Following its issuance last week of marketing denial orders (MDOs) to three companies for their flavored electronic nicotine delivery system (ENDS) products, the U.S. Food and Drug Administration (FDA) has now issued MDOs to an additional 31 companies for approximately 300,000 flavored ENDS products from Aug. 27 through Sept. 2.
Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA.
Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. To protect confidential commercial information (CCI), FDA said it cannot release additional information about those actions.
Products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement, the agency said.
FDA explained that it continues to make substantial progress reviewing the unprecedented number of applications received by the Sept. 9, 2020, court-ordered deadline for submission of premarket applications for deemed new tobacco products.
The aggregate information on these actions will be provided within our regular updates on the Tobacco Product Applications: Metrics and Reporting page.