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Talk to a SpecialistTalk to a SpecialistBrilliant Enterprises LLC was warned for marketing four mushroom products (Lion's Mane, BoomChaga, CordaCex, and LVL:MAX) as unapproved new drugs through their website and social media channels. The company made disease claims including that Lion's Mane relieves depression, anxiety, and dementia/Alzheimer's disease, and that BoomChaga lowers cholesterol—claims that established these products as drugs under the Federal Food, Drug, and Cosmetic Act requiring FDA approval. These products were being sold without the required new drug approvals, violating the Act by introducing or delivering them into interstate commerce for therapeutic uses.