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Amniotic Essence and Exosome Lore: FDA's Position We Explore

  • Writer: Kaleidoscope Marketing
    Kaleidoscope Marketing
  • Mar 13
  • 1 min read


In recent years, the FDA has increased scrutiny on products derived from exosomes and amniotic fluid due to concerns about misleading claims and improper regulatory classification.


Exosomes


  • Exosome products have been marketed for regenerative medicine, including uses in anti-aging, immune modulation, and tissue repair.

  • The FDA considers exosomes as more than minimally manipulated because they are isolated and processed extensively.

  • In December 2019, the FDA issued a public safety notification, warning that exosome products lack FDA approval and may pose safety risks.

  • The FDA has also sent warning letters to clinics and companies marketing exosome therapies without an IND or BLA.


Amniotic Fluid


  • Amniotic fluid-based products have been marketed for joint pain, wound healing, and inflammation reduction.

  • The FDA considers amniotic fluid as more than minimally manipulated.

  • Companies making therapeutic claims (e.g., promoting amniotic fluid for osteoarthritis) have received warning letters from the FDA.


Final Thoughts

Navigating the FDA’s regulations on tissue products and biologics requires careful planning and precise marketing language. Companies should be mindful of processing techniques, claims, and training materials to remain within the HCT/P framework and avoid 510(k) or BLA pathways.

 
 
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