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  1. Market and Distribute a Tobacco Product

Tobacco Products Marketing Orders

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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.

Marketing a New Tobacco Product

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). 

Premarket Tobacco Product Applications (PMTA)

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.

Marketing Granted Orders 

Marketing Denial Orders 

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. 

Substantial Equivalence (SE) Reports

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. 

SE Orders

Provisional Not Substantially Equivalent (NSE) Orders

Provisional SE Products Removed from Review 

Exemption from Substantial Equivalence Requests (EX REQ)

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.

Found Exempt Orders

Additional Resources

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