After years of a logjam that defined the U.S. vape market, the FDA says it has essentially cleared the deck: the agency has finished reviewing 185 of 186 major vape applications it was under court order to decide, and the number of authorized vapor products has climbed to 34 — including, for the first time, a flavored e-cigarette.
What happened
According to a court-ordered status report covered by CSP Daily News, the FDA now counts 186 "covered applications" — premarket tobacco product applications (PMTAs) for e-cigarette products that were on the market as of August 8, 2016, filed by September 9, 2020, and sold under major brands like JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Of those, the agency has completed its review of 185. The single application still pending is likely JUUL's, after the FDA rescinded its earlier denial order and moved the application back to pending status.
The bigger shift is on the approval side. For the first time since June 2022, new PMTAs received marketing granted orders — including Vuse Alto tobacco pods and, notably, NJOY menthol-flavored products, the first flavored e-cigarette to clear FDA review. That brings the total authorized vapor products to 34. At the same time, the FDA reported it has denied more than 18 million PMTA submissions across various stages and continues to review roughly 9,500 synthetic nicotine applications.
Why it matters
The PMTA backlog has been the single biggest source of uncertainty in the legal vape market. The vast majority of products sold in the U.S. have no FDA authorization at all, and the agency's slow pace gave both retailers and manufacturers little clarity about what would ultimately be allowed. Finishing the review of nearly every covered application — and granting the first flavored authorization — signals the agency is finally moving from review mode to enforcement and market-shaping mode.
That first flavored MGO is the headline within the headline. After years of denials that wiped out flavored products on PMTA grounds, an authorized menthol e-cigarette suggests the door isn't permanently shut on flavors that can clear the agency's bar.
What this means for vapers
Practically, the list of FDA-authorized vapes is still short — 34 products in a market with thousands of SKUs — so most of what's on shelves remains unauthorized and exposed to enforcement. The upside for adult vapers is direction: a defined, slowly growing set of products the FDA has signed off on, and at least one flavored option now among them. Expect "FDA-authorized" to become a sharper selling point, and expect enforcement against the unauthorized disposables that dominate the market to intensify now that the review backlog is largely behind the agency.
The FDA has completed its review of 185 of its 186 covered vape applications, leaving just one — likely JUUL — still pending. — CSP Daily News, citing the FDA's court-ordered status report
The bottom line
The FDA clearing its review backlog and authorizing its first flavored e-cigarette is the most consequential vape-regulation news of the year so far. It doesn't legalize the whole market overnight — but it sets the boundaries of the authorized lane, and tells everyone where enforcement is heading next. For vapers, the takeaway is simple: the authorized list is real, it's growing, and it's worth watching which products make it on.
