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That language, which was provided by Senator Frist, drew extensively on the acts existing drug and device provisions in Chapter V, but with modifications.35 By establishing new legal authority within the FFDCA for regulating tobacco products, the bills sponsors sought to address the unique challenges tobacco products present and avoid the safety and effectiveness standard that applies to the regulation of drugs and devices

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And another study, which further emphasises this, found the reduction in cigarette sales between 20162019 was five times greater than the drop between 20112015.[9] Figure 1 Our own Global State of Tobacco Harm Reduction research, which compares sales volumes, clearly demonstrates the reduction in the number of cigarettes consumed

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