Dietary Supplement and Nutraceutical Research Studies If you are a practitioner interested in conducting a study on dietary supplements and nutraceutical, Solutions IRB can assist. Below are the following guidelines to assist researchers in determining if FDA guidelines apply. The Dietary Supplement Health and Education Act (DSHEA) An IND is not required for a marketed drug product if the criteria in the paragraph below are met. For more information: Guidance Information Sheet Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the products use and effects.  Use of a marketed product in this manner when the intent is the “practice of medicine” does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).   However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight. The investigational use of approved, marketed products differs from the situation described above. “Investigational use” suggests the use of an approved product in the context of a clinical study protocol [see 21 CFR 312.3(b)]. When the principal intent of the investigational use of a test article is to develop information about the product’s safety or efficacy, submission of an IND or IDE may be required. However, according to 21 CFR 312.2(b)(1), the clinical investigation of a marketed drug or biologic does not require submission of an IND if all six of the following conditions are met: (i) it is not intended to be reported to FDA in support of a new indication for use or to support any other significant change in the labeling for the drug; (ii) it is not intended to support a significant change in the advertising for the product; (iii) it does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product; (iv) it is conducted in compliance with the requirements for IRB review and informed consent [21 CFR parts 56 and 50, respectively]; (v) it is conducted in compliance with the requirements concerning the promotion and sale of drugs [21 CFR 312.7]; and (vi) it does not intend to invoke 21 CFR 50.24.   The IND forms can be found at: IND Approval Process   Code of Federal Regulations can be found at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.   An investigator should make the determination whether he/she needs an IND to conduct a study.  If the investigator needs something in writing, perhaps for the IRB, this would need to come from the FDA new drug review division responsible for the study. Feel free to contact Solutions IRB, a private IRB services company, if we can assist in any fashion.   Keywords: Dietary Supplement Health Education Act, Dietary Supplement Research, Nutraceuticals, IRB Services, Private IRB, Commercial Institutional Review Board, Independent IRB, Independent Institutional Review Board, Alternative Medicine IRB, Alternative Medicine Research, Dietary Supplement IRB, Holistic IRB, Holistic Research IRB, Homeopathic Medicine IRB, Homeopathic Research IRB