Why are peptides like BPC-157 being restricted by the FDA?

Dealing with government health agencies can feel like reading a manual for a VCR from 1985—confusing and slightly irritating. But as of March 2026, the FDA has made some very specific calls on several popular peptides that you should know about.

Why are some peptides suddenly harder to find?

You might have noticed that some substances are being pulled from shelves or compounding pharmacies (special labs that mix custom medications). This is largely because the FDA moved a group of peptides into something called Category 2.

In plain English, being in Category 2 means the FDA thinks these substances pose a significant safety risk and they aren't allowed to be routinely made by compounding pharmacies. The regulators are worried about immunogenicity—which is just a fancy way of saying your immune system might have a bad reaction to the substance—and a general lack of safety data.

Here is the current breakdown for specific peptides:

• BPC-157: This is now in Category 2 as of September 2023. The FDA cited safety risks and a lack of data. It also has a history of warning letters sent to companies like Tailor Made Compounding and Predator Nutrition.
• TB-500: Also in Category 2. The FDA is concerned about immune system risks and notes there is no data on how it affects humans.
• CJC-1295, Ipamorelin, and Selank: These were originally nominated for use, but those nominations were withdrawn or removed in late 2024. For CJC-1295, the FDA specifically mentioned safety issues like an increased heart rate.
• GHK-Cu: Even though it sounds like something from a periodic table, the FDA has labeled this an injectable drug that is not approved, citing immune reaction risks.

What about the ones approved in other countries?

It turns out the human body is complicated, and different countries have different rules. Thymosin Alpha-1 is approved in over 35 countries as a drug called Zadaxin, but it is not FDA-approved here. In the US, it was moved to Category 2, and even though there was a brief pause on that, it is still considered a "substance of concern."

Similarly, Semax and Selank are approved in Russia, with Semax being used there for strokes. However, in the US, they remain on the FDA's restricted list without approval.

Keeping an eye on safety signals

When a drug is widely used, like Semaglutide, the government tracks "safety signals"—basically a heads-up that a side effect is happening often enough to notice. For Semaglutide, these include:

• Gastrointestinal issues: Nausea and vomiting are very common and listed on the label.
• Delayed Gastric Emptying: This means food stays in your stomach longer, which can be a problem before surgery.
• NAION: This is a serious eye condition. As of January 2025, European regulators are formally reviewing 96 cases to see if there is a link.
• Pancreatitis and Gallstones: These are already listed as warnings on the official label.

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.