The American Medical Association is calling on the FDA to require botanical drug products, including kratom and cannabis, to prove safety and efficacy in clinical trials before they are marketed or prescribed, warning that unproven products can pose serious risks to patients.
The AMA made its case in an Oct. 28 letter to FDA Deputy Commissioner Grace Graham. The physician group argued that rising consumer demand, anecdotal claims and influencer marketing on social media should not replace high-quality clinical trials or postmarket safety monitoring.
AMA President Willie Underwood III, MD, said manufacturers are producing increasingly potent botanical products in forms ranging from gummies and powders to oils and injections. He said consumers face harms that include dependence, substance use disorders, overdose and death.
“Calling something ‘natural’ doesn’t make it safe,” Dr. Underwood said.
The letter credited the FDA’s safety assessments that informed the Drug Enforcement Administration’s emergency scheduling of three kratom-related compounds in August.
The AMA said it supports research into botanical products, including well-controlled clinical studies of cannabis to identify potential medical uses and short- and long-term risks, but cautions against bypassing established drug approval pathways.
The association also warned that FDA decisions should not bend to political considerations, conflicts of interest or commercial pressure, and urged the agency to resist efforts to fast-track products based on popularity or unsupported claims.
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