FDA To Publish List Of Nicotine Products That Have Submitted PMTA’s
The Food and Drug Administration (FDA) recently announced it will publish a public list of currently marketed electronic nicotine delivery system (ENDS) products for which the Agency has received a premarket tobacco product application (PMTA) by the September 9, 2020 deadline.
In a statement, Director of the FDA’s Center for Tobacco Products (CTP) Mitch Zeller stated, “We request your patience as we work through the appropriate processes to ensure the posted information is accurate and compliant with federal laws. In the interim, we encourage retailers and other interested parties to refer to the public statements made by the companies or contact the companies directly to get information about applications they may have submitted.”
By law, ENDS products that were first introduced into the marketplace or modified after February 15, 2007, also known as the predicate date, are required to submit PMTA’s for the FDA to review and approve by the September 9, 2020 deadline.
PMTA’s require a product to meet a regulatory hurdle that can be complex and costly.
By the FDA providing a public list of ENDS products that meet the proper requirements, retailers of these products will be informed as to which they can sell legally in their stores.
PMAA recently joined four other groups in urging the FDA to publish a public list. Joining PMAA were the National Association of Convenience Stores (NACS), the National Association of Truckstop Operators (NATSO), the Society of Independent Gasoline Marketers of America (SIGMA) and the Food Industry Association (FMI).