Marketing Denial Orders
If the FDA issues a Marketing Denial Order (MDO) after reviewing a Pre-Market Tobacco Application (PMTA), then the tobacco product covered under an MDO cannot be legally marketed, sold, or introduced into interstate commerce in the U.S. without risking FDA enforcement. The FDA website includes a list of companies whose products have been the subject of a MDO. However, the list only includes those products which were already on the market and for which a PTMA was submitted to the agency and then subsequently denied. The FDA does not include in this list those new tobacco products which were the subject of a PMTA, were not yet on the market, and which received an MDO. These products are not included in the list to prevent the disclosure of potential confidential commercial information. Click here to view this list.
Questions? Contact Tom Briant (tomb@cdaweb.net; (703) 208-1641),
Kathee Facchiano (kfacchiano@capitoldecisions.com; (202) 638-1950)
or Sarah Herbert (sherbert@capitoldecisions.com; (202) 638-0326).