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10.1093/nar/gky693 185 SumidaA.FukuenS.YamamotoI.MatsudaH.NaoharaM.AzumaJ

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In this case, the company did not provide sufficient evidence of a benefit that outweighs the risk, particularly given evidence that adults who smoke generally do not stop or significantly curtail consumption of cigarettes when using this product. Tobacco products that receive an MDO from the FDA may not be introduced or delivered for introduction into interstate commerce and must be removed from the market

The usual excuse is, It wont happen to me. Which is exactly what most accident victims told a Consumer Product Safety Commission task force formed to review data concerning accidents

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"Misleading 26 percent of the 36 million smokers in the U.S