煙草在線據FDA官方網站報道編譯 煙草產品科學顧問委員會(TPSAC)3月1日向美國FDA提交了其關于可溶解性煙草產品的自然屬性和對公眾(包括兒童在內)健康影響的現有科學依據的最終報告和建議書。
TPSAC的可溶解性煙草產品報告及建議書中提到:
·整體來看,承擔可溶解性煙草產品的風險和益處的人群包括該煙草產品的使用者和非使用者
·正在使用可溶解性煙草產品者停止使用產品的可能性或許會增加,也或許會減少
·可溶解性煙草產品的非使用者開始使用該產品的可能性或許會增加,也或許會減少
FDA將會仔細考慮這份報告和建議書,并繼續審查涉及可溶解性煙草產品的所有現有科學依據。之后,FDA會做出未來應采取何種有效行動的決定。《家庭吸煙預防和控制法案》(《煙草控制法案》)并沒有對FDA就此建議書做出決定的時間設立最后期限。
FDA還將繼續進行可溶解性煙草產品的研究,持續提供監測以及時發現使用此類產品的弊端,保護公眾健康,并隨時在其職權范圍內采取包括檢查新產品申請報告和實質等價報告在內的必須的法律手段。
TPSAC是一個由領先的公共衛生組織代表、科學專家和煙草業不同部門代表參與組成的協會,專門負責就煙草產品相關的健康事宜及其他與煙草產品相關的法律法規事宜向FDA提供建議、信息和意見。
《煙草控制法案》要求TPSAC代表衛生和公眾服務部(HHS)部長在2012年3月23日向FDA提交最終報告和建議書。
待審查完畢,且所有商業或貿易機密信息都被重新編輯后,FDA將在其煙草產品中心的公共網頁上及時公布該最終報告和建議書。
Update from FDA on the Tobacco Products Scientific Advisory Committee's Report and Recommendations on Dissolvable Tobacco Products
FDA
Mar 1, 2012
On March 1, the Tobacco Products Scientific Advisory Committee (TPSAC) submitted their final report and recommendations to FDA on the evaluation of the available scientific evidence on the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children.
TPSAC's report and recommendations on dissolvable tobacco products addresses:
·the risks and benefits of dissolvable tobacco products to the population as a whole, including users and nonusers of tobacco products
·the increased or decreased likelihood that current tobacco users will stop using such products
·the increased or decreased likelihood that those who don't currently use tobacco products will start using such products
FDA will consider the report and recommendations and continue to review all of the available science concerning dissolvable tobacco products.? FDA will then determine what future action(s), if any, are warranted. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) does not set a required deadline or timeline for FDA to act on these recommendations.
FDA will also continue conducting research on dissolvable tobacco products, provide ongoing monitoring of adverse events related to these products to protect public health, and take any regulatory actions necessary under its authority, which includes reviewing new product applications and substantial equivalence reports1.
TPSAC is a panel of leading public health, scientific experts and representatives of various parts of the tobacco industry, charged with providing advice, information, and recommendations to FDA on health issues related to tobacco products and other issues relating to the regulation of tobacco products.
The Tobacco Control Act requires TPSAC to deliver its final report and recommendations to FDA on behalf of the Secretary of Health and Human Services (HHS) by March 23, 2012.
The final report and recommendations will also be made available to the public on the FDA's Center for Tobacco Products website, once it has been reviewed and all commercial confidential or trade secret information has been redacted.
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