GMP Standards in the Kratom Industry: What They Are and Why They Matter

A kratom packet cannot tell you much about the product's history. There is no way to know, from the packaging alone, how the raw material was handled or what happened if a batch failed a quality test. Without that information, the packaging offers little basis for judging the quality of what is inside.

The American Kratom Association is an organization based in USA that advocates for kratom consumers, with a focus on product quality and access to reliable information. It established the Program to set quality requirements for kratom vendors. Vendors that seek qualification must undergo an independent audit of their operations.

Kratom does not have a dedicated federal manufacturing-certification scheme, so the AKA program offers vendors a voluntary set of standards against which their quality controls can be assessed. These standards help you judge what a vendor’s GMP status confirms about its quality controls.

What Are GMP Standards for Kratom?

The GMP are actually the procedures and controls designed to help businesses produce goods that meet defined quality specifications. They cover the way a product is handled throughout the manufacturing process, from the arrival of raw materials to packaging and storage.

In the kratom industry, the Good Manufacturing Practice offers a specific framework for these practices. Launched in 2019, the program has since been updated to GMP 4.0.

Its manufacturing requirements draw largely on 21 CFR Part 111, the US Food and Drug Administration's regulations for the existing manufacturing practices in dietary supplements. The AKA has adapted this framework for its own voluntary kratom program. 

That distinction is important. The AKA administers its own qualification scheme; it is not an FDA certification program. The FDA does not approve kratom products as dietary supplements.

A vendor that achieves qualification has undergone an independent audit against the AKA's requirements. The designation concerns the vendor's practices related to manufacturing but it’s not an endorsement of every product it sells.

What Does the AKA GMP Program Require?

The program covers the operations involved in bringing kratom products to market. The specific requirements depend on the work a business does. Manufacturers are assessed on their production processes, whereas distributors are evaluated against requirements relevant to their activities.

Independent auditors check the documented procedures and controls against the program’s standards.

Manufacturing Procedures and Facility Hygiene

As a natural product, kratom leaf can become contaminated during processing or storage. If sanitation standards slip or raw material is handled improperly, contamination may occur before the batch ever reaches a laboratory.

The AKA GMP program requires vendors to document the procedures relevant to their operations. A manufacturer’s SOPs might set out how equipment must be cleaned or how incoming leaf should be handled before processing begins. During an audit, the vendor must be able to show that staff follow those instructions. Training records and other documentation give the auditor evidence of how the business operates beyond what is written in its procedures.

An auditor checks the vendor’s records against conditions at the facility. If the written procedures require staff to follow a particular cleaning routine, for example, the inspection should establish whether that routine is actually carried out. Together, the records and the physical inspection give the auditor a basis on which to assess the vendor’s compliance with the program.

Laboratory Testing and Quality Control

Kratom may show no visible signs of contamination, even when harmful bacteria or heavy metals are present.The only way to detect their presence is through laboratory analysis.

Alkaloid testing is obviously used to establish a sample's alkaloid profile, but vendors also commission microbial testing checks for pathogens such as Salmonella and mold, while heavy-metal analysis measures contaminants including lead or mercury.  

Under the AKA GMP program, vendors must use approved laboratories and review lab results against the relevant specifications before a batch is released for sale. 

A failed result must not be treated as a routine formality. The business is required to investigate the problem and decide what should happen to the affected material. Records of those decisions are used to help an auditor establish whether the vendor's quality controls are effective.

Product Labels and Batch Traceability

Lot numbers allow vendors to trace a finished product back to the batch from which it came. If laboratory tests reveal a problem, the vendor can identify which products share that batch and take the affected stock off sale or launch a product recall. This is especially important when a vendor sells multiple batches of the same product, since a problem with one batch does not automatically mean that every batch is affected. Without adequate records, it can be difficult to identify the relevant stock or establish where it went.

The AKA program also sets requirements for product labels. These concern the information supplied to consumers, such as product identification and other details required under the program's labeling standards. The label should give you useful information about your purchase, and the lot number can help you locate the relevant batch documentation.

Auditors use the records to check whether the vendor adheres to its stated procedures. The documentation must account for the material handled by the business and show how it was controlled throughout production.

Product Recalls

A complaint about kratom can emerge after a product has been sold. The vendor must have a process in place to investigate the report and establish whether it points to a problem with a particular batch. 

The AKA GMP program requires procedures to handle such concerns and recall products when necessary. With traceability records, vendors can determine which products came from the affected batch and remove those items from sale.

A vendor's qualified status depends on continued compliance with the AKA program. The AKA can withdraw their qualification when it falls short of program requirements or fails to address problems identified during an audit. Multiple reports of adverse events associated with a participant's products can also be grounds for removal.

