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The ultimate goal of AKA’s GMP Standards Program is to provide consumers with information to help them make an informed decision regarding their selection of kratom-containing products. The GMP Standards Program includes requirements that participants must satisfy to demonstrate that they have taken steps necessary to ensure the safety, identity, wholesomeness, and quality of the kratom-containing products they manufacture or distribute and that the label and labeling of such products ensures consumers have all the meaningful information required to make an informed purchasing decision.
Participants that qualify and maintain the high standards of this program will be listed as an AKA Qualified Vendor and the products they manufacture or distribute under the standards of the program can be listed on the AKA website and will be eligible to bear the “AKA GMP Qualified” seal on its label and labeling.
The listing of a vendor as an AKA QualifiedManufacturer and displaying the AKA GMP Qualified seal on their qualifying products is intended to convey to consumers the quality of the products they are considering purchasing.
AKA’s GMP Standards Program is based upon a comprehensive third-party inspection of the participant’s facilities, their GMP-related documentation, and any product label and labeling to verify compliance with the requirements of the program’s established standards. This program evaluates elements of the manufacturing, packaging, labeling, and holding process to provide reasonable assurance that participant’s kratom-containing products meet their established specification for quality, including identity, purity, strength, and composition, and are labeled appropriately.
The AKA GMP Qualified designation does not allow a Qualified Vendor to make any representations beyond that they have successfully passed an independent 3rd party audit that demonstrates they are compliant with the AKA GMP Standards Program. The GMPStandards Program is only administered by AKA and AKA does not endorse the quality of the product, only that an independent, third-party auditor verifies that the program standards are being met. Vendors qualified under AKA’s GMPStandards Program are not permitted to make any claims that AKA endorses their product.
The AKA GMP Standards Program is intended to verify only that a QualifiedVendor’s manufacturing and labeling practices for kratom-containing products conform to the rigorous requirements set by AKA.
The American Kratom Association has updated its GMP Standards Program in an effort to further enhance the safety of kratom-containing products offered to consumers. As vendors are approved as AKA GMP Qualified, they will be included in a list on this page:
GMP Vendor List
The AKA Good Manufacturing Practice Standards Program has been reframed and revitalized to better provide a mechanism for program participants to evaluate the practices and procedures they undertake to ensure that the kratom-containing products they manufacture or distribute are of the highest quality and that the labels and labeling of these products provides all the information required for consumers to make an informed purchasing decision. The reframed and revitalized program is intended to better reflect the complexity of brining a kratom-containing product to market. As with many products, the process of bring a kratom-containing product to market encompass many discrete operations and activities.
Program participants seeking to obtain status as an AKA Qualified Vendor must demonstrate, through a rigorous third-party evaluation, that they adhere to the strict manufacturing, testing, processing, packaging, storage, distribution, and label and labeling standards as outlined in the AKA GMP Standards ProgramRequirements and Terms and Conditions as they apply to their specific activities and efforts in bringing their kratom-containing products to market.
The scope of the AKA GMP Standards Program requirements for the manufacturing of kratom-containing products is largely based on the GMP requirements of 21C.F.R. 111 – “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” This does not, however, require that the products a program participant placed into commerce must be labeled as dietary supplements. The scope of the AKA GMP StandardsProgram’s requirements for the labeling of kratom-containing products is based on the AKA’s model Kratom Consumer Protection Act:
To maintain the AKA GMP Qualified status, each vendor must register and pass an annual independent audit annually.
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.
The AKA will review all audits of GMP Standards Program participants and make the final determination on the participant’s certification and 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 Vendor designation and product qualification under the AKA GMP Standards Program does not allow the vendor to make any representations beyond that they have successfully passed an independent 3rd party audit that demonstrates they are compliant with the AKA GMP Standards Program. The AKA does not endorse the quality of the product, only that an independent, third-party auditor verifies that the program’s standards are being met. No GMP Standards Program participant is permitted to make any claims that AKA endorses any of their product.AKA GMP Standards Program certification as a Qualified Vendor and display of the AKA GMP Standards Program certification seal demonstrates to suppliers, retailers, consumers and the public that products have been “manufactured” using good manufacturing practices and provide a means of self-assessment and independent, third-party evaluation of compliance to program standards by participants. AKA GMP Standards Program certification represents facility and process certification versus product certification.
Qualified GMP Program participants agree AKA has the right to remove or suspend any program participant’s “Qualified Vendor” status for any reason including, but not limited to, the following:
1. Failure to maintain the required standards of the 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 marketed products.
Please review the full Website Terms of Use. The AKA administers the GMP Standards Program and provides the list of Qualified Vendors for informational purposes only. An organization’s or vendor’s participation in the AKA GMP Standards Program or listing on AKA’s Qualified Vendors list should not be construed as the AKA’s endorsement of any organization, vendor, product, or service.
Participation in AKA’s GMP Standards Program does not relieve program participants from satisfying any statutory or regulatory obligations, including those related to their operations or product. Nothing on this Website should be construed as the provision of medical and/or legal advice or a recommendation regarding any decision or action related to you, your health, others’ health, your products, and/or your business.
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