Scientific Standards for Studies on Modified Risk Tobacco Products PDF Download

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Scientific Standards for Studies on Modified Risk Tobacco Products

Scientific Standards for Studies on Modified Risk Tobacco Products PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309223989
Category : Medical
Languages : en
Pages : 370

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Book Description
Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.