Donate

    AKA Good Manufacturing Practice (GMP) Standards Program

    Please be sure and read our April 2020 update below

     

    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.

    April 2020 Update 

    The American Kratom Association developed the AKA GMP Standards Program in an effort to enhance the safety of kratom products offered to consumers. The foundational principles of this program are to assure that kratom manufacturers commit to strict manufacturing and processing standards that would apply if the FDA were to appropriately regulate kratom as a dietary ingredient or supplement.

    We also expect manufacturers and vendors adhere to marketing standards set by the Food, Drug, and Cosmetic Act (FD&C Act) related to impermissible health claims on kratom products. The FDA has already painted a target on kratom use in the United States, and our community is put at further risk of regulatory intervention by the FDA when claims are made related to kratom’s value as a treatment or prophylactic for COVID-19.

    In short, such claims paint a larger target on the kratom industry for the FDA to hit.

    It is not sufficient to attribute claims made by others, including researchers who offer opinions or who speculate on the potential value kratom’s alkaloids or compounds may have in helping to reduce the symptoms or prevent COVID-19 infections. It is also inappropriate for manufacturers or vendors to distribute news articles or even peer-reviewed published articles making such claims. That kind of activity directly violates labeling provisions of the FD&C Act because of the obvious economic benefits that accrue from increased sales of kratom products.

    The FDA has already launched an aggressive enforcement campaign against CBD companies making claims about CBD’s effectiveness against COVID-19. More that 30 companies have received warning letters from the FDA, with 5 who specialize in CBD on FDA’s target list. The FDA is also focusing on indirect claims being made.  For example, one company received a warning letter for making the statement: “Can CBD help with Corona Virus? Possibly! But one thing is for sure, it will help you relax when everyone else is panicking.” 

    The FDA’s CBD warning letters end with this ominous warning: “Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.”

    Accordingly, we expect every participant in the AKA GMP Standards Program to strictly adhere to the restrictions on any claims related to COVID-19 and kratom. We expect each participant to provide a report on any prior marketing efforts involving COVID-19 to allow AKA to determine if additional guidance is necessary.

    In addition, the AKA has received an escalating number of complaints about some vendors failing to fulfill on orders, both among vendors and consumers, that threaten to impair the credibility of the AKA GMP Standards Program in the kratom community. The AKA expects that program participants will conduct their business affairs ethically and fairly. If a persistent pattern of complaints emerges documenting business practices inconsistent with acceptable standards, it could result in suspension from the AKA GMP Standards program.

    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

    © 2020 American Kratom Association.

    Search