Article
16. Kratom Consumer Protection Program
111224.8.
As used in this article, the following terms have the following definitions:(a) “Attractive to children” means any of the following:
(1) Use of images that are attractive to children, including, but not limited to, images of any of the following, except as part of required health warnings:
(A) Cartoons, toys, or robots.
(B) Any real or fictional humans.
(C) Any fictional animals or creatures.
(D) Fruits or vegetables, except when used to accurately describe ingredients or flavors contained in a product.
(2) Any likeness to images, characters, or phrases that are popularly used to advertise to children.
(3) Any imitation of candy packaging or labeling, or other packaging and labeling of cereals, sweets, chips, or other food products typically marketed to children.
(4) The terms “candy” or “candies” or variants in spelling such as “kandy” or “kandee.”
(5) Brand names or close imitations of brand names of candies, cereals, sweets, chips, or other food products typically marketed to children.
(6) Any other image or
packaging that is easily confused with commercially available foods that do not contain kratom and are typically marketed to children.
(7) Anything else that the department determines in regulation to be attractive to children.
(8) Anything else that is attractive to children in light of all relevant facts and circumstances.
(a)
(b) “Kratom leaf” means the leaf of the kratom plant, also known as mitragyna speciosa, in fresh or dehydrated form, and subjected to no postharvest processing except
for drying or size reduction, by cutting, milling, or similar procedure, and to cleaning or sterilization through application of heat, steam, pressurization, irradiation, or other standard treatments applied to food ingredients. The total alkaloid content of kratom leaf material used in a kratom product shall not exceed 4 percent on a dried weight basis.
(b)
(c) “Kratom leaf extract” means the material obtained by extraction of kratom leaves with a solvent consisting of water, ethanol, or food grade carbon dioxide, or any other solvent authorized by regulation to be used in manufacturing a food ingredient
and that meets all of the following requirements:
(1) That contains an amount of residual solvent not to exceed the amount specified in Chapter 467 of the United States Pharmacopeia and the National Formulary.
(2) That contains mitragynine as the most abundant alkaloid on a weight-by-weight basis and at a level that is more than twofold that of any other alkaloid present.
(3) The ratio of mitragynine to other alkaloids is the same or greater than that of the starting material.
(c)
(d) (1) “Kratom product” means a food, ingredient, or dietary supplement that meets all of the following requirements:
(A) Consists of or contains kratom leaf or kratom leaf extract.
(B) Does not contain any synthesized kratom alkaloids or other
synthesized kratom constituents, or synthesized metabolites of any kratom constituent.
(C) The level of 7-hydroxymitragynine on a percent weight basis is not greater than 1 percent of the amount of total kratom alkaloids confirmed with a high-performance liquid chromatography or an ultra-performance ultraperformance liquid chromatography testing method.
(2) For purposes of this subdivision, “synthesized” means produced using directed synthetic or biosynthetic chemistry rather than traditional food preparation techniques, such as heating or extracting.
(d)
(e) “Processor” means the party responsible for manufacturing, packaging, labeling, or distributing kratom products, or the party that advertises, represents, or holds itself out as manufacturing, preparing, packaging, or labeling kratom products.
(e)
(f) “Total kratom alkaloids” means the sum of mitragynine, speciociliatine, speciogynine, paynantheine, and 7-hydroxymitragynine in a kratom product.
111224.81.
(a) A kratom product produced, manufactured, distributed, sold, or offered for sale, if consisting of or containing kratom leaf extract, shall not exceed the amount specified for pharmaceutical products in
Chapter 467 of the United States Pharmacopeia and the National Formulary of any residual solvent used in manufacturing of the extract.(b) A product containing a synthesized kratom alkaloid or other synthesized kratom constituents, or synthesized metabolites of a synthesized kratom constituent, shall not be produced, manufactured, distributed, sold, or offered for sale.
111224.82.
A kratom product produced, manufactured, distributed, sold, or offered for sale shall have a label that clearly and conspicuously provides all of the following information on each retail package:(a) A recommendation against the use by individuals who are under 21 years of age, who are pregnant, or who are breastfeeding.
(b) A recommendation to consult a health care professional prior to use.
(c) An advisement that kratom may be habit forming.
(d) The following statement: “These statements have not
been evaluated by the United States Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
(e) The name and place of business of the processor,
manufacturer, packer, or distributor.
(f) Directions for use that include all of the following:
(1) A recommended amount of the kratom product per serving.
(2) A recommended number of servings that can be safely consumed in a 24-hour period.
(3) Quantitative declarations of the amount per serving of each of the following:
(A) Total kratom alkaloids.
