By Timothy S. Donahue

Top Takeaways:

• Four new authorizations: The FDA has granted marketing orders for four additional on! nicotine pouches.
• Pilot program continues: The applications were reviewed through the FDA’s nicotine pouch PMTA pilot, which the agency says has accelerated scientific reviews.
• Expanding portfolio: The latest orders further expand Helix Innovations’ authorized on! lineup, reinforcing the brand’s position as one of the two largest FDA-authorized nicotine pouch portfolios.

The FDA’s nicotine pouch pipeline continues to move.

The U.S. Food and Drug Administration on Tuesday authorized four additional nicotine pouch products through the premarket tobacco product application (PMTA) pathway, marking another step in the agency’s ongoing effort to expand the number of legally marketed modern oral nicotine products in the United States.

The new marketing granted orders (MGOs) cover on! brand Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg, all manufactured by Helix Innovations LLC, a subsidiary of Altria Group. With the latest approvals, the FDA has authorized 30 nicotine pouch products for sale in the United States.

The agency said its review concluded that the products meet the statutory public health standard required by the PMTA process.

“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,” the agency said. “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.”

The FDA also said the products contain lower levels of most harmful and potentially harmful constituents (HPHCs) than traditional smokeless tobacco products, with many constituents present at levels too low to quantify.

“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,” the agency said, while emphasizing that complete switching—not dual use—offers the greatest potential reduction in health risks.

The applications were reviewed under the FDA’s nicotine pouch pilot program, an initiative launched to streamline reviews for the rapidly growing product category. According to the agency, the pilot has shortened review timelines by reducing the time required to resolve scientific deficiencies and respond to deficiency letters.

“The FDA has begun implementing efficiencies learned from the pilot to the review of other PMTAs,” the agency said.

The latest authorizations continue the steady expansion of Helix Innovations’ FDA-authorized on! portfolio. Earlier marketing granted orders covered multiple mint, citrus, coffee, and cinnamon varieties across different nicotine strengths, making on! one of the most extensively authorized nicotine pouch brands in the U.S. market.

The additional authorizations also underscore the FDA’s increasingly active approach to regulating nicotine pouches. After several years of limited PMTA activity, the agency’s pilot program has accelerated reviews, leading to a growing list of authorized products and providing manufacturers with greater regulatory certainty.

The FDA has indicated that lessons learned from the nicotine pouch pilot are now being applied more broadly across its tobacco product review program.