Traditional Chinese Medicine (TCM) is an essential part of the healthcare system in China and several Asian countries, which is considered a Complementary or Alternative Medical (CAM) System in most Western countries (1). Today about 80% of the world still uses plants and plant-based products to treat medical conditions (2).
During the past 30-40 years, the healthcare and scientific communities have paid increasing attention to the role of Traditional Chinese Medicine in preventing and treating chronic diseases and metabolic syndromes. Increasing use of TCM approaches in the United States contributed to the establishment in 1998 of the National Center for Complementary and Alternative Medicine within the U.S. National Institutes of Health (NIH). This led to a dramatic expansion in the number and quality of clinical trials funded to study TCM and botanical products. Today, many leading health care centers in the U.S. like the Mayo Clinic, Cleveland Clinic, and Johns Hopkins offering TCM practices to treat chronic diseases.
What Is Traditional Chinese Medicine?
Traditional Chinese Medicine, by definition, according to the U.S. National Cancer Institute (NCI) at NIH is:
"A medical system that has been used for thousands of years to prevent, diagnose, and treat disease. It is based on the belief that qi (the body's vital energy) flows along meridians (channels) in the body and keeps a person’s spiritual, emotional, mental, and physical health in balance.
Traditional Chinese medicine aims to restore the body’s balance and harmony between the natural opposing forces of yin and yang, which can block qi and cause disease. Traditional Chinese medicine includes acupuncture, diet, herbal therapy, meditation, physical exercise, and massage. Also called Oriental medicine and TCM"(3).
Short Overview of FDA Regulations and Guidance for the Traditional Chinese Medicine (TCM) By Lin Zhang
What Are Botanical Drugs?
Botanical products are finished, labeled products that contain plant-derived ingredients. FDA describes the "botanicals" to mean products derived from "plant materials, algae, macroscopic fungi, and combinations thereof"(4). Internationally, botanical products are regulated under different classifications, some of which are:
• Dietary supplements in the U.S.
• Herbal medicines (i.e., Europe)
• Traditional herbal medicines (i.e., China)
Botanical drugs may be available in various forms, including solutions, powders, tablets, capsules, topicals, or injectables.
(However, FDA also describes fermentation products and highly purified or chemically modified botanical substances are NOT considered botanical drug products)(4). Due to these unique characteristics, FDA generally considers the entire botanical drug substance to be the active ingredient (API) of the botanical drug product.
New Botanical Drug Guidance (2016)
In 2016, FDA published a revised guidance document for industry on botanical drug development (4). This guidance describes the FDA Center for Drug Evaluation and Research’s (CDER’s) current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommend...
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