Why are some peptides harder to find? FDA safety update

This content is sourced exclusively from TruthTides clinical reference data and does not constitute medical advice.

Why are some peptides harder to find lately?

You might have noticed some peptides are suddenly missing from your favorite sites. The FDA, our government agency that oversees drug safety, has been busy sorting peptides into different categories. Many popular names like BPC-157, TB-500, and CJC-1295 were placed into Category 2 in September 2023.

Being in Category 2 basically means the FDA has significant safety concerns. For BPC-157, they cite a lack of safety data and concerns about immunogenicity—which is just a fancy way of saying your immune system might react poorly to it. For CJC-1295, the FDA pointed to specific safety issues like an increased heart rate.

Since 2020, several companies have even received warning letters from the FDA regarding these substances. The regulators are essentially saying, "Look, we need more proof that these are safe before people keep using them."

What do the science and safety reports say?

While some peptides are facing red tape, others like Semaglutide have mountains of data. In a major study called STEP 1, people saw 14.9% weight loss. Another study called SELECT showed a 20% reduction in major heart-related events.

However, being well-studied also means we know more about the downsides. Large-scale safety tracking (FAERS) has identified several signals you should know about:

• The Usual Suspects: Nausea and vomiting are very common and usually tied to how much you take.
• Stomach Issues: There are strong signals for delayed gastric emptying (food stays in your stomach longer) and emerging reports of intestinal blockages.
• Rare but Serious: There are moderate signals for pancreatitis and gallbladder issues.
• New Concerns: Regulators are currently reviewing reports of a specific eye issue called NAION and risks of breathing food into the lungs during surgery due to slow digestion.

Are there any other options being studied?

Scientists are still working on this one—turns out the human body is complicated. Who knew? Here is what the current research landscape looks like:

• Tirzepatide: In the SURMOUNT-1 study, this one showed 22.5% weight loss and actually outperformed semaglutide in a head-to-head trial.
• Retatrutide: Still in the early stages, but a Phase II trial showed 24.2% weight loss at certain doses.
• Tesamorelin: This is actually FDA-approved for specific types of fat loss in patients with HIV, showing an 18% reduction in belly fat in trials.
• Thymosin Alpha-1: While it is approved in over 35 countries, a recent trial for sepsis was negative and showed no reduction in deaths.

This is a great one to bring up with your doctor. You can find peptide-experienced physicians in our Find a Doctor directory.