This is a pivotal time for the kratom industry
The kratom industry is thought to be valued between $1.2 and $5 billion, with an estimated 121,254 pounds entering the U.S. between 2014 and 2016. Because of our significance expertise in this space, Santé Laboratories is heavily involved with most of the kratom manufacturers in the United States. Those that choose to work with Santé want their products to be clean and high quality.
We believe that kratom could follow a similar path as that forged by CBD because it is a natural product with potential therapeutic promise. But incidents of dangerous concentrations of lead and nickel, as well as salmonella contamination, could derail its otherwise upward trajectory. While kratom can be effective and free of contaminants, this cannot be verified without proper and consistent testing. Some states have not even taken the chance that kratom could be sold contaminated, such as Wisconsin and Indiana which have banned kratom products. There is significant room to elevate the kratom industry and the timing for change is crucial.
Santé Laboratories intends to help shape the kratom industry, in part by establishing testing guidelines, and by helping to develop dosage and safety profiles.
Kratom is a significant growth opportunity
As a potential natural alternative to opioids, kratom may be a global game-changer as the world seeks a solution to the multi-billion dollar opioid dependence burden. Kratom’s active ingredient, 7-hydroxymitragynine, binds to the body’s opioid receptors and has been shown to be 43 times more potent than morphine. Limits should certainly be established for this alkaloid, and as a step in the right direction, Santé Laboratories applies a limit of 2% 7-hydroxymitragynine for the materials we test.
It’s important to note that dangerous heavy metals are not inherent to kratom itself.
However, without proper oversight from regulatory bodies and rigorous testing performed by kratom supplement manufacturers, kratom users may be susceptible to unhealthy heavy metal exposure. It’s more critical than ever before that the kratom community, from importers to consumers, require all kratom raw material and finished product that is imported into and manufactured in the U.S. to be thoroughly tested.
This testing should only be done by an ISO/IEC 17025:2017 accredited laboratory, such as Santé Laboratories, to provide traceability through a validated certificate of analysis (COA) to verify compliance to heavy metal limits as defined in the USP and/or American Herbal Products Associations (AHPA) compendiums.
Santé Laboratories’ testing precision and accuracy matter
We want to build the kratom industry standards, from label compliance and GMP protocols to testing guidelines including genetic and chemical testing for authenticity, and ultimately bioanalytical assays. Only through precision, thoroughness and accuracy comes trust in a laboratory. And that’s how an industry is built: on a foundation of safety procedures and high-quality science.
We are among the very few labs accredited to test specifically for the alkaloids found in kratom including the most active: mitragynine and 7-hydroxymitragynine. And using Thermo Fisher’s most advanced Ultra-High Performance Liquid Chromatography machinery, Santé Laboratories is the only lab in the world that has developed the method and can test for up to 7 different alkaloids; every other lab can only test for two.
This precision and accuracy will give us the capacity to develop innovative methods for research and development, as funds become available.
If you have questions about kratom, or if you are ready to have us test your product, contact us.