FDA warns USApeptide.com over semaglutide and tirzepatide

FDA sent a warning letter dated February 26, 2025 to USApeptide.com, a website the agency lists as based in Germany. The letter is titled “Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet.” It concerns semaglutide and tirzepatide offered to buyers in the United States.

What FDA said

FDA wrote that the site “introduces into interstate commerce misbranded and unapproved new drugs,” and cited five provisions of the Federal Food, Drug, and Cosmetic Act: sections 301(a), 301(d), 301(k), 503(b) and 505(a). It asked the site to “cease offering any unapproved and misbranded drugs for sale to U.S. consumers.”

The core of the letter is about labels. The site’s product pages carried statements such as “research use only,” “not for human consumption,” “lab purposes only,” and “not intended to diagnose, cure, mitigate, treat or prevent disease.” FDA said that, despite those statements, “evidence obtained from your website establishes that certain products … are drugs intended for human use.”

The evidence FDA quoted came from the site’s own copy. For a product listed as “Semaglutide (GLP-1 Analogue) 5mg” and “10mg,” the page said semaglutide is “also marketed under the brand names Ozempic, Rybelsus and Wegovy” and is “an FDA-approved injectable for weight loss.” The letter cites 21 CFR 201.128, the regulation that defines intended use by looking at claims and circumstances, not just a disclaimer.

Why the letter is typical

The letter follows the pattern of FDA’s internet warning letters to research-chemical sellers: product claims, comparisons with approved drugs and dosing language are used to show intended human use, and the disclaimer is set aside. FDA used the same reasoning in its December 2024 letters about semaglutide and retatrutide (report) and in later letters in 2025 and 2026.

FDA also noted general risks of drugs sold outside regulated channels: they “may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.”

Where the site stands

A warning letter is not a court finding. FDA’s letter asks for corrective action. We checked usapeptide.com on October 19, 2026; it returned HTTP 200. We have not assessed what it currently sells. The dated record is on our USApeptide.com status log.