Glam Derma
FDA issued a warning letter to Glam Derma (Netherlands), operator of glamderma.com, for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'NABOTA 100 Type A' and 'Nabota 100' — to U.S. consumers without FDA approval under FD&C Act sections 301(a), 301(d), 503(b), and 505(a). The products were marketed with therapeutic claims (e.g., treating hyperhidrosis and blepharospasm) that establish drug intent, yet no approved NDA exists for these products in the U.S. FDA demands cessation of sales to U.S. consumers, a written corrective-action response within 15 working days, and warns that failure to comply may result in seizure or injunction.
Flagged claims (2)
Armpits, palms for treating hyperhidrosis
It is perfect for treating blepharospasm symptoms.
Required actions (3)
FDA requests that www.glamderma.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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