Dive Brief:
- Altria has received marketing authorization for six of its On! Plus nicotine pouch products, according to a Monday announcement from the U.S. Food and Drug Administration.
- The approved items include 6- and 9-milligram nicotine varieties in mint, wintergreen and tobacco flavors.
- The decision was the first made under an FDA pilot program aimed at making the marketing authorization review process more efficient.
Dive Insight:
Nicotine and vape products have faced a years-long timeline to get either marketing denial or approval, creating a legal gray area that has led to confusion among retailers, according to NACS. The expedited review that the FDA is currently testing could help c-stores get popular products in their stores legally much faster.
“Today’s marketing authorizations confirm that rigorous and efficient standards of scientific review are not mutually exclusive,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products.
The FDA created the pilot program based on the scientific understanding that different nicotine products carry different amounts of risk, with products that are burned, like cigarettes, carrying more risk than smokeless products like nicotine pouches. Updates include real-time communication with applicants and focusing on the most critical areas for each product.
Once the pilot program ends, the FDA plans to incorporate process improvements into its application review program.
On! Is the second brand to gain approval for nicotine pouches. Philip Morris International’s Zyn received approval for 20 varieties in January, marking the first time these products had been approved for marketing in the U.S.
Smokeless products continue to gain momentum, and were the only nicotine category to see growth in 2025, according to Goldman Sachs.
