24款Velo尼古丁袋获批上市：美国食品药品监管局授权Modoral品牌4毫克产品，累计授权达67款
美国食品药品监管局（Food and Drug Administration，FDA）10月30日宣布，授权24款新的尼古丁袋产品在美国上市销售，授权经上市前烟草产品申请（PMTA）路径作出。这批产品由 Modoral Brands Inc. 以 Velo 品牌生产，尼古丁含量均为每袋4毫克。
24款产品来自8个产品名，按三种包装形式组合而成。Velo Mini Pouch 有 Crema、Lime、Orange Crema 与 Passion Fruit 四种口味，Velo Mini Pouch 2 有 Crema、Lime、Orange Crema 与 Cinnamon 四种口味，每个产品名均为400毫克规格、含4毫克尼古丁，8个产品名乘以三种包装共24款。
FDA 说，包装形式会影响产品的稳定性、保质期、水分与安全性，是新烟草产品审查的重要一环；此次授权的三种包装形式全部采用经认证的儿童安全包装。FDA 此前已敦促生产商对尼古丁袋采用儿童安全包装或其他措施，降低幼儿误食中毒的风险。
这批产品按 FDA 的尼古丁袋试点计划审查。FDA 说，该计划使审查流程更高效：问题解决更快、申请人回复补正通知的时间缩短、科学审查也更有效率。
按美国法律，任何新的烟草产品在合法上市前都必须经过严格的科学审查，FDA 要权衡产品对美国全体人口的风险与益处，包括评估21岁及以上现有烟草使用者完全改用潜在风险较低产品可能获得的益处，并审慎考虑对青少年与非使用者的风险；只有证据显示产品的公共健康益处大于风险时，才会授予上市授权。
FDA 的评估发现，这24款新授权产品所含有害与潜在有害成分（HPHCs）的水平低于卷烟与无烟烟草产品，其中许多成分低到无法量化；数种与无烟烟草使用者口腔癌风险升高有关的致癌性有害成分，在这批产品中测不到可测量的水平。
FDA 表示，此次授权体现该局致力于让21岁及以上吸烟者更容易获得可帮助他们摆脱燃吸卷烟与无烟烟草产品的替代品；但成年人必须完全改用经 FDA 授权的尼古丁袋或其他低风险替代品，双重使用不能带来同等程度的健康益处。
截至此次授权，FDA 已累计授权67款尼古丁袋产品，名单见 FDA 已授权尼古丁袋产品名单页面。
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.
来源：GSM·美国（原文链接）
图片来源：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.
