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In conducting nicotine experiments on pregnant humans the authors effectively ignored scores of animal studies finding that nicotine during pregnancy causes what the authors term "serious detrimental effects." As reviewers, three of the study's authors, including the lead author, were involved in producing a 2005 UK guidance advocating NRT use by pregnant smokers

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But because IQOS was unlike any previously available product, it was subject to the FDAs onerous premarket tobacco product application (PMTA) pathway to be authorized for sale

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