MDO Recipients Warned for Continued Marketing

The U.S. Food and Drug Administration has issued warning letters to 20 companies for continuing to unlawfully market electronic nicotine-delivery system (ENDS) products that are the subject of marketing denial orders (MDOs). These are the first warning letters issued for products subject to MDO determinations on their premarket tobacco product applications (PMTAs).

The FDA also issued warning letters today for the unlawful marketing of tobacco products to one company that received “refuse to file” (RTF) determinations on their PMTA, one company that received 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.

“Today’s action shows that we’re prioritizing enforcement against tobacco product manufacturers who received a negative action on their application, such as a marketing denial order or refuse to file notification and continue to illegally sell those unauthorized products as well as products for which manufacturers failed to submit a marketing application,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement.

“It is our responsibility to make sure that tobacco product manufacturers comply with the law to protect public health, and we’ll continue to hold companies accountable for breaking the law.”

As of Sept. 23, the FDA has issued a total of 323 MDOs, accounting for more than 1,167,000 flavored ENDS products.