Chapter 30 – Nonclinical Safety Assessment of Botanical Products

Botanical medicine is defined as the use of herbs for their therapeutic or medicinal value. Plants have a long history of use in medicine and have been used by all cultures or ethnic groups throughout history to improve human health. It is considered to be the oldest form of medicine known to mankind. According to the FDA guideline on botanical drug products, herbal products are classified as a drug if they are intended for diagnostic, mitigation, therapeutic, or prophylactic use. If the intended use of a botanical product is to affect the structure or function of the human body, it may be regulated either as dietary supplement or as a drug, depending on the circumstances. The Dietary Supplement Health and Education Act (DSHEA) of 1994 extended the definition of dietary supplements beyond vitamins and minerals and established a formal definition of a dietary supplement using new criteria. In the United States, herbal products are regulated both at the state and federal levels, with distinct pathways dependent upon intended utility. This chapter focuses on the safety assessments of botanical products.