AceCosm
FDA issued a warning letter to AceCosm (Hong Kong), operator of acecosm.com, for selling unapproved and misbranded injectable botulinum toxin products — specifically 'Nabota 200U Botulinum Toxin Type A' — to U.S. consumers without an approved NDA under FD&C Act section 505. The products bore therapeutic claims (chronic migraine prevention, urinary incontinence treatment, hyperhidrosis management) that established drug intent, yet lacked FDA approval, adequate directions for use, and required prescription-drug safeguards. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
Treatment of urinary incontinence due to neurogenic detrusor overactivity, resulting from conditions such as spinal cord injury or multiple sclerosis
Prevention of chronic migraine in adults
Management of focal armpit hyperhidrosis
Required actions (3)
FDA requests that www.acecosm.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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