FDA警告公司停止非法銷售電子煙產(chǎn)品

FDA警告公司停止非法銷售電子煙產(chǎn)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.

美國(guó)食品藥品監(jiān)督管理局(FDA)周四開(kāi)始打擊非法銷售的煙草產(chǎn)品，向四家涉嫌未經(jīng)合法授權(quán)銷售電子煙和水煙的公司發(fā)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.

根據(jù)FDA的說(shuō)法，這些產(chǎn)品在美國(guó)缺乏必要的營(yíng)銷權(quán)。目前電子煙還沒(méi)有獲得批準(zhǔn)，但許多電子煙被允許暫時(shí)留在市場(chǎng)上，因?yàn)樗鼈兪窃?016年8月FDA接管電子煙當(dāng)局之前推出的。

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.

根據(jù)FDA的規(guī)定，公司在銷售新產(chǎn)品前必須向FDA提出申請(qǐng)。FDA周五表示，這四家公司——強(qiáng)力蒸汽、液體實(shí)驗(yàn)室、V8P國(guó)際果汁公司和水煙進(jìn)口公司——未能做到這一點(diǎn)。

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說(shuō)，他們一共銷售了44種沒(méi)有得到必要授權(quán)的調(diào)味電子液體和水煙產(chǎn)品。三家公司沒(méi)有立即回應(yīng)CNN的置評(píng)請(qǐng)求。被FDA列為V8P果汁國(guó)際公司所有者的亞歷克斯·德·拉·埃斯普利亞拒絕置評(píng)。

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給每家公司15個(gè)工作日的時(shí)間來(lái)解決他們的擔(dān)憂，并警告說(shuō)，“如果不能糾正違規(guī)行為，可能會(huì)導(dǎo)致查封或禁令等進(jìn)一步的行動(dòng)。”該機(jī)構(gòu)周四說(shuō)，它有幾個(gè)方法來(lái)確保合規(guī)，包括罰款和裁決。

"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代理專員內(nèi)德·夏普萊斯博士說(shuō):“今天的行動(dòng)表明，我們將繼續(xù)密切關(guān)注公司是否違法，一旦發(fā)現(xiàn)違規(guī)行為，我們將迅速采取行動(dòng)。”“我們?cè)谶@個(gè)領(lǐng)域的工作已經(jīng)導(dǎo)致一些公司將產(chǎn)品撤出市場(chǎng)。”

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.

這些警告發(fā)布之際，美國(guó)食品藥品監(jiān)督管理局正因其對(duì)青少年電子煙流行的反應(yīng)而面臨審查。包括美國(guó)兒科學(xué)會(huì)在內(nèi)的一個(gè)健康組織聯(lián)盟去年起訴了該機(jī)構(gòu)，原因是它推遲了對(duì)電子煙安全和健康影響的評(píng)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，一名聯(lián)邦法官裁定，美國(guó)食品藥品監(jiān)督管理局的行為是非法的，在公司申請(qǐng)F(tuán)DA授權(quán)之前，允許電子煙在市場(chǎng)上保留到2022年。7月，法官提前了截止日期，給公司只有10個(gè)月的時(shí)間申請(qǐng)。

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

“美國(guó)食品藥品監(jiān)督管理局隨時(shí)準(zhǔn)備加快對(duì)電子煙和其他新煙草產(chǎn)品的審查，”夏普萊斯當(dāng)時(shí)說(shuō)。