Rep. RUTHERFORD proposes the following amendment (LC-4641.VR0009H):

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) "Attractive to children" means a product manufactured:
   (a) in a shape that resembles a human, a cartoon character or an animal; or
   (b) in a form that resembles an existing candy product that is a widely distributed, branded food item.
 (1)(2) "Department" means the South Carolina Department of Public Health.
 (2)(3) "Food" means any food, food product, food ingredient, dietary ingredient, dietary supplement, or beverage intended for human consumption.
 (3)(4) "Kratom" means any part of the tropical evergreen plant mitragyna speciosa.
 (4)(5) "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)(6) "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)(7) "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 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) contains more than twenty milligrams of 7-hydroxymitragynine per serving, package unit, or other single intended serving; or contains more than one hundred milligrams of mitragynine per serving, package unit, or other single intended serving;
   (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 labeling requirements established pursuant to Section 44-53-2030 and a regulation promulgated to implement the provisions of that section.
 (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.
 (B) It is unlawful for a kratom retailer, processor, or distributor to sell, offer for sale, transfer, deliver, or dispense a kratom product at any establishment or event where persons under twenty-one years of age are permitted unrestricted entry, including but not limited to gas stations or similar locations designated by regulation of the department.
 (C) It is unlawful for a person to market, advertise, promote, package, label, or display a kratom product in a manner that is attractive to children.

 Section 44-53-2030. (A) 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) a list of the ingredients used in the manufacture of the product;
 (2) the amount of mitragynine and 7-hydroxymitragynine contained in the product;
 (3) the recommended serving size of the product;
 (4) the number of servings per container;
 (5) the name and the principal street address of the vendor or the person responsible for distributing the product;
 (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.
 (B) For each batch of a registered finished kratom product, the processor shall retain and submit, upon request, a certificate of analysis to the department from an accredited laboratory. The laboratory must be accredited under the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025:2017 General Requirements for Competence of Testing and Calibration Laboratories standard by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement or a subsequent arrangement. The processor may not have any direct or indirect financial or economic interest in the laboratory or accrediting body. The processor shall maintain the certificates of analysis for a minimum of one year after the finished kratom product's expiration date. The certificate of analysis must demonstrate that the finished kratom product is in compliance with statutory and regulatory concentration limits.
 (C) A certificate of analysis for each production batch must be made available to consumers by QR code, website link, or printed copy upon request. A retailer or processor shall maintain testing records for not less than one year and shall make such records available to the department upon request.

 Section 44-53-2040. (A) A retailerperson found to be in violation of Section 44-53-2020 or 44-53-2030, 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, and product seizure.
 (B) The department is authorized to promulgate regulations as necessary for enforcement of the provisions of this chapter.

SECTION 2. This act takes effect upon approval by the Governor.

Renumber sections to conform.

Amend title to conform.