Breaking Down the FDA’s First Kratom Study: What You Need to Know

Kratom, a Southeast Asian botanical used for centuries, has recently gained attention in the United States for its potential to ease day-to-day discomfort and promote a sense of calm. Despite widespread use, kratom has faced significant scrutiny from government agencies, including the U.S. Food and Drug Administration (FDA). Past concerns from the FDA have revolved around potential abuse, opioid-like properties, and safety risks. 

However, the FDA’s first official pilot study on kratom presents new insights—particularly for its powdered leaf form—that could reshape the conversation. Here’s what we’ve learned from the kratom study and why it matters.

Understanding the FDA Pilot Study on Kratom

The FDA’s preliminary research focused on dried, powdered kratom leaves in capsule form. The study, known as a Single Ascending Dose (SAD) trial, aimed to assess kratom’s potential for abuse and tolerance rather than its broader applications. This marks a significant milestone, as it’s the first time the FDA conducted a controlled investigation into kratom, paving the way for future, more extensive research.

The trial, conducted at the University of Florida, involved 40 healthy participants. Crucially, none of the participants had a history of substance abuse, ensuring a controlled environment for objective results. The researchers administered different doses of kratom (1 gram, 3 grams, 8 grams, 10 grams, and 12 grams) and monitored participants. Researchers observed vital signs such as blood pressure, respiratory rates, and body temperature while also noting any adverse responses.

Additionally, this kratom study avoided testing more concentrated formulations of kratom such as kratom extracts or beverages, as these products may vary in alkaloid levels. By focusing on raw kratom leaf powder, researchers ensured a controlled and focused examination.

Key Findings From the Study

Although preliminary, the findings reveal promising signs about kratom’s general safety when used responsibly. The study found:

• Tolerability Across Doses: Kratom was well-tolerated in all dose groups, even up to 12 grams.
• Mild Side Effects: Nausea was the most common adverse reaction, particularly in higher-dose groups (above 8 grams). This was attributed to the number of capsules consumed rather than the kratom itself.
• No Severe Reactions: Issues like respiratory distress, a significant risk in opioid-based products, were absent in this kratom study.

Participants in the 12-gram dose group consumed 24 capsules in five minutes, leading to discomfort driven primarily by capsule volume. Researchers noted that the capsule burden likely caused the nausea. This underscores the need for consumer guidance on serving sizes and access to high-quality products like kratom capsules developed by trusted sources.

Researchers also noted minor pupil dilation in some participants, considered a normal reaction due to kratom’s alkaloids binding to opioid receptors but not seen as concerning.

Implications for Kratom Regulation

These findings support the call for regulating kratom rather than banning it outright. The American Kratom Association (AKA) has argued for maintaining kratom’s legal status while focusing on safety oversight. The kratom study provides evidence supporting proper regulation to ensure safe, high-quality access for consumers.

Mac Haddow, a senior fellow at AKA, emphasized that regulation could help remove adulterated or unsafe products, ensure labeling compliance, and enforce industry-wide Good Manufacturing Practices (GMPs). For users, the current findings emphasize the value of choosing products from transparent and reputable brands. 

Limited Scope and Need for Future Research

While the kratom study provides valuable insights, it represents a small piece of the broader kratom story. The FDA study used kratom sourced from a single manufacturer and did not address popular variations like beverages or concentrated products. Kratom’s complexity adds layers to its study. The plant contains over 50 known alkaloids, including mitragynine and 7-HMG, each with potential properties. 

Researchers emphasized the importance of exploring how alkaloid composition varies across products and strains, like Green Maeng Da or White Horn, to understand their broader uses. Future research could expand into multiple ascending dose (MAD) trials or studies examining the long-term impact of kratom use. Additionally, studies targeting diverse markets, including beverages and extracts, could shed light on emerging trends.

Key Takeaways for Consumers

For those exploring kratom, staying informed and responsible is key. Here are some takeaways:

• Choose Responsible Sources: The kratom study clearly shows that it’s best to opt for products from trustworthy brands with strong reputations. When you want to buy kratom, look for reliable suppliers offering premium-quality products that emphasize quality and ethics.
• Enjoy Tasteful Preparations: Mixing kratom powder with tea or lemonade can improve taste and create a more pleasant experience.
• Start Low, Go Slow: Beginners should begin with smaller portions to determine what works for them.

The Road Ahead for Kratom Research

The FDA study represents an important step forward but also highlights the need for further exploration. Future studies on kratom’s long-term use, diverse formulations, and strain-specific properties are necessary before drawing broader conclusions.

Regulation backed by research will help guide kratom into a safer, more transparent industry, ultimately benefiting both consumers and advocates. With clarity and responsibility on the part of vendors as shown by the kratom study, kratom can occupy a more defined space in today’s botanical market.

Explore More at The Kratom Company

The FDA’s pilot study offers new insights into kratom’s tolerability and provides a foundation for future research and regulations. While encouraging, its findings only scratch the surface of this complex botanical. For now, users should prioritize reputable sources and follow responsible practices. Science and regulations will continue to demystify kratom and ensure its safe use for the growing number of people interested in its potential.

Want to stay informed as kratom research moves forward? Explore our blog at The Kratom Company.