title: Regulation of research: is it a drug trial or a supplement trial?
abstract: Investigators and sponsors of dietary supplement research need to know the relevant regulatory requirements and how to comply with them. This brief review describes how research on dietary supplements is regulated by FDA. In general, whether an FDA sanctioned Investigational New Drug (IND) application is required for a human research project on dietary supplement depends on the intended use and clinical setting of the clinical study, and not on the supplement's physical or chemical properties. Even if the study product is already available on the market as a dietary supplement, an IND will be required for products that will be used as a drug to treat, mitigate or prevent a disease or its related conditions in the proposed clinical study. On the other hand, for studies on structure and function endpoints, and not on drug use, no IND will be required. The paper also discusses the principles FDA uses to determine whether an IND is needed for clinical studies of surrogate endpoints that do not lead to approvable drug claims. Useful FDA contact information is also provided.
authors.affiliation: Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD 20993-0002, USA. shaw.chen@fda.hhs.gov
authors.forename: Shaw T
authors.initials: ST
authors.lastname: Chen
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D019587:Dietary Supplements; D004335:Drug and Narcotic Control; D033161:Government Regulation; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*