Disclaimer: FDA Exosome Notice July 22, 2020 > Click Here
All statements provided on this website are for informational purposes only and should not be used for diagnosis or treatment of any medical problem. Currently, there are no FDA-approved exosome products. Exosomes don’t prevent, cure or treat diseases or conditions.
With offices in Englewood Cliffs and Old Bridge board-certified New Jersey dermatologist Jeffrey Rapaport treats hair and scalp disorders. In the last 4 years, he has performed non-surgical hair sessions with PRP on close to 3,000 patients, making him one of the busiest doctors in the country.
What are Exosomes?
Exosomes are micro vesicles that are involved in intercellular communication and are only about 0.001 the size of a normal cell. It is important to remember that not all exosomes are the same. There are many companies producing exosomes and the contents of these exosomes differ widely.
Exosomes need to be produced buy a FDA certified, registered laboratory. Also, the donor must to be healthy, fully screened and processed with the highest level of scrutiny and oversight in a certified clean facility that functions under the FDA regulations.
The company must be dedicated to ensuring your safety by requiring uniform high-quality processing control standards. Exosomes must be safe and free from infections or communicable diseases. All exosomes must be tracked and registered.
The FDA considers exosomes to be experimental. On December 6, 2019 the FDA issued a notice on exosome: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products