FDA WARNING_LETTER - RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. - March 23, 2021

The FDA issued a Warning Letter to RAAS Nutritionals, LLC following an inspection from March 15-23, 2021, which reviewed RAAS's role as a sponsor of clinical investigations. The inspection, part of the Bioresearch Monitoring Program, identified objectionable conditions and concluded that RAAS failed to adhere to statutory requirements in the FD&C Act and 21 CFR Part 312 governing clinical investigations and human subject protection.

The primary violation was the failure to submit Investigational New Drug (IND) applications for clinical investigations involving investigational new drugs subject to 21 CFR 312.2(a), specifically for studies on (b)(4), (b)(4), and (b)(4). RAAS initiated and conducted these studies without an effective IND. RAAS argued in its April 7, 2021, response that the articles were dietary supplements, not drugs, and thus did not require an IND. They cited communications with NIH and other entities, believing that if products could be sold as supplements, they could be tested without an IND, provided they weren't advertised as drugs.

The FDA concluded that the investigational products were intended for use as drugs, as defined by Section 201(g)(1) of the FD&C Act, because they were studied for the diagnosis, cure, mitigation, treatment, or prevention of disease. The FDA refuted RAAS's claims