FDA wants to Advance the Development of Herbal Medicinal Products

The U.S. Food and Drug Administration (FDA) is seeking public input on ways to advance the development of botanical drug products (BDPs).

In a notice titled “Advancing Development of Botanical Drug Products; Request for Information,” published in the Federal Register on 04 September 2026, the agency opened a public docket to gather information on the current state of botanical drug development in the United States, the challenges encountered and possible solutions.

The notice states: "There is broad public interest in botanical products among consumers, researchers, clinicians, industry, the U.S. Federal Government, and international regulators. Consumers report widespread use of botanical products for self-treatment of a variety of conditions. In light of this, FDA seeks to facilitate additional research on botanicals, with the goal of accelerating drug product development and review of clinical treatments in this space."

The FDA defines botanical drug products as products that include or may be derived from plant materials, algae, macroscopic fungi or combinations of these materials, and are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. They may take various forms, including teas, powders, tablets, capsules, tinctures, topical products and injections.

The FDA is seeking comments in three main areas:

• Research and BDP development experience: Challenges encountered in development programmes, use of existing FDA resources, and systems or practices that support the collection of information required under U.S. law.
• General challenges: Scientific and economic barriers, including differences between developing whole-plant or minimally purified products and highly purified products or isolated constituents.
• General opportunities: Innovative approaches to support development, potential updates to FDA guidance and other resources, quality standards, suitable study designs for complex botanical mixtures, and the use of products with well-established use, generally accepted scientific knowledge or real-world evidence.

Comments may be submitted until 03 November 2026.

Further information is also available in the FDA press release dated 03 September 2026