SPONSOR: Murphy
This bill creates the "Missouri Kratom Consumer Protection Act", which requires all kratom products to be manufactured and sold in the State only by a processor who is subject to and in compliance with all laws and regulations for food processors. Kratom products must not be manufactured or distributed by a cottage food production operation.
A processor that manufactures, processes, packs, or offers for sale kratom, kratom products, or finished kratom products must be:
(1) Properly registered with the U.S. Food and Drug Administration;
(2) Comply with the fFederal Current Good Manufacturing Practices; and
(3) Maintain product liability insurance with an occurrence limit of $3 million.
For each batch of a registered finished kratom product, the processor must retain and submit, upon request, a certificate of analysis from an accredited laboratory. The certificate of analysis must demonstrate that the finished kratom product is in compliance with concentration limits for certain metal and chemical compounds detailed in the bill.
A finished kratom product served by a kratom food service establishment must be registered with the Department of Health and Senior Services. It is unlawful to serve kratom beverages with alcohol, drugs, or other kratom products.
The provisions of the bill do not apply to finished kratom products processed or manufactured in the State and subsequently shipped or transported out of state for sale or use. Finished kratom products shipped or transported out of the state must meet certain requirements specified in the bill.
If a processor or the Department receives notice of any adverse health event suspected to be related to the processor's kratom product, the processor or the Department must submit an adverse event report to the U.S. Food and Drug Administration. If probable cause exists that a kratom product might be adulterated, the Department can require an independent third-party test by a laboratory of the Department's choice at expense of the processor.
A violation of the Act is a class B misdemeanor. Kratom products possessed, manufactured, delivered, offered for sale, distributed, or sold in violation of the specified requirements can be detained or embargoed, and the entity in violation is subject to all penalties and remedies that apply for violations of other food statutes.
If a processor fails to provide the Department with a certificate of analysis within seven days after receiving a request from the Department or fails to immediately report an adverse health event, the Department can revoke the processor's finished kratom product registration.
A laboratory that fails to ensure the accuracy of its certificates of analysis is subject to an administrative fine in an amount determined by the Department by rule.
Statutes affected: