Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistBeach Weekend Management LLC was selling "Nicotina Energy Citrus Surge Lite 3 MG" and "Nicotina Energy Grapefruit Spark Lite 3 MG" as unapproved new drugs in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company's website made disease claims and structure/function claims without FDA approval, including statements that the products "boost dopamine," "enhance motivation," "sharpen reaction time," and "regulate mood." These marketing claims established the products' intended use as drugs, requiring FDA approval before distribution in interstate commerce.