Chara Biologics, Inc.
FDA issued a warning letter to Chara Biologics, Inc. (CEO Joy Kong, M.D.) following a July–August 2024 facility inspection, finding that its three products—CharaExo (amniotic fluid), CharaCore, and CharaOmni (umbilical cord-derived)—are unapproved new drugs and unlicensed biological products marketed for a wide range of serious diseases including Parkinson's, ALS, autism, and diabetes without an approved BLA or active IND. The products were also found to violate CGMP and CGTP requirements, and CharaExo was misbranded due to unsupported expiration date extensions. FDA warned that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (10)
How Can CharaCore help my patients? REGULATE INFLAMMATION, SCARRING & PAIN Birth tissue products have been shown to reduce inflammation, fibrous tissue growth, and potential scar tissue formation.
…Alzheimer's…Asthma…Autism…Chronic Pain…COPD…Crohn's Disease…Degenerative Disc Disease…Heart Disease…Kidney Failure…Liver Cirrhosis…Lupus…Macular Degeneration…Migraines & Tension Headache…Multiple Sclerosis…Nerve Injury…Osteoarthritis… Osteoporosis…Parkinson's…
stem cells have been shown to have clinical benefits in a long list of conditions including various autoimmune disorders, "neurodegenerative conditions (Parkinson's, Alzheimers, Multiple Sclerosis, ALS, etc.)", diabetes, cardiovascular and lung diseases, autism, spinal cord injuries, and cirrhosis.
Chara offers the most comprehensive stem cell product CharaCore and high potency growth factor/extracellular vesicle product CharaExo.
CharaExo also contains larger extracellular vesicles, as well as concentrated growth factors from amniotic fluid… Extracellular vesicles contain proteins, microRNAs and lipids, and all eukaryotic cells secrete and take up these nanoparticles, and they are a means of communication between cells. These nanoparticles have been increasingly recognized as playing an important role as the mediator of many of the MSC-associated therapeutic benefits. They can be quite useful therapeutically, as they may elicit a more immediate therapeutic response, although the benefits tend to be shorter-lasting than that of cell therapy.
CharaCore® is highly rich in MSC's…MSC's: have anti-microbial properties, helpful in fighting acute, chronic or systemic infections… shown to be effective against protozoa (as in Lyme disease)
[W]hat set[s] CharaOmni apart from all other skincare products on the market: 1) Regenerative Stem Cell Components… Wharton's Jelly Extract… reduces scar formation, and enhances wound healing…. Amniotic Extracellular Matrix - possesses powerful anti-inflammatory...properties.
How Can CharaCore help my patients? ANTI-MICROBIAL Application of birth tissue products has been shown to reduce bacteria counts in the wound…
stem cell treatment can benefit its audience by reducing inflammation, improving immune function, and enhancing tissue repair.
The stem cell regenerative elements in CharaOmni… have been known to provide crucial and powerful growth factors, extracellular matrix, as well as other cell signaling molecules that highly beneficial in skin repair and regeneration.
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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