USP Quality Review

No. 65, Issued 04/99

Development of USP Monographs

In response to concerns about the quality and safety of botanicals available as dietary supplements, the delegates to the 1995 United States Pharmacopeial Convention adopted a resolution to explore the feasibility and advisability of setting standards and developing information for botanicals used as dietary supplements. The United States Pharmacopeia (USP), throughout its history, had consisted of standards for botanicals, which over time were replaced by refined substances of synthetic chemistry. Renewed interest in natural products has prompted the compendia to again include botanical product specifications. The development of standards for botanicals classified as dietary supplements, however, poses unique challenges. Inherent properties of botanicals constitute significant technical, scientific, and clinical hurdles for criteria development. Likewise, creating information monographs presents a challenge. There is a wide variance of clinical and scientific literature about botanicals. Medical professionals have differing opinions on the utility and objectivity of these data.