What happened
FDA reviewed DesBio/Deseret Biologicals’ website in July 2026 and determined that CHLA:10M was marketed as a drug for temporary relief of symptoms associated with chlamydia infection. FDA cited labeling claims concerning burning during urination, testicular tenderness or pain, vaginal discharge, and painful sexual intercourse. The agency stated that CHLA:10M was a new drug because it was not generally recognized as safe and effective for its labeled conditions of use, and no approved application was in effect for the product. FDA therefore concluded that its introduction or delivery for introduction into interstate commerce violated the FD&C Act. Although the labeling described CHLA:10M as homeopathic, FDA noted that its listed ingredient, Chlamydia trachomatis 10M, was not listed in the Homeopathic Pharmacopeia of the United States. FDA requested a written response describing corrective and preventive measures. The letter reports a website review and does not describe an inspection or identify manufacturing, laboratory, validation, contamination-control, data-integrity, facility, or other CGMP observations.
Why it matters
From a pharmaceutical manufacturing perspective, the letter’s principal issue is the marketing of a drug without an approved application, rather than documented deficiencies in production or quality systems. FDA emphasized that homeopathic labeling does not exempt a drug from applicable statutory requirements. However, because the source contains no manufacturing inspection findings or CGMP observations, it does not provide a basis for conclusions about the firm’s quality unit, laboratory controls, validation, contamination controls, facilities, utilities, or data integrity.
Key topics: CHLA:10M marketed as an unapproved new drug, Chlamydia symptom-relief claims in product labeling, Chlamydia trachomatis 10M not listed in the HPUS