USApeptide.com
FDA issued a warning letter to USApeptide.com (based in Germany) for selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers via the internet. The site marketed these GLP-1 receptor agonists with claims referencing FDA-approved brand names (Ozempic, Wegovy, Rybelsus, Mounjaro) and human therapeutic uses, despite labeling them 'research use only' and 'not for human consumption.' FDA found the products to be unapproved new drugs lacking valid section 505 applications and misbranded because they lacked adequate directions for use and were dispensed without a prescription. FDA demanded cessation of sales to U.S. consumers and a written corrective response within 15 working days, warning that failure to comply may result in seizure and injunction.
Flagged claims (8)
Tirzepatide is a compound that has been shown to help with weight loss…
Semaglutide, also marketed under the brand names Ozempic, Rybelsus and Wegovy, is an FDA-approved injectable for weight loss…
Semaglutide is a potent once-weekly GLP-1 RA, significantly reducing HbA1c, body weight and systolic blood pressure.
… recently approved in the US to help type 2 diabetes patients better manage blood sugar.
not for human consumption
not intended to diagnose, cure, mitigate, treat or prevent disease
… stimulates the release of hormones that signal the brain to reduce food intake and increase feelings of fullness.
research use only
Required actions (3)
FDA requests that www.usapeptide.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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