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SANA Group LLC marketed "Sleep Drops" and "Sleep Shots" as drugs without FDA approval by making disease-treatment claims on their website, violating the Federal Food, Drug, and Cosmetic Act. The company's website attributed therapeutic benefits to product ingredients, including claims that GABA relieved anxiety and ADHD symptoms, L-tryptophan treated insomnia and depression, and valerian addressed sleep disorders—statements that established the products as unapproved new drugs. The products were not demonstrated to be generally recognized as safe and effective for their intended uses, constituting both a new drug violation and misbranding issue.