FDA's pilot project on nicotine pouches would significantly ease scientific requirements for manufacturers

The U.S. Food and Drug Administration (FDA) has launched a pilot program that will ease some requirements for nicotine pouch manufacturers.[1]Until now, the agency subjected all new nicotine products to a strict process, including detailed and expensive studies of their effects on a population-wide basis. With this experimental design, certain specific studies will no longer be required, as the FDA will rely more on existing research on this category of products.

A signal of regulatory change under the Trump administration

This initiative marks a possible shift in U.S. policy toward tobacco alternatives. Industry giants such as Philip Morris International (PMI), Altria, and British American Tobacco (BAT), whose pouch brands Zyn, On!, and Velo are already present, are expected to benefit.

The program also provides for shorter review times and more regular communication with manufacturers. Several industry players welcomed this development, believing it would facilitate smokers' access to products they market as potentially less harmful and a means of quitting smoking, despite scientific research on their health risks (palpitations, malaise, tachycardia, nausea, vomiting, dizziness, tremors, etc.) and their highly addictive nature.

As a reminder, France banned on September 5, 2025 "the production, manufacture, transport, import, export, possession, offer, transfer, acquisition and use" of nicotine pouches, with the exception of medicines and medical devices. Belgium had done the same in October 2023.

In his statement, Bret Koplow, acting director of the FDA's Center for Tobacco Products (CTP), stated that the CTP had not been pressured by the Trump administration or the agency's leadership to lower its scientific standards. However, the Trump administration has removed from key CTP officials and, in early September 2025, Robert F. Kennedy Jr., U.S. Secretary of Health, also fired the CDC director and promoted nicotine pouches and vaping.

Debates around benefits and risks

The FDA emphasizes that, overall, nicotine pouches pose lower risks than other nicotine products and have not yet led to heavy use among youth.

At the meeting, Bret Koplow indicated that the pilot could inspire updates to the review process for other product categories, including e-cigarettes.[2].

However, former Center for Tobacco Products officials Brian King and Mitch Zeller believe that product-specific studies are still needed to verify their effectiveness in reducing cigarette consumption and to anticipate potential public health consequences. Zeller cautions, in particular, that these products are very popular among young people, who use them discreetly, recalling the precedent of e-cigarettes and their high adoption by young people.

Moreover, according to Mary Hrywna, an associate professor at Rutgers University who has studied nicotine pouches, approving new nicotine products for faster market introduction doesn't necessarily mean that smokers will adopt them.

Two tobacco industry analysts said a streamlined FDA process would boost sales in the already rapidly growing pouch category. But Jessica Zdinak, CEO of the consulting firm ARAC, said that based on the details of the minutes, clinical studies would still be required even under the streamlined pilot process.

This includes what she called " studies among the most costly in terms of time and resources » currently required, meaning applications would remain difficult for manufacturers to fulfill.

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[1]Patrick Wingrove, Emma Rumney, Exclusive: FDA nicotine pouch pilot to ease manufacturers' research burden, transcript shows, Reuters, published September 19, 2025, accessed the same day

[2]Reuters, Exclusive – FDA experiment on nicotine pouches eases research burden on manufacturers, transcript shows, Zonebourse, published on September 19, 2025, consulted the same day

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