烟草在线据FDA官方网站报道编译 烟草产品科学顾问委员会(TPSAC)3月1日向美国FDA提交了其关于可溶解性烟草产品的自然属性和对公众(包括儿童在内)健康影响的现有科学依据的最终报告和建议书。
TPSAC的可溶解性烟草产品报告及建议书中提到:
·整体来看,承担可溶解性烟草产品的风险和益处的人群包括该烟草产品的使用者和非使用者
·正在使用可溶解性烟草产品者停止使用产品的可能性或许会增加,也或许会减少
·可溶解性烟草产品的非使用者开始使用该产品的可能性或许会增加,也或许会减少
FDA将会仔细考虑这份报告和建议书,并继续审查涉及可溶解性烟草产品的所有现有科学依据。之后,FDA会做出未来应采取何种有效行动的决定。《家庭吸烟预防和控制法案》(《烟草控制法案》)并没有对FDA就此建议书做出决定的时间设立最后期限。
FDA还将继续进行可溶解性烟草产品的研究,持续提供监测以及时发现使用此类产品的弊端,保护公众健康,并随时在其职权范围内采取包括检查新产品申请报告和实质等价报告在内的必须的法律手段。
TPSAC是一个由领先的公共卫生组织代表、科学专家和烟草业不同部门代表参与组成的协会,专门负责就烟草产品相关的健康事宜及其他与烟草产品相关的法律法规事宜向FDA提供建议、信息和意见。
《烟草控制法案》要求TPSAC代表卫生和公众服务部(HHS)部长在2012年3月23日向FDA提交最终报告和建议书。
待审查完毕,且所有商业或贸易机密信息都被重新编辑后,FDA将在其烟草产品中心的公共网页上及时公布该最终报告和建议书。
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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