The FDA on Oct. 30 authorized 24 flavored VELO nicotine pouch products, giving British American Tobacco (BAT) its first U.S. marketing authorizations for the brand.
The decision puts VELO alongside ZYN and Altria's on! products in the small group of nicotine pouch brands that have passed the agency's premarket review. It also raises the number of FDA-authorized nicotine pouch products to 67.
The new marketing-granted orders cover products manufactured by Modoral Brands Inc., a Reynolds American subsidiary. Although the agency authorized 24 separate products, there are only eight flavor and pouch combinations. Each comes in three different packaging configurations.
VELO Mini Pouch is authorized in Crema, Lime, Orange Crema, and Passion Fruit. VELO Mini Pouch 2 comes in Crema, Lime, Orange Crema, and Cinnamon. All contain 4 milligrams of nicotine per pouch, and each pouch weighs 400 milligrams.
The unusual count reflects the FDA's decision to evaluate the packaging as part of each application. Containers can affect moisture, product stability, shelf life, and safety. All three approved packaging configurations feature certified child-resistant closures, intended to reduce accidental nicotine exposure among young children.
The authorizations came through the agency's nicotine pouch pilot program, launched in September 2025 to speed up premarket tobacco product application (PMTA) reviews. The FDA says the program has shortened applicant response times and helped reviewers resolve scientific questions more efficiently.
The agency also found that the VELO products contain substantially fewer harmful and potentially harmful chemicals than cigarettes and conventional smokeless tobacco. Several cancer-causing constituents, including some associated with oral cancer in smokeless tobacco users, were not measurable in the tested products. That does not mean nicotine pouches are harmless. The potential health benefit depends in large part on smokers switching completely rather than continuing to smoke.
BAT's new approvals follow a series of nicotine pouch decisions this year. The FDA authorized 11 ZYN ULTRA products in August, expanding the range of permitted strengths and flavors. In June, the agency allowed 20 previously authorized ZYN products to carry a specific reduced-risk claim, a separate regulatory action that does not apply to VELO.
For adults who smoke, the VELO decision means more legally marketed noncombustible nicotine choices. It also shows that the FDA can authorize flavored nicotine products when the evidence meets its public-health standard, rather than treating flavor as an automatic reason for rejection.
CBG (cannabigerol) is the mother of all cannabinoids, including CBD and THC. Learn more about CBG flower, its effects, strains, and whether it can get you high.
Learn how old you have to be to buy caffeine pouches, including federal and state age restrictions, retailer policies, and rules for minors.
Learn whether caffeine pouches are safe, including potential side effects, caffeine limits, oral health risks, and who should avoid them.
Because of declining cigarette sales, state governments in the U.S. and countries around the world are looking to vapor products as a new source of tax revenue.
