Herbal and Nutraceutical Clinical Trials

Unlike drugs that require premarket approval by the FDA prior to marketing, dietary supplements intended for the purposes of affecting the structure and function of the human body are not subject to approval under the Dietary Health Supplement and Health Education Act of 1994 (DSHEA). However, the manufacturers of dietary supplements must ensure that their products are manufactured in accordance with Good Manufacturing Practice (GMP) guidelines, are labeled accurately, and are safe and free of contaminants. The European Union (EU) regulations for supplements also supports health benefits and not therapeutic or medicinal claims. However, if the dietary supplement is intended to be used as a drug to diagnose, cure, mitigate, prevent, or treat a disease an IND is required to conduct clinical investigations in humans.

Despite not being under the purview of the FDA, clinical trials for herbal supplements and nutraceuticals would help substantiate claims of health benefits, facilitate product differentiation in the market and allow for their use as medicinal products with proven efficacy. Furthermore, clinical studies would help support manufacturers who perform them a significant advantage over the ever-increasing competition. Safety and toxicity concerns are often associated with dietary supplements due to their complex nature and thus clinical trials are necessary to ensure safety to consumers. Clinical trials are the ‘gold standard’ in clinical research and provide information on the safety and efficacy of a product in humans.