Many clinical studies of academic investigators evaluate the effect of foods or dietary supplements on the disease or physiological parameters. Some of these studies may require an IND submission. If the foods or dietary supplements are investigated for diagnosis, cure, mitigation, treatment, or prevention of disease and are used to affect the structure or function of the body, then the food or dietary supplement will be considered a drug for the purposes of this study. The study will be the subject to the same regulations as any other unapproved drug.
Penn State’s IRB relies on written communication from the FDA with regard to the use of foods and dietary supplements to determine the need for an IND. According to IRB policy, Penn State investigators are required to contact the FDA to obtain written communication from the FDA documenting the IND number or stating that an IND is not required for any human research study evaluating a food or dietary supplement, with limited exceptions. Exceptions to this policy generally include the following; 1) taste and food quality evaluations and consumer acceptance studies which qualify as exempt from IRB review or 2) studies in which the use of a food or dietary supplement would qualify as exempt from IRB review if not combined with other procedures that do not qualify as exempt from IRB review (i.e. must be reviewed at expedited or committee level). This written communication from the FDA must be provided to the IRB with the CATS IRB submission. For more on IRB policy, see the IRB Investigator Manual.