FDA tobacco center authorized 48 vapor products by late 2026

The FDA has authorized 48 vapor products and 67 nicotine pouch products, the National Association of Tobacco Outlets’ executive director David Spross wrote in a year-end review of the Center for Tobacco Products. The center also granted marketing orders to 24 Velo nicotine pouches at the end of October.

Those counts sit alongside a slower headline number: the Government Accountability Office found the agency averaged 507 days to complete review of tobacco product applications, against a statutory 180-day deadline for action.

Marketing orders now cover 48 vapor and 67 pouch products

The vapor list spans tobacco, menthol and other flavors, according to Spross. May brought one of the more closely watched decisions, when the FDA authorized Glas Inc.’s G2 age-gated device and five pods, including mango and blueberry variants alongside menthol and tobacco.

Spross writes that the agency’s review found the Glas products offered benefits for adult smokers, including substantial rates of complete switching from cigarettes, while accounting for youth-access protections. He treats the decision as evidence that flavored vapor products can clear the premarket tobacco product application (PMTA) standard.

The 24 Velo orders fall under a pilot program launched in September 2025 that aims to speed reviews of nicotine pouch applications. For those orders, the FDA determined the products are appropriate for the protection of public health, Spross writes.

Average PMTA review ran 507 days against a 180-day deadline

The GAO report credited improvements but recommended the FDA strengthen data collection so it can measure performance and timeliness across the whole PMTA evaluation chain, according to the review. In a separate move, the FDA said it is reviewing how the PMTA rule is implemented and is also reviewing a federal lawsuit challenging the current framework.

The agency cited lessons from the existing process, the growth of the illicit market and the speed of new product launches, and said it intends to evaluate changes through federal rulemaking. The current PMTA process continues in the meantime, Spross writes.

Koplow’s permanent appointment and a new enforcement chief

Bret Koplow became CTP director in September after serving as interim director since spring 2025, according to the review. Spross points to Koplow’s six years in CTP leadership and his appearances at stakeholder events, including NATO’s Legislative Conference at the end of September, as signs of stability and wider engagement.

Jessica Zeller was selected to lead CTP’s Office of Compliance and Enforcement, Spross writes. She joins from Edwards Lifesciences, where she was vice president, corporate counsel and general counsel for quality, and has more than 20 years of compliance, enforcement and regulatory experience. She previously held senior roles in the same CTP office, including as its first deputy director.

Retailers and suppliers weigh authorization counts against review times

For US retailers, the practical figure is how many products carry marketing orders: 48 vapor and 67 pouch. A larger authorized catalog gives buyers more legally marketed stock to plan around, but the GAO’s 507-day average suggests the queue for new entrants stays long.

For manufacturers and exporters, especially in the Shenzhen supply chain, the Glas decision is the one to read closely. The authorization covered an age-gated device with mango and blueberry pods, which supports the view that flavored vapor can be authorized when the application meets the public health standard. That is analysis, not a guarantee: each application stands on its own evidence, and the FDA’s stated review of the PMTA rule could change the process later.

Order timing follows the same logic. Companies planning US launches should treat the authorization path as long and evidence-heavy, and should watch whether the rulemaking produces procedural changes. Any shift would come through federal rulemaking, so the current process remains in force for now.

What comes next

The FDA has not set a date for concluding its review of the PMTA rule or the lawsuit, and Spross gives no timetable. NATO says it will keep pressing CTP for more transparency, efficiency and authorizations. Distributors should watch the next pouch orders under the pilot program and any FDA statement on rulemaking.

Questions readers ask

How many vapor products has the FDA authorized?

The FDA has authorized 48 vapor products, spanning tobacco, menthol and other flavors, according to NATO executive director David Spross.

How long does FDA take to review a PMTA?

The GAO found the FDA averaged 507 days to complete review of tobacco product applications, against a statutory 180-day deadline for action.