FDA WARNING_LETTER - www.24hreup.biz

On April 23, 2025, the FDA issued a Warning Letter to www.24hreup.biz (Germany) for unlawfully selling unapproved and misbranded drugs, specifically semaglutide products, to U.S. consumers via their website. The Center for Drug Evaluation and Research (CDER) observed violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The website offers unapproved new drugs, including "Ozempic 0.5mg," "Ozempic 1mg," and "Rybelsus Semaglutide 14mg," which lack FDA approval under section 505(a) of the FD&C Act. These products are also misbranded under sections 502(f)(1) and 503(b)(1) because they are prescription drugs sold without a prescription and lack adequate directions for layperson use. The injectable nature of the "Ozempic" products further heightens public health concerns due to risks like septicemia.

The FDA requires www.24hreup.biz to cease offering all unapproved and misbranded drugs to U.S. consumers. A written response detailing corrective actions and prevention measures is required within 15 working days. Failure to comply may result in