FDA letters to Chara Biologics & Evolutionary Biologics continue its unprecedented slew of warnings

What is Chara Biologics? Why did the FDA just warn them and another firm?

FDA’s CBER keeps up fast pace of warnings

Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13 months.

I wrote late last year how 2024 was already likely a record year by a large margin for biologics warning letters.

This pace has just continued in early 2025.

I just wrote earlier this week about a warning letter to INCELL Corporation, which was linked to another recent warning letter to XO Biologix.

Now, it’s notable that more warning letters have gone to two firms marketing perinatal and exosome therapy products including related to Wharton’s Jelly. For more on where things stand with exosome therapy development, I’ve linked to an explainer. Here’s a piece on Wharton’s Jelly.

Chara Biologics

Let’s look at the FDA warning to Chara Biologics. It is addressed to Dr. Joy Kong here in California.

As usual in the birth-tissue space, the letter notes the products in question are unapproved new drugs and raises cGMP issues.

The FDA noted three Chara Biologics products: an amniotic product called CharaExo, and human umbilical cord products, CharaCore and CharaOmni.  The FDA highlighted marketing of one or more of these products for several human diseases. CharaExo is marketed as containing exosomes.

The agency letter also notes misbranding and adulteration.

A Clinicaltrials.gov search for Chara Biologics and some of the product names gave no results.

One unusual thing about this letter is how fast CBER has made it public. The letter is dated January 17 yet was posted just 11 days later on January 28. That’s strikingly quick.

As an update, Chara Biologics also received an untitled letter back in 2020. HT to Dr. Don Buford for reminding me on this, which I wrote about briefly back then.  Here’s a direct link to that past FDA untitled letter, which also related to CharaCore. This highlights how slow the FDA has been at times. I’ve written before about how firms can get two or more letters of some kind or even warning letters but not much else seems to be happening about the products or sponsors.

Evolutionary Biologics

Another FDA warning recently went to Evolutionary Biologics of New York.

This one went to CEO Jim Morrison. Here is the info on the products:

“FDA has determined that you sell the following products in the United States: EXO RNA™ (exosome product), EVO JEL™ (an umbilical cord-derived product), and EVO HYBRID™ (a cellular product derived from umbilical cord, “placental tissue,” and amniotic membrane) (collectively, “your products”)…In addition, we have concerns with your products EXO RX, EXO ELIXIR™ and EXO PERIO™, “

The FDA letter says these are drugs.

You might think you know what I’m going to say next based on the more than a dozen other warnings in this space recently, but this letter does not go on to note cGMP issues. So there’s a change and it seems there are no manufacturing issues with these products.

The letter says that some of the products are claimed to have diverse actions. For example, per the letter:

“EVO PERIO™ Is a Wharton’s Jelly product rich with Mesenchymal Stem Cell exosomes. MSC exosomes induce bone, cartilage, dentin, mucosa, and pulp tissue formation while enhancing oral and craniofacial tissue engineering and regeneration.”

This is just one product. I’m curious if some of the target customers are dentists or oral surgeons.

CBER continues stream of warnings

Overall, CBER has issued around 16 cell and tissue-related warning letters in the last 13 months, most to perinatal biologics firms that seem to supply unproven clinics. Again, for context, there have been past years when CBER issued no such letters at all to anyone. Other years they issued one or two in total.

Why the burst in activity?

I think two things have changed. First, the number of manufacturers in this space has exploded. Second, CBER is more willing or able to quickly act on them, which is a major positive change in my view.

I wonder if the FDA has already conducted many inspections in this space and has been trying to get the related warning letters out the door fast before the process might be shut down.

I see yet another warning in this space now on the FDA page but that’ll have to wait for a future post.