Kratom Product Registration

1. Visit the AIMS portal: https://agbusiness.utah.gov/s/
2. Log in to your account.
3. Click on the “Kratom” section.
4. Select “Product Registration.”
5. Click “Continue.”
6. Choose “New Application”, then “Save and Proceed”.
7. Verify your information, then click “Save and Proceed”.
8. Complete the application and pay the application fee.
   1. Add each unique product to the application.
      1. If the label and ingredients are identical, product sizes are not considered unique and do not require separate registrations.
   2. Submit all required information and documentation as outlined below.

For each product, the following are mandatory and must be uploaded:

• Product Labeling:
  • Compliance: Labels must be fully compliant with the detailed requirements outlined in Rule R66-51.
    • Immediate Container
    • Outer Box
    • Image of Final Product with Lot/Batch Number Visible
    • Image of Gummy (if applicable)
• Product Certificates of Analysis (COAs):
  • Compliance: COAs must meet the standards specified in Rule R66-52.
    • Testing performed within the last 6 months
    • Mitragynine and 7-hydroxymitragyine concentrations
    • Foreign Matter
    • Microbial
    • Heavy Metal
    • Pesticides (if applicable)
    • Residual Solvents (if applicable)
    • Additives (if applicable)

Note: The Specialized Products Division reserves the right to request additional information from the applicant if the submitted materials are deemed insufficient for approval.

• Non-refundable Fee: A non-refundable fee of $475 is required for each unique kratom product registration.
• Payment Requirement: Applications will not be reviewed until full payment is received.
• Notification: Applicants will receive email notifications regarding the status of their application, including requests for additional information, approval, or denial.
• Approved Products: If approved, your product will be added to the official registered product list.

To renew a previously registered kratom product, follow these steps:

1. Visit the AIMS portal: https://agbusiness.utah.gov/s/
2. Log in to your account.
3. Click on the “Kratom” section.
4. Select “Product Registration.”
5. Click “Continue.”
6. Choose “Renewal” as the application type, then “Next.”
7. Select the specific product you wish to renew from the list.
8. Complete the Renewal application with the current labeling and most recent testing.

For changes to a previously registered kratom product, follow these steps:

1. Visit the AIMS portal: https://agbusiness.utah.gov/s/
2. Log in to your account.
3. Click on the “Kratom” section.
4. Select “Product Registration.”
5. Click “Continue.”
6. Choose “Change Request” as the application type, then “Next.”
7. Select the specific product you wish to update from the list.
8. Complete the Change Request application with the necessary modifications.

Important: For substantial changes to a product (e.g., formulation, significant changes to labeling), a new product registration may be required. Please contact [email protected] if you are unsure if your change constitutes a “substantial change”.