Did you know there’s immunotherapy toothpaste? It’s intended to provide immunotherapy of a kind while you brush. Some of this is meant to help allergies so the products can also be called allergenic toothpastes.
Let’s start this week’s recommended reads with a warning from the FDA here.
Immunotherapy toothpaste Allerdent
I became aware of this because of an FDA warning letter to Allovate Therapeutics, LLC. The letter discusses an allergenic toothpaste Allerdent marketed to provide allergy relief. The FDA warning says this is an unapproved drug.
One of the other unusual things about this warning is that it involves Weill Cornell Medical College, where William Reisacher developed the product. The FDA sent the warning to Reisacher.
I couldn’t find any trial listings for Allerdent or allergenic toothpaste more generally on Clinicaltrials.gov.
This was another one of the recent biologics warnings where it doesn’t appear an FDA in-person inspection occur, which as I’ve said in the past is generally probably a good thing. The agency should not be requiring itself to do in-person inspections where marketing alone is of concern.
FDA warnings on birth-related biologics and exosomes
Here’s another warning letter: New Life Medical Services. Under Makary and Prasad, the agency continues a steady stream of warnings of what it deems to be unapproved drugs in the cell and tissue therapy space.
This specific warning letter went to New Life Medical Services leader Joshua M. Mansavage. From the letter:
“During the inspection, FDA documented that your company sells human products derived from umbilical cord (Restor+1, Regain, and Renyte), an amniotic fluid derived product (ReCyte/Cytosomes2), and an exosome product (also referred to as an “extracellular vesicle” product, named Rexo) for allogeneic use (collectively, “your products”)…This letter is to advise you that your products are unapproved new drugs “
Overall, the FDA focus over the past 6 years on birth-related products continues in 2025. There are also more mentions of exosomes in warnings.
I do wonder about the toothpaste warning though. Why warn about that but not other things like unproven RNA therapies?
Other recent FDA letters on biologics
More recommended reads
- Hiltzik: How Amazon provides a marketplace for worthless stem cell supplements, LA Times. I also just wrote on Friday about how some of these supposed stem cell supplements are actually drugs and I called on the FDA to take action here.
- Gene therapy delivers lasting immune protection in children with rare disorder, UCLA. It’s exciting to see continued success from Don Kohn’s team for treating SCID. Remarkably, immune system function has been maintained in 59 of 62 treated children born with ADA-SCID.
- Human adult hippocampal neurogenesis is shaped by neuropsychiatric disorders, demographics, and lifestyle-related factors, Cell Stem Cell.
- EZHIP restricts noncanonical PRC2 binding and regulates H3K27me3 intergenerational inheritance and reprogramming, Cell Stem Cell.
- Why simply ending animal testing isn’t the answer in biomedical research Animal models provide insights that alternative approaches can’t. A heated debate about which method is better is distracting researchers from doing good science, Nature. This is from UC Davis’s own professor Kent Lloyd.