What is going on with the FDA and peptides?
It turns out the rules for making peptides in specialized pharmacies—what the industry calls compounding—have changed quite a bit. As of March 2026, the FDA has placed several popular compounds into Category 2. This is a specific list for substances that have significant safety risks and are not allowed to be routinely made by compounding pharmacies.
Here is a look at what that means for specific compounds:
- BPC-157: This is currently a Category 2 substance. The FDA has cited concerns about its ability to trigger an immune response and a general lack of safety data. It was also the subject of a warning letter to Predator Nutrition in October 2020.
- CJC-1295: This was removed from the list after its nomination was withdrawn in September 2024. The FDA mentioned safety issues like an increased heart rate.
- AOD-9604 and Selank: Both had their nominations withdrawn in September 2024. While Selank is approved in Russia, it remains on the FDA's radar.
- GHK-Cu: Even though you might see this in skin products, the FDA notes it is not an approved injectable drug and carries risks related to your immune system reacting to the peptide.
What are scientists seeing in the real world?
When a drug is approved, the government keeps a list of "safety signals." These are reports of side effects that need to be watched closely.
For semaglutide, the data shows a few things you should be aware of. Common issues like nausea and vomiting are well-known and listed on the label. However, some newer signals have emerged. For example, there is an emerging signal for NAION, which is a type of eye condition. This was under review by European health authorities in early 2025.
There is also a warning for pulmonary aspiration, which is when food or liquid accidentally enters the lungs. This is a concern during surgery because the drug slows down how fast your stomach empties.
Are these compounds actually being tested?
Yes, but the results are a mixed bag. Scientists are still working on these—turns out the human body is complicated. Who knew?
- Tirzepatide: In the SURMOUNT-1 trial, this led to a 22.5% weight loss. It was also found to be superior to semaglutide in a head-to-head study.
- Thymosin Alpha-1: While it is approved in over 35 countries, a recent Phase III trial for sepsis was negative and showed no reduction in mortality.
- Retatrutide: This one is still in the testing phase. Early results showed a 24.2% weight loss, and a larger Phase III trial is expected to finish between 2025 and 2026.
How to act on this information
Safety rules change often, and what worked in a study might not be right for your specific health history. This is a great one to bring up with your doctor. If you are looking for professional guidance, you can learn how to find a peptide prescriber who understands these regulatory shifts.
You can find peptide-experienced physicians in our Find a Doctor directory. They can help you navigate these safety signals and explain how recent FDA updates affect your options.
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.