The guidance for manufacturers to submit new tobacco product applications through the premarket tobacco product application (PMTA) pathway was finalized on June 11. This is for electronic nicotine delivery systems (ENDS), like vapes, and the associated liquid nicotine.
“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.
“The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product. There are no authorized e-cigarettes currently on the market and we encourage companies to use this valuable document now as a guide to submit applications. At the same time, the public can be assured that the FDA has been and will continue to take all necessary actions to protect children as part of our Youth Tobacco Prevention Plan, including maintaining our focus on enforcement actions and policies aimed at ensuring e-cigarettes aren't being marketed to, sold to or used by kids.”
The PMTA pathway will require manufacturers to ensure, in part, that marketing is not geared toward underage youth. The FDA must consider whether these products will cause people who do not smoke to take up smoking.
It is a mission of the FDA to make tobacco less appealing to youth by regulations including marketing regulations.
