Blue Horizon International, LLC
FDA's Center for Biologics Evaluation and Research issued a warning letter to Blue Horizon International, LLC (Dr. Brian Mehling, CMO/Founder) in Hackensack, NJ, citing the company's marketing of unapproved umbilical cord blood-derived Stem Cell Therapy and WJ-MSC-derived Exosome Therapy for allogeneic use without a valid biologics license application (BLA) or investigational new drug (IND) application. The company's website made extensive disease-treatment claims spanning neurological, cardiovascular, musculoskeletal, metabolic, and other conditions, rendering the products unapproved new drugs and unlicensed biological products under the FD&C Act and PHS Act. Both products were also found to be misbranded under section 502(f)(1) for failing to bear adequate directions for use. FDA warned that failure to respond adequately may result in seizure and/or injunction.
Flagged claims (18)
Diabetes Remissions
Our stem cell treatments use ethically sourced cells from umbilical cord blood and adipose tissue to treat chronic conditions, injuries, and degenerative diseases.
These exosomes demonstrate strong regenerative and anti-inflammatory properties…
Spinal Cord Regeneration
Rheumatoid Arthritis Breakthrough
Reversing Atherosclerosis
Tissue regeneration[;] Immune modulation[;] Anti-inflammatory effects[; and] Pain reduction
Defying COPD
Stroke Recovery
Osteoarthritis Solutions
Cardiomyopathy Triumph
Cirrhosis Reversal
These next generation therapies enhance tissue regeneration, reduce inflammation, and support natural healing processes through the body.
Multiple Sclerosis Relief
Myocardial Rejuvenation
Functionally, exosomes are pivotal in regulating immune responses, promoting tissue repair, and facilitating cellular regeneration.
Conquering Crohn's Disease
Explore the power of stem cells in treating various medical conditions
Required actions (2)
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
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