got approved, but not flavor. The message is becoming consistent, isn’t it Jim? Flavored nic is not gonna happen anytime soon. But it IS good to see products actually getting approved! As for JUUL…. Hard to call that one after all their shenanigans. But we all know money talks in this game. Altria is far from short on cash, lawyers, and scientists.

John Hastings
John Hastings
5 months ago
Reply to  John Hastings

Proof of my point 24 hours later straight from the FDA: a menthol cigarette ban.