NAVIGATING REGULATORY CHALLENGES: ENSURING SAFTEY EFFICACY OF HERBAL DRUGS IN COMPLIANCE WITH USFDA STANDARDS

Abstract

In recent years, herbal medicines have gained significant popularity in the United States. This growing interest, with potential safety risks, highlights the urgent need for standards that can adequately assess the safety and efficacy of these products. The regulatory landscape governing herbal medicines is complex, as it is surrounded with the production, distribution, and consumption of a diverse array of products. Historically, herbal drugs have played an important role in traditional medicine, yet modern challenges complicate their regulation. Unlike pharmaceutical drugs, which undergo rigorous testing and approval processes, many herbal products are marketed with less oversight, leading to concerns about quality, safety, and accurate labelling. This review aims to explore the existing regulatory framework, examining how it addresses the unique characteristics of herbal medicines. It will also dig into the historical context of herbal drug use and the challenges faced in establishing consistent regulations in the U.S. By shedding light on these issues, the review emphasizes the importance of developing comprehensive standards that ensure consumer safety while allowing for the benefits of herbal therapies.