31031481, 5KER26-8 - Florida Administrative Rules, Law, Code, Register

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Notice: 31031481

Notice of Emergency Rule

Department:

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division:

Division of Food Safety

Overview

RULE:

5KER26-8

Requirement to Label the Concentration of 7-Hydroxymitragynine on Kratom Products

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE:

On August 20, 2025, the Attorney General of Florida adopted Emergency Rule 2ER25-2, and on December 8, 2025 adopted Emergency Rule 2ER25-3, adding 7-Hydroxymitragynine (methyl (E)-2[(2S,3S,7aS,12bS)-3-ethyl-7a-hydroxy-8-methoxy-2,3,4,6,7,12b-hexahydro-1H-indolo[2,3-a]quinolizin-2-yl]-3-methoxyprop-2-enoate) concentrated at a level above four hundred parts per million on a dry-weight basis, to the list of Schedule I Controlled Substances in subsection 893.03(1)(a), F.S., and excluding mitragynine from the declaration. Kratom Products are food products sold in Florida that commonly contain 7-Hydroxymitragynine, its isomers, esters and ethers. In order to protect the public health, safety, and welfare, the Department is adopting this emergency rule to require that the concentration of 7-Hydroxymitragynine, its isomers, esters, and ethers, be declared on the label of Kratom Products. The rule provides requirements for reporting the concentration of 7-Hydroxymitragynine and its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, in the product and provides parameters for how the concentration(s) should be displayed permanently on the product label to provide the public adequate notice of the contents. Without this information clearly and conspicuously identified on the product label, consumers may not know how much 7-Hydroxymitragynine, including isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, they are consuming, and businesses may not know whether they are buying and selling controlled substances.

REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES:

This rule is fair and justified because it takes only the actions necessary to protect public health, safety, and welfare by ensuring Kratom Products are properly labeled to put consumers on notice that the product contains a substance that is a controlled substance in certain concentrations.

SUMMARY:

The emergency rule provides requirements for labeling the 7-Hydroxymitragynine concentration on Kratom Products.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS:

Darby Shaw, darby.shaw@fdacs.gov, 850-245-4420, 3125 Conner Blvd., Tallahassee, FL 32399

PRINT PUBLISH DATE:

6/18/2026 Vol. 52/118

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://flrules.org/gateway/ruleno.asp?id=5KER26-8&PDate=6/18/2026&Section=4

REFERENCE MATERIALS:

No reference(s).

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