AKA Good Manufacturing Practice (GMP) Standards Program

    The American Kratom Association developed AKA GMP Standards Program in an effort to enhance the safety of kratom products offered to consumers.  As manufactures are approved as AKA GMP Qualified, they will be included in a list on this page

    To qualify, manufacturers must commit to following strict manufacturing and processing standards as outlined in this document , which will then need to be verified by a pre-approved, independent auditor. 

    Download the AKA GMP Sample Audit Form

    To maintain AKA GMP Qualified status, each manufacturer must continue to pass annual independent audits.  To help with this approval process, AKA has developed a checklist listed below that walks through the various steps.

    The AKA GMP Standards Program is designed to provide kratom consumers with a list of vendors who have completed the process of meeting the required standards for participation in this program. The initial registration step is for a vendor who enrolls in the AKA GMP Standards Program to have 90 days from enrollment to complete an independent 3rd party audit verifying the vendor has met the required standards. The standards are rigorous, and it is not uncommon for a vendor to miss the 90-day audit window, and that results in a removal from the listing on the AKA website as a “qualified” vendor in the AKA GMP Standards Program until the audit is complete.

    There are a myriad of reasons why a vendor might miss the 90-day audit requirement, including equipment acquisition, employee training, SOP document development, legal review, and scheduling of site visits with the independent auditing companies. The AKA is working with a number of vendors who have demonstrated a commitment to qualify for ongoing participation in the AKA GMP Standards Program and who are working to achieve full compliance. In these cases, the vendors remain active participants in the program.

    No consumer should be misled by any third-party making a claim about a vendor who missed the first 90-day cycle for an audit in the AKA GMP Standards Program to impute a failure of that vendor to not being in compliance with GMP standards. Consumers should look to the AKA for updates on our qualified vendor list, and for notice of any vendor who has affirmatively elected to drop out of the AKA GMP Standards Program. Any third-party who misuses this information to promote themselves, or to attack a vendor who is actively working to qualify for the program, is doing a disservice to the kratom consumer community and should be disregarded for such irresponsible actions.

    AKA GMP Standards Checklist

    Below are the necessary steps to obtain the “AKA GMP Qualified” status. Once obtained, the vendor must submit proof of an annual successful 3rd party audit to the AKA to maintain qualified status.

    Register for the AKA GMP Standards Program using the link above or going to:

    AKA GMP Registration

    https://americankratom.salsalabs.org/officialakagmpregistration/index.html

    • Submit the $500 registration fee to the AKA. The registration fee will help cover administrative costs.

    *By registering for the AKA GMP Standards, vendors are committing that they will abide by standards listed within the program

    • Review the AKA GMP Standards

    • Take necessary steps to become “AKA GMP Qualified”. Some vendors may choose to hire outside consultation to reach compliance.

    • Once a vendor feels they meet the AKA GMP Standards, contact a 3rd party auditor to arrange an inspection. The AKA can recommend an auditor if needed.

    • Complete and pass a 3rd party audit to achieve the “AKA GMP Qualified” designation.

    • Request that the 3rd party auditor submit their audit report to the AKA, with their contact information, stating that the vendor has met the qualifications outlined in the AKA GMP Standards document

    The AKA will review the audit and make the final determination. Follow-up information and inspection verification may be requested. From the time of registration, each vendor will have 90 days to submit a qualifying audit from a 3rd party auditor or be removed from the AKA list.

    Fee Information:

    • Initial program registration fee: $500

    • Annual Re-Certification Fee: $1,000

    • 3rd Party Auditing and Consulting Costs: All costs are negotiated between the vendor and any outside companies

    DAYS THE FDA HAS IGNORED AKA’S MEETING REQUEST

    © 2019 American Kratom Association.

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