Requests that the FDA formally issue a new drug exclusion declaration for Kratom (Mitragyna speciosa) and Mitragynine-Containing articles under 21 U.S.C 321 (ff)(3)(B) and update Import Alert 54-15 accordingly. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-8204

Requests that the FDA formally issue a new drug exclusion declaration for Kratom (Mitragyna speciosa) and Mitragynine-Containing articles under 21 U.S.C 321 (ff)(3)(B) and update Import Alert 54-15 accordingly.

Documents

Comments

Key Dates

Comment Period OpensJul 27, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Acknowledgement Letter from FDA DMB to End Kratom Addiction	Jul 27, 2026	--

Keywords

HFP

End Kratom Addiction

formally issue a new drug exclusion

declaration for Kratom (Mitragyna speciosa)

and Mitragynine-Containing

articles under 21 USC 321 (ff)(3)(B)

and update Import Alert 54-15 accordingly

OPEN

Data from Regulations.gov