Why is the FDA restricting peptides like BPC-157?

Trying to keep up with what the government thinks about peptides is a bit like trying to follow a plot twist in a soap opera. One day things are fine, and the next, your favorite compound has been moved to a new list with a scary-sounding name.

The Category 2 Problem

You might have noticed several peptides getting labeled as Category 2. This is basically the FDA (the agency that regulates food and drugs) saying there is a significant safety risk, making these substances ineligible for routine compounding. Compounding is when a pharmacy custom-mixes a medication just for you.

Here is who is currently on that list as of March 2026:

• BPC-157: Listed due to concerns about immunogenicity (the risk of your immune system overreacting to the drug) and a lack of safety data.
• TB-500: Also flagged for immunogenicity risk and a lack of any data regarding what happens when humans use it.
• CJC-1295: The FDA pulled this one due to safety issues like an increased heart rate.
• GHK-Cu: Not approved as an injectable drug due to immunogenicity risks.
• Ipamorelin and AOD-9604: These were moved to Category 2, and their official nominations were withdrawn in September 2024.

Wait, I Thought These Were Approved Elsewhere?

It turns out, different countries have different rules. For example, Thymosin Alpha-1 is approved in over 35 countries as a drug called Zadaxin, but it is not FDA-approved here. In fact, a Phase III trial (the final stage of testing) for sepsis showed negative results, meaning it did not reduce mortality.

Similarly, Selank and Semax are approved in Russia, but the FDA still has them in the Category 2 bin. Both have received warning letters in the past, specifically involving a company called Tailor Made Compounding back in 2020.

The Safety Signals for Weight Loss Peptides

Even when a drug is FDA-approved, like Semaglutide, scientists keep a close eye on FAERS safety signals (a database where people report side effects). Here is what the data shows for Semaglutide through the end of 2023:

• Gastrointestinal issues: Nausea and vomiting are very common. There are also emerging signals for Intestinal Obstruction (a blockage in the gut) and Delayed Gastric Emptying (when food stays in your stomach too long).
• Gallbladder and Kidneys: There are moderate signals for Cholethiasis (gallstones) and reports of Acute Kidney Injury, usually caused by dehydration from stomach issues.
• Eye Concerns: A rare condition called NAION (a type of vision loss) is an emerging signal with 96 cases reported through December 2024. This is currently under review by regulators.

Surprisingly, while there is a warning for Suicidal Ideation, the current data does not actually support a higher risk compared to the general population.

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.