FDA warned DesBio over a homeopathic 'chlamydia symptom relief' kit sold online

In a warning letter dated October 1, 2026 (reference 735464), FDA told DesBio/Deseret Biologicals CEO Jake Carter that 'CHLA:10M', sold on the company's website, is an unapproved new drug. The product label reads 'Chlamydia 10M' and 'Chlamydia trachomatis 10M . . . Burning Sensation During Urination, Testicular Tenderness or Pain, Vaginal Discharge, Painful Sexual Intercourse', and the product page markets it as 'chlamydia, series symptom relief'.

FDA's letter frames the stakes: it has approved no over-the-counter drug for the treatment, cure, mitigation or prevention of any sexually transmitted infection, and people who rely on such products 'may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death'. A false sense of having been treated may also lead people to unknowingly transmit infections to partners. Effective treatment, the agency writes, requires diagnosis and supervision by a licensed healthcare professional.

The homeopathic framing did not help. The product's active ingredient, Chlamydia trachomatis 10M, is not listed in the Homeopathic Pharmacopeia of the United States, putting it outside the scope of FDA's December 2022 homeopathic enforcement guidance — and even if it qualified, the agency says it would fall into the guidance's priority category of homeopathic products marketed without required approval that potentially pose higher risks to public health.

The product is an unapproved new drug; FDA threatens seizure and injunction without further notice and prioritizes it under its 2022 homeopathic enforcement guidance.

The pathogen itself is the active ingredient at '10M' dilution — and it isn't in the Homeopathic Pharmacopeia.

STI self-treatment has a second victim: partners infected by someone who feels already treated.

FDA has approved no OTC drug for treating or curing any STI; diagnosis and supervision require a professional.

The December 2022 guidance makes unapproved homeopathic products with disease claims an enforcement priority.

Homeopathic labels don't exempt a product: claim it treats a disease and it becomes an unapproved drug with the full risk profile of forgone treatment.

The letter orders prompt correction of the violations and warns that failure to adequately address them 'may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.'