Meamo
FDA issued a warning letter to Meamo (operating via meamoshop.com, based in South Korea) for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'X4 Wondertox 100U Set' and 'Wondertox' — to U.S. consumers without an approved NDA under section 505 of the FD&C Act. The products were marketed with drug-intent claims and lack adequate directions for use required for prescription drugs, constituting misbranding under section 502(f)(1). FDA demands cessation of sales to U.S. consumers, a written corrective-action response within 15 working days, and warns that failure to comply may result in seizure or injunction.
Flagged claims (1)
Treatment of benign essential blepharspasm in adult patients.
Required actions (3)
FDA requests that www.meamoshop.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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