Kratom (Mitragyna speciosa) has become a topic of significant debate among clinicians, policymakers, and the public due to differing views on its safety, pharmacology, and regulatory requirements. A recent article raises important concerns about kratom’s pharmacological actions, potential for addiction, psychiatric risks, and regulatory challenges. Although the goal of protecting public health is admirable, it is crucial that discussions around kratom are rooted in current scientific evidence and avoid overgeneralization or unsupported claims. This article seeks to respond to key assertions made in that article, clarify misunderstandings, and promote a balanced, evidence-based approach to kratom policy and education.

Kratom pharmacology: clarifying potency and mechanisms

The author describes kratom’s primary alkaloids, mitragynine and 7-hydroxymitragynine (7-OH), as “highly potent opioids,” suggesting a similarity to classical opioids like morphine or fentanyl. However, this does not align with the pharmacological evidence. Mitragynine, the most prevalent alkaloid in kratom, acts as a partial agonist at the mu-opioid receptor. While 7-OH is more potent, it is found in kratom leaf in trace amounts, typically less than 0.02 percent of total alkaloids. Human pharmacokinetic studies show that after typical kratom consumption, blood levels of 7-OH are negligible and mitragynine’s opioid activity is far weaker than that of prescription opioids. Mitragynine does not cause respiratory depression or notable euphoria, making it safer than traditional opioids.

7-OH is not kratom

When 7-OH is isolated or synthesized, its concentration can reach levels up to 1,000 times higher than in natural kratom leaf. While 7-OH can be produced from trace amounts found in kratom leaves, it is a semi-synthetic compound and not the same as natural leaf kratom. Comparing the two is like calling baking soda a cake simply because it is used in baking. The implications of ingesting large amounts of 7-OH and reporting it as kratom use are misleading.

On July 29, 2025, FDA Director Dr. Marty Makary proposed the prohibition of 7-OH, stating: “Our focus is not on the natural kratom leaf, but rather the concentrated derivative known as 7OH.”

Addiction and withdrawal: an evidence-based perspective

Discussion around kratom’s addiction potential and withdrawal symptoms is common, but clinical data indicate that its profile is distinct from opioid use disorder. While dependence can occur in some individuals, especially with heavy and prolonged use, epidemiological studies and clinical reports consistently show that kratom withdrawal is usually milder than withdrawal from prescription opioids or heroin. Symptoms can include muscle aches, irritability, and insomnia, but severe or life-threatening withdrawal is rare. It is important for clinicians and policymakers to differentiate between physical dependence (which can occur with various psychoactive substances, including caffeine) and the compulsive, harmful patterns seen in opioid addiction.

Psychiatric effects: context and evidence

The original article cites psychiatric side effects and case reports of psychosis associated with kratom. While isolated cases of adverse psychiatric outcomes exist, these are rare considering the millions of kratom users in the United States. Most published reports are anecdotal or involve polydrug use, adulterated products, or underlying psychiatric vulnerabilities. Controlled studies and population-level surveys do not show a strong link between kratom consumption and psychosis or severe psychiatric disorders. Many users report turning to kratom to manage anxiety, depression, or opioid withdrawal symptoms. As with any psychoactive substance, the risk is not zero, but public health communication should distinguish between rare adverse events and the broader context of use.

Regulation and consumer safety: advocating for the Kratom Consumer Protection Act

Instead of prohibition, which could move kratom markets underground and increase the risk of adulterated or contaminated products, the evidence supports reasonable, science-based regulation. The Kratom Consumer Protection Act (KCPA), adopted in several states, provides a model for ensuring consumer safety without criminalizing responsible use. Key provisions of the KCPA include:

• Setting limits on allowable levels of contaminants, such as heavy metals and pathogens
• Prohibiting the sale of adulterated or synthetic kratom products
• Requiring accurate labeling of alkaloid content and appropriate warnings
• Restricting sales to minors

These regulations improve consumer safety and empower users to make informed choices, while preserving access for those who benefit from kratom. The greatest risks associated with kratom in the United States stem from adulterated products, not the natural plant material.

Recommendations: toward evidence-based education, policy, and clinical practice

To ensure public health and safety, the following recommendations are proposed:

• Promote accurate, evidence-based education for clinicians, consumers, and policymakers about kratom’s pharmacology, risks, and benefits.
• Support continued research into kratom’s therapeutic potential and risks to inform balanced policy and clinical guidelines.
• Adopt regulatory frameworks, like the KCPA, that prioritize consumer safety, product purity, and informed use over punitive prohibition.
• Encourage clinicians to assess kratom use in a nonjudgmental, patient-centered manner, distinguishing between problematic and non-problematic use.

Conclusion: a call for balanced, science-driven kratom policy

Discussion about kratom must be led by rigorous scientific evidence, not fear or sensationalism. While the author’s concerns highlight important issues, a balanced consideration of the literature challenges the portrayal of kratom as a “dangerous opioid.” Notably, 7-hydroxymitragynine (7-OH), a potent metabolite produced in the body, is not found in significant amounts in raw kratom leaf and should not be conflated with kratom in policy or public messaging. Kratom’s unique pharmacology and relatively low addiction risk make it a botanical with notable benefits and minimal harm when used responsibly. Sensible regulation, exemplified by the Kratom Consumer Protection Act, is the best route to consumer safety and public health. It is vital for health professionals, policymakers, and the public to engage in open, evidence-based discussion so that kratom policy is grounded in science rather than stigma.

Heidi Sykora is a retired nurse practitioner and former health care executive whose writing and advocacy focus on evidence-based interventions that improve patient outcomes and experiences. Her career has encompassed clinical education, public health policy, and regulatory reform, with special emphasis on misinformation, caregiver support, and safe access to plant-based and alternative therapies. Published work includes clinical research, continuing education, book chapters, and public health commentary. Her recent contributions appear in Home Healthcare Now, the Chicago Daily Herald, the International Plant & Herbal Alliance, and Nursing CE Central. She is also a contributor to 10 Nursing Interventions for Family Caregivers: Guide to Best Practices in Adult-Gerontology Patient Care and has written policy advocacy articles through the American Kratom Association. Professional updates and advocacy work are available on LinkedIn.