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An e-cigarette or electronic nicotine delivery system (ENDS) manufacturer, on the other hand, is stuck with the PMTA process, and the overwhelming task of demonstrating that its products are appropriate for the protection of the public health. Even companies with the financial resources and scientific acumen to navigate the PMTA and obtain a marketing granted order (currently limited to tobacco-flavored ENDS), must go through the time-consuming supplemental PMTA process to make even minor product changes (even if those changes will not have any meaningful impact on risks or how the product is consumed)
CONFLICTS OF INTEREST The authors state that the present manuscript was supported by Grants R01DA060884 and U54DA036151 from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) and the Center for Tobacco Products (CTP) of the United States Food and Drugs Administration (FDA) and payments were made to institutions (Duke University School of Medicine)
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