FDA Fast-Tracks Nicotine Pouches—But Leaves Vaping Behind

Last week, the U.S. Food and Drug Administration announced it has authorized U.S. sales of six on! PLUS nicotine pouch products. These approvals mark the first authorizations issued under a newly launched FDA Center for Tobacco Products (CTP) pilot program, designed to accelerate review of select nicotine pouch applications. 

What Was Authorized—and What Wasn’t 

The FDA granted marketing authorization for on! PLUS pouches in three flavors—Mint, Tobacco, and Wintergreen—each approved in 6 mg and 9 mg nicotine strengths. Notably, the 12 mg strength was excluded, despite being part of the original application package. 

The products were submitted for review in June 2024 by Altria Group, which sells on! and on! PLUS products manufactured by Helix Innovations. 

A Narrow Fast Track 

With these approvals, on! PLUS joins ZYN as the only nicotine pouch brands to receive FDA Marketing Granted Orders (MGOs). The ZYN line—now totaling 20 authorized varieties—was approved earlier this year following a review process that took nearly four years. 

The FDA’s fast-track pilot program currently includes: 

• on! / on! PLUS (Altria / Helix Innovations) 
• ZYN Ultra (Swedish Match / Philip Morris International) 
• Velo Mini (R.J. Reynolds) 
• Fre and Alp (Turning Point Brands) 

A common thread runs through the list: every product included is produced by major tobacco companies or their affiliates. 

The Vaping Elephant in the Room 

Perhaps the most striking aspect of the announcement is what’s missing. 

Despite thousands of vapor product PMTAs remaining in regulatory limbo—many pending for five years or more—the FDA did not include a single vaping product in the accelerated review program. This exclusion persists even as vaping products continue to demonstrate significant potential for adult smoking cessation and harm reduction. 

The contrast is hard to ignore: nicotine pouches tied to large tobacco firms are moving through a newly expedited pathway, while independent vapor manufacturers and retailers remain stuck in an indefinite review process with no clear timeline. 

What This Signals 

The on! PLUS authorizations show that the FDA is willing—and able—to move quickly when it chooses to. But the narrow scope of the pilot program raises broader questions about regulatory balance, fairness, and whether innovation outside of legacy tobacco interests is being left behind. 

As nicotine regulation continues to evolve, stakeholders across the harm-reduction spectrum will be watching closely to see whether accelerated review becomes more inclusive—or remains limited to a select few.