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  1. Substantial Equivalence

Marketing Orders for SE

Note: 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Certain documents included in the list below may include the outdated CTP terminology "grandfathered tobacco product.'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 2021 Substantial Equivalence Marketing Orders

FY 2020 Substantial Equivalence Marketing Orders

Additional Resources

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