Pilot Program Update: FDA Authorizes 4 New Nicotine Pouches
August 4, 2026
Today, the U.S. Food and Drug Administration (FDA) authorized the marketing of four new nicotine pouch products through the premarket tobacco product application (PMTA) pathway: Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg. The authorized products, made by Helix Innovations LLC, are sold under the “on!” brand name.
As part of its thorough scientific review of new tobacco products, the FDA considers the risks and benefits to the U.S. population as a whole — including the benefits to adults who currently use tobacco products and switch to a potentially lower-risk product, as well as the risks posed to youth and non-users of tobacco products. To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.
The review of these products was part of the agency’s nicotine pouch pilot program, which aims to increase efficiency and streamline the review process of nicotine pouches through the PMTA pathway. The pilot streamlined the FDA’s review processes, which has led to faster resolution of issues, decreased time needed for applicants to respond to deficiency letters, and more efficient scientific reviews. The FDA has begun implementing efficiencies learned from the pilot to the review of other PMTAs.
The FDA’s evaluation found that these new products contain lower levels of most harmful and potentially harmful constituents (HPHCs) when compared to other oral and smokeless tobacco products, many of which were too low to be quantified in the new products. For adults 21 and older who use smokeless tobacco or smoke cigarettes, switching completely to FDA-authorized nicotine pouches may reduce exposure to many harmful chemicals found in smokeless tobacco or cigarettes. Today’s authorizations are another important step to provide greater access to products that can promote full switching for adults who smoke and prevent downstream health risks associated with combustible cigarettes. However, it is important that they switch completely to nicotine pouches, as dual use does not provide the same degree of health risk reduction.
To date, the FDA has authorized 30 nicotine pouches. These products are listed at www.fda.gov/authorizednicotinepouches.
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