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Modified risk tobacco product : ウィキペディア英語版
Modified risk tobacco product
A Modified Risk Tobacco Product (MRTP) poses lower health risks to individual users and the population as a whole when compared to existing products on the market such as cigarettes.〔(【引用サイトリンク】url=http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/ucm304465.htm )〕 The Family Smoking Prevention and Tobacco Control Act, signed into law in 2009, gave the U.S. Food & Drug Administration broad authority to regulate tobacco products, including approval or rejection of MRTP applications.
Without FDA approval from the Center for Tobacco Products, a tobacco company may not legally make reduced risk claims or change warning label statements.〔(【引用サイトリンク】url=http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm237092.htm )
==First application accepted for review==

An MRTP application submitted by smokeless tobacco maker Swedish Match in 2014 was the first ever accepted for review by the FDA. On June 11, the 135,000-page MRTP application was submitted electronically to the FDA in compliance with formatting and data requirements.〔(【引用サイトリンク】url=http://www.globalsubmit.com/Services/Tobacco-Submissions )
The application cites historical data and various studies to support the modified risk claim.
Swedish Match is seeking approval to remove warnings about mouth cancer, gum disease, and tooth loss from its product packaging. The company also asked the FDA to strike a statement reading "this product is not a safe alternative to cigarettes" as required by the Family Smoking Prevention and Tobacco Control Act. The company is asking the FDA to replace the statement with language acknowledging the harmful nature of all tobacco products and the reduced risk profile of Swedish snus by comparison.〔

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
ウィキペディアで「Modified risk tobacco product」の詳細全文を読む



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