FDA WARNING_LETTER - Blue Horizon International, LLC - May 01, 2026

On May 26, 2026, the FDA issued a warning letter to Blue Horizon International, LLC, following a review of the company’s website and marketing materials. The agency found that the company is marketing stem cell therapies derived from umbilical cord blood and exosome therapies derived from Wharton’s Jelly for the treatment of numerous serious conditions, including stroke, multiple sclerosis, diabetes, and cardiovascular diseases. These products are being distributed without the required FDA approval or biologics licenses, making them unapproved new drugs and unlicensed biological products under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Additionally, the FDA identified the products as misbranded because they lack adequate directions for use; the complexity of the diseases being treated prevents safe use without professional medical supervision. The products also failed to meet the criteria for simplified regulation because they are not intended to perform the same function in the patient as they did in the donor and depend on the metabolic activity of living cells. Blue Horizon International is required to respond within 15 working days with a detailed plan to correct these violations. Failure to take corrective action could result in legal consequences, such as product seizures or court-ordered injunctions.