FDA warns Frontier Biologics as part of its more active trend

The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm.

Tallying the many FDA biologics warnings in 2024

It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the FDA has been doing much more on this front in 2024.

With the new warning, I now count 13 FDA warning letters on cell or tissue-related biologics in 2024. There were past periods when the FDA might have taken six or seven years collectively to send out that many warnings.

Let’s look at the new warning.

FDA warning to Frontier Biologics

Frontier Biologics is a manufacturer that produces “human amniotic fluid and membrane- derived products, (b)(4) for allogeneic use.” Such donor biologics are generally drugs that require working with the FDA.

Note that (b)(4) is a common FDA redaction placeholder. Oddly, some of the product names are redacted in this letter, which is a bit unusual in my experience looking at these warnings. A footnote mentions another name for a product: Evexcell.

The agency notes that Frontier’s products appear to be unapproved drugs.

In addition, as is typical for these types of birth-related biologics warning letters, the FDA notes CGMP deviations. Overall, these types of warning letters are a big red flag that suppliers of perinatal biologics generally do not follow good manufacturing practices.

Why does this matter?

Such deviations pose risks to the people who ultimately receive these products. Liveyon is a worst-case example of how bad the results can be, with their contaminated product sending dozens of people to the hospital and ICU.

Who runs Frontier Biologics?

The FDA letter went to Chad W. Justice. I wasn’t able to find out much about his background on that LinkedIn page that I linked to.

Is Mr. Justice a regenerative medicine expert? Under his interests, LinkedIn listed something called the Regenerative Medicine Institute of Louisiana. This seems to be an unproven stem cell clinic.

I don’t see that Mr. Justice has a role there at least based on the website. In addition, a search of PubMed found no relevant publications for him.

I found two YouTube videos on the firm and have included one above. There’s not much too it except the idea of the frontier. There’s a second video entitled “FRONTIER BIOLOGICS STEM CELL MOGUL SCOTTY RAY HANDLEY” but it’s just a guy singing.

Of course, then I had to do an internet search for Scotty Ray Handley. The main thing I found was a lawsuit mentioning Scotty Ray Handley and Chad Justice. The plaintiffs are listed as J. Matthew Burnett, Angela Huinker, Meghan Murphy Englund and Legacy Medical Centers.

Legacy Medical Centers rang a bell. I had mentioned them in a past post on Fountain Life, but I’m not sure if this is the same firm. It’s a pretty genetic name.

Broader trend of concerning biologics firms

There is a broader trend among American stem cell clinics these days of entrepreneurs without much or any rigorous biologics research experience opening up stem cell and similar clinics or manufacturing firms.

Iffy stem cell training courses, often offered by clinics themselves, may be one catalyst for this trend.

It’s highly risky for the public in my view.