Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistEnergetic Essences, LLC marketed an unapproved new animal drug product called "Seizures" intended to reduce seizure frequency, severity, and duration in animals, in violation of the Federal Food, Drug, and Cosmetic Act. The company's website contained explicit drug claims stating the product could "help reduce the frequency, severity, and duration of seizures" and "manage seizures as they occur," establishing the product as a drug requiring FDA approval before marketing. The FDA determined during its October-November 2024 website review that introducing or delivering this unapproved new animal drug into interstate commerce violated section 301(a) of the FD&C Act.