ORLANDO, Fla. — Federal regulators are warning consumers about unapproved weight-loss injections sold online, citing concerns ranging from uncertain ingredients to dosing errors that have sent some patients to hospitals.
In a Sept. 24 warning letter, the Food and Drug Administration told the website Cheap Medicine Shop to stop offering unapproved and misbranded injectable semaglutide products to U.S. consumers.
The FDA’s letter warns that drugs sold outside regulatory safeguards could contain contaminants, incorrect ingredients or inconsistent amounts of medication.
Compounded does not mean FDA approved
Compounded drugs are prepared to meet particular patient needs. They do not undergo the FDA’s premarket review for safety, effectiveness and quality.
The agency says compounding can be appropriate when an available approved medicine cannot meet a patient’s medical needs.
Compounded products and counterfeit drugs are different categories. Counterfeits falsely claim to be authentic medicines.
As of May 31, the FDA reported 990 adverse-event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide.
Those reports do not establish that the m...