08/27/2025
Is your doctor or clinic selling or injecting products derived from placenta tissue, Wharton's Jelly, amniotic fluid, or umbilical cord blood?
If yes, then you're being scammed.
NONE of these products are FDA cleared or approved for clinical use! In fact, the FDA has again dropped the hammer on another manufacturer of perinatal products, Platinum Biologics, based in Orlando. Here's the link to the FDA's warning letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/platinum-biologics-llc-705090-08152025
From the letter:
"The United States Food and Drug Administration (FDA) reviewed your company’s website at www.platinumbiologics.com/ (last visited August 2025), through which your company sells two umbilical cord derived products, Nano PRP Jelly and Nano Flex, and two exosome products, NanoEx and Nano Xsomes, for allogeneic use (collectively, “your products”). This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products . . ."
I don't know how many times I, the FDA, and other leaders in the regenerative medicine and orthobiologics field have to emphasize that, with a very rare exception for use in certain wound healing and cosmetic applications, NO product derived from perinatal sources (cord blood, Wharton's Jelly, placenta, amnion, etc.) is FDA cleared for clinical use in orthopedic, musculoskeletal, or neurologic applications. Period.
It doesn't matter what the doctor or clinic tells you. Don't be scammed and don't waste your money on illegal treatments!
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)