5KER26-11. Requirement to Label Kratom Products

(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), including, when present in the Kratom Product, the 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 for each, expressed in milligrams per gram (mg/g) for solid or powdered Kratom Products and milligrams per milliliter (mg/mL) for liquid Kratom Products. The compound 7-Hydroxymitragynine shall be identified on the label as the concentration of “7-Hydroxymitragynine”, “7-OH”, or “7-Hydroxy”. The concentration(s) of isomers, esters, ethers, salts, and salts of isomers, esters, and ethers shall be listed individually, if present. (2) If the concentration(s) required in subsection (1) is/are below the method detection limit, the method detection limit shall be used as the stated concentration so long as the limit of quantitation or practical quantitation limit is below 1 mg/g or 1 mg/mL, for solids or liquids, respectively. If the concentration(s) is/are above the method detection limit, the actual concentration must be stated on the label. The method detection limit may be identified as the “method detection limit”, “MDL”, “Limit of Detection”, or “LOD”. (3) Kratom Products shall declare the alkaloid ratio on the label. The alkaloid ratio is the mass, in milligrams, of mitragynine, to the mass, in milligrams, of 7-Hydroxymitragynine, including, when present in the Kratom Product, the isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, in the Kratom Product expressed in whole integral numbers. For example, a Kratom Product weighing more than 5g and containing 500.2 mg of mitragynine and 0.9 mg of 7-Hydroxymitragynine would be expressed as “Alkaloid Ratio 500 mg:1 mg”. Standard rounding practices shall be used when determining the correct whole integral number. (4) Labeling requirements. The concentration required in subsection (1) and the alkaloid ratio required by subsection (3): (a) Shall be available to the customer prior to the purchase of the Kratom Product; (b) Shall be permanently affixed to the Kratom Product package or container or available via a quick response code that is permanently affixed to the Kratom Product package or container; (c) Shall be printed on the label or available via the quick response code 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; (d) Shall not be provided by solely affixing the required information or quick response code to the bottom of the package or container; and (e) When made available by quick response code, shall be made available in three or fewer steps. (5) Controlled substances do not meet the definition of a Kratom Product as provided in s. 500.92, F.S., and Rule 5K-4.030, F.A.C., and are adulterants as provided in s. 500.10, F.S. (6) The sale of Kratom Products in violation of Chapter 500, F.S., 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.