- (1) A kratom manufacturer shall register as a food establishment with the department under Section 4-5-301, before operating.
- (2) A kratom manufacturer registered in another state may satisfy this requirement by providing the department with a copy of the current registration from the federal or state regulatory agency whose requirements meet or exceed those in Section 4-5-301.
- (3) A kratom manufacturer shall be subject to any statutes, rules, regulations, policies, and procedures for food establishments specific to the form of the kratom product offered for sale.
(4) In their application for registration, each kratom manufacturer shall identify:
- (a) any business names under which it operates; and
- (b) the person who is legally responsible for the operation. If the legally responsible person changes, the kratom manufacturer shall notify the department of the change within 30 days.
(5) The kratom manufacturer shall maintain a Manufacturing Batch Record (MBR) that documents, at a minimum:
- (a) batch-to-batch uniformity;
- (b) that each batch conforms to kratom raw material specifications;
- (c) each step of the manufacturing process was performed, ensuring reliable and reproducible results;
- (d) the unique lot or batch identification number of the product; and
- (e) the name and address where the MBR records are maintained and available for inspection by the department.
- (6) A kratom manufacturer shall make its establishment and all records, including MBRs, available for inspection by the department upon request.
- (7) A kratom manufacturer registered under this rule is also responsible for complying with Rule R66-51, Kratom Product Registration and Labeling, for each product offered for sale.
KEY: kratom, kratom manufacturer registration, kratom processor, kratom food establishment registration, warehouse, manufacturing batch record, inspection
Date of Last Change: November 24, 2025
Notice of Continuation: March 3, 2026
Authorizing, and Implemented or Interpreted Law: 4-45-107; 4-5-301(1)