SPOILER ALERT: None of these products are regulatory compliant in the USA for sales or general use in humans!!!
*2024 FDA Untitled Letters and what it means for Orthobiologics*
In 2024, there have been 5 Untitled Letters sent out for regulatory noncompliance with biologics. Untitled letters typically give the company or person a chance to correct the variance before any further FDA regulatory action and clearly show the current FDA regulatory stances on various orthobiologics.
#1 www.achievevitality.net (Wharton's Jelly/human umbilical cord based products) This company was asked to correct or remove their marketing and sales since human umbilical cord based products need FDA drug approval....according to the FDA!
#2 www.exocelbio.com (Exosome products for hair, aesthetics and orthopedic applications) Exosomes are considered drugs and therefore cannot be sold or used in humans without FDA approval. The FDA also clearly states there is no such thing as an off-label use of a product that has no FDA approvals....refuting claims made on the Exovex youtube channel by Dr. Shanthala. Virtually any company still selling and using exosomes is non compliant with FDA regulations....DYOR
#3 https://amnion.us Amnion Florida (amniotic membrane and fluid)
This company was also informed that amniotic membrane and fluid products are indeed considered drugs by the FDA so they cannot be sold in the US and used in the USA without FDA regulatory compliance or a valid exception
#4 https://lnkd.in/gkzycAqz (Wharton's Jelly/umbilical cord)
This company was asked to correct or remove their marketing and sales since human umbilical cord based products need FDA drug approval....according to the FDA! They were also marketing these products as stem cell treatments....incorrectly in my opinion.
#5 www.vitacellbiologics.com (exosomes, umbilical cord)
Same story, same regulatory non-compliance......same FDA notification that exosomes and umbilical cord products can not be sold or marketed or advertised for use in humans in the USA in the manner that virtually all are currently.
DYOR.... I am not an attorney nor is this legal advice.
Given the straightforward FDA explanations and requirements, there is simply no way I would risk my medical license, medical practice, malpractice insurance, or assume the personal liability for using exosomes, wharton's jelly, amniotic fluid, placental tissues, or any other allograft topical or injectable product without FDA approval!
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