Regulatory Updates | Botanical Drug Products

There is broad public interest in botanical products among consumers, researchers, clinicians, industry, federal partners, and international regulators.

In response, FDA has taken action to advance the development of botanical drug products. Recent and upcoming activities include publishing a Request for Information to better understand stakeholders’ perspectives on the state of botanical drug product development in the United States, holding a public workshop with the European Medicines Agency (EMA) on regulatory perspectives on herbal medicinal/botanical drug product development, and convening a roundtable with the Reagan-Udall Foundation for the FDA to identify current challenges with and opportunities for botanical drug product development.

Request for Information

Submit a public comment on the Federal Register notice.

Joint FDA/EMA Workshop

Register for the joint FDA/EMA workshop on September 25, 2026.

Botanical Drug Development RoundtableExternal Link Disclaimer

Learn about the recent roundtable on botanical drug development.

Guidance for Industry

Read FDA’s guidance on botanical drug development. 

Background

Botanical drug products are complex 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. While there is broad interest in botanical products, their inherent complexity and variability can present unique challenges for research, product development and regulatory review.

FDA has longstanding experience with botanical drug development and issued guidance in 2016 addressing characterization, quality control, clinical investigation, and regulatory considerations for these products.

To date, four botanical products have been approved for marketing as prescription drugs under the new drug application (NDA) and biologics license application (BLA) pathways. The three NDAs include drug products containing the active ingredients sinecatechins, crofelemer, and birch triterpenes, respectively. The BLA contains the active ingredient anacaulase-bcdb. Additionally, botanical active ingredients such as psyllium and witch hazel can be marketed under certain over-the-counter monographs.

More information is available at FDA’s “What is a Botanical Drug?” webpage.

Source: U.S. Food and Drug Administration (FDA)

This article was prepared by Botanicure based on publicly available official information. Please refer to the official websites of the FDA, EMA, and other relevant authorities for the latest and definitive information.

Information reviewed on: September 18, 2026