A New Era For Kratom: What The Latest FDA Study Reveals About Kratom Leaf

For years, kratom has been clouded by controversy, largely fueled by media portrayals that paint a negative picture of this natural plant. Much of the confusion stems from a lack of distinction between kratom leaf and its more concentrated extracts, leading to a fragmented and inconsistent regulatory landscape. As the co-founder of Super Speciosa, I've seen firsthand how misinformation can skew public perception and hinder progress toward balanced regulation. But now, thanks to the recent FDA study we were part of, the conversation around kratom—especially the raw leaf—could finally be shifting.

Laying The Groundwork For Regulation

In the early 2010s, government agencies began issuing warnings about kratom use, setting the tone for how many Americans still view the plant today. This created a stigma similar to that faced by cannabis. By 2016, the DEA nearly scheduled kratom as a controlled substance, and despite subsequent efforts to ban it, including under the Trump administration in 2018, no concrete regulations have been put into place at the federal level. The industry remains unregulated, with products on the market ranging from traditional kratom leaf to highly concentrated extracts that pose very different risks to consumers.

This is where the FDA's recent study comes in. It's the first to examine the effects of kratom leaf in human subjects, focusing solely on the leaf—not the more potent extracts that have often been at the center of negative reports. While more studies are needed, this study provides critical data about the safety and potential benefits of kratom in its natural form.

Key Takeaways: Safety, Efficacy, And The Road Ahead

No Serious Adverse Events (SAEs): One of the most significant findings is that there were no SAEs reported, meaning no deaths or hospitalizations, even when participants took larger-than-recommended serving sizes.

Well-Tolerated Raw Kratom: The study demonstrates that kratom leaf is well-tolerated by users when used responsibly. This supports the idea that kratom leaf, as opposed to more concentrated extracts, presents minimal risk.

Need for Further Research: The study highlights the need for more comprehensive research at the federal level. It indicates that additional studies could provide valuable insights into kratom and its associated alkaloids. This research serves as a valuable starting point, opening doors for continued investigation.

The Problems With The Kratom Market: Why Regulation Is Essential

Despite these promising findings, the kratom market is still riddled with challenges. A lack of regulation has resulted in a fragmented industry where consumers face risks from poorly manufactured products. Many kratom products do not comply with Good Manufacturing Practices (GMP) standards, and consumers may be exposed to contaminants like lead, or face inconsistencies in dosage from batch to batch.

For example, some products contain wildly varying amounts of mitragynine (the active alkaloid in kratom)—one serving may contain 35mg, while another might contain 150mg. This makes it difficult for consumers to safely manage their intake, especially for first-time users. Proper labeling is also a major issue, with some products lacking even basic instructions for use or necessary safety information. The market desperately needs standardized labeling, akin to how alcohol percentages are listed on wine and beer.

The introduction of synthetic kratom products, such as 7-Hydroxymitragynine (7OH), further complicates the landscape. This potent metabolite is not found in traditional kratom and carries a different, potentially riskier safety profile. Yet, it is often lumped in with kratom leaf products, contributing to the confusion. Without clearer labeling and distinction between raw leaf and isolates, consumers are left navigating a potentially hazardous marketplace.

Educating Policymakers: Addressing Regulatory Gaps

One significant issue with the current state of kratom regulation is that each state creates its own set of rules, leading to a patchwork of regulations. Policy makers often lack a clear understanding of the differences between kratom leaf and its extracts, resulting in either overly harsh restrictions or a lack of regulation altogether. This inconsistency arises because policy makers are not always equipped to address the nuances of kratom regulation, leading to a broad-brush approach that lumps all kratom products together.

To move forward effectively, it is crucial to educate policymakers about these differences and the specific needs for regulating various kratom products. Understanding that kratom leaf and kratom extracts pose different risks and benefits will help in crafting regulations that protect consumers without stifling access to beneficial products.

Building A Framework For Sensible Regulation

The FDA's recent study should be a wake-up call—it's time to stop talking about banning kratom and start discussing how to regulate it properly. Here's what that regulation should look like:

• Consistency in Regulations: At present, kratom regulations vary widely, creating a confusing and inconsistent patchwork of rules. We need federal guidelines that unify these standards across the country. Without this consistency, both consumers and responsible businesses are left at a disadvantage.
• Upper Serving Size Limits for Extracts: Highly concentrated kratom extracts and isolates should have strict serving size limits to protect consumers from unintentional overuse.
• Proper Labeling and Product Transparency: Kratom products should clearly state what they contain—whether it’s raw leaf or an isolate like 7OH. Labels should include proper serving sizes, usage instructions, and safety warnings. Each batch of kratom should be traceable through a QR code linked to lab results, and companies should adhere to GMP standards to prevent contamination and ensure product quality.
• Testing Standardization: There must be a uniform standard for testing kratom products. Currently, companies can shop around for favorable lab results, which undermines trust in the safety and efficacy of kratom. By implementing stricter testing guidelines, we can ensure consumers are getting what they pay for, without the risk of contaminants or misinformation.

Looking Forward: A New Era For Kratom

The recent FDA study marks an important step toward deeper exploration of kratom's effects, especially on different product types like extracts and isolates. This study, challenges the portrayal of kratom leaf as a public health threat and highlights the need for a more informed understanding.

As the conversation around kratom evolves, we in the industry remain committed to upholding the highest standards of safety and quality. There's a growing call for further federal research and responsible practices. By maintaining these rigorous standards, we can help ensure kratom products are safe, responsibly sourced, and contribute to a more balanced regulatory approach.