尽管设有快速审批通道，美国食品药品监督管理局（FDA）仍决定推迟处理Zyn、Velo等尼古丁袋产品的上市申请。据知情人士透露，监管机构主要担忧这类产品可能对非吸烟者及未成年人产生健康风险。
此类烟草替代品通过口腔黏膜直接吸收尼古丁，近年在美国市场迅速扩张。行业巨头英美烟草公司旗下Velo与奥驰亚集团投资的Zyn品牌，原本希望通过FDA的“改良风险烟草产品”认证路径加速上市进程。该机制允许企业通过科学证明产品比传统香烟危害更小来获得营销优势。
然而FDA审查发现，尼古丁袋可能吸引从未接触烟草的群体，尤其是青少年。内部报告指出，水果口味和隐蔽的使用方式易导致未成年人误用。与此同时，菲利普莫里斯等烟草企业虽未直接涉足该领域，但其加热不燃烧产品的监管经验正被同行参考。
业内人士分析，审批延迟可能影响Turning Point Brands等专营尼古丁袋企业的战略布局。尽管企业方强调产品旨在帮助成年吸烟者减害，但监管机构仍要求补充针对二手暴露风险及儿童误食防护的评估数据。这场拉锯战折射出新型尼古丁产品在公共健康与商业利益间的平衡难题。
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