Aesthetic Essentials Limited
FDA issued a warning letter to Aesthetic Essentials Limited (Hong Kong), operator of aesthetic-essentials.com, for selling unapproved and misbranded injectable botulinum toxin products — specifically 'Rentox 200U' — to U.S. consumers without an approved NDA under section 505 of the FD&C Act. The products were marketed with therapeutic indications (blepharospasm, hyperhidrosis, cervical dystonia) that establish drug intent, yet lack FDA approval and required prescription labeling. FDA demands cessation of U.S. sales and a written corrective action response within 15 working days, warning that failure to comply may result in seizure or injunction.
Flagged claims (3)
Cervical dystonia (spastic torticollis)
sweating of palms and armpits (hyperhidrosis)
Blepharospasm
Required actions (3)
FDA requests that www.aesthetic-essentials.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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