As Kratom Consumers Face Global Market Disruption, It’s Time For FDA To Put Safety Over Stigma (Op-Ed)
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“For the past decade, kratom has fought tooth and nail to remain legal, but the lingering specter of prohibition continues to distort the policies surrounding it.”
By Caro Freinberg and Soren Shade, Top Tree Herbs
For over a decade, the U.S. Food and Drug Administration (FDA) has quietly crippled the kratom supply chain. 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.
At the end of 2024, the Indonesian government enacted sweeping new trade regulations aimed at tightening the export market for kratom, a tree native to Southeast Asia with leaves containing psychoactive alkaloids that have long been used as an herbal remedy.
One provision of the policy strengthens quality control for kratom exports, which was notably absent in the past. Moving forward, all kratom shipments must be sterilized before leaving Indonesia, and only batches that meet minimum thresholds for the concentration of the primary active compound, mitragynine, will qualify for export. These steps are designed to limit contamination and prevent exporters from bulking up shipments with non-kratom plant material.
The second component of the regulations is a prohibition on the export of raw kratom leaf with a particle size over 0.6 millimeters, which includes crushed-leaf kratom. In the United States, crushed leaf is most often used to make extracts. By imposing particle size restrictions, Indonesia aims to ensure that the economic value of processing raw kratom into finished extract products stays within its own borders, rather than being captured by foreign companies.
These new standards represent a step forward for kratom quality control and international industry fairness. The intentions are worth celebrating and supporting.
However, the new regulations have also inadvertently disrupted the supply chain of safer, more traditional kratom products while failing to address the root cause of regulatory tension between the U.S. and Indonesia.
The Real Barrier to Easy Trade: FDA’s Import Alert 54-15
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. The aim, as he explained it, was to demonstrate Indonesia’s willingness to self-regulate and take action against low-quality or adulterated 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.
Since 2012, FDA has targeted kratom by issuing a series of import alerts that instruct U.S. Marshals to detain kratom shipments at the border, even though people can legally sell and possess kratom in most states once it’s inside the country. FDA justified this by claiming that kratom was an unapproved new dietary ingredient, and later, that it poses a risk due to contamination and a lack of safety data.
FDA has maintained that position to this day, but kratom science and production standards have not stood still. Over the last decade, kratom quality control has improved dramatically. Many U.S. companies now lab test every batch, quarantine imports, and invest in clean manufacturing. Meanwhile, academic researchers and clinicians have built a growing body of data supporting kratom’s safety at common consumer serving sizes.
And yet, the kratom import alert hasn’t budged.
FDA’s posture toward kratom appears to be rooted less in current scientific evidence than in legacy stigma and a zero-tolerance approach to many non-pharmaceutical products with psychoactive potential. No amount of sterilization or alkaloid testing will change that.
A large number of scientists, consumer advocates, and businesses are trying to combat this root cause of the import alert, to expose the lack of evidence of kratom dangers and reduce stigmatization of kratom. But the second arm of Indonesia’s regulations—the ban on crushed leaf exports—is making this harder for some.
Collateral Damage: Low-Potency Kratom Tea Products and Market Reputation
The global kratom industry has long struggled with a reputation problem, thanks in large part to reckless companies pushing poorly labeled, ultra-concentrated extracts or making illegal medical claims about kratom.
As kratom companies raced to the bottom, regulators responded with prohibitionist laws. At many points in the past decade, the future of the kratom industry in America and abroad looked bleak.
In 2020, we created a kratom company, Top Tree Herbs, to offer a different kind of product: low-potency kratom tea bags, always lab tested and labeled with consumer safety in mind. Our goal wasn’t just to create a milder product, which was previously lacking in the market. It was to restore cultural context, reduce stigma, and help steer the entire industry in a better direction.
This is the type of product that regulators should support, not choke off. 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.
A Smarter Path Forward
Kratom deserves honest regulation, not blanket prohibitions disguised as consumer protection. And consumers deserve access to a full range of products to meet a wide range of needs, not just the products that have the highest profit margin for American or Indonesian businesses.
Though Indonesia’s export laws won’t change in the immediate future, there are actions that everyone connected to kratom (including consumers, advocates, business owners, and legislators) can take now to ameliorate supply chain issues and product safety concerns in the United States and abroad.
First and foremost, U.S. lawmakers should demand a formal review and revocation of Import Alert 54-15. It was issued without public input, relies on outdated justifications, and destabilizes the entire global supply chain for kratom.
Consumers can push their elected officials to take this action, and can of course vote with their dollar. Supporting companies that prioritize safety, labeling accuracy, and transparency pushes bad actors out of the market.
Additionally, companies can (and are currently trying to) diversify their sourcing so that a single country’s regulatory changes don’t upend the kratom supply chain. In addition to indefinitely hampering Americans’ access to crushed-leaf kratom, the rollout of the new policies caused months-long delays for shipments of powder. Thailand, Malaysia and Uganda have nascent kratom export industries, though their ability to develop competitive and stable marketplaces largely depends on whether or not importing countries adopt more favorable, science-based policies for kratom products.
In the short term, prices for some kratom products may be higher, but by standing behind responsible brands and pressuring U.S. regulators to act, we can help steer this industry in the right direction.
Kratom Regulation Without Repression
For the past decade, kratom has fought tooth and nail to remain legal, but the lingering specter of prohibition continues to distort the policies 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. Meaningful public health reform shouldn’t rely on prohibition as a blunt instrument for managing complex issues. It should elevate the safest options and give individuals the tools to make informed, responsible choices.
Soren Shade is the founder of Top Tree Herbs, a Colorado-based kratom tea bag company focused on reducing the stigma surrounding kratom. Caro Freinberg is Top Tree Herbs’ co-owner and graphic designer.
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Photo courtesy of Caro Freinberg.
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