By Timothy S. Donahue

Top Takeaways:

• New Authorizations: The FDA cleared 24 Velo nicotine pouch products, bringing the total number of authorized pouches to 67.
• Eight Varieties: All products contain 4 mg of nicotine and come in three child-resistant packaging configurations.
• Pilot Progress: The products were reviewed through the FDA’s program designed to streamline nicotine pouch applications.

Velo just got a lot more shelf space, courtesy of the FDA.

The U.S. Food and Drug Administration authorized 24 Velo nicotine pouch products on October 30, marking another milestone for the agency’s accelerated nicotine pouch review program and bringing the total number of authorized nicotine pouch products to 67.

Manufactured by Modoral Brands Inc., a subsidiary of British American Tobacco (BAT), the products include eight varieties across the Velo Mini Pouch and Velo Mini Pouch 2 lines, each available in three packaging configurations. All contain 4 mg of nicotine.

The Velo Mini Pouch varieties include:

• Velo Mini Pouch 400 mg Crema 4 mg nicotine
• Velo Mini Pouch 400 mg Lime 4 mg nicotine
• Velo Mini Pouch 400 mg Orange Crema 4 mg nicotine
• Velo Mini Pouch 400 mg Passion Fruit 4 mg nicotine
• Velo Mini Pouch 2 400 mg Crema 4 mg nicotine
• Velo Mini Pouch 2 400 mg Lime 4 mg nicotine
• Velo Mini Pouch 2 400 mg Orange Crema 4 mg nicotine
• Velo Mini Pouch 2 400 mg Cinnamon 4 mg nicotine

Although the FDA issued 24 marketing authorizations, they cover eight distinct product formulations packaged in three configurations.

All three packaging types include certified child-resistant features, an issue the agency has increasingly emphasized in response to reports of accidental nicotine exposure among young children.

The FDA said packaging is an important part of its scientific review because it can affect product stability, shelf life, moisture levels, and safety.

The authorizations were granted through the agency’s nicotine pouch pilot program, established to accelerate application reviews while maintaining scientific standards.

According to the FDA, the pilot has improved communication with applicants, reduced response times for deficiency letters, and made scientific reviews more efficient.

The agency said its evaluation found that the newly authorized Velo products contain lower levels of harmful and potentially harmful constituents than cigarettes and smokeless tobacco products do.

Many of those constituents were present at levels too low to quantify, while several carcinogenic compounds linked to increased oral cancer risk among smokeless tobacco users were not detectable in the authorized products.

The FDA determined that the products met the statutory public health standard for marketing authorization, which requires consideration of both the potential benefits for adult tobacco users and the risks to youth and to people who do not use tobacco.

The latest decision brings the number of FDA-authorized nicotine pouch products to 67, expanding the range of legally marketed products in a category that is experiencing significant growth and increased regulatory scrutiny.