In September 2021, the Office of Scientific Investigations of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) issued a Warning Letter to dietary supplement company RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. (RAAS) for failure to comply with the requirements under the Federal Food, Drug, and Cosmetic Act and applicable regulations under 21 CFR Part 312 governing the conduct of clinical investigations and the protection of human subjects.1 In particular, RAAS failed to submit an investigational new drug application (IND) before initiating clinical investigations of the safety and efficacy of its dietary supplements. The FDA had inspected RAAS in April 2021 and issued a Form FDA 483, and found RAAS's response to the FDA's inspectional observations inadequate, as RAAS failed to provide a corrective action plan.
In response to its failure to obtain an effective IND before conducting its clinical investigations, RAAS argued that it was not obligated to submit an IND because it was studying dietary supplements and not drugs, stating that it believed that if it was legally able to sell nutritional supplements to the general public, then it should be able to test and observe effects of the supplements without an IND, as long as it did not advertise drug claims in connection with a supplement sold in the market. However, the FDA disagreed and made it clear that the intent of the investigation matters, regardless of whether a product is an investigational drug or a commercially distributed dietary supplement. Further, the FDA noted that the Generally Recognized as Safe (GRAS) status of one or more dietary supplements does not exempt the supplements from the IND requirements, as GRAS status and how a company plans to market its products constitute separate determinations from whether the company conducted the clinical studies without an effective IND.
This Warning Letter serves as a reminder to manufacturers and study sponsors that the IND requirements do not apply only to investigational drugs that require regulatory approval by the FDA before they are marketed, but also apply to dietary supplements that are being studied for medical conditions and diseases. Companies that plan to conduct studies in human subjects should not rely solely on whether the product is a consumer product (like a dietary supplement), but instead should consider the intent of the clinical investigation and the totality of circumstances, including the study design and whether the investigation implicates medical conditions and disease, in determining whether an IND is required before commencing investigations in human subjects.
For questions regarding FDA regulatory requirements and compliance, please contact any member of Wilson Sonsini's FDA regulatory, healthcare, and consumer products practice.
Eva F. Yin contributed to the preparation of this Wilson Sonsini Alert.
[1] FDA, Warning Letter to RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc., September 30, 2021, available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/raas-nutritionals-llcrare-antibody-antigen-supply-inc-616560-09302021.
