Some Breather For E-Cigarette Maker Juul As FDA Reconsiders Marketing Denials Issued Two Years Ago
Some Breather For E-Cigarette Maker Juul As FDA Reconsiders Marketing Denials Issued Two Years Ago
The FDA has rescinded the marketing denial orders (MDOs) issued to JUUL Labs Inc., partially due to new case law and further information provided by JUUL.
由於JUUL向FDA提供了新的案例法和更多信息，FDA已撤銷對JUUL Labs Inc.發出的營銷否決令(MDOs)的部分支持。
This rescission returns the applications to pending status and does not indicate whether they will be authorized or denied.
此次撤銷將申請回到待定狀態，並不表示它們會被授權或被拒絕。
The FDA continues its substantive review of the applications, adhering to its regulations, which limit the disclosure of pending application content.
FDA持續進行對申請的實質性審查，遵守其規定，限制披露待決申請的內容。
Related: E-Cigarette Maker Juul's Financial Rescue Marred by Allegations Against Key Directors' Self-Interest.
相關新聞: 吉利德的 Trodelvy 在普通膀胱癌最常見類型的後期研究中未能達到主要目標。電子煙製造商Juul的經濟拯救計劃受到針對關鍵董事自身利益的指控所困擾。
In June 2022, the FDA announced it would ban Juul brand e-cigarettes in the country, wiping away a significant chunk of the $21.63 billion industry, of which Juul owns 41%.
FDA在2022年6月宣佈禁止朱爾(Juul)品牌電子煙在美國銷售，抹去了價值21.63億美元行業的一個重要部分，而朱爾佔有該行業的41%。
The agency cited insufficient evidence regarding the toxicological profile of JUUL's products, raising concerns over conflicting data about genotoxicity and harmful chemicals leaching from e-liquid pods.
該機構認爲，關於JUUL產品的毒理學特性證據不足，存在關於基因毒性和有害化學物質從電子液體盒子中滲出的數據的矛盾，引發了擔憂。
This lack of conclusive data prevented the FDA from completing a full toxicological review, leading to the initial denial.
這種缺乏確鑿數據使FDA無法完成全面的毒理學評估，從而導致最初的否決。
By July 2022, the FDA had administratively stayed the MDOs, recognizing the need for further scientific review.
到2022年7月，FDA已經行政暫停了MDOs，承認需要進一步的科學評估。
Since then, the FDA has conducted additional evaluations in toxicology, engineering, social science, and clinical pharmacology.
此後，FDA在毒理學、工程學、社會科學和臨床藥理學方面進行了更多的評估。
This continued review process underscores the requirement that all e-cigarette products, including those by JUUL, must have FDA authorization to be legally marketed.
這個持續的審查過程強調了所有電子煙產品(包括JUUL的產品)都必須經過FDA的授權才能合法銷售的要求。
The rescission follows the FDA's updated understanding of e-cigarette products and recent litigation outcomes involving other manufacturers' MDOs.
此次撤銷是基於FDA對電子煙產品的更新理解和其他製造商MDOs的訴訟結果。
These court decisions have provided new case law influencing the FDA's product review process. The agency remains dedicated to issuing final decisions that are scientifically sound and legally appropriate.
這些法院判決提供了影響FDA產品審查過程的新案例法。該機構仍然致力於發佈既有科學依據又合法適當的最終決定。
Although the FDA ban was put on hold, it sent Juul into a financial tailspin. The company also considered filing for bankruptcy.
雖然FDA的禁令被擱置，但已使Juul陷入金融困境。公司還考慮申請破產。
Juul Labs seeks FDA approval for its next-generation vaporizer, which is already available in the U.K. and Canada. The company is waiting for word on whether its current products can stay on the market.
Juul Labs正在尋求FDA批准其下一代霧化器，在英國和加拿大已經上市。該公司正在等待是否可以繼續銷售其當前的產品。
Photo via Wikimedia Commons
照片通過Wikimedia Commons
譯文內容由第三人軟體翻譯。