Derma Solution
FDA issued a warning letter to Derma Solution (www.derma-solution.com) on November 3, 2025, for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'Botulax 300 Units' and 'Botulax 300' — to U.S. consumers without FDA approval. The site made therapeutic claims positioning these products as treatments for hyperhidrosis, blepharospasm, migraines, and overactive bladder, which established drug intent under the FD&C Act. Because no approved NDA exists for these products and they lack adequate directions for use by laypersons, they constitute both unapproved new drugs and misbranded drugs under sections 505(a) and 502(f)(1) of the FD&C Act. FDA demanded cessation of sales and a written corrective action response within 15 working days, warning that failure to comply may result in seizure or injunction.
Flagged claims (2)
This product helps treat conditions such as hyperhidrosis and blepharsopasm
people suffering from migraines, excessive sweating, slow eye movements, and an overactive bladder can also benefit from this medication.
Required actions (3)
FDA requests that www.derma-solution.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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