Elle Pharm
FDA issued a warning letter to Elle Pharm (www.ellepharm.com) for selling unapproved and misbranded injectable botulinum toxin drug products, specifically 'Hutox 100ui' and 'Hutox 100,' to U.S. consumers. The products were marketed with drug-intent claims such as 'blepharospasm correction' and 'hyperhidrosis' but lack FDA-approved applications under section 505 of the FD&C Act. The products also lack adequate directions for use required for prescription drugs, constituting misbranding under section 502(f)(1). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (2)
hyperhidrosis
blepharospasm correction
Required actions (3)
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.
FDA requests that www.ellepharm.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice.
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