FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes

FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes

Today, the U.S. Food and Drug Administration finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco product application (PMTA) pathway for electronic nicotine delivery systems (ENDS), such as e-cigarettes or “vapes,” and the liquid nicotine and nicotine-containing e-liquids used with such products, as part of the agency’s continued commitment to its oversight of tobacco products. “The FDA’s ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death. The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health,” said Acting FDA Commissioner Ned Sharpless, M.D. “The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to...

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