California Firm Draws Warning Letter for Conducting Trials Without Submitting an IND

California-based RAAS Nutritionals was slapped with a Warning Letter by the FDA for conducting trials on human subjects without first submitting an investigational new drug (IND) application.

RAAS, which stands for Rare Antibody Antigen Supply, sells several dietary supplements that the agency considers drugs because RAAS studied the efficacy and safety of the investigational products to cure, mitigate and/or treat disease.  Upon inspecting the company’s Thousand Oaks, Calif., facility in March, the agency saw evidence of human trials of three of RAAS’ products.

RAAS argued that it was not obligated to submit an IND before initiating the clinical investigations because the products under study are not drugs, but the FDA disagreed.