What is going on with the FDA and peptides?
You might have noticed that some peptides are getting a lot more attention from regulators lately. As of March 2026, the FDA has been busy classifying several substances under Category 2. This is a fancy way of saying the agency has flagged them for having significant safety risks or not enough data to prove they are safe for routine use in compounding pharmacies.
- BPC-157: This one is currently in Category 2 because of concerns regarding immunogenicity—which is when your body has an unwanted immune response to a substance. The FDA also notes a lack of safety data and issued warning letters to companies like Tailor Made Compounding and Predator Nutrition in 2020.
- TB-500: Similar to BPC-157, this is in Category 2. The FDA cites a lack of human exposure data and worries about immune system risks.
- CJC-1295 and Ipamorelin: These were both moved to Category 2, and their nominations for compounding were withdrawn in late 2024. For CJC-1295, the FDA specifically pointed to safety issues like an increased heart rate.
Are any of these actually approved?
It depends on where you live. Scientists are still working on these—turns out the human body is complicated. Who knew?
- Thymosin Alpha-1: While it is approved in over 35 countries under the name Zadaxin, it is NOT FDA-approved in the United States. It was recently removed from the compounding list pending a special review because it is considered a substance of concern.
- Selank and Semax: Both are approved in Russia (Semax specifically for stroke), but neither is FDA-approved here. They remain in Category 2 as of March 2026.
What about the peptides that ARE approved?
Even when a peptide is approved, like Semaglutide, the FDA keeps a very close eye on it through FAERS safety signals. This is a system that tracks side effects reported by real people.
For Semaglutide, researchers have found strong signals for common issues like nausea, vomiting, and delayed gastric emptying (when food stays in your stomach longer than it should). There are also some newer, emerging signals being watched:
- Intestinal Obstruction: A signal for blockages in the gut was recently added to the label.
- Pulmonary Aspiration: This is the risk of inhaling food or liquid into the lungs during surgery, which was added to the Ozempic label in 2025.
- NAION: This is a serious eye condition that is currently under review by European regulators as of January 2025.
This is a great one to bring up with your doctor. You can find peptide-experienced physicians in our Find a Doctor directory.
This content is sourced exclusively from TruthTides clinical reference data and does not constitute medical advice.
Referenced Peptides
This content was generated from TruthTides clinical reference data. It does not constitute medical advice. Always consult a qualified healthcare provider.