FDA botanical drug comments close: AMA seeks trials, herbal makers defend route

The US Food and Drug Administration (FDA) closed public comments on Tuesday, 3 November 2026, on how it should help companies turn plant-based medicines into approved prescription drugs. The consultation, titled "Advancing Development of Botanical Drug Products; Request for Information", was opened in the Federal Register on Friday, 4 September 2026, under docket FDA-2026-N-9550. Two of the best-known replies pull in different directions: the American Medical Association (AMA) asked the FDA to require clinical trials before botanical products are marketed or prescribed, while the American Herbal Products Association (AHPA), an industry trade group, defended the existing pathway and asked the agency to promote it more.

A botanical drug, in the FDA's sense, is a medicine made from plants, algae or fungi that has gone through the same approval process as any other prescription drug. That is different from an herbal dietary supplement, which can be sold in the United States without proof that it treats a disease. The gap between the two is the same gap that Ayurveda, Unani, Siddha and other traditional systems face everywhere: long use and tradition on one side, and the clinical evidence regulators ask for on the other.

The FDA's own questions show where the difficulty lies. Many traditional preparations are complex mixtures of several plants, and the chemistry of a plant can change from one harvest or batch to the next. A roundtable that fed into the consultation flagged that batch-to-batch variation as a challenge that better quality frameworks could address. The agency also asked how data from botanicals with well-established use could be applied, and whether real-world evidence, meaning information gathered from ordinary medical practice rather than a controlled trial, could help development.

The AMA's position is that popularity is not proof. Its letter said growing consumer use, anecdotal claims and marketing by social media influencers should not get around the approval process, and asked for funding and supplies of products and placebos so that proper studies can be done. AHPA, for its part, said botanical drugs play a separate role alongside herbal supplements, and that few have been approved since the 2004 guidance, which it wants the FDA to explain and advertise better.

Peepals timeline: The FDA issued its botanical drug guidance in 2004, according to AHPA. Crofelemer, made from the sap of the Croton lechleri tree, was approved in late 2012 for diarrhoea in people with HIV on antiretroviral therapy, the first botanical drug taken by mouth to win approval. The current consultation opened on 4 September 2026. The FDA and the European Medicines Agency held a joint workshop on herbal and botanical medicines on 25 September 2026. The AMA wrote on 28 October, comments closed on 3 November, and AHPA published its response on 4 November.

Short-term: The FDA now has to read and weigh the comments in the docket. The consultation itself does not change any rule, and the agency has not said when, or whether, it will issue new guidance.

Long-term: If the FDA updates its guidance on complex mixtures, quality standards or the use of real-world evidence, the route from a traditional plant formula to an approved medicine could become clearer. Any such change would apply to products seeking drug approval, not to supplements already sold as supplements.

Who is affected: Makers of plant-based medicines, researchers running trials on traditional formulations, doctors who prescribe or are asked about herbal products, and patients who use them. Indian Ayush companies and researchers who look to the US market would follow any new guidance closely, because many Ayurvedic and Unani preparations are exactly the kind of multi-plant mixture the FDA asked about.

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