美FDA證實電子菸減害並合法上市 世衛專家王郁揚:邱泰源要繼續說謊危害國民健康?
美國FDA2024年6月21日通過第一款薄荷尼古丁電子菸，證實對成年人吸菸危害較小，世衛菸草減害專家王郁揚痛批台灣衛福部造謠抹黑電子菸，拿菸捐搞認知作戰，此舉已嚴重危害國民健康，並點名衛福部長邱泰源是否要繼續危害國民健康。
美國食品藥物管理局在進行廣泛科學審查後授權四款薄荷味電子煙產品上市
授權包括限制措施以減輕青少年風險
即時發布: 2024年6月21日
美國食品藥物管理局(FDA)今天在進行廣泛的科學審查後,通過初階減害菸品認證(PMTA)途徑，授權四款電子菸產品在美國上市。FDA向NJOY LLC公司發出了四款薄荷味電子菸產品的上市許可令 – NJOY ACE Pod 薄荷味2.4%、NJOY ACE Pod 薄荷味5%、NJOY DAILY 薄荷味4.5%和NJOY DAILY EXTRA 薄荷味6%。兩款獲授權的ACE產品是密封、預填充、不可重複使用的菸彈，用於之前獲授權的ACE設備中,而兩款獲授權的DAILY產品則是一次性電子菸，帶有預填充、不可重複使用的電子液體儲存器。
今天的授權標誌著FDA首次授權非菸草口味的電子煙產品。重要的是，每項申請都是根據具體情況進行審查，今天的行動僅針對這四款產品 – 授權不適用於任何其他薄荷味電子菸產品。要在美國合法銷售新的菸草產品，公司必須收到FDA的書面上市許可令。雖然這一行動允許這些特定菸草產品在美國合法銷售,但並不意味著這些菸草產品是安全的，也不意味著它們是”FDA批准(FDA approved)”的。所有菸草產品都是有害的,並可能導致成癮。不使用菸草產品的人不應開始使用。
FDA煙草產品中心主任Brian King博士表示:”申請人有責任提供獲得上市授權所需的必要證據，FDA已經明確說明了成功實現這一結果所需的內容。這一行動進一步強調，當向機構提交足夠的科學證據來證明時，電子菸產品是可能獲得授權的。”
FDA根據公共衛生標準評估PMTA申請，該標準考慮了產品對整體人口的風險和益處等因素。在審查公司的申請後，FDA確定有足夠的證據表明，允許這些產品上市將適合保護公眾健康,這是2009年《家庭吸煙預防和菸草控制法》法律要求的標準。具體來說，申請人提交的證據表明，與申請人之前獲授權的煙草口味產品相比，這些薄荷味產品在完全轉換方面為吸煙成年人提供了足夠的益處，足以超過產品的風險，包括對青少年的吸引力。
FDA菸草產品中心科學辦公室主任Matthew Farrelly博士表示:”我們是一個以證據為導向的機構，將繼續遵循科學來指導我們對預減害菸品申請的審查。基於我們嚴格的科學審查，在這個案例中，成年吸煙者完全轉向危害較小的產品所帶來的益處的證據足夠強大，足以超過對青少年的風險。”
FDA仍然關注所有電子煙產品對青少年使用的風險 – 特別是更吸引青少年的調味產品。與之前獲授權的產品一樣，FDA對新產品施加了嚴格的營銷限制，以防止青少年接觸和暴露。FDA將密切監控這些產品的行銷方式，如果公司未能遵守任何適用的法定或監管要求，FDA將採取適當行動。如果機構確定繼續營銷不再適合保護公眾健康，包括青少年或前吸煙者使用產品的情況明顯增加，或完全轉向這些產品的現有吸煙者數量減少，機構可能會暫停或撤銷授權。
今天的行動是FDA採取的眾多行動之一，以確保在美國上市的所有新菸草產品都經過科學審查,並獲得機構的上市授權。FDA已收到近2700萬件被視為產品的申請，並已對其中超過2600萬件申請做出決定。迄今為止，FDA已授權27款菸草和薄荷味電子菸產品和設備，包括今天授權的四款。該機構維護一份所有獲授權電子菸產品的列印單頁傳單；這些是目前唯一可以在美國合法銷售的電子菸產品,那些未經必要的預市授權而製造、進口、銷售或經銷電子煙的人面臨執法風險。希望了解可在美國合法銷售的菸草產品(包括電子菸)清單的人，可以訪問FDA新的菸草產品數據庫。
相關資訊 可搜索菸草產品數據庫 NJOY ACE: 命令信 (PDF) 和決定摘要 (PDF) NJOY DAILY: 命令信 (PDF) 和決定摘要 (PDF) 預市煙草產品申請 戒煙和其他煙草公共衛生資源
FDA是美國衛生與公眾服務部下屬的一個機構，通過確保人用和獸用藥物、疫苗和其他生物製品以及醫療設備的安全性、有效性和安全性來保護公眾健康。該機構還負責我國食品供應、化妝品、膳食補充劑、輻射電子產品的安全和安全，並負責監管菸草產品。
台灣世衛菸草減害專家王郁揚回應：「對這些年一直隱匿電子菸真相的衛福部以及董氏基金會，還有在政府高層幕後策劃禁止電子菸的醫藥財團、菸草財團，以及協助政府亂帶風向的特定媒體，感到不齒，我更替台灣國人以及小朋友因為衛福部錯誤政策，嚴重危害國民健康，違背菸害防制法第一條立法宗旨，感到遺憾與憤怒。」
王補充，衛福部官員曾說：台灣50年後再來討論電子菸合法議題，意思就是台灣人要繼續遭受黑箱修惡的菸害防制法繼續拿紙菸捐荼毒50年，請問邱泰源部長你還要繼續對電子菸說謊，危害國民健康嗎？
我希望更多人能開始思考「台灣菸害防制法方向為何跟國際上的說詞、證據差異這麼多」，最後還是那句「菸草減害 2040無煙台灣」。
FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review
Authorization Includes Restrictions to Mitigate Youth Risk
For Immediate Release:June 21, 2024
Following an extensive scientific review, the U.S. Food and Drug Administration today authorized the marketing of four e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for four menthol-flavored e-cigarette products – NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%. The two authorized ACE products are sealed, pre-filled, non-refillable pods that are used with the previously authorized ACE device, and the two authorized DAILY products are disposable e-cigarettes with a prefilled, non-refillable e-liquid reservoir.
Today’s authorizations mark the first non-tobacco flavored e-cigarette products to be authorized by the FDA. Importantly, each application is reviewed on a case-by-case basis and today’s actions are specific to these four products only – the authorizations do not apply to any other menthol-flavored e-cigarette products. To legally market a new tobacco product in the U.S., a company must receive a written marketing order from the FDA. While this action permits these specific tobacco products to be legally marketed in the U.S., it does not mean these tobacco products are safe nor are they “FDA approved.” All tobacco products are harmful and potentially addictive. Those who do not use tobacco products shouldn’t start.
