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Blue Poppy Enterprises Inc was cited for marketing herbal products including Modified Perilla & Mentha, Empowered Cordyceps, Empowered Reishi, and others as unapproved new drugs through their websites www.peoplesherbs.com and www.bluepoppy.com, as well as Amazon and social media platforms. The products violated the Federal Food, Drug, and Cosmetic Act because claims on their websites established the products were intended to cure, mitigate, treat, or prevent disease—such as claims that Modified Perilla & Mentha addressed diarrhea, dysentery, and lower abdominal pain—making them drugs requiring FDA approval. These products were being introduced into interstate commerce without the required new drug application approvals, constituting both new drug and misbranding violations.