1. (1) Kratom Products, as defined in Rule 5K-4.030, F.A.C., shall declare on the label the concentration of 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), also known as “7-OH” or “7-Hydroxy”, and each of its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, expressed in parts per million (PPM) on a dry-weight basis, of the net contents of the package. The sale of Kratom Products in violation of Rule 5K-4.030, F.A.C., or of this emergency rule shall be subject to penalties as provided in subsection 5K-4.030(5), F.A.C.

2. (2) For purposes of declaring the concentration of 7-Hydroxymitragynine on a product label as required in subsection (1), if the concentration of 7-Hydroxymitragynine is below the method detection limit, the method detection limit may be used as the stated concentration of 7-Hydroxymitragynine if the limit of quantitation or practical quantitation limit for 7-Hydroxymitragynine is below 400 PPM. If the concentration of 7-Hydroxymitragynine is above the method detection limit, the actual concentration must be stated on the label. The label must state the concentration of 7-Hydroxymitragynine as described above in parts per million (PPM) and denote that it is on a dry weight basis.

   

   

   

   

   age PAGE 2 of NUMPAGES 2

Rulemaking Authority 500.09, 500.12, 500.92, 570.07(23) FS. Law Implemented 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.92, 500.172 FS. History–New 12-17-25.