美FDA加快尼古丁袋審批 白宮施壓背後揭秘

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Transform the original photo into a dramatic, photorealistic, ultra wide-angle shot with an extreme camera angle (including views from directly below or above), where one or more body parts are right next to the lens and look huge, the rest of the body recedes in perspective, and the same person strikes a stylish, complex, powerful pose in a consistent, expanded version of the original environment. The woman in the photo is wearing yellow stilettos and a black and silver metallic ball gown and stylish black sunglasses.
Certainly! Here is your enhanced, artistic, and detailed prompt for an AI image generator:

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A captivating portrait of a young Asian woman, inspired by Imada Mio and embodying an exquisitely delicate, doll-like (精緻洋娃娃臉) aesthetic. She has large, round, expressive eyes that radiate innocence and curiosity, subtly accented with a moist shimmer. Her petite V-line face is framed by soft, rosy cheeks, and her lips are naturally pink and slightly parted, exuding an energetic, slightly flirty, yet pure aura. Her expression is a candid blend of sweetness and playful allure.

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She is dressed in an oversized, translucent white button-down shirt (男友風白襯衫) with the top buttons casually undone, delicately revealing her collarbones and a slender neckline. The shirt drapes loosely, giving a tasteful "bottomless" look (下衣失蹤風格), her bare legs just barely visible beneath the shirt's hem, enhancing the innocent-meets-sensual ambiance.

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The background is minimalist and softly blurred, ensuring complete focus on the subject, and enhancing the overall sense of warmth, comfort, and inviting allure typical of high-end Japanese photobooks.

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美國FDA加快尼古丁口袋審批程序 白宮施壓促進計劃啟動

根據路透社獲得的會議紀錄,美國食品藥品監督管理局(FDA)計劃於本週一啟動一項試點計劃,加快四家煙草企業的尼古丁口袋產品審批程序,此舉是在特朗普政府的壓力下推動的。FDA目標是在年底前完成對Philip Morris International(菲利普莫里斯國際)、Altria(奧爾特里亞)、Reynolds American(雷諾茲美國公司,隸屬於英美煙草)及Turning Point Brands的尼古丁口袋審查。

過往,煙草企業申請產品審批往往需耗時數年。FDA在今年一月首次批准了PMI旗下Zyn品牌的20款尼古丁口袋產品,但距首次申請已逾五年。此次納入試點計劃的產品包括PMI尚未上市的升級版Zyn Ultra,這些產品正等待FDA放行,期間競爭對手已藉由更具競爭力的產品搶占市場份額。

該試點計劃有望為參與企業提供更快捷的合法上市通道,對於已在市場上未經授權銷售的產品,FDA批准將消除其法律地位的疑慮,降低被執法行動威脅的風險。據另一場會議紀錄顯示,FDA官員透露,該局受到包括白宮在內的高層壓力,要求提高尼古丁口袋的審核效率。

負責監督FDA的美國衛生與公共服務部及白宮暫未對此置評。今年以來,煙草企業積極遊說特朗普總統及其他關鍵官員,爭取更快速及明確的FDA授權流程。資料顯示,英美煙草旗下的Reynolds American曾向特朗普支持的超級政治行動委員會“Make America Great Again Inc”捐贈1000萬美元。

尼古丁口袋是一種放入口唇下以攝取尼古丁的產品,是美國增長最快的煙草替代品類。由於不涉及吸入煙霧且不含煙草,這類產品被視為相對低風險的替代品,但公共衛生倡導者擔心其對青少年等新用戶仍有吸引力,存在健康風險。

煙草無煙兒童運動(Campaign for Tobacco-Free Kids)執行長Yolonda Richardson強調,FDA對新產品的嚴格審查對保護青少年和公共健康至關重要,「在孩子健康問題上不應該有任何捷徑」。不過,FDA官員在周五的會議中表示,目前並無證據顯示青少年對這類產品的使用顯著增加。

PMI的Zyn品牌在美國市場遙遙領先,近年來季度出貨量增長達40%至80%,成為公司最重要的產品之一。此次試點計劃中包括PMI的Zyn Ultra、Altria的on!和on! Plus、Reynolds的Velo mini及Turning Point Brands的Fre和Alp,其中Alp品牌由前福克斯新聞主持人Tucker Carlson共同擁有。

對於FDA的快速審批計劃,PMI表示此舉或是向正確方向邁進的一步,但該公司並不知情有此計劃。Altria則認為FDA的做法令人鼓舞,是減害策略的積極進展;Turning Point Brands則表示,這條簡化路徑展現了政府持續致力於效率、效能及透明度的承諾。Reynolds方面則拒絕置評。

FDA在會議中指出,參與試點的產品將經歷申請程序,審查流程將更加精簡,FDA工作人員與申請者之間的溝通也將更頻繁,審批速度加快。審查重點會集中於尼古丁口袋的科學評估啟動所需資料、核心產品特性、製造一致性與穩定性,以及濫用風險數據。

編輯評論:

這次FDA在白宮壓力下加快尼古丁口袋審批流程,反映出美國政府在煙草替代品監管上的政策調整,試圖在促進市場創新與公共健康保護間尋求平衡。尼古丁口袋作為一種非吸入式產品,確實有助於降低吸煙相關的健康風險,但仍不可忽視其對青少年和非吸煙者可能造成的誘惑和依賴問題。

在香港,我們亦見到類似的煙草替代品如加熱不燃燒煙草和電子煙的監管爭議。美國的這一試點計劃或為本地監管機構提供參考:如何在嚴格審批與市場發展之間找到合適節奏,既避免市場過度擴張引發公共衛生問題,又不至於扼殺創新與消費者選擇。

此外,這次事件也揭示了煙草企業透過政治遊說影響監管政策的現象,值得公眾和監管機構保持警覺。透明且科學嚴謹的審查程序,配合有效的市場監管和公共教育,才是長遠保障民眾健康的關鍵。未來如何在促進減害與防止青少年成癮之間取得良好平衡,將是全球煙草替代品監管的重大挑戰。

以上文章由特價GPT API KEY所翻譯及撰寫。

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