Key Points：
- The FDA authorized six on! PLUS nicotine pouch products on December 19, granting marketing authorization (MGO) through the PMTA pathway after more than a year of review.
- Altria said three additional on! PLUS products remain under FDA review, and the authorization applies only to the six specified products.
- on! PLUS will resume taking new retail orders in Florida, North Carolina and Texas, with e-commerce sales expected to follow.
- Altria subsidiary Helix submitted PMTAs in June 2024, with applications exceeding 25,000 pages and covering multiple flavors and nicotine strengths.
- During 2025, on! PLUS moved ahead with launch preparations before FDA authorization, before later being included in the agency’s nicotine pouch review acceleration pilot.
2Firsts, December 20, 2025, Shenzhen-The U.S. Food and Drug Administration (FDA) said on the evening of December 19 Eastern Time that it had authorized the marketing of six on! PLUS nicotine pouch products through the premarket tobacco product application (PMTA) pathway. Altria later responded to the decision in a statement posted on its official social media accounts.
Altria said the FDA had granted marketing authorization for certain on! PLUS nicotine pouch products, adding that the decision was made under the legal standard of being “appropriate for the protection of the public health” as set out in the Family Smoking Prevention and Tobacco Control Act. The company also disclosed that three additional on! PLUS products remain under FDA review.
According to the statement, Altria’s on! PLUS brand will resume accepting new retail orders in Florida, North Carolina and Texas, and plans to proceed with sales through e-commerce channels.
Background: PMTA Submission in 2024
According to information published on Altria’s website in June 2024, its wholly owned subsidiary Helix Innovations LLC submitted PMTAs to the FDA for on! PLUS nicotine pouch products.
Altria said at the time that the application exceeded 25,000 pages and was prepared by more than 50 experts, covering scientific studies and regulatory compliance materials. The submission included multiple on! PLUS product variants, including tobacco, mint and wintergreen flavors, offered in different nicotine strengths.
The company said it had submitted ingredient disclosures, manufacturing facility information and supporting scientific data as required.
Unapproved Launch Plans and Entry Into Review Acceleration Pilot
In 2025, before the FDA had reached a final decision on the on! PLUS PMTAs, Altria’s plans to move forward with market deployment drew industry attention.
As previously reported exclusively by 2Firsts, Altria and its subsidiary Helix disclosed via official social media in August 2025 that they planned to introduce on! PLUS in the United States in the autumn. Market activity around an October 14rollout in North Carolina, Texas and Florida later surfaced through consumer reports and online posts, while Altria separately said at the time that the products had not yet received FDA marketing authorization.
Altria said at the time that although the FDA’s review had exceeded the statutory 180-day timeframe, the company continued to comply with regulatory requirements, including ingredient disclosures, cooperation with facility inspections and submission of marketing materials, and had proactively communicated with the FDA regarding its launch plans.
Separately, Reuters reported on September 8 that, under pressure from the White House, the FDA planned to use the pilot program to speed up reviews of nicotine pouch products from companies including Altria’s on! and on! PLUS, Philip Morris International’s ZYN, British American Tobacco’s Reynolds American unit and Turning Point Brands, with the goal of completing reviews by the end of 2025. The report said some products included in the pilot were already being sold without authorization, and that FDA clearance would help remove legal uncertainty around their marketing.
In its December 19 announcement, the FDA stressed that the marketing authorization applies only to the six specific on! PLUS nicotine pouch products, does not extend to other Helix or Altria products, and does not mean the products are FDA-approved or considered safe.
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