AKA Good Manufacturing Practice (GMP) Standards Program

    Updated October 2021

    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

    The AKA Good Manufacturing Practice (GMP) Standards Program is designed to ensure the safety and integrity of kratom food products that are marketed to consumers. The program establishes exacting manufacturing, testing, packaging, labeling, storage, distribution, marketing, and verification requirements for kratom food products that meet or exceed the minimum requirements for manufacturing food products established by the U.S. Food and Drug Administration (FDA). For example, companies participating in this program will need to test every production lot of kratom to assure it is free of any microorganisms of public health concern, disclose contents in the product, and agree to independent 3rd party audit of their facility and compliance programs.

    To qualify, vendors must commit to following strict manufacturing, testing, processing, packaging, storage, distribution and marketing standards as outlined in this document which will then need to be verified by a pre-approved, independent 3rd party auditor.

    To maintain the AKA GMP Qualified status, each vendor must continue to register annually and pass an annual independent audit.

    Program Summary:

    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. Registered participants will be added to the “Pending” vendor list and will have 90 days from enrollment to complete an independent 3rd party audit verifying the vendor has met the required standards.

    All auditors must be pre-approved by the AKA. Please send a list of the auditor’s qualifications and experience to gmp@americankratom.org.

    The standards of this program are rigorous, and it is not uncommon for a vendor to miss the 90-day audit window. If a vendor does not complete the audit within 90 days, they will be removed from Pending status and will not be added back to AKA’s website until they successfully pass and submit their independent audit.

    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 following 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.

    1) Download & review the complete program requirements 

    2) Download & review AKA GMP program terms and conditions

    3) Complete registration form

     

    AKA GMP Standards Process:

    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 along with their annual registration fee to the AKA to maintain qualified status. As a reminder, vendors will have 90 days from the date of registration to complete their audit. We recommend contacting a consultant prior to registering to understand the needed time to become compliant with the standards outlined within the program. Please note, this is not a one size fits all program. The GMP requirements outlined in this program must be tailored to each vendor’s business model, business size and finished goods output.

    Program Checklist:

    • Review the AKA GMP Standards Requirements and Terms and Conditions

    Complete the registration form and submit the initial registration fee to the AKA. This annual registration fee will help cover ongoing administrative costs. As a reminder, read the Terms and Conditions of the program found during the application process.

    • Setup an initial “Orientation Call” with the AKA to discuss the process and answer any questions. This can be done by sending an email with available dates and times for the meeting to: gmp@americankratom.org.

    • Take the necessary steps to become “AKA GMP Qualified.” Some vendors may choose to hire outside consultation to reach compliance. The AKA can recommend a consultant if needed.

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

    • All auditors and testing laboratories must be pre-approved by the AKA. Send qualifications and experience to gmp@americankratom.org.

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

    • Request that the 3rd party auditor submit the audit report to the AKA, using the AKA GMP Audit Form.

    • Upon a satisfactory audit, vendors who become AKA GMP Qualified will receive the official AKA GMP Qualified logo. No other logo can be used with this program.

    • Please note, a satisfactory audit may include multiple observations by the 3rd party auditor. Those observations must be addressed by the vendor in a timely fashion and incorporated into their quality system.

    The AKA will review all audits of GMP Program participants and make the final determination on the qualification for the program. The AKA will have up to three business days from the submission of the annual audit to review the audit report. If additional information or inspection verification is requested by the AKA, the three-business day review period is restarted on the date a response is received with the requested information.

    Qualified GMP Program participants agree AKA has the right to remove or suspend any “Qualified” participants from the program for any reason including, but not limited to, the following:

    1. Failure to maintain the required standards of the GMP Program.

    2. Failure to pay the annual registration fee.

    3. Failure to submit an annual audit from an AKA approved auditor.

    4. Failure to correct any audit findings identified in the audit report.

    5. Multiple reports of adverse events associated with the participant’s products associated with the marketed products.

    6. Violations of the AKA Truth in Labelling Program.

    7. Actions that negatively impact the good standing and reputation of the AKA.

    Click Here for AKA GMP Audit Form


    --- Click Here to Register for the AKA GMP Standards Program ---

    DAYS THE FDA HAS IGNORED AKA’S MEETING REQUEST

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