There is no doubt that kratom is gaining in popularity. New brands are popping up each week as others disappear. Dietary supplements as a whole have always faced questions about quality and kratom is no different.
Unfortunately, issues with product quality are very pervasive in the kratom industry and there are many unscrupulous kratom vendors that are not taking the proper steps to protect their customers. The good news is that organizations like the American Kratom Association (AKA) are answering the call and providing guidance to the industry in the form of their GMP standards program.
GMP stands for Good Manufacturing Practice. GMP is promulgated by FDA regulations, and compliance is required to market dietary supplements. The regulations provide a quality control framework for manufacturers and distributors to follow. While the regulations do not explicitly tell businesses how to operate – as all businesses have unique ways of doing things – they do provide clear guidelines to follow.
By implementing GMP processes, kratom manufacturers can ensure the quality and safety of their products. This is especially important because kratom that is imported to the United States is delivered in a raw form that does not meet modern food safety standards.
The kratom that arrives in the U.S. comes from leaves that are harvested by villagers in Indonesia where quality controls are virtually non-existent. There have been anecdotal reports of some processors in Indonesia milling kratom leaves in open facilities with chickens and other livestock.
Leaves are also dried in the open air where they are exposed to natural elements, including insects, birds, and other animals. Also, hygienic food handling practices and sanitation are not always observed. This results in natural kratom products that become contaminated with harmful bacteria like Salmonella and E. coli.
Kratom products may also fail testing due to high levels of coliforms, yeast and mold. Contamination of kratom products with heavy metals such as lead is also a concern.
Not to mention, the kratom that is imported into the United States is not always packaged well. Sometimes, they arrive with rips and tears in the packaging, resulting in kratom powder leaking from the container and leaving a trail of green dust.
The lack of quality control at the source in Indonesia underscores the need for heightened quality controls for manufacturers and distributors of kratom products in the United States. There are many small distributors in the United States are operating out of their garage, home, or apartment without properly handling or testing for contamination.
“Garage” vendors are generally importing kratom from Indonesia, scooping the kratom from boxes, placing the powder into smaller pouches, and then distributing to customers without doing any quality checks for contamination. This places consumers at risk. Without a proper facility and equipment, it’s impossible to properly handle, test, and manufacture kratom products. These type of vendors will commonly use the “not for consumption” labeling to skirt their responsibilities to consumers (or so they hope).
A kratom vendor who has properly implemented a GMP quality system can ensure the safety of their kratom products by eliminating risks of contamination and adulteration. Just as importantly, by voluntarily cooperating with GMP regulations, GMP vendors are supporting the continued access to kratom products.
One of the most valid arguments that lawmakers hear about why kratom should be banned is that the market is tainted with sub-standard products. Kratom products are widely available in smoke shops, convenience stores, and health food stores. Many of these products are improperly labeled and untested.
One of the most telltale signs that a product is not tested is when it does not have a lot or batch number. When a product has passed lab testing, it is advantageous for the manufacturer to be able to prove it. However, without labeling the product with an identifier, it is impossible to do so. When you support vendors who act ethically, you also support a sustainable industry that can keep kratom products legal and accessible.
Here at OPMX, corresponding sets of lab tests are reviewed by our Quality Control Team before they can be approved for sale to our customers. Every single OPMX kratom product is fully traceable to the specific batch it came from.