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.
- View all marketing granted order letters, and other related documents.
- View information on companies that have been issued a marketing denial order
- Marketing Denial Orders (CSV – Last updated 11/8/21)
- View a Sample Decision Summary Document. This sample does not reflect the decision rationale for each MDO action taken by the FDA.
Note: FDA understands that the public may be interested in the specific names of the currently marketed products subject to the negative decisions. However, before releasing this information, FDA needs to ensure the Agency is not releasing the applicant’s commercial confidential information. Given the large number of products involved, sharing this information requires additional time and resources. Accordingly, FDA is actively exploring options related to this issue.
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.
- View all Found Exempt order letters, decision summaries, EAs, and FONSIs
- 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