Online Vendors Sell Unapproved GLP-1 Drugs, FDA Issues Warnings

Last week, the United States Food and Drug Administration (FDA) issued two warning letters to online vendors selling unauthorized versions of semaglutide and tirzepatide, active ingredients in glucagon-like peptide-1 (GLP-1) medications used for weight and diabetes management. The organization’s letters were sent to www.semaspace.com and www.gorillahealing.com.

According to the letters from the Center for Drug Evaluation and Research (CDER) with authority under the Federal Food, Drug, and Cosmetic (FD&C) Act, both companies have sold unapproved or misbranded drugs. The unapproved drugs include semaglutide, 2 mg and 5 mg.

The FDA letter notes, “While there are FDA-approved semaglutide products on the market in the US, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Semaglutide 2 mg” or “Semaglutide 5 mg” offered by www.semaspace.com.” A similar statement was made for the “Semaglutide (GLP-1 analogue)” offered by  www.gorillahealing.com.

The latter website also offers “Tirzepatide 10 mg,” an unapproved version of the tirzepatide product. Additionally, both vendors have been warned for misbranded drugs that do not have adequate directions for use and can only be prescribed by a licensed healthcare professional.

The FDA notes that both organizations should “take prompt action to address any violations of the FD&C Act” and review “websites, product labels, and other labeling and promotional materials” to ensure they follow appropriate federal guidelines. Both companies have 15 business days from the date of notice to respond to the letter providing detailed steps to address violations and prevent future violations. 

Considering the rising popularity of GLP-1 drugs for managing chronic diseases, including type two diabetes (T2D) and obesity, providers and regulatory organizations must monitor the unauthorized or unlawful sale or distribution of these medications.

Earlier this year, the FDA also warned patients to avoid compounded semaglutide products if they can access the approved versions.

According to the FDA, “When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act.” However, compounding comes with risks.

Moving forward, healthcare providers must warn patients about the dangers of unauthorized, unapproved, or compounded semaglutide products.