(B) Mitragynine.
(C) 7-hydroxymitragynine.
111224.83.
(a) A kratom product shall be packaged in a retail container that
clearly marks the number of servings in the container.(b) A kratom product offered for retail sale that is in liquid form and contains more than three servings shall include a calibrated measuring device.
(c) If the kratom product is in powdered form, the package shall include a calibrated measuring device.
111224.84.
(a) A processor shall register pursuant to Section 111224.86 and shall annually register each kratom product it manufactures, packs, distributes, or labels. A product that contains the same kratom ingredients in the same kratom delivery form but a different container, package, or volume shall be included under the processor’s individual registration.(b) Annual registration of a kratom product shall include a certificate of analysis from an independent laboratory. The laboratory shall be accredited under the standards of the International Organization for Standardization 17025:2017 accreditation from an accreditation body that is a signatory to the International
Laboratory Accreditation Cooperation Mutual Recognition Arrangement.
(c) The certificate of analysis shall confirm the contents of the kratom product, and include a certification that the product complies with the requirements for a kratom product described in Sections 111224.8 and 111224.81.
(d) The manufacturer shall certify that the kratom product does not contain a substance listed in Section 11054, 11055, 11056, 11057, or 11058.
(e) Upon receipt of evidence that suggests a kratom product may be adulterated, the department may require an independent third-party test of a registered kratom product by a laboratory of the department’s choice, and the processor shall be required to submit payment for the
test and equitable administrative fee within a reasonable timeframe. If the processor does not tender payment to the department within 30 days of receipt of the invoice for the testing and administrative fee, the department shall revoke the registration for that product.
111224.85.
(a) An individual, business, or other entity shall not sell, offer for sale, provide, or distribute kratom leaf or a kratom product to a person under 21 years of age.(b) An online retailer or marketplace of kratom leaf or a kratom product shall implement an age-verification system to ensure compliance with subdivision (a).
(c) An individual, business, or other entity shall not produce, sell, or distribute a kratom product that is attractive to children.
(d) The manufacture or sale of
an inhalable kratom product is prohibited.
111224.86.
(a) The department, in implementing this article, may establish an annual fee or assessment for any processor registering to produce, manufacture, or offer for sale kratom leaf or a kratom product. Except as otherwise required by law, an individual or entity registering pursuant to this article is not required to register pursuant to Article 2 (commencing with Section 110460).(b) Commencing February 1, 2026, and every February 1 thereafter, the department shall report to the Legislature and publish both of the following on its internet website:
(1) A list of estimated fees.
(2) A report of all costs for activities of the Kratom Consumer Protection Program, including, but not limited to, both of the following:
(A) Projected workload and costs for applicants and annual registrants, including workload costs for inspection and enforcement activities.
(B) A staffing and systems analysis to ensure efficient and effective utilization of fees collected, proper allocation of departmental resources to registration activities, inspections, complaint investigations, enforcement and appeal activities, and data collection and reporting.
(c) A report to be submitted pursuant to subdivision (b) shall be submitted in compliance with Section
9795 of the Government Code.
(d) The department may develop registration fees based on the number of units produced by registrants and total annual sales in California. The fee schedule may consist of tiers of registration fees denoted by unit production, total annual sales in California, and corresponding fees to the number of units produced and annual sales in California. The fees shall not exceed the reasonable regulatory costs of administering this article. The calculation of estimated fees is exempt from the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code).
111224.87.
A local authority shall not impose additional restrictions greater than those enumerated in this article or enact additional requirements on the manufacture of kratom leaf, kratom extract, or a kratom product.111224.88.
A kratom processor who is operating in conformance with this article and in good faith compliance with their responsibilities under this article may manufacture or sell kratom or kratom products without authorization until April 1, 2025.111224.89.
(a) A violation of this article shall be grounds for denying, suspending, forfeiting, revoking, or surrendering a registration.(b) The department may deny, suspend, forfeit, revoke, or order to surrender a registration issued under this article when a peace officer, state official, or local official has notified the department that a processor within its jurisdiction is in violation of state law relating to this article, and the department, through an investigation, has determined that the violation is grounds for, or contributes to, other factors for denial, suspension, forfeiture, revocation, or surrender of the processor’s registration. An investigation conducted pursuant to this subdivision shall include reasonable notice to the
processor and an opportunity for the processor to defend any allegations of a violation.
111224.9.
(a) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department shall have the authority to promulgate regulations as may be necessary to implement this article. (b) The department may execute an interagency agreement with other state or local government agencies in the performance of any or all of the requirements of this section.