The FDA recently issued warning letters to six companies, five in the U.S. and one in Germany, for selling compounded versions of retatrutide, an experimental weight-loss drug that is not yet approved for public use.
The agency’s message is straightforward: retatrutide is still in clinical testing, and any compounded or marketed version currently being sold online is not legal for use outside of official clinical trials.
What Is Retatrutide?
Retatrutide is an investigational compound developed by Eli Lilly that acts on three hormone receptors: GLP-1, GIP, and glucagon. Early trial data have shown impressive weight-loss results: in one study, participants on the highest dose lost nearly a quarter of their body weight within a year.
Those early results have sparked widespread attention on social media, especially among influencers and wellness communities eager for “the next semaglutide.”
But the science, and the approval process, aren’t finished yet. Retatrutide remains in Phase II clinical trials, meaning safety and efficacy have not been fully established.
Why the FDA Issued Warnings
The FDA determined that companies marketing compounded retatrutide:
- Sold an unapproved new drug without FDA authorization
- Misbranded products by providing no adequate directions for safe use
- Improperly claimed compounding exemptions that do not apply to investigational substances
In short, these products are not permitted for compounding or distribution under current federal law.
As of mid-October, most of the companies that received warning letters were still advertising retatrutide for sale online, at prices ranging from around $100 to $1,000 per vial.
What This Means for Healthcare Providers
The popularity of GLP-1 medications has led to a surge in online marketing for compounded or “research” versions of drugs that have not yet received FDA approval. While patient interest is understandable, it’s important for providers to proceed cautiously.
Here are a few practical takeaways:
- Use only FDA-approved medications. Experimental compounds like retatrutide should be reserved for formal clinical trials.
- Educate patients. Many people hear about new drugs on social media and assume they’re available. Explaining the approval process can help manage expectations.
- Vet compounding sources carefully. If you offer compounded medications, confirm that the pharmacy complies with federal and state requirements and uses approved ingredients.
- Be cautious with marketing. Avoid referencing investigational or unapproved drugs in promotional materials.
The Bottom Line
Interest in next-generation weight-loss drugs like retatrutide will likely continue to grow. For now, though, the safest, and most compliant, approach is to stick with FDA-approved treatments and ensure patients understand why newer compounds aren’t yet ready for clinical use.
Keeping communication transparent and sourcing legitimate products helps protect both patient safety and professional integrity as the field of metabolic medicine continues to evolve.