Korean Aesthetic dba Korean Fillers
FDA issued a warning letter to Korean Aesthetic dba Korean Fillers (www.koreanfillers.com) for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'MEDITOXIN BOTULINUM TOXIN,' 'Cosmetics Medi 2,' and 'Meditoxin Botulinum Toxin 200U' — to U.S. consumers without FDA approval under section 505 of the FD&C Act. The products were marketed with therapeutic disease claims and lacked adequate directions for use, constituting misbranding under section 502(f)(1). FDA warned that unapproved injectable drugs pose serious risks including contamination, counterfeit ingredients, sepsis, and death. The company was directed to cease sales of these products and respond within 15 working days, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (2)
It also shows significant effects on controlling cerebral palsy and helping to reduce post-stroke upper limb spasticity.
it can also function as a treatment for essential blepharospasm
Required actions (3)
FDA requests that www.koreanfillers.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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