Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistThrasio, LLC was warned that ZymaDerm for Molluscum, marketed and sold through their website and social media, is an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain FDA approval before introducing the product into interstate commerce, despite molluscum contagiosum being a condition requiring professional medical evaluation that currently has no legally marketed over-the-counter treatments. The violation was particularly concerning because the product was marketed for use in children, a vulnerable population requiring healthcare professional oversight rather than self-treatment.