24 Velo Nicotine Pouches Authorized for Marketing: FDA Clears Modoral Brands 4 mg Products, Bringing the Total Authorized to 67
The U.S. Food and Drug Administration (FDA) announced on October 30 that it has authorized the marketing of 24 new nicotine pouch products through the premarket tobacco product application (PMTA) pathway. The products are made by Modoral Brands Inc. under the Velo brand and are all listed as containing 4 mg of nicotine.
The 24 products come from eight product names combined with three types of packaging. The Velo Mini Pouch comes in Crema, Lime, Orange Crema and Passion Fruit, and the Velo Mini Pouch 2 comes in Crema, Lime, Orange Crema and Cinnamon; each product name is a 400 mg product containing 4 mg of nicotine, and the eight names across three packaging types make 24 unique tobacco products.
The FDA said packaging is an important aspect of its review of new tobacco products because the type of packaging can greatly affect stability, shelf life, moisture and safety, and that all three packaging types authorized today incorporate certified child-resistant packaging. The agency has previously urged manufacturers to use child-resistant packaging or other measures to mitigate the risk of accidental poisoning in young children.
The products were reviewed under the agency's nicotine pouch pilot program. The FDA said the pilot enables a more efficient and streamlined review process, with 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 United States, it must undergo a rigorous scientific review in which the FDA considers the risks and benefits to the U.S. population as a whole. That 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 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. The products contain no measurable levels of several carcinogenic HPHCs, including those linked to an increased oral cancer risk in smokeless tobacco users.
The FDA said the authorizations underscore its 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, but that adults must 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. The products are listed on the FDA's authorized nicotine pouches page.
Source: GSM · USA (original Chinese edition)
Photo: 图：美国食品药品监管局（FDA）位于马里兰州 Silver Spring 白橡树园区的一号大楼。经 Wikimedia Commons，公共领域。 / Photo: Building 1 at the U.S. Food and Drug Administration's White Oak campus in Silver Spring, Maryland. Via Wikimedia Commons, public domain.
