The FDA is expected to announce measures in the coming days that would speed up approvals for nicotine pouches and vaping products, the Wall Street Journal reported on September 24, citing people familiar with the matter. The agency plans to revisit the premarket tobacco application (PMTA) requirements it set in 2021 — and could also simplify requirements for scientific studies and shorten review times, according to the report, which Reuters could not independently verify.

What PMTAs Mean for Nicotine Pouches

Every nicotine pouch brand on the U.S. market is supposed to have FDA authorization through the PMTA process. In practice, thousands of applications have sat in review for years. Companies like Swedish Match (now owned by Philip Morris International) and British American Tobacco have publicly criticized the FDA for taking too long to rule on their products.

The 2021 requirements set the current standard for what companies must submit: everything from toxicology data to marketing plans to evidence that their product benefits public health more than it harms it. That last part—the "appropriate for the protection of public health" standard—has been the sticking point. The FDA has issued very few authorizations and has left most applications in limbo.

What Could Change

According to the WSJ report, the expected package has two concrete parts: revisiting the 2021 rule that defines what new tobacco applications must contain, and simplifying the scientific-study requirements while speeding up review times — giving the FDA more flexibility to authorize more products. Tobacco companies have long urged the Trump administration for exactly that: a faster, clearer authorization process. An HHS spokesperson said the administration "is committed to keeping nicotine out of the hands of kids, getting counterfeit vaping products off the streets and providing safer alternatives for adults who want to quit smoking cigarettes." The specifics aren't yet public, but any shift in the PMTA process would directly affect which nicotine pouch products can legally stay on shelves and which new ones can launch.

For retailers and users, the practical consequence is this: the products you see today may not be the ones that survive a reformed review process, depending on which direction the FDA moves.

Why This Matters Now

The PMTA backlog has created a strange market: products are sold while their applications sit unanswered. Some companies have received marketing denial orders and fought them in court. Others are still waiting for any decision at all. A process overhaul could force the FDA to either clear the backlog faster or reset the rules entirely.

The industry has been pushing for this. Whether the result makes it easier or harder for nicotine pouches to get authorized depends entirely on what the new requirements look like.

SOURCES:
Tobacco Reporter
WSJ via Reuters (Devdiscourse)
FDA: Authorizations and enforcement priorities