COSMO KOREA
FDA issued a warning letter to COSMO KOREA, a South Korea-based website (www.cosmo-korea.com), for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'Nabota 200ui' — to U.S. consumers without an approved NDA under section 505 of the FD&C Act. The product was marketed with therapeutic claims such as 'blepharospasm elimination' and 'hyperhidrosis elimination,' establishing drug intent, yet lacks FDA approval and adequate directions for use required for prescription drugs. FDA demands cessation of sales to U.S. consumers and a written corrective action response within 15 working days, warning that failure to comply may result in seizure or injunction.
Flagged claims (2)
hyperhidrosis elimination
blepharospasm elimination
Required actions (3)
FDA requests that www.cosmo-korea.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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