Three recent FDA warning letters, including one issued to publicly-traded Celularity, paint a helpful picture of where FDA oversight stands. They illustrate how the FDA’s classification of placental/amniotic products greatly depends on how a firm positions a product clinically. The marketing is key. Comparing these warnings three letters offers a useful window into current and near-future FDA oversight of perinatal products.
In today’s post, I’ll also discuss how these warnings and other FDA actions resonate with recent developments such as Florida’s new stem cell law and public statements by HHS Secretary RFK Jr.
Celularity background
I’ve followed Celularity for many years, particularly its investigational placental-derived NK cell programs for oncology, which remain distinct from the product addressed in the warning letter. For me as a stem cell and cancer biologist as well as a cancer survivor, the NK work is of greatest interest.
Still, the company also markets other placental-derived products, and its leader Robert Hariri has been outspoken about FDA oversight of regenerative medicine. I’ve found these other factors to be of interest too.
Against that backdrop, the FDA’s recent warning letter to Celularity regarding a placental tissue product stood out to me.
Comparing the three recent warnings
The agency also recently released two other warning letters on placental/amniotic products. One of those other letters went to Mekonnen Abebe of Lux Therapeutics (dba Ponya). The other went to Bruce R. Werber of BioXTek.
Lux
Let’s start with the letter to Lux. It got a typical 361-type warning about validation and records related to its “dehydrated, dual layer amniotic membrane patch, TheraMend.” Interestingly, the letter does not mention products being unapproved drugs here.
BioXTek
Moving on, in regard to BioXTek, the warning letter was more complex.
Unlike Lux, FDA advised BioXTek that its amniotic membrane-derived products, Sanoplast ECM and Sanoplast Duo, constitute “unapproved new drugs” and unlicensed biological products, reflecting FDA’s view that these products are being marketed for therapeutic effects beyond permissible 361 uses.
Celularity
Finally, the warning to Celularity relates to its placental ECM product Interfyl. As with BioXTek, this warning advised that Interfyl is an “unapproved new drug” and unlicensed biologic. Importantly, the FDA is not evaluating Celularity’s NK-cell oncology pipeline here. The focus of the warning is solely on a commercial placental ECM product. The NK pipeline is distinct and has multiple INDs from the FDA.
Why the differences in these three warnings letters and drug classifications? Marketing seems central.
The two warning letters mentioning unapproved new drugs specifically highlight certain marketing like for tendon issues. These kinds of uses appear to go beyond anything that placenta or amnion do normally, which per the FDA triggers a 351 or drug classification.
Human amniotic membrane can be used as a 361 product (non-drug) in limited ways such as a a replacement membrane or covering. Some firms have marketed such HCT/P’s without apparent issues from the FDA.
A word on terminology
Although CBER is FDA’s biologics center, not everything it regulates is a drug or a biological product.
Some products are regulated simply as HCT/Ps under 21 CFR Part 1271, without being classified as drugs or biologics. Others—particularly 351 HCT/Ps—may simultaneously be HCT/Ps, drugs under the FD&C Act, and biological products under the PHS Act.
Note that HCT/P is just a generic acronym for human cell and/or tissue products. Generally, we need to know more than that something is an HCT/P to understand how it will be regulated.
Confusion also often arises because the term “biologic” in common usage does not align with FDA’s statutory definitions. I often have to remind myself that what I think of as biologics such as certain tissues may not technically be biologics.
Additional layers: Florida’s stem cell law & RFK Jr. statements
Getting back to the three new warning letters, part of what they are telling us is that today’s FDA and its CBER branch remain very active with oversight in the biologics space. The FDA trend that started more than 5 years ago of a main focus on perinatal products by CBER continues too.
What about RFK Jr’s statements on stem cells? I’m somewhat pleasantly surprised that the FDA enforcement trend is continuing even with RFK Jr. having posted a year ago that he was going to end the FDA’s supposed war on/suppression of stem cells and other things like peptides. This is a signal that Kennedy’s statements do not necessarily equate with sudden, risky changes in FDA oversight. I do expect more softening of oversight by CBER in 2026 though, probably under pressure from HHS.
Florida’s new stem cell law also came to mind here. Celularity recently said it is going to market perinatal cells in Florida based on the state law. To my knowledge, the firm doesn’t have FDA approval to market cells that are drugs.
While Florida’s law states that FDA approval is not required, federal law governs the regulation of drugs and biological products. State laws cannot authorize conduct that violates federal statutes, leaving open the question of how aggressively the FDA will assert its authority in this context in 2026 and beyond.
Taken together, these warning letters suggest that FDA’s oversight of perinatal products remains active and surprisingly unchanged, even amid political or ideological rhetoric and state laws. The result in 2026 is likely to be a mixed and sometimes unpredicted enforcement landscape, particularly for firms operating based on state laws that seem to conflict with FDA enforcement.