FDA Authorizes Marketing of 24 Velo Nicotine Pouches

October 30, 2026

Today, the U.S. Food and Drug Administration authorized the marketing of 24 new nicotine pouch products through the premarket tobacco product application (PMTA) pathway. The authorized products are made by Modoral Brands Inc. under the Velo brand and are all listed as containing 4 mg of nicotine.

The 24 authorized products include three types of packaging for the Velo Mini Pouch and Velo Mini Pouch 2, each of which also comes in four different flavors:

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

These eight product names are shared across the three different types of packaging, resulting in a total of 24 unique tobacco products. Packaging is an important aspect of the FDA’s review of applications for new tobacco products as the type of packaging can greatly affect the product in areas such as stability, shelf life, moisture and safety. All three of the packaging types authorized today incorporate certified child-resistant packaging. The FDA has previously urged manufacturers to use child-resistant packaging or other measures to mitigate the risk of accidental poisoning in young children for their nicotine pouches.

Today's authorized products were reviewed under the agency's nicotine pouch pilot program, which enables a more efficient and streamlined review process. Through the pilot, the agency has achieved faster resolution of issues, reduced response times for applicants addressing deficiency letters, and more efficient scientific reviews.

Before any new tobacco product can be marketed legally in the U.S., it must undergo a rigorous scientific review where the FDA considers the risks and benefits to the U.S. population as a whole. This includes evaluating whether the product could benefit adults aged 21 and older who currently use tobacco products by completely switching to a potentially lower-risk product, while also carefully considering the risks to youth and non-users. Marketing authorization is granted only when the evidence demonstrates that a product's public health benefits outweigh its risks.

The FDA's evaluation found that the 24 newly authorized products contain lower levels of harmful and potentially harmful constituents (HPHCs) compared to cigarettes and smokeless tobacco products, many of which were too low to be quantified in the new products. Notably, these products contain no measurable levels of several carcinogenic HPHCs, including those linked to an increased oral cancer risk in smokeless tobacco users.

Today’s authorizations underscore the FDA’s commitment to provide greater access to products that can help adults aged 21 and older who smoke transition away from combusted cigarettes and smokeless tobacco products. However, it is important that these adults switch completely to FDA-authorized nicotine pouches or other lower-risk alternatives, as dual use does not provide the same degree of health benefit.

To date, the FDA has authorized 67 nicotine pouches. These products are listed at www.fda.gov/authorizednicotinepouches.

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