“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”
The FDA evaluates PMTAs based on a public health standard that considers, among other things, the risks and benefits of the product to the population as a whole. After reviewing the company’s applications, the FDA determined there was sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, evidence submitted by the applicant showed that these menthol-flavored products provided a benefit for adults who smoke cigarettes relative to that of the applicant’s previously authorized tobacco-flavored products—in terms of complete switching—that is sufficient to outweigh the risks of the product, including youth appeal.
“We are a data driven agency and will continue to follow the science to inform our review of premarket tobacco applications,” said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products. “Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth.”
The FDA remains concerned about the risk of youth use of all e-cigarettes – particularly flavored products that are more appealing to youth. Like previously authorized products, the FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure. The FDA will closely monitor how these products are marketed and will act as appropriate if the company fails to comply with any applicable statutory or regulatory requirements. The agency may suspend or withdraw authorization if the agency determines that continued marketing is no longer appropriate for the protection of the public health, including if there is a notable increase in use of the products among youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.
Today’s actions are among many the FDA has taken to ensure all new tobacco products that are marketed in the U.S. undergo science-based review and have received marketing authorizations by the agency. The FDA has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of these applications. To date, the FDA has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices, including the four authorized today. The agency maintains a printable one-page flyer of all authorized e-cigarette products; these are the only e-cigarette products that currently may be lawfully marketed and sold in the U.S. and those manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement. Those seeking a list of tobacco products—including e-cigarettes—that may be legally marketed in the United States, can visit the FDA’s new Searchable Tobacco Products Database.
Related Information
- Searchable Tobacco Products Database
- NJOY ACE: Order Letter (PDF) and Decision Summary (PDF)
- NJOY DAILY: Order Letter (PDF) and Decision Summary (PDF)
- Premarket Tobacco Product Applications
- Quitting Smoking and Other Tobacco Public Health Resources
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
Inquiries
Media: Jim McKinney (240) 328-7305
延伸閱讀：
NJOY薄荷電子菸可在美上市 史上首例
https://www.worldjournal.com/wj/story/121469/8047333
美FDA批准四款薄荷醇調味電子煙 允許其在美國市場銷售
美國批准首批薄荷味電子煙
FDA OKs first menthol e-cigarettes, citing potential to help adult smokers
https://apnews.com/article/ecigarettes-menthol-fda-njoy-vaping-6493efc348291434af9d7c88601154e9
NJOY Receives First FDA Authorizations for Menthol E-Vapor Products
Altria’s Menthol E-Cigs Get FDA Nod as Menthol Debate Continues
In a first, FDA authorizes flavored vape products from Altria’s NJOY for sale
