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AlzClipp/UniUni was cited for marketing "AlzClipp," a nasal inhalation product, as an unapproved new drug in violation of sections 505(a) and 301(d) of the FD&C Act, as well as misbranding violations under section 502. The FDA found that product labeling and website claims—including "Prevent Alzheimer's," "Reverses dementia," "Boosts brain cognition," and descriptions of neural stimulation to treat memory decline and dementia—established the product's intended use as a drug without required FDA approval. The company made therapeutic claims indicating the product was indicated for patients with memory decline, dementia, and Alzheimer's disease, yet failed to obtain necessary new drug approval before introducing the product into interstate commerce.