FDA开始针对未经授权的电子尼古丁传送装置执行烟草控制条例

美国食品药品监督管理局(FDA)已向电子尼古丁传送装置(ENDS)的制造商发送了第一批警告信,该制造商未在9月9日截止日期之前提交上市前烟草申请。
 

1月15日,该机构向制造和运营销售ENDS产品(特别是电子液体)的网站的10家公司发出警告信,通知他们销售未经售前授权的这些产品是非法的,因此不能出售或分发。

在美国,根据法院命令,必须在2020年9月9日之前向FDA提交截至2016年8月8日的某些认定的新烟草产品的上市前审查申请,包括电子烟油。在该截止日期之前,FDA通常打算将执行推迟最多一年,直到FDA审查,除非FDA对申请采取了负面行动。FDA计划发布该机构已收到其申请的产品清单。但是,在提供此类清单之前,FDA正在核实有关这些产品的某些信息,以使清单的发布符合联邦公开法。

史蒂芬·哈恩

FDA专员史蒂芬·哈恩(Stephen M. Hahn)在一份声明中说:“上市前的申请程序确保了包括烟草产品在内的许多新型烟草产品都将受到FDA的强有力的科学评估。” “对新产品进行科学审查是我们执行使命的关键部分,以保护公众(尤其是孩子们)免受烟草使用带来的危害。除了重要的售前科学审查之外,我们还致力于通过销售未经授权的产品来对违法者进行优先处理,这是我们保护公众健康的方式。”

收到警告信的10家公司是Little House Vapes;城堡岩蒸气;滴烟完美Vapes; CLS交易;会话供应公司;沿海电子液体实验室/ GC蒸气;克里米博士;CMM Capital LLC;和电子烟谷仓。

米奇·泽勒(Mitch Zeller)

FDA烟草产品中心主任Mitch Zeller说:“这些警告信是对违反烟草法律法规的持续监视和互联网监视的结果。” “我们想向所有烟草制品制造商和零售商表明,FDA将密切关注市场,并将要求公司对违反法律负责。”

FDA已要求每家公司在收到这封信的15个工作日内做出回应,详细说明每家公司打算如何解决该机构的问题。

文章来源:电子烟,如若转载,请注明出处:http://www.hhdye.com/3716.html

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