www.semaspace.com
FDA issued a warning letter to www.semaspace.com for selling unapproved and misbranded semaglutide drug products ('Semaglutide 2mg' and 'Semaglutide 5mg') directly to U.S. consumers over the internet without requiring a prescription. The site marketed these injectable products as weight-loss medicines for obesity and excessive hunger, despite no approved NDA being in effect for these specific products. FDA found violations of FD&C Act sections 301(a), 301(d), 301(k), 503(b), and 505(a), and demanded corrective action within 15 working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (4)
You need Semaglutide if you have: Excessive body weight, Obesity, Excessive hunger and cravings.
Semaglutide is a weight-loss medicine that works by mimicking a body hormone called glucagon-like peptide-1 (GLP-1), which targets areas of the brain that regulate appetite. Semaglutide helps balance out hormones like insulin, significantly reduces blood sugar, and therefore suppresses your appetite and reduces food cravings.
Generic semaglutide 2mg vial
Generic semaglutide 5mg vial
Required actions (3)
FDA requests that www.semaspace.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice.
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