The American Medical Association (AMA) is urging the Food and Drug Administration (FDA) to uphold rigorous, evidence-based standards for evaluating botanical drug products, warning that those marketed with unproven health claims can pose serious risks when their safety and efficacy have not been established.
In a letter (PDF) to FDA Deputy Commissioner Grace R. Graham, the AMA emphasized that botanical products—including kratom, cannabis and other plant-derived substances—should be subject to the same scrutiny as other drugs. Growing consumer use, anecdotal claims and marketing by social media influencers should not circumvent the FDA approval process or replace the requirement for high-quality clinical trials and postmarket safety monitoring.
“As botanical manufacturers develop increasingly potent products in everything from gummies and powders to oils and injections, consumers are becoming the real-world guinea pigs—and suffering tragic consequences, including dependence, substance use disorders, overdose, and death,” said AMA President Willie Underwood III, MD, MSc, MPH. “Calling something ‘natural’ doesn’t make it safe. We need science, not social media hype, to determine what belongs in our medicine cabinets.”
The AMA commended the FDA’s safety assessments that informed the Drug Enforcement Administration’s emergency scheduling of three kratom-related compounds in August 2026. The letter also urged the FDA to ensure that botanical products and their derivatives demonstrate safety and efficacy through clinical trials before being marketed or prescribed to treat medical conditions.
The AMA supports research into botanical products to identify potential therapeutic benefits and safety concerns but cautions against bypassing established drug approval standards. AMA policy supports well-controlled clinical research into cannabis to better understand its potential medical uses and short-and long-term risks. The AMA also supports appropriate safeguards and regulatory oversight to protect patients and the public from potentially dangerous botanical products.
The AMA stressed that FDA decisions should not be swayed by political considerations, conflicts of interest or commercial pressure that could put patients and the public at risk. The AMA urges the agency to maintain established scientific standards and resist efforts to fast-track products based on popularity or unsubstantiated claims.
Read the entire letter here (PDF).
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About the American Medical Association
The American Medical Association is the physicians’ powerful ally in patient care. As the only medical association that convenes 190+ state and specialty medical societies and other critical stakeholders, the AMA represents physicians with a unified voice to all key players in health care. The AMA leverages its strength by removing the obstacles that interfere with patient care, leading the charge to prevent chronic disease and confront public health crises and, driving the future of medicine to tackle the biggest challenges in health care.
