美政府向六家電子煙商提告 要求立即停止生產及行銷

美國司法部(DOJ)代表美國食品藥物管理局(FDA)本周在聯邦法院提起訴訟，要求法院對六家電子煙製造商做成永久禁制令之判決，禁止該等公司繼續產銷電子煙。案是FDA首次依據聯邦食品、藥物和化妝品法(FD&C)，而對違反新型菸品申請上市審查 (PMTA)的電子煙商進行起訴禁令程序。

根據美國FDA 發表的聲明稿指出，這六家被告的電子煙商都沒有依照PMTA提交電子煙上市前申請，卻繼續非法生產及銷售其產品，儘管FDA之前已提出警告，但電子煙商仍無視政府法律。FDA與DOJ聯手提告，要求這些公司與被點名的個人立即停止生產及行銷電子煙。

FDA菸草製品中心主任布萊恩·金(Brian King)表示，FDA已經提供新型菸品業者完整的上市前申請機制，此次正式起訴行動, 是讓業者知道政府對新型菸品的強行闖關與違法絕對不會袖手旁觀。

因此，美國司法部代表FDA在以下六家違法電子煙商所在地之聯邦地方法院提出禁令及訴訟：

　‧西維吉尼亞州- Soul Vapor LLC
　‧明尼蘇達州- Morin Enterprises Inc.
　‧華盛頓州- Super Vape'z LLC
　‧喬治亞州- Vapor Craft LLC
　‧堪薩斯州-Lucky's Convenience & Tobacco LLC
　‧亞利桑那州-Seditious Vapors LLC

美國司法部民事處負責人、首席副助理總檢察長賴恩·博因頓 (Brian M. Boynton)表示，此次行動為打擊未經授權與禁止非法的新型菸品跨出重要的一步，美國司法部將繼續與FDA密切合作，阻止非法、未經授權的新型菸品產銷。

根據FD&C規範，若發現在未經授權下生產製造及分裝銷售的新型菸品，FDA通常會先發警告信，若持續違規，FDA可以要求司法部採取司法強制措施，請求法院簽發禁制令或扣押，對於違反FD&C規範之廠商或個人，FDA亦可進行罰緩之行政處分。

從2021年1月到2022年9月9日，在美國FDA註冊的新型菸品品項有1700萬個, 而針對未依法提交上市前申請的電子煙公司, FDA共發出近300封的警告信。在收到警告信後，大多數的公司都配合遵守規定，將產品從市場上撤下，但仍有如同上述六家電子煙公司未遵守FDA的警告。

例如，稍早FDA已向經營Puff Bar品牌的EVO Brands LLC和PVG2 LLC發出警告信，原因是這兩家公司在未經FDA授權下，進行製造、分裝及行銷，急速成為美國年輕人最受歡迎的電子煙品牌之一。該公司之違法行為，未來將面臨司法及行政機關的處分及處罰。

【註】多年來, 美國政府抱持「成年人選擇，青少年勿用」的鴕鳥心態，未正視菸草公司透過新型菸品開拓尼古丁成癮新市場的策略。直至2019年8月, 美國開始出現一連串的電子煙相關肺傷害(EVALI)住院確診病例，醫藥學界與家長團體要求白宮禁止電子煙、挽救年輕人，美國食品藥物管理局(FDA)才下令所有新型菸品重作「上市前菸品申請」(PMTA)審查。

文：董氏基金會菸害防制中心主任 林清麗

FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers

First Injunction Actions Relating to Tobacco Products

Today, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers. These cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.

Each of these defendants failed to submit premarket applications for their e-cigarettes and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law. The injunctions would require the companies and named individuals to stop manufacturing, selling, and distributing their e-cigarettes. The injunctions would also require the defendants to obtain marketing authorization from the FDA before marketing such products, as required by law. 

“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.” 

DOJ institutes judicial enforcement actions under the FD&C Act in court. Therefore, the injunctions were filed by DOJ on behalf of the FDA against the following defendants in their respective U.S. District Courts:

　‧Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota
　‧Soul Vapor LLC in the Southern District of West Virginia
　‧Super Vape’z LLC in the Western District of Washington
　‧Vapor Craft LLC in the Middle District of Georgia
　‧Lucky’s Convenience & Tobacco LLC doing business as Lucky’s Vape & Smoke Shop in the District of Kansas
　‧Seditious Vapours LLC doing business as Butt Out in the District of Arizona

The FDA had previously warned each of the defendant companies that they were in violation of the FD&C Act’s premarket review requirements for new tobacco products by manufacturing, selling, and distributing new tobacco products without first obtaining marketing authorization from the FDA. However, the defendants continued to manufacture, sell, and distribute unauthorized e-cigarettes to consumers. The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction. 

Defendants have the opportunity to agree to consent decrees of a permanent injunction, which prevent them from directly or indirectly manufacturing, selling or distributing any new tobacco products unless and until certain prerequisites are met. These prerequisites include that the tobacco products receive FDA marketing authorization, that the agency inspect the defendants’ facilities to determine compliance, and that the FDA notify defendants in writing that they appear to be in compliance with the law. For those defendants who do not agree to consent decrees, the government can request the relevant courts to enter injunctions preventing those defendants from directly or indirectly manufacturing, selling or distributing any unauthorized tobacco products.

“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.” 

When companies are manufacturing and distributing unauthorized tobacco products, the FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law. If continuing violations are documented by the FDA, the agency may request that DOJ pursue a judicial enforcement action, such as an injunction or seizure. The FDA also has administrative civil money penalty authority for violations of the FD&C Act relating to tobacco products. 

Between January 2021 through Sept. 9, 2022, the FDA issued nearly 300 warning letters, to firms that collectively have more than 17 million e-cigarettes listed with the agency, for failure to submit a timely premarket application. After receiving warning letters, a majority of these companies have complied and removed their products from the market. 

These actions are part of a comprehensive approach to enforcing the law. For example, earlier this month, the FDA issued a warning letter to EVO Brands LLC and PVG2 LLC, doing business as Puff Bar, which is one of the most popular brands among U.S. youth, for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. All e-cigarettes on the market without the statutorily required premarket authorization are marketed unlawfully and risk FDA enforcement action. It is illegal to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty. 

The FDA encourages retailers to discuss new tobacco products in their inventory with their suppliers, to determine whether such products have the required marketing authorization. The FDA provides the names of authorized e-cigarettes on the FDA’s Tobacco Product Marketing Orders page. The FDA encourages the public to submit potential violations to us through our online form. 

資料來源：https://www.fda.gov/news-events/press-announcements/fda-doj-seek-permanent-injunctions-against-six-e-cigarette-manufacturers?utm_medium=email&utm_source=govdelivery