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Dear Friends of AHP,
On August 27, 2026, Republican Congresswoman Lauren Boebert (Colorado) introduced into the House of Representatives HR 10150 Advancing Botanical Drug Development Act of 2026. The stated objective of the legislation is to advance the development of botanical drugs due to the expressed claim that botanicals inherently work through multiple pathways in contrast to “most currently approved therapies [that] are designed to target a single molecular pathway.” The legislation proposes that a 12-year exclusivity period be granted to approved marketers of approved botanical drugs. It does not give any indication of the impact of botanicals marketed as dietary supplements, nor does it provide any structure for how this is to manifest.
One month after the introduction of the legislation, on September 23, 2026, the US Food and Drug Administration (FDA) issued a Federal Register notification asking for public input into the development of botanical drug products. As many stakeholders are aware, the botanical drug guidance was initially proposed by FDA in 2000, a guidance document was published in 2004, and the guidance document has been updated since then. In the 25 years since the guidance document was provided, only four botanical drugs have been approved (see below).
The stated purpose of the guidance document is to “encourage the clinical study and submission for marketing approval of botanical drug products...The guidance also provides scientific and regulatory guidance to sponsors about conducting initial and expanded clinical investigations of botanical drugs, including those botanical products currently lawfully marketed as foods and dietary supplements in the United States.”
Botanical Drugs Approved in the United States (2000-2026)
Drug: Veregen; Botanical Origin: Green tea leaves (Camellia sinensis); Characterization: Ointment made from sinacatechins; Indication: Topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older
Drug: Fulyzaq/Mytesi (crofelemer); Botanical Origin: Dragon’s blood (Croton lechleri); Characterization: Oral: Oligomeric proanthocyanidin mixture made up of catechin and epicatechin monomers; Indication: Non-viral, non-bacterial diarrhea in HIV+/AIDS patients specifically using antiviral medications
Drug: NexoBrid; Botanical Origin: Pineapple stems (bromelain); Characterization: Gel containing proteolytic enzymes; Indication: Used to non-surgically remove dead or charred skin tissue (eschar) from severe thermal burns
Drug: Filsuvez; Botanical Origin: Birch bark (Betula spp.); Characterization: Gel containing triterpenes (betulin); Indication: Wounds secondary to dystrophic and junctional Epidermolysis bullosa
Each of the approved botanical drugs, while derived from botanical ingredients, would not be defined as botanical drugs internationally. Internationally, botanical drugs are generally defined as Galenic preparations, representing relatively crude products; powders, teas, simple extracts (tinctures and syrups); and traditional, topical preparations. Highly concentrated, semi-pure or pure compounds, and synthetic ingredients are not included in the definition of traditional herbal drugs, worldwide. The US-approved botanical drugs are more similar to conventional pharmaceuticals than they are to traditional medicines. Throughout most of the world, botanical drugs can be approved by competent medical authorities for as little as <$100 (Ghana), $10,000 (EU), and $100,000 (UK), compared to $100-$200 million in the US. By current figures, bringing a conventional drug to the US market costs more than $500 million.
The FDA notification reports that ‘experts’ were brought together for a roundtable discussion hosted by the Reagan-Uddall Foundation (RFI) for the FDA to discuss the issue; the experts were not disclosed. A summary of the meeting can be accessed here: https://reaganudall.org/projects/botanical-drug-development-roundtable
Federal Register Excerpts
The Federal Register defines botanical drugs as: “Botanical drug products are products that include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials and are intended to diagnose, cure, mitigate, treat or prevent disease.”
“Botanical drug products represent a critical area where greater scientific development can unlock new therapeutic opportunities for American patients while maintaining the highest safety standards...Given that many people use botanicals for self-treatment, botanical drug products represent an area where greater scientific development could create new opportunities for patients…We want to hear directly from researchers, clinicians, industry and other stakeholders about the barriers they face and practical approaches that could help bring safe and effective botanical drugs to patients.”
“Through the RFI, the FDA is seeking feedback on topics including challenges encountered in botanical research and drug development; innovative approaches to support and accelerate development; potential updates to FDA guidance and other resources; quality standards; appropriate study designs for complex botanical mixtures; and the potential use of real-world evidence and other scientifically credible information to facilitate development.”
The formal public commenting period to the Federal Register notification closes November 3, 2026. The Federal Register notification can be accessed here: https://www.govinfo.gov/content/pkg/FR-2026-09-04/html/2026-18133.htm
The FDA notification of this initiative can be accessed here: https://www.fda.gov/drugs/resources-drugs/botanical-drug-products
HR 10150 can be accessed here: https://www.congress.gov/119/bills/hr10150/BILLS-119hr10150ih.pdf
We strongly encourage all stakeholders to review the content of both the Federal Register and proposed legislation, specifically through the lens of how this may impact access to dietary supplements, whether it is in the best interest of public health, or if this is an attempt for sectors of the industry to gain a market advantage purely for commercial motivations that may intentionally or unintentionally impede consumer access to herbal supplements.
For more information about AHP, or if you are interested in becoming an AHP member, please visit herbal-ahp.org. Be sure to follow us on LinkedIn at https://www.linkedin.com/company/herbal-ahp.
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