FDA WARNING_LETTER - Ozempen.com - July 02, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
The FDA issued a Warning Letter to www.ozempen.com on June 24, 2024, for unlawfully selling unapproved and misbranded semaglutide drug products to U.S. consumers over the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Specifically, www.ozempen.com offers "4mg Semaglutide Pen" and "8mg Semaglutide Pen," which are considered unapproved new drugs under sections 201(g) and 201(p) of the FD&C Act. These products lack FDA approval, violating sections 301(d) and 505(a). The website claims the products have the "Same active ingredient as Ozempic, Rybelsus and Wegovy," but there are no approved applications for these specific products.
Furthermore, the products are misbranded under section 502(f)(1) of the FD&C Act because their labeling fails to bear adequate directions for use. As prescription drugs, semaglutide products require supervision by a licensed practitioner and cannot be safely used by a layperson, thus lacking adequate directions for use and violating section 301(
ID · 17939642-617e-4eb2-a0e8-3c96b29313fc
Full citation text and observation details available on the Dashboard.