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, 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, on a product label as required in subsection (1), such concentration(s) must be stated as follows:

   1. (a) If the concentration(s) is/are below the method detection limit(s), the method detection limit(s) shall be used as the stated concentration so long as the total limit(s) of quantitation or total practical quantitation limit(s) is/are below 400 PPM. If the concentration(s) is/are above the method detection limit(s), the actual concentration(s) must be stated on the label;
   2. (b) The concentration(s) shall be stated in parts per million (PPM), and denote that the concentration(s) are measured on a dry weight basis; and
   3. (c) The concentration(s) shall be permanently affixed to the package in a clear and conspicuous manner, including using a color, type size, and contrasting background that render the information likely to be read and understood by the ordinary individual under customary conditions of purchase and use, and does not include affixing the required information solely to the bottom of the container.

3. (3) Isomers of 7-Hydroxymitragynine that must be accounted for in the labeled concentration include, but are not limited to, pseudoindoxyl (methyl (E)-2-[(2S,6'S,7'S,8'aS)-6'-ethyl-4-methoxy-3-oxospiro[1H-indole-2,1'-3,5,6,7,8,8a-hexahydro-2H-indolizine]-7'-yl]-3-methoxyprop-2-enoate).

   

   

   

   

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 6-17-26.