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Native Remedies dba Silver Star Brands was cited for marketing MindSoothe Drops and MindSoothe Capsules as unapproved drugs by making disease claims on their website, including that the products "relieve feelings of depression," "regulate disturbed sleep patterns," and improve appetite without disclosing the harmful side effects of prescription medicines. The company violated the Federal Food, Drug, and Cosmetic Act by establishing intended use as drugs through explicit therapeutic claims and customer testimonials describing use for treating depression and other disease symptoms, while failing to obtain FDA approval for these products as new drugs. These products were being sold and distributed in interstate commerce without the required new drug application or exemption status.