These provisions make qualification an ongoing commitment. One successful audit does not exempt a business from further checks to ensure it continues to meet the program’s requirements in the future.

How Does AKA GMP Qualification Work?

When a vendor seeks AKA GMP Qualified status, it has to register with the association and meet the requirements relevant to its operations. The AKA recommends that businesses review the program standards before they register, since it takes commitment and preparation to bring procedures and facilities into compliance.

The vendor then arranges an independent audit with an auditor approved by AKA. The inspection covers the relevant facilities and documentation, as well as applicable product labels. 

The completed audit report is submitted to the AKA, which reviews the findings and makes the final decision on qualification. 

The program requires the audit to be completed no later than 90 days of registration. Vendors must submit evidence of a successful independent audit each year, together with the annual registration fee, to retain their qualified status. 

Testing laboratories used under the program must also receive AKA approval.

Any shortcomings identified during the audit need to be resolved before the vendor can receive or retain its qualification. The AKA can request further information and can suspend or withdraw a vendor's status if program requirements are not met.

The requirements are far more substantial than a vendor claim that it follows GMP principles. 

What Does GMP Qualification Mean When You Buy Kratom?

A current AKA GMP Qualified listing offers evidence that a vendor has passed an independent audit of its relevant practices related to labeling and manufacturing. It provides a useful point of reference when you compare businesses whose quality claims may otherwise be difficult to assess.

It does not, however, settle every question about a product. An audit assesses a vendor's systems; it cannot guarantee that every unit is free from contamination. 

The AKA classification does not imply that the FDA has approved the product or established that kratom is risk-free.

You should also distinguish GMP qualification from a Certificate of Analysis (COA). A COA reports laboratory results for a particular sample. GMP qualification relates to the vendor's broader quality-control practices. Each serves a different purpose.

For example, a vendor may have passed its GMP audit, but as a consumer you still need the relevant test report to find out whether a particular batch was tested for heavy metals or microbial contaminants. 

GMP qualification is therefore useful evidence, not a reason to stop asking questions.

How to Check If a Kratom Vendor Is GMP Qualified

The simplest way to check a vendor's current status is to consult the association's official Qualified Vendors list and search for the business by name rather than relying on a badge displayed on its website. Qualification is subject to annual renewal, so a claim made several years ago will not tell you whether it still meets the required standards.

You can then look for a COA that corresponds to the lot number on the product you intend to buy. Read the report to see which tests were performed and whether the results meet the stated limits. If you cannot find the relevant report, ask the vendor how to access it.

Kratom GMP FAQ

Does AKA’s Good Manufacturing Practice qualification mean a kratom product is FDA-approved?

No. The Program GMP is a voluntary industry initiative. Qualification does not signify FDA approval or signify that the FDA has certified a vendor's products.

Is GMP qualification the same as third-party lab testing?

GMP qualification tells you that a vendor’s practices have been assessed against the program’s requirements. A lab report gives you information about the kratom in a particular batch. When you choose a product, check both rather than relying on GMP status alone.

How can I check whether a kratom vendor is qualified?

The American Kratom Association(AKA) publishes a list of vendors that qualify for its GMP program. If a company claims to hold this status but doesn't appear on the list, ask for clarification before relying on that claim.

Does GMP qualification guarantee that kratom is safe?

Even if a vendor passes a GMP audit, that doesn't mean every package is free from contamination. The qualification gives you some reassurance about the vendor's practices, but it can't replace test results for the batch you plan to buy.

Why should I check the lot number on a kratom package?

The lot number links a product to its specific production batch, allowing you to check that the Certificate of Analysis (COA) corresponds to the kratom you’re buying. A report from another batch provides no direct evidence of the quality of your product.

What should I do if a vendor cannot provide a COA?

A vendor that cannot supply a COA for its kratom has left an important gap in the information available to you as a buyer. Without independent test results for the product, you have no way to verify its composition or check what the laboratory found in terms of its purity or potency.

What should I look for when choosing a kratom vendor?

Look for a vendor that is open about its quality-control practices and makes its laboratory reports available to customers. A clear explanation of its testing procedures is also useful to help you understand what the tests cover. A vendor’s claim to hold AKA GMP qualification carries more weight when you can confirm it through the association itself. The aim is to find information you can verify before you buy, rather than having to take the vendor's word for it.

Choose Kratom With Verifiable Quality Controls

You have good reason to look beyond a product's name or price when choosing kratom. The systems behind it deserve attention, too. GMP qualification provides evidence that a vendor's practices have passed an independent assessment, while a batch-specific COA lets you examine the results of particular laboratory tests.

Jack Botanicals takes product quality seriously, with third-party testing and results made available to customers. You can explore the range and review the available quality information at the Jack Botanicals website. Discover their range and take a closer look at the rigorous testing behind its products before you choose your next kratom purchase.