FDA Authorizes 24 New Velo Nicotine Pouch Products
The U.S. Food and Drug Administration on Friday authorized the marketing of 24 new nicotine pouch products under the Velo brand, the agency's first marketing authorizations for the British American Tobacco brand in the United States.
The products are made by Modoral Brands Inc., whose U.S. parent is Winston-Salem, North Carolina-based Reynolds American Inc., a British American Tobacco Group subsidiary. The authorization covers eight product varieties; each comes in three types of packaging, resulting in a total of 24 unique tobacco products, the FDA said in its announcement.
The products were reviewed under the agency's nicotine pouch pilot program, announced in September 2025, which allows a more efficient and streamlined review process. Packaging played a specific role in the review: the FDA said the type of packaging can affect stability, shelf life, moisture and safety, and all three authorized packaging configurations incorporate certified child-resistant packaging.
The agency's evaluation found that the 24 products contain lower levels of harmful and potentially harmful constituents (HPHCs) compared with cigarettes and smokeless tobacco products, with many constituents too low to be quantified in the new products. The products contain no measurable levels of several carcinogenic HPHCs, including those linked to an increased oral cancer risk in smokeless tobacco users, the FDA said.
Tobacco Reporter reported the products all contain 4 mg of nicotine. Before any new tobacco product can be legally sold in the United States, it must undergo scientific review in which the FDA considers the risks and benefits to the U.S. population.
David Waterfield, president and CEO of Reynolds American, said the marketing granted orders "demonstrate the FDA's leadership in accelerating progress toward a Smokeless America." With adult smoking rates below 10% for the first time in recorded history, he said, science-based decisions like this highlight the role that FDA-authorized alternatives can play in driving further declines in cigarette smoking.
The authorization brings Velo into a fast-growing authorized category: to date, the FDA has authorized 67 nicotine pouches, including varieties of Swedish Match USA Inc.'s Zyn pouches, owned by Philip Morris International, and Helix Innovations LLC's On Plus nicotine pouches, owned by Altria.
[Reference]
- CSP Daily News (original report) — https://www.cspdailynews.com/tobacco/fda-authorizes-24-new-velo-nicotine-pouch-products
- FDA CTP newsroom (Oct. 30, 2026) — https://www.fda.gov/tobacco-products/ctp-newsroom/fda-authorizes-marketing-24-velo-nicotine-pouches
- Tobacco Reporter coverage — https://tobaccoreporter.com/2026/10/30/fda-authorizes-24-velo-pouch-products/