MJS Medicals
FDA issued a warning letter to MJS Medicals, a South Korea-based company, for selling unapproved and misbranded injectable botulinum toxin products ('Innotox 100ui' and 'Innotox 100u') to U.S. consumers via its website. The products were marketed with specific clinical efficacy claims but lack FDA-approved drug applications under section 505 of the FD&C Act, and their labeling fails to bear adequate directions for use as 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)
Neurological Disorders: 78% reduction in blepharospasm episodes (Jankovic Rating Scale)
Hyperhidrosis Control: 89% sweat reduction persisting 9.2 months (gravimetric analysis)
Required actions (3)
FDA requests that www.mjsmedicals.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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