美国食品药品监督管理局因允许未经授权的电子烟产品遭起诉


2026-07-14 19:00:07 UTC / 路透社

路透社 报道
2026年7月14日 世界标准时间19:00 更新于1小时前

2024年5月21日,美国科罗拉多州阿瓦达市苏丹烟店货架上的Spree Bar电子烟。该产品含有一种模拟尼古丁的新型化学物质。路透社/凯文·莫哈特 获取授权许可,将在新标签页打开

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7月14日(路透社)—— 一个由公共卫生组织、儿科医生和家长组成的联盟于周二起诉美国食品药品监督管理局,质疑其一项新政策,该政策允许部分制造商在未获得法定许可的情况下销售电子烟和尼古丁产品。

此次诉讼于马里兰州美国联邦地区法院提起,矛头直指FDA5月发布的指导意见。该指导意见称,如果相关公司的营销申请正在审核中,该局将不会优先执法查处某些未经授权的电子烟和尼古丁袋产品。

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  • 原告方包括无烟儿童运动、美国儿科学会、美国癌症协会癌症行动网络、美国心脏协会、美国肺脏协会、真相倡议组织以及反对电子烟家长联盟,同时还有一名儿科医生和一名子女在使用调味电子烟后对尼古丁上瘾的家长。
  • 原告方认为,该政策非法允许产品在未获得《烟草控制法》要求的营销授权的情况下继续在市场上销售。
  • 该团体还表示,该指导意见可能会让数千款未经授权的产品无限期上市销售,其中包括受年轻人欢迎的调味电子烟和尼古丁袋产品。
  • 他们还指控FDA绕过了《行政程序法》要求的公众意见征询程序,且未为此次政策转变提供合理依据。
  • 此次诉讼还对FDA计划发布一份其无意优先执法的产品清单提出质疑,称这将为未经授权产品的销售提供便利。
  • 这起案件将由马里兰州同一法院审理,该法院曾在2017年推翻了FDA此前一项允许多款电子烟未经授权继续在市场销售的政策。
  • FDA未立即回应路透社的置评请求。

路透社班加罗尔记者桑斯克里蒂·谢卡尔报道;塔西姆·扎希德编辑

我们的报道准则:汤森路透信托原则,将在新标签页打开

US FDA sued for allowing unauthorized vaping products

2026-07-14 19:00:07 UTC / Reuters

By Reuters

July 14, 2026 7:00 PM UTC Updated 1 hour ago

Spree Bar which contains a new chemical that mimics nicotine, is pictured on the shelf at Sultans’ Smoke in Arvada, Colorado, U.S., May 21, 2024. REUTERS/Kevin Mohatt Purchase Licensing Rights, opens new tab

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U.S. Food and Drug AdministrationFollow

July 14 (Reuters) – A coalition of public health organizations, pediatricians and parents sued the U.S. Food and Drug Administration on Tuesday, challenging a ​new policy that allow some manufacturers to sell vapes and ‌nicotine without the legally required license.

The lawsuit, filed in U.S. District Court in Maryland, targets FDA guidance issued in May. The guidance states the agency would ​not prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouch ​products if the companies have marketing applications under review.

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  • Plaintiffs ⁠include the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, ​the American Cancer Society Cancer Action Network, the American Heart Association, ​the American Lung Association, Truth Initiative and Parents Against Vaping, along with a pediatrician and a parent whose children became addicted to nicotine after using flavored ​e-cigarettes.
  • Plaintiffs argue the policy unlawfully allows products to remain on ​the market without the marketing authorization required under the Tobacco Control Act.
  • The group also ‌said ⁠the guidance could permit thousands of unauthorized products, including flavored e-cigarettes and nicotine pouches popular with young people, to be sold indefinitely.
  • They also contend the FDA bypassed required public notice and comment procedures ​under the Administrative ​Procedure Act ⁠and failed to justify the policy shift.
  • The lawsuit also challenges the FDA’s plan to publish a list ​of products it does not intend to prioritize for ​enforcement, ⁠arguing it would facilitate sales of unauthorized products.
  • The case will be heard in the same Maryland court that struck down an earlier FDA ⁠policy in ​2017 that had allowed many e-cigarettes ​to remain on the market without authorization.
  • The FDA did not immediately respond to Reuters ​request for comment.

Reporting by Sanskriti Shekhar in Bengaluru; Editing by Tasim Zahid

Our Standards: The Thomson Reuters Trust Principles., opens new tab

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