FDA warns companies whose marketing ends up subject to MDO


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SILVER SPRING, Maryland – The United States Food and Drug Administration (FDA) on Thursday issued warnings to 20 companies that continue to market electronic nicotine delivery system (ENDS) products that are subject to denial-of-market orders ( MDO).

These are the first warning letters issued for the marketing of products subject to MDGs on their tobacco pre-market applications (PMTAs).

Separately, the agency issued warning letters for the illegal marketing of tobacco products to a company that received a refusal of filing (RTF) decision on its PMTA, a company that received both RTF determinations and MDO and six companies that did not submit any pre-market applications. .

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

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

The FDA may refuse to file a PMTA due to the lack of one or more elements required by federal food, drug and cosmetic law. MDOs are issued after the FDA has reviewed a pre-market application and determined that it will not issue a marketing order. The agency has issued around 300 MDOs since September 9, a year after the PMTAs expired.

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