Deseret Biologicals Inc – FDA Warning Letter, Jul 1, 2026

The FDA issued a warning letter to DesBio/Deseret Biologicals, Inc. following a website review in July 2026, which revealed the sale of an unapproved drug product. The letter focuses on "CHLA:10M," marketed for the relief of symptoms associated with Chlamydia, such as vaginal discharge and painful urination. The FDA determined this product is an unapproved new drug under the Federal Food, Drug, and Cosmetic Act because it lacks the required clinical approval and is not recognized as safe and effective for treating sexually transmitted infections (STIs). The agency highlighted that marketing over-the-counter STI treatments poses a serious public health risk, as consumers may forgo necessary medical diagnosis and treatment, leading to severe outcomes like infertility or the spread of infection. While the product is labeled as "homeopathic," it contains an ingredient not listed in the official Homeopathic Pharmacopeia of the United States and does not meet the criteria for legal distribution without an approved drug application. DesBio must investigate these violations and implement corrective actions to prevent recurrence. The company was given 15 business days to provide a written response detailing their remediation steps and documentation. Failure to address these concerns may result in legal action, including product seizures or injunctions.