FDA Warns Companies Marketing ENDS Subject to MDO

Separate warning letters issued for 6 tobacco products that did not submit any premarket applications
Man vaping
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) on Thursday issued warnings to 20 companies continuing to market electronic nicotine delivery systems (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 MDOs on their premarket tobacco product applications (PMTAs).

Separately, the agency issued warning letters for the unlawful marketing of tobacco products to a company that received a refuse to file (RTF) determination on its PMTA, a company that received both RTF and MDO determinations and six companies that did not submit any premarket applications.

Collectively, the companies have a total of more than 600,000 products with the FDA.

Retailers can find the warning letters and company names on the FDA’s warning letters page by entering “Center for Tobacco Products” in the issuing office box in the “filter by” section of the search tool.

The FDA may refuse to file a PMTA due to the application missing one or more items required by the federal Food, Drug and Cosmetic Act. MDOs are issued after the FDA has reviewed a premarket application and determined it will not issue a marketing granted order. The agency has issued about 300 MDOs since Sept. 9, a year after PMTAs were due.

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