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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Tobacco Products
  3. Products, Guidance & Regulations
  4. Market and Distribute a Tobacco Product
  5. Substantial Equivalence
  6. Marketing Orders for SE
  1. Substantial Equivalence

Marketing Orders for SE

To legally market a new tobacco product in the United States, a company must receive a written marketing order from FDA. Companies may receive marketing authorization through one of the three pathways; the following products have been issued marketing orders under the SE pathway.

Note:This page will not be updated after March 28, 2024. For the latest information on tobacco products that may be legally marketed in the United States, view the “Searchable Tobacco Products Database,” which now serves as the new location for this information.

Before making documents available to the public, FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the order letter, full decision summary, environmental assessment and finding of no significant impact (FONSI) memo for marketing authorizations may be posted to the website after the order issuance date.

Certain documents included in the list below may include the outdated CTP terminology "grandfathered tobacco product." In August 2022, FDA updated the term "grandfathered tobacco product" to "pre-existing tobacco product."

FY 2022 Substantial Equivalence Marketing Orders

FY 2021 Substantial Equivalence Marketing Orders

FY 2020 Substantial Equivalence Marketing Orders

Additional Resources

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