FDA WARNING_LETTER - www.semaspace.com - October 10, 2023

The FDA issued a Warning Letter to www.semaspace.com after reviewing its website and observing the unlawful sale of unapproved and misbranded semaglutide drug products to U.S. consumers. The website introduces unapproved new drugs, specifically "Semaglutide 2mg" and "Semaglutide 5mg" for injection, into interstate commerce without prior FDA approval, violating sections 301(d) and 505(a) of the FD&C Act. These products lack the safety and effectiveness assurances of FDA-approved drugs and carry significant risks, including potential contamination, counterfeiting, and serious adverse effects like thyroid C-cell tumors, as noted in FDA-approved semaglutide products. Furthermore, the drugs are misbranded because their labeling fails to bear adequate directions for use, violating section 502(f)(1) of the FD&C Act. The firm is also introducing misbranded drugs into interstate commerce (violating 301(a)) and dispensing prescription drugs without a required prescription, which misbrands the drugs while held for sale (violating 301(k) and 503(b)(1)). The FDA emphasizes the heightened public health concern due to these being injectable products, bypassing natural defenses. www.semaspace.com must promptly cease offering these unapproved and misbranded drugs and respond within 15 working days, detailing corrective actions and prevention plans. Failure to comply may result in legal action, including seizure and injunction, and potential detention of products for non-U.S. firms.