DesBio/Deseret Biologicals, Inc. - 735464 - 10/01/2026

FDA's Center for Drug Evaluation and Research sent a warning letter dated October 1, 2026 (reference 735464) to DesBio/Deseret Biologicals CEO Jake Carter, citing the product "CHLA:10M," sold on desbio.com for relief of chlamydia-related symptoms, as an unapproved new drug under sections 301(d) and 505(a) of the FD&C Act. The letter follows a website review in July 2026 and notes that FDA has not approved any OTC drug product for treating or preventing any STI. The company must send a written response to FDAAdvisory@fda.hhs.gov within 15 business days or face possible seizure or injunction.