On this page:
- Marketing a New Tobacco Product
- Premarket Tobacco Product Applications (PMTA)
- Substantial Equivalence (SE) Reports
- Exemption from Substantial Equivalence Requests (EX REQ)
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.
To legally market a new tobacco product in the United States, a company must receive a written marketing order from FDA. FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco. Instead, FDA regulates tobacco products based on a public health standard intended to reduce the toll that tobacco product use takes on public health. Companies may receive marketing authorization through three types of submissions: Premarket Tobacco Product Applications (PMTA), Substantial Equivalence (SE) Reports and Exemption from Substantial Equivalence Requests (EX REQ).
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’s announcements on the latest marketing decisions:
- June 23, 2022: Marketing Denial Orders JUUL Labs Inc (JUUL System)
- June 10, 2022: Marketing Granted and Denial Orders NJOY LLC (NJOY Daily)
- May 12, 2022: Marketing Granted and Denial Orders R.J. Reynolds Vapor Company (Vuse Vibe and Vuse Ciro)
- April 26, 2022: Marketing Granted and Denial Orders NJOY LLC (NJOY Ace)
- April 8, 2022: Marketing Denial Orders Fontem, US, LLC (myblu)
- March 24, 2022: Marketing Granted and Denial Orders Logic, LLC (Logic Vapeleaf, Logic Pro, Logic Power)
- October 19, 2021: Marketing Granted Orders U.S. Smokeless Tobacco Company LLC (VERVE®)
- October 12, 2021: Marketing Granted and Denial Orders R.J. Reynolds Vapor Company (Vuse Solo)
- View all marketing granted order letters, and other related documents.
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.
- View information on companies that have been issued a marketing denial order
- Marketing Denial Orders (CSV – Last updated 8/31/22)
- View a Sample Decision Summary Document. This sample does not reflect the decision rationale for each MDO action taken by the FDA.
A SE Report can be submitted by any manufacturer for any new tobacco product seeking an FDA substantially equivalent order. A new tobacco product may be found “substantially equivalent” to a valid predicate product where it has the same characteristics as that predicate product, or if the product has different characteristics, it does not raise different questions of public health than the predicate product.
- View all provisional tobacco products issued NSE orders
- View the list of provisional products that have been removed from review (CSV)
An EX REQ can be submitted by the original manufacturer for any new tobacco product seeking an FDA exemption order. A tobacco product that is modified by adding or deleting a tobacco additive, or by increasing or decreasing the quantity of an existing tobacco additive may be considered for an exemption from demonstrating SE.
- Tobacco Products Application Submissions: Metrics and Reporting
- Submit Tobacco Products Applications for Deemed Tobacco Products
- Common Issues Found in Substantial Equivalence Reports
- Refuse To File Determinations
- Public Health Rationale for Recommended Restrictions on New Tobacco Product Labeling, Advertising, Marketing, and Promotion