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FDA警告公司停止非法销售电子烟产品

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2019年08月13日

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FDA warns companies to stop illegally marketing vape products

FDA警告公司停止非法销售电子烟产品

The FDA began to crack down on illegally marketed tobacco products Thursday, issuing warning letters to four companies for allegedly selling e-liquids and hookah tobacco without legal authorization.

美国食品药品监督管理局(FDA)周四开始打击非法销售的烟草产品,向四家涉嫌未经合法授权销售电子烟和水烟的公司发出警告信。

The products, according to the FDA, lack the necessary marketing authorization to be sold in the United States. No e-cigarette currently has that approval, but many are allowed to stay on the market temporarily because they were introduced before the FDA assumed authority over vapes in August 2016.

根据FDA的说法,这些产品在美国缺乏必要的营销权。目前电子烟还没有获得批准,但许多电子烟被允许暂时留在市场上,因为它们是在2016年8月FDA接管电子烟当局之前推出的。

FDA警告公司停止非法销售电子烟产品

Under the agency's rules, companies now have to apply to the FDA before selling new products. The FDA said Friday that the four companies -- Mighty Vapors, Liquid Labs, V8P Juice International and Hookah Imports -- failed to do so.

根据FDA的规定,公司在销售新产品前必须向FDA提出申请。FDA周五表示,这四家公司——强力蒸汽、液体实验室、V8P国际果汁公司和水烟进口公司——未能做到这一点。

Together, they sold 44 flavored e-liquid and hookah products that lacked necessary authorization, the FDA said. Three companies did not immediately respond to CNN's requests for comment. The man listed by the FDA as the owner of V8P Juice International, Alex De La Espriella, declined to comment.

FDA说,他们一共销售了44种没有得到必要授权的调味电子液体和水烟产品。三家公司没有立即回应CNN的置评请求。被FDA列为V8P果汁国际公司所有者的亚历克斯·德·拉·埃斯普利亚拒绝置评。

The FDA has given each company 15 working days to address the agency's concerns and warned that "failure to correct violations may result in further action such as seizure or injunction." The agency said Thursday that it has several tools to ensure compliance, including fines and the courts.

FDA给每家公司15个工作日的时间来解决他们的担忧,并警告说,“如果不能纠正违规行为,可能会导致查封或禁令等进一步的行动。”该机构周四说,它有几个方法来确保合规,包括罚款和裁决。

"Today's actions make clear that we will continue to keep a close watch on whether companies are breaking the law and will take swift steps when violations are found," said Acting FDA Commissioner Dr. Ned Sharpless. "Our work in this area has already resulted in a number of companies removing products from the market."

FDA代理专员内德·夏普莱斯博士说:“今天的行动表明,我们将继续密切关注公司是否违法,一旦发现违规行为,我们将迅速采取行动。”“我们在这个领域的工作已经导致一些公司将产品撤出市场。”

FDA警告公司停止非法销售电子烟产品

The warnings come as the FDA faces scrutiny over its response to the youth vaping epidemic. A coalition of health groups, including the American Academy of Pediatrics, sued the agency last year for delaying a review of the safety and health impacts of e-cigarettes.

这些警告发布之际,美国食品药品监督管理局正因其对青少年电子烟流行的反应而面临审查。包括美国儿科学会在内的一个健康组织联盟去年起诉了该机构,原因是它推迟了对电子烟安全和健康影响的评估。

A federal judge ruled in May that the FDA acted illegallyby allowing e-cigarettes to remain on the market until 2022 before companies applied for FDA authorization. In July, the judge moved up that deadline, giving companies just 10 months to apply.

今年5月,一名联邦法官裁定,美国食品药品监督管理局的行为是非法的,在公司申请FDA授权之前,允许电子烟在市场上保留到2022年。7月,法官提前了截止日期,给公司只有10个月的时间申请。

"The FDA stands ready to accelerate the review of e-cigarettes and other new tobacco products," Sharpless said at the time.

“美国食品药品监督管理局随时准备加快对电子烟和其他新烟草产品的审查,”夏普莱斯当时说。


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