Dermacare dba Filler Outlet
FDA issued a warning letter to Dermacare dba Filler Outlet (operating at filleroutlet.com, based in South Korea) for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'Innotox 50u' — to U.S. consumers without an approved NDA under section 505 of the FD&C Act. The products were marketed with therapeutic claims (e.g., treating hyperhidrosis and blepharospasm) that establish drug intent, yet lack FDA approval and adequate directions for use required for prescription drugs. FDA demands cessation of sales to U.S. consumers and a written corrective-action response within 15 working days, warning that failure to comply may result in seizure or injunction.
Flagged claims (2)
The product has been shown to help reduce hyperhidrosis, or excessive sweating, offering a solution for individuals dealing with this issue
the product can also be used to treat involuntary eyelid twitching, providing relief for those with this condition
Required actions (3)
FDA requests that www.filleroutlet.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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