Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistLifted Naturals was warned for marketing its Mood Boosting Probiotic as a drug without FDA approval, based on disease claims made on its website stating the product could help with anxiety, depression, and mental health issues. The company's website contained explicit therapeutic claims—including that its prebiotic ingredient was "proven to help with anxiety" and positioning probiotics as "a first line of defense and even prevention for mental health issues"—that classified the product as a new drug under the Federal Food, Drug, and Cosmetic Act. The FDA determined the product was not generally recognized as safe and effective for these uses, making its introduction into interstate commerce a violation of federal law.