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!
https://www.fda.gov/.../bimoteam-biologicsinternet...
Common questions
- Are exosome injections legal in the United States?
- No. In 2024 the FDA sent 5 Untitled Letters for biologics noncompliance, two of them to exosome sellers, exocelbio.com and vitacellbiologics.com. The FDA treats exosomes as drugs, so they cannot be sold or used in humans without approval. The agency also stated there is no such thing as off-label use of a product that has no FDA approval at all.
- What is an Untitled Letter, and how serious is it?
- An Untitled Letter is the FDA's early notice that a company is out of compliance, giving it a chance to correct the problem before stronger action follows. It sits a step below a Warning Letter, and it is not a formality. The 5 sent in 2024 name the exact product categories the agency considers unapproved drugs: Wharton's jelly, umbilical cord, exosomes, and amniotic membrane and fluid.
- A clinic says their amniotic fluid product is FDA registered. Is that the same as approved?
- No. Registration of a tissue establishment is not approval of a product. Amnion Florida was told in 2024 that amniotic membrane and fluid products are considered drugs and cannot be sold or used in the USA without FDA regulatory compliance or a valid exception. Registration records that a facility exists. Approval requires evidence that the product is safe and works for a stated use.
