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# AMA Urges FDA to Uphold ‘Rigorous Standards’ for Botanicals
- URL: https://www.fdaweb.com/ama-urges-fda-to-uphold-rigorous-standards-for-botanicals/
- Published: 2026-10-30T17:52:08.000Z
- Updated: 2026-10-30T17:52:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General

The American Medical Association (AMA) is urging FDA to “uphold rigorous, evidence-based standards for evaluating botanical drug products,” warning that products marketed with unproven health claims can pose serious risks when their safety and efficacy have not been established. 

In [comments](https://searchlf.ama-assn.org/letter/documentDownload?uri=/unstructured/binary/letter/LETTERS/lff.zip/2026-10-28-Letter-to-Graham-re-FDA-RFI-Botanicals.pdf&ref=fdaweb.com) to FDA, 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,” the group says.

The AMA commended the agency’s safety assessments that formed the basis behind a Drug Enforcement Administration emergency scheduling of three kratom-related compounds in August.

The letter also urged 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. It stressed that agency decisions should not be swayed by political considerations, conflicts of interest or commercial pressure that could put patients and the public at risk.