Posted by The unregulated world of botanicals includes things like kava which are recognized as a food. However, some may be labeled as a new dietary ingredient. Botanicals arose out of a need for easier access to plant-based and lab-created bioactive compounds to enhance a wellness lifestyle. That means without federal oversight imposing limited circumstances from which to obtain them.
The first association people usually have of “unregulated” is “unsafe.” However, the fact that the FDA has done many recalls for unsafe products shows that regulations don’t prevent violations of quality control.
In fact, there are a number of botanical vendors that show some of the best quality control standards equivalent or better than the food, cosmetics, and pharmaceutical manufacturing industries. Here’s an explanation of what that means and how excellent quality control gets recognition.
Why Are Botanicals Unregulated?
To be fair, not all botanicals are unregulated. But in the United States, many of them are. Those that are regulated are not officially recognized as botanicals (health and wellness supplements) but as food, such as kava, under FDA guidelines. And botanicals are often marketed as new dietary ingredients. Food, cosmetics, and pharmaceuticals generally follow the same manufacturing practices for quality control, with nuances depending on the specific products.
Now to the point: The reason why the category of “botanicals” is unregulated is because they are not recognized by the FDA. For this distinction, there must be enough research to the point where official medical bodies accept their use for alleviating certain conditions.
American Kratom Association Approved
Here is a special distinction for kratom vendors that signal to people they are safe according to the AKA. It’s a voluntary one, so it’s not necessary, but it helps to inspire trust. What it involves is an independent, third-party audit with a set of kratom-specific manufacturing standards – Good Manufacturing Practices. It’s not a one-time thing, either, but is done every year, and reviews the following:
- Covering critical aspects of production: Sourcing, sanitation, batch testing, recordkeeping, and label accuracy; and
- Meeting established specifications: Identity, purity, strength, and composition
In short: The labels make no unsubstantiated claims and are accurate, with transparent ingredients and information, and the products meet quality control standards.
Good Manufacturing Practices
GMP refers to the system of guidelines that ensures consistent control, manufacture, and testing of products to meet quality and safety standards. In this case, the AKA has two distinctions.
The AKA GMP Standards Program
The GMP Standards Program by the AKA is a baseline of requirements where participants (kratom vendors) follow certain steps to ensure the identity, quality, and wholesomeness of their products. It requires the following:
- Reviewing the requirements, terms and conditions;
- Registering and submitting the initial registration fee;
- Setting up the initial orientation call with the AKA;
- Taking the necessary steps;
- Contacting an AKA pre-approved third-party auditor with testing laboratory;
- Passing the audit and submitting the report to the AKA; and
- Receiving the public logo
If you see a vendor with a stamp on their website or product packaging that says “AKA-approved,” then they already follow the GMP program. But if they say “cGMP,” it’s a somewhat different story.
GMP-Certified (cGMP)
GMP certification takes the AKA GMP a step further. It’s a continuous improvement beyond basic standards and is based on FDA dietary supplement rules:
- Strict manufacturing standards
- Strict hygiene codes and sanitation protocols with clean facilities
- Annual third-party audits and testing with Master Manufacturing Records and batch documentation (ensures consistent quality and accountability with unique lot numbers and other detailed information)
The label will look like this, sometimes with different colors:
Are There Equivalent Quality Control Standards?
Yes. Just because a vendor doesn’t choose to seek AKA approval or GMP certification doesn’t mean they don’t follow the same standards. It’s known as self-reported GMP, also known as being GMP-compliant. Although it’s not a formal verification, there are ways to vet a vendor for quality control.
Independent, Third-Party Testing with Comprehensive Reports
The bare minimum, already included in the GMP, is independent, third-party lab testing. Even though annual testing is not required for unregulated products, most vendors engage in it and people want it for their own peace of mind. There’s in-house testing, but that’s subjective, so it cannot be trusted.
Manufacturer-Direct Vendor
It’s wonderful to cut out middlemen whenever possible, and that’s the main benefit of a botanicals vendor that does all the manufacturing themselves. Outside of cultivating and harvesting any natural botanicals, they can still engage in sustainable practices. It’s easy to manage quality control, inventory, and delivery and inspire customer trust this way.
Private Laboratory
If a botanical vendor has a private lab, they meet enhanced quality control standards and regulatory compliance with comprehensive and transparent testing. This means in-house testing and third-party testing for even more trustworthiness.
A Pioneer in Botanical Quality Control
Although the category of botanicals is unregulated, it doesn’t mean they’re unsafe. It refers to the avoidance of federal scheduling, which would make certain botanicals a controlled substance if antis had their way. The existence of Good Manufacturing Practices can be applied to kratom just as easily as to food, cosmetics, and pharmaceuticals.
Real Botanicals adheres to GMP guidelines by participating in independent, third-party lab testing and transparent Certificates of Analysis and other information. They’re also a manufacturer-direct vendor with a private lab. Quality control doesn’t get better than that.
You might also want to read: “The Problem with Gas Station Kratom and 7-OH Products”