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Abstract
The passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) provided formal recognition of botanical products as dietary supplements, opening a pathway for their entry into the growing dietary supplement and pharmaceutical markets. In 2004, the U.S. Food and Drug Administration (FDA) issued the Botanical Drug Development Guidance for Industry, outlining how botanical products could seek approval as prescription drugs if proven to treat, prevent, diagnose, or mitigate disease through rigorous clinical investigation. This guidance was revised in 2016 to encourage further investment in botanical drug research and development. Despite these regulatory efforts, very few botanical products have been approved as prescription drugs by the FDA. The lack of standardized quality parameters, challenges in ensuring consistent safety and efficacy, and insufficient scientific data have hindered their development. This is especially concerning given that 35% of prescription drugs worldwide are derived from plants (Calixto, 2019; Miller, 2001), including morphine, aspirin, digoxin, vincristine, and many chemotherapy drugs. Yet, few botanicals have undergone rigorous clinical trials to establish their therapeutic effectiveness for prescription drug approval. This study explores the quality challenges affecting the development of botanicals into prescription medicines. The findings may provide insights to help researchers and manufacturers improve botanical drug development, encourage greater industry investment, and assist regulators in refining policies that currently hinder clinical investigations and approval processes.