FDA authorises six on! PLUS nicotine pouch products under fast-track review pilot
January 7, 2026
on! PLUS nicotine pouch (Photo: Helix Sweden AB)
The US Food and Drug Administration (FDA) has authorised the marketing of six on! PLUS nicotine pouch products, completing its scientific review in record time under a new pilot programme designed to speed up assessments without lowering regulatory standards.
The authorisations, announced on 19 December 2025, are the first outcomes from the FDA’s nicotine pouch pilot, launched in September to streamline the premarket tobacco product application (PMTA) process. The agency said process changes – including real-time communication with applicants – enabled a faster review while maintaining rigorous scientific scrutiny.
The newly authorised products are manufactured by Helix Innovations LLC, a subsidiary of Altria, and sold under the on! PLUS brand. They include Mint, Tobacco and Wintergreen flavours in 6mg and 9mg nicotine strengths.
“[These] marketing authorisations confirm that rigorous and efficient standards of scientific review are not mutually exclusive,” said Bret Koplow, acting director of the FDA’s Centre for Tobacco Products. “As a result of the FDA’s nicotine pouch pilot program, adults who smoke cigarettes and would like to switch to a lower-risk alternative tobacco product will now have an expanded array of options.”
According to the FDA, evidence submitted by the company met the public health standard set out in the 2009 Family Smoking Prevention and Tobacco Control Act. This requires regulators to assess whether the potential benefits to adults who switch from cigarettes or other smokeless tobacco products outweigh the risks, including those to youth and non-users.
As part of its review, the agency found that the authorised nicotine pouches contain lower levels of many harmful and potentially harmful constituents compared with other oral and smokeless tobacco products. Several carcinogenic compounds linked to oral cancer risk were found to be below measurable levels. The FDA also highlighted that the products could offer a potential benefit to adult smokers seeking a lower-risk alternative.
All six products will be sold in certified child-resistant cans with safety lids, reflecting the FDA’s ongoing push for packaging measures to reduce the risk of accidental exposure among children.
Marketing restrictions form a key part of the authorisations. Digital, TV and radio advertising must be carefully targeted at adults aged 21 and over, and Helix Innovations is required to monitor, measure and report the effectiveness of its youth prevention measures, including detailed analysis of advertising audience demographics.
The latest decision builds on earlier regulatory milestones in the category. In January 2025, the FDA authorised ZYN nicotine pouches, making ZYN the first nicotine pouch brand to receive marketing authorisation in the US.
The FDA said it is continuing to review additional applications under the nicotine pouch pilot programme and will evaluate whether the streamlined approach should be rolled out more widely across the PMTA review system.
