The spectre of prohibition has continued to influence the policy surrounding kratom.
By Caro Freinberg and Soren Shade, Top Tree Herbs
Over the past decade, the U.S. Food and Drug Administration has been quietly crippling the kratom industry. Now, Indonesia’s new export regulations—meant to raise kratom quality standards and appeal to U.S. regulators—may have just squeezed the most responsible products out of the market.
The Indonesian government has enacted new regulations to tighten the market for exports of kratom. Kraatom is a plant native to Southeast Asia whose leaves contain psychoactive alkaloids and have been traditionally used as a herbal remedy.
The policy includes a provision that strengthens the quality control of kratom, which had been notably lacking in the past. All shipments of kratom must now be sterilized prior to leaving Indonesia. Only batches meeting minimum concentration thresholds in mitragynine (the primary active component) will qualify for export. The steps taken are intended to prevent contamination, and exporters will not be able to bulk up their shipments by adding non-kratom plants.
In the second part of the regulations, it is prohibited to export raw leaf kratom with particle sizes greater than 0.6 millimeters. This includes crushed-leaf Kratom. The United States uses crushed leaves to produce extracts. Indonesia has imposed particle size limits to prevent foreign firms from capturing the value created by processing raw kratom and turning it into finished extracts.
The new international standards are a significant step in the right direction for quality assurance and fairness within the kratom industry. It is worth celebrating the intentions and supporting them.
But the new rules have inadvertently disrupted kratom supply chains for safer and more traditional products, while failing address the root of regulatory tensions that exist between Indonesia and the U.S.
FDA Import Alert No. 54-15: The real barrier to easy trade
At the fourth annual Kratom Science Symposium at the University of Florida earlier this year, Dr. Masteria Yunovilsa Putra—director of vaccines and drugs at BRIN, Indonesia’s national research agency—candidly stated that one of the goals behind the new regulations was to appease FDA. He explained that the goal was to show Indonesia’s commitment to self-regulation and to take action to combat low-quality or contaminated kratom.
But there’s a fundamental problem with this strategy: It doesn’t address the root cause of friction in the U.S. import process—which isn’t about Indonesia’s quality control standards, but rather FDA’s refusal to recognize kratom as a legitimate dietary ingredient.
FDA began targeting kratom in 2012 by issuing import alerts to U.S. citizens. Even though kratom is legally available in many states, the Marshals detain the shipments of kratom when they arrive at the border. FDA justified their actions by saying that kratom is an unapproved new food ingredient and that there are concerns about contamination or lack of data.
FDA’s position has not changed, however. The science behind kratom and its production standards are constantly evolving. Quality control for kratom products has significantly improved over the last decade. Many U.S. firms now test each batch in a lab, quarantine imported products, and invest heavily in clean manufacturing. Academic researchers and clinical practitioners have compiled a large body of evidence supporting the safety of kratom at typical consumer serving sizes.
Yet, despite the warnings against importing kratom, it has not changed.
FDA’s attitude toward kratom seems to be less rooted in scientific evidence as it is in a legacy of stigmatization and zero-tolerance policy towards non-pharmaceutical items with psychoactive potency. Sterilization or testing for alkaloid will not change this.
Many scientists, businesses, and consumer groups are working together to fight this import alert. Their goal is to dispel the myths about kratom’s dangers while also reducing the stigmatization. But the second arm of Indonesia’s regulations—the ban on crushed leaf exports—is making this harder for some.
Market reputation and low-potency Kratom Tea Products: Collateral damage
Global kratom has been plagued by a bad reputation for a long time, largely due to companies that have made illegal claims or sold ultra-concentrated, poorly labeled extracts.
In response to a race between kratom businesses for the bottom of the market, regulators enacted prohibitionist legislation. In the last decade, it was clear that the kratom market in America and overseas would not survive.
Top Tree Herbs is a company that was founded in 2020. Its goal is to create a low-potency, lab-tested kratom product. The goal was not just to produce a milder tea bag, as this product had been lacking. The goal was to bring back the cultural context and reduce stigma in order to steer industry forward.
It is this kind of product which regulators must support and encourage, rather than suppress. But because of Indonesia’s new particle size rule, crushed-leaf kratom—the key raw material used in our tea bags—is nearly impossible to source.
Take a Smarter Approach
Kratom is a substance that deserves to be regulated honestly, and not by blanket bans disguised under the guise of consumer protection. The consumer deserves to have access to all products, and not just those that offer the greatest profit for American businesses or Indonesian ones.
While Indonesia’s export law won’t be changing in the near future, anyone involved with kratom, including consumers, advocates and business people, can start taking steps now to address supply chain problems and safety concerns both in the United States as well as abroad.
The first thing that U.S. law makers should do is demand an official review and the revocation Import Alert 54-15. This alert was released without any public input and relies on out-of-date justifications. It also destabilizes kratom’s global supply chains.
Customers can encourage their elected officials to act, as well as vote with their dollar. By supporting companies who prioritize transparency, accuracy of labeling, safety and quality, they drive out the bad actors.
In addition, businesses can (and currently are) try to diversify sourcing in order that regulatory changes from a country do not disrupt the supply chain for kratom. The new policy has caused delays in shipments for months, and it’s not just that the Americans will no longer be able to access crushed leaf kratom. Thailand, Malaysia, Uganda and other countries have just-initiated kratom industry, but their ability develop stable, competitive marketplaces depends largely on whether or how importing nations adopt better, scientifically-based policies.
While some prices of kratom might be higher in the short-term, by standing with responsible brands and pressing U.S. authorities to act we can steer the industry towards the right path.
Kratom Regulation with No Repression
The specter that kratom is illegal has been a constant in the minds of many for the past decade. But the threat continues to sway the laws surrounding it. FDA’s stance has cast a long shadow—so much so that even well-intentioned regulations like those recently enacted in Indonesia can end up harming the safest, most traditional kratom formulations.
We need a new paradigm—one where psychoactive substances can exist without being burdened by outdated stigma and moral panic. A meaningful public health reform should not rely solely on prohibitions to deal with complex issues. The safest choices should be highlighted and individuals given the necessary tools to make responsible, informed decisions.
Soren shade is the co-owner and graphic designer of Top Tree Herbs. The company, which manufactures kratom bags in Colorado, strives to remove the stigma that surrounds kratom. Caro Freenberg is Top Tree Herbs’ co-owner, graphic designer and cofounder.
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Caro Freenberg provided the photo.