May 26, 2026 FDA Warning Letter: Blue Horizon International, LLC Cited for Unapproved New Drugs/Unlicensed Biological Product Violations

FDA Warning Letter — Violations FDA cited at Blue Horizon International, LLC

WARNING LETTER Blue Horizon International, LLC MARCS-CMS 728085 — May 26, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via UPS and EMAIL Reference #: CBER 26-728085 Product: Biologics Recipient: Recipient Name Dr. Brian Mehling Recipient Title Chief Medical Officer and Founder Blue Horizon International, LLC 214 State Street Suite 101 Hackensack , NJ 07601 United States bmehling@bluehorizoninternational.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States WARNING LETTER May 26, 2026 CBER 26-728085 Dear Dr. Mehling: The United States Food and Drug Administration (FDA) reviewed your company’s website at https://bluehorizonstemcells.com (last visited May 2026), through which your company markets “Stem Cell Therapy” derived from umbilical cord blood and “Exosome Therapy” 1 derived from Wharton’s Jelly Mesenchymal Stem Cells (“WJ-MSC[s]”) for allogeneic use (hereafter, “your products”). This letter is to advise you that your misbranding of your products while held for sale after shipment in interstate commerce violates section 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(k). Unapproved New Drug and Unlicensed Biological Product Violations Based on information and records reviewed by FDA, including your website, https://bluehorizonstemcells.com, (last visited May 2026), your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body. For example, After identifying your products, and under the heading “What Can We Treat,” your homepage lists various diseases and conditions, including: o Digestive System Diseases, including Hepatic steatosis and Chronic pancreatitis o Respiratory Diseases, including Allergic rhinitis, Rhinitis, and Sinusitis o Rheumatic Diseases, including Lupus o Endocrine Diseases, including Hashimoto’s thyroiditis and Hypothyroidism o Musculoskeletal Diseases, including Myositis, and Sports-related injury complications o Cardiovascular Diseases, including Coronary artery disease Your home page states, “Our stem cell treatments use ethically sourced cells from umbilical cord blood and adipose tissue to treat chronic conditions, injuries, and degenerative diseases.” This statement is followed by a link to your stem cell treatment webpage and a list of uses for stem cells: “Tissue regeneration[;] Immune modulation[;] Anti-inflammatory effects[; and] Pain reduction”. Under the heading “Revolutionary Stem Cell Therapy,” your stem cell treatment webpage states, “Explore the power of stem cells in treating various medical conditions[,]” followed by, among other conditions and diseases: o Neurological Marvels  …Spinal Cord Regeneration  Stroke Recovery  Multiple Sclerosis Relief o Cardiovascular Miracles  …Myocardial Rejuvenation  …Cardiomyopathy Triumph  Reversing Atherosclerosis o Musculoskeletal Wonders  …Osteoarthritis Solutions  Rheumatoid Arthritis Breakthrough o Lung Restoration  … Defying COPD o Liver Regeneration  Reviving Liver Function  Cirrhosis Reversal o Bowel Revolution  Conquering Crohn’s Disease o Metabolic Transformation  Diabetes Remissions Under the heading “Our Results” on your exosome webpage, “These exosomes demonstrate strong regenerative and anti-inflammatory properties…” Under the heading “Our Exosomes” on your homepage: “These next generation therapies enhance tissue regeneration, reduce inflammation, and support natural healing processes through the body.” Under the heading “What Are Exosomes” on your exosome webpage, “Functionally, exosomes are pivotal in regulating immune responses, promoting tissue repair, and facilitating cellular regeneration.” Therefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 2