Although not yet approved by the FDA, Altria still plans to launch its new nicotine pouch product, on! PLUS™, in the U.S

Aug.25.2025
Although not yet approved by the FDA, Altria still plans to launch its new nicotine pouch product, on! PLUS™, in the U.S
Altria announced that its subsidiary, Helix, will launch a new nicotine pouch product, on! PLUS™, in the U.S. this fall, with the initial markets covering North Carolina, Texas, and Florida. The product has not yet been approved by the FDA. It is noteworthy that the launch time and regions for on! PLUS™ are highly similar to those of BAT's planned disposable e-cigarette, Vuse One.

KEY POINTS:
 

Altria focuses on nicotine pouches: Its subsidiary, Helix, announced the launch of a new product, on! PLUS™, this fall in three U.S. states (North Carolina, Texas, and Florida).

 

FDA approval is still pending: Currently, the FDA has only approved Philip Morris International's (PMI) ZYN for sale in the U.S.; on! PLUS™ has not yet been approved.

 

Titans are racing to the market: British American Tobacco (BAT) plans to pilot its disposable synthetic nicotine e-cigarette, Vuse One, in the U.S. in late September, a product also lacking FDA approval.

 

Significant market overlap: The launch of on! PLUS™ and Vuse One is highly similar in both timing and initial markets, such as Florida and Georgia.


On August 22, 2Firsts noticed that Altria officially announced on its X (formerly Twitter) account that its subsidiary, Helix, will officially launch a new nicotine pouch product, on! PLUS™, this fall in North Carolina, Texas, and Florida.

 

According to the announcement, on! PLUS™ is a spit-free, tobacco-derived oral nicotine pouch designed for adult consumers aged 21 and over, aiming to provide a more convenient smokeless alternative. Produced at its Richmond, Virginia factory, the product will initially be available in Mint, Wintergreen, and Tobacco flavors, with nicotine strengths of 6mg, 9mg, and 12mg. It features the unique NICOSILK™ mesh technology.

 

Although not yet approved by the FDA, Altria still plans to launch its new nicotine pouch product, on! PLUS™, in the U.S
on! PLUS™ nicotine pouch | Source: on! UK

 

Altria stated that Helix submitted a premarket tobacco product application (PMTA) to the FDA in June 2024, which spanned over 25,000 pages. Written by more than 50 experts, the application covered scientific and compliance research in accordance with the requirements of the Tobacco Control Act. Helix has also proactively informed the FDA of its launch plans.

 

Altria added that despite the FDA's review period far exceeding the statutory 180-day limit, Helix has strictly followed all compliance procedures, including ingredient disclosure, factory inspections, and submission of marketing materials.

 

Image
Helix submitted a 25,000+ page PMTA document to the FDA | Source: Altria's X account

 

Below is the content posted by Altria on its official X social media account:

 

虽未获FDA批准,奥驰亚仍计划在美推出尼古丁袋新品on! PLUS™
Content posted by Altria on its social media platform | Source: Altria's X account

 

Currently, the FDA has only approved Philip Morris International's (PMI) nicotine pouch brand, ZYN, for legal sale in the U.S. There is no public information about the approval of on! PLUS™.

 

Notably, just one day before Altria's announcement (August 21), Reuters reported that British American Tobacco (BAT) plans to pilot its disposable synthetic nicotine e-cigarette, Vuse One, in the U.S. It is expected to launch in late September in South Carolina, Florida, and Georgia, a product that also has not received FDA approval.

 

It is worth noting that on! PLUS™ and Vuse One not only have very similar launch timelines (one in the fall, the other in late September), but their initial markets also have significant overlap, as both plan to enter Florida and Georgia.

Altria’s USSTC to Close Nashville Plant and Shift Operations to Kentucky by 2028
Altria’s USSTC to Close Nashville Plant and Shift Operations to Kentucky by 2028
U.S. Smokeless Tobacco Company (USSTC), a subsidiary of Altria Group, announced plans to close its Nashville manufacturing facility by 2028 and consolidate production operations at a new facility in Hopkinsville, Kentucky.
Market
Jun.02
FDA Launches Elsa 4.0 and Completes HALO Data Platform Consolidation
FDA Launches Elsa 4.0 and Completes HALO Data Platform Consolidation
The U.S. Food and Drug Administration announced on May 6 that it has advanced its modernization initiative by launching Elsa 4.0, an upgraded internal AI tool, and consolidating more than 40 application and submission data sources, systems and portals into a new platform called HALO. FDA said the integration of HALO and Elsa will allow staff to query data and build workflows without manually uploading documents in each chat.
May.07 by 2FIRSTS.ai
Disposable Vape Ban Shifts Purchasing Formats as UK Vape Volume Falls 10.3%
Disposable Vape Ban Shifts Purchasing Formats as UK Vape Volume Falls 10.3%
Data from convenience insight agency Talysis shows that the value of tobacco, vapes and smoking alternatives in the independent convenience sector fell by 4.4% in the first quarter of 2026, while volume fell by 7.8%. The vaping subcategory declined by 3.9% in value and 10.3% in volume over the same period. Talysis said the impact of the disposable vape ban continues to pressure turnover and footfall.
May.08 by 2FIRSTS.ai
Türkiye Records 4,163 E-Cigarette Smuggling Raids Over Five Years, With Seizures Worth TRY 1.84 Billion
Türkiye Records 4,163 E-Cigarette Smuggling Raids Over Five Years, With Seizures Worth TRY 1.84 Billion
Turkish Trade Minister Ömer Bolat disclosed enforcement figures on e-cigarette smuggling in response to a written parliamentary question. Over the past five years, Türkiye recorded 4,163 raids targeting e-cigarette smuggling, preventing illegal e-cigarettes, liquids and components worth TRY 1.84 billion, or about USD 40.68 million based on an exchange rate of USD 1 = TRY 45.2339, from reaching the market.
May.07 by 2FIRSTS.ai
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Federal Environment Minister Carsten Schneider said he is preparing legislation to ban disposable e-cigarettes and will present a bill this year. Industry data estimated that legal e-cigarette sales in Germany rose by about one quarter in 2025 to €2.4 billion. Refillable devices are not expected to be affected by the ban.
May.09 by 2FIRSTS.ai
RJR Vapor Loses Tax Refund Case as Texas High Court Finds VELO Pouches Taxable
RJR Vapor Loses Tax Refund Case as Texas High Court Finds VELO Pouches Taxable
The Texas Supreme Court issued a case summary on May 8, 2026, describing its decision in Hancock v. RJR Vapor Co. LLC. The dispute centered on whether RJR Vapor’s VELO oral nicotine pouches are taxable as “tobacco products” under the Texas Tax Code. Lower courts had held that the pouches were not taxable tobacco products, but the Texas Supreme Court reversed, concluding that VELO pouches are taxable because they are made of “a tobacco substitute.”
May.09 by 2FIRSTS.ai