美国FDA将放松对部分处于审核阶段的非法电子烟的执法打击


2026-05-08 21:08:29 UTC / 路透社

路透社报道
2026年5月8日 美国东部时间晚上9:08 更新于1小时前

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2025年4月9日,美国纽约,一名男子在纽约证券交易所外的华尔街使用电子烟。路透社/凯莉·库珀

5月8日(路透社)——美国食品药品监督管理局(FDA)周五表示,如果相关公司的营销申请正在审核中,该局将不会优先对某些未经授权的电子烟和尼古丁袋产品执法。

该机构称,新指南适用于已被受理的上市前申请产品,以及等待审核超过180天的补充备案产品。

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由于青少年使用问题引发严格审查,非烟草口味电子烟制造商还必须提供足够的科学数据,以证明其产品“适合保护公众健康”。

这一调整意味着,符合该局条件的制造商即便在未取得法定许可的情况下销售产品,也不太可能面临执法行动。

此举对菲利普莫里斯国际公司(PM.N)等企业而言是一大利好。这些企业此前因等待FDA的审批决定而推迟推出新产品,有时甚至为此牺牲了市场份额。

烟草企业一直在游说美国总统唐纳德·特朗普和政府其他关键官员,要求改革包括加快审批流程、明确审批标准在内的监管政策。

本周早些时候,FDA批准了部分水果口味电子烟的营销,这是该局首次批准非烟草口味的电子烟产品。

FDA周五还表示,包含产品成分、健康风险和设备规格详细数据的申请,更有可能符合监管标准。

该局称:“通过不对这些烟草产品优先采取执法行动,FDA将能够更好地分配执法资源。FDA没有足够资源对所有未获得授权的产品进行执法。”

FDA仍可能对带有某些“推定适合未成年人的元素”的产品采取行动,例如描绘卡通虚构角色、伪装成电子烟产品,或外形酷似儿童玩具、手机或游戏平台。

本报由艾什瓦里亚·维努戈帕尔在班加罗尔报道,艾玛·拉姆尼在伦敦补充报道;斯里拉吉·卡卢维拉编辑

本报遵循:汤森路透信托原则。

US FDA to ease crackdown on some under-review unauthorized vapes

2026-05-08 21:08:29 UTC / Reuters

By Reuters

May 8, 2026 9:08 PM UTC Updated 1 hour ago

A man uses an e-cigarette on Wall Street outside the New York Stock Exchange (NYSE) in New York City, U.S., April 9, 2025. REUTERS/Kylie Cooper

May 8 (Reuters) – The U.S. Food and Drug Administration (FDA) said on Friday it would not prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouch products if ​the companies have marketing applications under review.

The new guideline applies ‌to products with premarket applications that have been accepted for review or supplemental filings that have been pending for more than 180 days, the agency said.

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Non-tobacco-flavored vape makers, ​who face heightened scrutiny due to youth usage concerns, must also ​provide sufficient scientific data to assess whether the products are “appropriate ⁠for the protection of the public health”.

The change means that manufacturers with ​products that meet the agency’s conditions are unlikely to face enforcement action even ​if they sell their products without the legally-required license.

It marks a boost for companies like Philip Morris International (PM.N), which have held off on launching new products while waiting ​for an agency decision, sometimes at the expense of market share.

Tobacco companies ​have been lobbying President Donald Trump and other key officials in the administration for changes ‌including ⁠a faster, clearer FDA authorization process.

Earlier this week, the agency approved the marketing of certain fruit-flavored e-cigarettes in a first authorization of non-tobacco-flavored vaping products.

The FDA also said on Friday that applications that include detailed data on product ​composition, health risks ​and device specifications ⁠are more likely to meet regulatory standards.

“By not prioritizing these tobacco products for enforcement, FDA will be able to ​better allocate its enforcement resources. FDA lacks the resources ​to pursue ⁠enforcement against every product that has not received authorization,” it said.

The FDA may still take action against products that have certain “presumptively underage-appealing elements such as depicting ⁠a ​cartoon-like fictional character, disguising its nature as ​a vaping product, or resembling a children’s toy, phone, or gaming platform.”

Reporting by Aishwarya Venugopal in ​Bengaluru and additional reporting by Emma Rumney in London; Editing by Sriraj Kalluvila

Our Standards: The Thomson Reuters Trust Principles.

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