FDA Authorizes Marketing of 24 Velo Nicotine Pouches
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.
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.
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