Altria, Reynolds to Launch New Vapes & Pouches Without Final FDA OK
Two of the nation’s largest tobacco companies, Altria and Reynolds American, are moving forward with plans to launch new smokeless alternative products without waiting for formal marketing orders from the U.S. Food and Drug Administration (FDA). The companies argue that the FDA has failed to adhere to statutory deadlines for reviewing new product applications, creating a market imbalance where illegal, unauthorized vapes proliferate while their own regulated products are stuck in a lengthy review process.
Altria’s subsidiary, Helix, plans to begin offering a new version of its “on!” nicotine pouches, called “on! PLUS,” in North Carolina, Texas, and Florida this fall. The company filed a Premarket Tobacco Product Application (PMTA) for these products in June 2024. Altria contends that the 2009 Tobacco Control Act requires the FDA to issue a marketing order or a denial order within 180 days of a PMTA submission. With that deadline long passed, Altria believes it has complied with all regulatory requirements and has proactively notified the FDA of its intent to launch. “While the FDA’s review timelines have extended far beyond the 180-day statutory requirement, Helix has complied with all regulatory requirements to bring on! PLUS to market,” an Altria spokeswoman said.
Similarly, Reynolds plans to launch a disposable vape called “Vuse One,” which contains synthetic nicotine, in South Carolina, Florida, and Georgia before the end of the year. Reynolds believes its new product meets the threshold requirements to be marketed absent an FDA order because it filed its PMTA before the May 14, 2022, deadline for synthetic nicotine products and the product was on the market prior to April 14, 2022.
The FDA, in response to queries, reiterated its official stance: “New tobacco products, including all e-cigarette and nicotine pouch products, must have FDA marketing authorization before they can be legally marketed in the United States.” The agency stated that having a pending application does not create a “legal safe harbor” from enforcement actions, which can include fines, seizures, and court orders.
Both companies argue their moves are necessary to compete against a massive illicit market of unauthorized disposable and flavored vapes, which they claim are often targeted at youth. They assert that the FDA’s failure to accelerate PMTA decision-making has resulted in a market with few authorized smoke-free products available for adult tobacco consumers seeking less harmful alternatives.
However, tobacco control advocates have raised serious concerns. Brian King of the Campaign for Tobacco-Free Kids stated that the FDA has been clear that any new product requires authorization before marketing and that simply submitting a PMTA does not protect a company from enforcement. Dave Lemmon, also from the campaign, described the moves by Altria and Reynolds as “brazenly bringing unauthorized products to market,” particularly given recent staff cuts at the FDA’s Center for Tobacco Products under the Trump administration. This sets the stage for a potential high-stakes confrontation between the tobacco giants and federal regulators over the interpretation of the Tobacco Control Act and the future of the U.S. nicotine market.
- Read more: BAT to Launch New Disposable Vape in US Despite No FDA Approval
- News source: Altria, Reynolds moving new products to market without FDA OK
- South Korea Escalates Tobacco Warnings with Blunt, Fatalistic Labels - June 22, 2026
- Magnolia Commissioner Proposes Ordinance to Ban Vape Shops - June 22, 2026
- Belarus Moves to Ban Vape and E-Cigarette Advertising Under New Bill - June 22, 2026
