FDA Approves Marketing for 24 New Nicotine Pouches

Last week, the U.S. Food and Drug Administration (FDA) 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,” FDA said.

To date, the FDA has authorized 67 nicotine pouches. In August, FDA authorized the marketing of four new nicotine pouch products made by Helix Innovations LLC under the “on!” brand name, and included Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg and Autumn Spice 2 mg.

Tobacco