The U.S. Food and Drug Administration (FDA) has announced plans to accelerate the review of nicotine pouches, responding to mounting pressure from the White House to bring the fast-growing but lightly regulated products under stricter control.
Nicotine pouches small, tobacco-free sachets placed under the lip have surged in popularity across the U.S., particularly among young adults. Marketed as smoke-free and discreet, they are sold in a range of flavors and strengths, raising concerns among health officials that they could attract new users and undermine anti-smoking efforts.
FDA officials confirmed that applications from pouch manufacturers will now be subject to an expedited review process aimed at determining whether the products meet the agency’s public health standards. The move follows months of pressure from the Biden administration, which has urged regulators to act swiftly amid fears that the category is slipping through regulatory gaps.
“Nicotine pouches present novel challenges, but our priority is clear: protecting public health, especially for youth,” an FDA spokesperson said. “Accelerating reviews will allow us to make timely, science-based decisions about which products should remain on the market.”
Industry leaders, including Swedish Match and Altria, argue that nicotine pouches provide a less harmful alternative to smoking and can play a role in reducing tobacco-related disease. However, critics warn that flavored varieties risk creating a new generation of nicotine-dependent consumers.
Public health groups welcomed the FDA’s decision but stressed that speed must not come at the expense of rigor. “The industry has raced ahead of regulation,” said Matthew Myers of the Campaign for Tobacco-Free Kids. “The FDA must ensure these products are subject to the same tough scrutiny as cigarettes and e-cigarettes.”
The agency has already received thousands of premarket applications from nicotine pouch makers but has been criticized for moving too slowly, allowing many products to remain on sale during the review process.
Analysts say the FDA’s move reflects a balancing act: acknowledging the harm-reduction potential for smokers while responding to political and public concern about youth uptake. The outcome of the fast-track reviews could reshape the U.S. nicotine market, which is projected to grow into a multibillion-dollar industry within the next decade.
The first decisions under the accelerated process are expected in the coming months, potentially setting a precedent for how the FDA regulates emerging nicotine products.
