The short supply, high prices, and despicable insurance restrictions for advanced obesity medicines have created many problems. For example, compounding of these medicines has been and continues to be controversial – for good reasons. Now, FDA is recognizing one of the most pernicious threats to emerge from this situation – sketchy sellers of “research” peptides.

So in a press release yesterday, the agency announced it is cracking down on “potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market.” Commissioner Marty Makary said:

“By strengthening oversight of imported APIs and cracking down on illegal drugs entering the U.S., we are taking aggressive action to protect consumers from poor-quality or dangerous GLP-1 drugs.”

False Pretense for Research Purposes

The agency yesterday updated its bulletin on issues with unapproved GLP-1 drugs for weight loss. Specifically, it calls out companies trying to profit from selling peptides under the pretense of research purposes:

“FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled ‘for research purposes’ or ‘not for human consumption.’ These products have been sold directly to consumers for human use with dosing instructions. The agency urges consumers not to purchase these products which are of unknown quality and may be harmful to their health.”

Gym Bros on Retatrutide?

For a glimpse of this dubious activity, Hilary Brueck and Mia de Graaf write for Business Insider about “gym bros” getting into this commerce and taking retatrutide “to shred fat.”

This is disturbing on many levels. First is the fact that retatrutide is a potent peptide, still in research, with an unknown safety profile. It might kill or seriously harm these idiots. Second, there is no way to know what’s in this potion they’re injecting. Does it actually match or even come close to the properties of retatrutide in clinical studies? We would not count on it.

Will It Help?

What’s not clear is whether FDA is actually doing anything to help the situation. Investors did not seem to think so. The news of an FDA “green list” for legitimate suppliers of API for compounders to use sent the price of both Lilly and Novo Nordisk stock down by two percent.

If FDA genuinely cracks down on sketchy suppliers and business practices in this market, maybe it will help. But if the net effect is to legitimize sources for compounded versions of semaglutide and related drugs, then it might make things worse.

Click here for the FDA press release and here for its bulletin. For the reporting by Brueck and de Graaf, click here.

Cauldron of the Sorceress, charcoal drawing by Odilon Redon / WikiArt