The Food and Drug Administration (FDA) has authorized 24 new nicotine pouch products made by Modoral Brands through the premarket tobacco product application (PMTA) pathway. The authorized products are marketed under the Velo brand and are all listed as containing four milligrams of nicotine.
The 24 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: Crema, Lime, Orange Crema and Passion Fruit for the Velo Mini Pouch; and Crema, Lime, Orange Crema and Cinnamon for the Velo Mini Pouch 2.
These eight products 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,” the agency noted in a statement. “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 authorized products were reviewed under the agency’s nicotine pouch pilot program. Through the pilot, the agency noted that it has achieved faster resolution of issues, reduced response times for applicants addressing deficiency letters, and more efficient scientific reviews.
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, the 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,” the statement continued.
To date, the FDA has authorized 67 nicotine pouches.
