RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc.
FDA issued a warning letter to RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. (CEO Kieu Hoang) following a March 2021 inspection under the Bioresearch Monitoring Program. The agency found that RAAS conducted multiple clinical investigations of investigational drug products — including a COVID-19 study — without submitting required Investigational New Drug (IND) applications, in violation of 21 CFR 312. RAAS argued its products were dietary supplements not subject to IND requirements, but FDA determined the products were being studied as drugs because the investigations were designed to evaluate their ability to cure, mitigate, and treat disease. RAAS was directed to respond within 15 business days with a corrective action plan, with failure to comply potentially triggering further regulatory action.
Flagged claims (4)
our hopes were that the botanicals could have drug-like impact on the participant's health (i.e., curing or preventing disease)[.]
RAAS stated that it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements to the general public, it should be able to test and observe the effects of those supplements without an IND.
RAAS stated that its products are Generally Recognized as Safe (GRAS) and are not new drugs, and that it had completed all legal steps to sell these products as dietary supplements.
RAAS argued that it conducted a "medical observation in order to ascertain the extent of the beneficial properties of the supplements in order to apply for health claims or for qualified health claims."
Required actions (2)
Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future.
Failure to adequately address this matter may lead to regulatory action.
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