FDA Issues First Warning Letters for MDO Violations

The U.S Food and Drug Administration today issued warning letters to 20 companies for unlawfully continuing to market electronic nicotine-delivery system (ENDS) products that are the subject of marketing denial orders (MDOs).

These are the first warning letters issued for the marketing of products subject to MDO determinations on their premarket tobacco product applications (PMTAs), according to an FDA statement. The FDA has also issued warning letters for the unlawful marketing of tobacco products to one company that received Refuse to File (RTF) determinations on their PMTA, one company that received both RTF and MDO determinations on their PMTA, and six companies that did not submit any premarket applications.

“Collectively, these 28 companies have listed a combined total of more than 600,000 products with the FDA. All new tobacco products sold, distributed, or imported in the United States without FDA authorization are marketed unlawfully and risk FDA enforcement,” the statement reads. “On FDA’s Warning Letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.”

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.

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.