Rep. BRITTAIN proposes the following amendment (LC-4641.VR0007H):
Amend the bill, as and if amended, by striking all after the enacting words and inserting:
SECTION 1. Article 20, Chapter 53, Title 44 of the S.C. Code is amended to read:Article 20
South Carolina Kratom Consumer Protection Act
Section 44-53-2010. As used in this article:
(1) "Department" means the South Carolina Department of Public Health.
(2) "Food" means any food, food product, food ingredient, dietary ingredient, dietary supplement, or beverage intended for human consumption.
(3) "Kratom" means any part of the tropical evergreen plant mitragyna speciosa.
(4) "Kratom processor" means a person or entity that prepares, manufactures, distributes, or maintains kratom products or advertises, represents, or claims to sell, prepare, or maintain kratom products.
(5) "Kratom product" means any food or dietary ingredient, produced as a food, drink, powder, pill, capsule, or any other format intended for oral consumption that:
(a) contains any part of the leaf of the plant mitragyna speciosa, either on its native leaf or extracted form; or
(b) contains any kratom alkaloids or constituents, or synthesized metabolites of any kratom alkaloids or constituents.
(6) "Kratom retailer" means a person or entity that sells or advertises, represents, or claims to sell kratom products.
Section 44-53-2020. (A) It is unlawful for a kratom processor or kratom retailer to:
(1) distribute, dispense, or sell any kratom product to any individual under twenty-one years of age; or
(2) prepare, manufacture, distribute, dispense, or sell any kratom product that:
(a) is adulterated with a dangerous non-kratom substance that affects the quality or strength of the product to such a degree that it may injure a consumer;
(b) contains a poisonous or otherwise harmful non-kratom ingredient including, but not limited to, any substance listed in Section 44-53-190, 44-53-210, 44-53-230, 44-53-250, or 44-53-270;
(c ) contains natural kratom with a quantity of 7-hydroxymitragynine that is more than two percent of total alkaloid content;
(c)(d) contains a fully synthetic alkaloid including, but not limited to, fully synthetic mitragynine, fully synthetic 7-hydroxymitragynine, or any other fully synthetically derived compound of the plant mitragyna speciosa;
(d)(e) contains levels of residual solvents higher than the standards set forth in Chapter 467 of the U.S. Pharmacopeia-National Formulary (USP-NF); or
(e)(f) does not meet the certificate of analysis, labeling, and marketing requirements established pursuant to SectionSections 44-53-2025, 44-53-2030, 44-53-2035, and 44-53-2036, and a regulationany regulations promulgated to implement the provisions of that sectionthose sections.
(B) It is unlawful for a kratom retailer to display or store a kratom product in a retail location in a manner that would allow the product to be accessed by an individual under twenty-one years of age.
Section 44-53-2025. (A) Every kratom product must include a certificate of analysis dated within the previous twelve months that is issued by an accredited lab, which is visible on the product, and which includes an accreditation number. The lab must not be affiliated with the manufacturer or distributor.
(B) The certificate of analysis must:
(1) match the batch/lot number on and otherwise be batch-specific;
(2) report both mitragynine and 7-hydroxymitragynine as a percentage of values of total alkaloids;
(3) confirm that 7-hydroxymitragynine is at or below two percent of total alkaloids;
(4) include a heavy metal panel that is within safe limits;
(5) include microbial testing that reflects pass/fail result;
(6) include pesticide screening panel; and
(7) include a synthetic analogue screening that confirms the absence of pseudoindoxyl.
Section 44-53-2030. Every kratom product must be accompanied by a clear label that provides adequate information for safe and effective use by consumers including, but not limited to:
(1) the botanical product name;
(2) the net weight or quantity clearly stated;
(1)(3) a list of the ingredients used in the manufacture of the product;
(2)(4) the amount of mitragynine and 7-hydroxymitragynine contained in the product;
(3)(5) the recommended serving size of the product;
(4)(6) the number of servings per container;
(5)(7) the name and the principal street address of the kratom processor and of the vendor or the person responsible for distributing the product;
(8) the batch or lot number and QR code or URL linking to batch-specific certificate of analysis;
(6) any precautionary statements as to the safety and effectiveness of the product;
(7) a statement that the product is not intended to diagnose, treat, cure, or prevent any medical condition or disease; and
(8) a statement that the sale or transfer of the product to a person under twenty-one years of age is prohibited.
Section 44-53-2035. (A) The kratom product label and certificate of analysis must confirm that the product contains only natural kratom alkaloids and the absence of any 7-hydroxymitragynine isolate, pseudoindoxyl, and synthetic opioid agonists.
(B) The certificate of analysis must quantify 7-hydroxymitragynine as a percentage of total alkaloid content, which must be a value confirmed to be at or below two percent.
(C) The certificate of analysis must explicitly confirm the absence of pseudoindoxyl, mitragynine pseudoindoxyl, and all synthetic compounds.
(D) No isolated or concentrated 7-hydroxymitragynine may be added to a kratom product at any stage of production.
(E) The certificate of analysis must include a synthetic analogue screening panel, the results of which must be negative.
Section 44-53-2036. (A) Any marketing of a kratom product must be directed exclusively at adults twenty-one years or older and must not include any of the following:
(1) cartoon characters, animated figures, or superhero imagery;
(2) candy, dessert, food, or beverage imagery on packaging;
(3) opioid, prescription drug, or street drug name references;
(4) claims that the product treats, cures, or mitigates any medical condition;
(5) marketing that targets individuals with opioid use disorder; and
(6) point-of-sale displays at minor eye level or near candy and snack products.
(B)(1) Any website or online store must require age verification before kratom product display or purchase.
(2) Any social media advertising must use platform age-restriction targeting tools to limit the advertising to verified adult users.
Section 44-53-2040. A retailerperson found to be in violation of SectionSections 44-53-2020, 44-53-2025, or 44-53-2030, 44-53-2035, or 44-53-2036, or a regulation promulgated pursuant to the provisions of this article, is subject to a civil penalty of not more than one thousand dollars for a first offense and a civil penalty of not more than two thousand dollars for a second or subsequent offense.
SECTION 2. This act takes effect upon approval by the Governor.
Renumber sections to conform.
Amend title to conform.