FDA Reconsiders IND Requirement for Food Research

October 30, 2015. FDA issued a stay on some provisions of their guidance pertaining to the need for an IND for human research on foods. ISAPP, along with other stakeholders involved in food research, filed comments objecting to guidance position that most human research needed to be conducted under an IND. The section of the guidance dealing with “Live Organisms” remains in effect and the impact of this on probiotic research remains to be seen. See legal perspectives on this action.