Glowface
FDA issued a warning letter to Glowface (www.glowface.store) for selling unapproved and misbranded injectable botulinum toxin drug products, specifically 'Botulax 200U set' and 'Botulax 200U,' to U.S. consumers without FDA approval 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 warned that unapproved injectables pose serious risks including contamination, counterfeit ingredients, and life-threatening conditions such as sepsis. Glowface was directed to cease sales of these products immediately and respond within 15 working days, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (1)
It is mainly used for improving mimic facial wrinkles, muscle spasm, hyperhidrosis and blepharospasm.
Required actions (3)
FDA requests that www.glowface.store 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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