FDA Is Raising Concerns About Unapproved GLP-1 Weight-Loss Drugs
August 19, 2026by Anna Zucker
WASHINGTON — Chances are you’ve seen the ads promoting cheaper weight-loss shots, no insurance required, delivered straight to your door. They’re everywhere you look right now, from social media to late-night TV
Be forewarned, not all of these products are what they claim to be. Here’s what you should know
What Are Compounded GLP-1s?
Compounded drugs are custom-made versions of a medication, produced by a pharmacy rather than the original drugmaker. For GLP-1 drugs like semaglutide and tirzepatide, compounding became popular during a shortage of the brand-name versions, often at a lower price and sold through telehealth platforms with varying levels of oversight. Compounded drugs can be legal, but unlike FDA-approved drugs, they aren’t reviewed by the FDA for safety, effectiveness, or quality before reaching patients
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
Compounded GLP-1s have become common enough, and reports of problems have become frequent enough, regulators felt the need to spell out exactly where things can go wrong. The FDA released an advisory statement in June 2026.
‘);
}
Ingredients That Can’t Legally Be CompoundedTwo substances showing up in some products, retatrutide and cagrilintide, cannot legally be used in compounding under federal law. Neither is a component of any FDA-approved drug, and neither has been found safe and effective for any condition.
The FDA has issued warning letters to telehealth companies marketing retatrutide directly to consumers, to distributors selling the raw ingredient to compounders, and to outsourcing facilities repackaging it
Storage and Quality ProblemsInjectable GLP-1 drugs must be refrigerated, as specified on their FDA-approved labels. The agency has received complaints that some compounded versions arrived warm or without sufficient ice packs to maintain the correct temperature during shipping.
The FDA recommends against using any injectable GLP-1 drug that arrives warm or is inadequately refrigerated, as this can affect how well the drug works.
Separately, the agency has set up an import alert to prevent raw GLP-1 ingredients with potential quality issues from entering the U.S. supply chain, though this doesn’t apply to manufacturers that meet FDA manufacturing standards
Fraudulent and Counterfeit ProductsSome compounded semaglutide and tirzepatide sold in the U.S. carry false information on their labels. In some cases, the compounding pharmacy listed on the label doesn’t exist. In others, the label uses the name of a real, licensed pharmacy that had no involvement in the product’s manufacture.
The FDA is also aware of outright counterfeit Ozempic circulating in the country. Counterfeit drugs can contain the wrong ingredient, too much or too little of it, no active ingredient at all, or other harmful substances. Their sale is illegal
‘);
}
