Clinical studies involving probiotics: When FDA’s investigational new drug rubric applies—and when it may not

Researchers from a diverse array of scientific disciplines have focused and continue to focus on opportunities and areas for responsible clinical research involving the possible beneficial health effects of “probiotics.” Investigators and researchers should be aware that not all clinical research involving probiotics reasonably falls within the requirements of the “investigational new drug” (IND) rubric administered and enforced by the US Food and Drug Administration. In determining whether an IND application is required before a clinical study may lawfully commence, investigators and researchers as well as institutional review boards should consider the regulatory classification, e.g., “drug,” “new drug,” “food,” “food additive,” “dietary supplement,” etc. that applies to the substance under investigation. A potential probiotic product can fall along a continuum of regulatory classifications, each having implications on the nature and degree of regulatory requirements for clinical research and, ultimately, for claim substantiation and market access.