Cosmenic
FDA issued a warning letter to Cosmenic (Panama), operator of www.cosmenic.net, for selling unapproved and misbranded injectable botulinum toxin products to U.S. consumers. The site marketed 'NABOTA® (JEUVEAU®) 100u' as an FDA-approved equivalent while it lacks any approved NDA, and made drug-indication claims such as prevention of chronic migraine headaches. FDA cited violations of FD&C Act sections 301(a), 301(d), 503(b), and 505(a), and warned that failure to comply may result in seizure or injunction.
Flagged claims (2)
NABOTA® (JEUVEAU®) 100u
Botulinum toxin type A (Nabota) is indicated for the prevention of headaches in adults with chronic migraine.
Required actions (3)
FDA requests that www.cosmenic.net 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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