The American Medical Association urged federal regulators to apply the same rigorous scientific standards used for conventional pharmaceutical drugs to botanical products, warning that widespread marketing of unregulated natural substances poses severe public health risks.
AMA Demands Pharmaceutical-Grade Scrutiny for Botanical Supplements
John J. Whyte, chief executive officer and executive vice president of the American Medical Association, sent a formal letter to the Food and Drug Administration pressing the agency to step up regulatory oversight of botanical products derived from plants such as cannabis and kratom. The medical organization expressed deep concern that consumers increasingly use these natural remedies without any research-backed evidence proving their safety or effectiveness.
Willie Underwood III, president of the AMA, emphasized that botanical manufacturers are developing increasingly potent products spanning gummies, powders, oils, and injections. Underwood stated that consumers have effectively become real-world test subjects, suffering severe clinical consequences that include dependence, substance use disorders, overdose, and death.
The AMA is urging the FDA to hold botanical products, including kratom, cannabis and other plant-derived substances, to the same scrutiny as other drugs. Growing consumer use, anecdotal claims and social media influencer marketing should not circumvent the FDA approval process.
Hidden Drug Interactions Complicate Clinical Practice
- Hidden Drug Interactions: Herbal and botanical extracts impact bleeding, blood pressure and metabolism of certain drugs.
- Diagnostic Blind Spots: Patients routinely fail to disclose botanical supplement usage during clinical encounters because they do not classify them as traditional drugs.
Anita Gupta, an adjunct assistant professor of anesthesiology and pain medicine at the Johns Hopkins School of Medicine, noted that patients frequently fail to report herbal remedies to their physicians. Gupta explained that these substances can significantly impact bleeding parameters, blood pressure stability, and the metabolic breakdown of prescription drugs.
The AMA specifically highlighted the dangers associated with kratom, a tropical tree native to Southeast Asia that individuals frequently use to self-treat pain, anxiety, and depression. Data from poison control centers reveals a dramatic 1,200% surge in exposure calls related to kratom between 2015 and 2025.
Federal Authorities Restrict Synthetic Derivatives
Federal authorities have moved to restrict certain synthetic derivatives of the plant. Whyte expressed support for the Drug Enforcement Agency’s emergency scheduling actions against specific kratom compounds, including mitragynine pseudoindoxyl, commonly known as MGPI, MGM-15, and MGM-16. The organization continues to collaborate with state medical societies to enact protective legislation limiting the promotion and sale of unregulated mitragynine and 7-hydroxymitragynine.
Gupta pointed out that kratom and its derivatives exhibit morphine-like pharmacological effects. She warned that relying on uncontrolled botanical extracts is a dangerous response to chronic pain treatment failures, emphasizing that approved medications undergo rigorous clinical trials to establish safe, predictable dosing guidelines.
| Botanical Substance | Reported Self-Treatment Uses | Identified Clinical Risks |
|---|---|---|
| Kratom (Mitragyna speciosa) | Pain, anxiety, depression, diarrhea | Morphine effects, dependence, overdose, death |
Regarding cannabis, Whyte reiterated the organization’s backing of adequate and well-controlled clinical investigations. The AMA called for expanded research funding, reliable product supplies for trials, and strong institutional review board safeguards for human subject protocols. Whyte urged the FDA to shield scientific evaluation from political interference.
Gupta served as a former U.S. FDA special government employee, senior advisor to the Milken Institute, advisor to the Gates Foundation, and member expert to the World Economic Forum.
References
- Healio Clinical News: AMA urges FDA to regulate botanical products like conventional drugs.
