Tobacco Products Marketing Orders | FDA

FDA works expeditiously to post all relevant documents for marketing orders. Please note that before these documents are posted, they are 1) redacted in accordance with applicable statutes and regulations and 2) reviewed to ensure compliance with Section 508, which requires that all website content be accessible to people with disabilities. Because of these requirements, relevant documents for marketing orders are usually posted several weeks after they are issued.

FDA regularly provides aggregate numbers and data on the progress of tobacco product applications that have been submitted on Metrics & Reporting.

A PMTA may be submitted to seek marketing authorization for any new tobacco product. PMTAs are evaluated based on several factors, including whether permitting the marketing of a new tobacco product would be appropriate for the protection of the public health, which is determined with respect to the risks and benefits of the product to the population as a whole, including users and non-users.

FDA has publicly named only products that the FDA or the manufacturer has confirmed to be currently marketed, due to potential confidential commercial information (CCI) issues. Similarly, company names are included in the MDO list below only if products from that company are currently marketed.