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Lysulin, Inc. was cited for marketing multiple products (including weight loss shakes, chewables, liquids, capsules, and powders) as unapproved new drugs without proper FDA authorization. The company made disease claims on its website, social media, and Amazon storefront—such as stating the products "help maintain healthy A1c blood sugar levels in diabetics and prediabetics" and "reduce blood glucose"—which classified the products as drugs intended to treat, mitigate, or prevent diabetes and prediabetes under federal law. These claims, combined with the marketing of unapproved products for therapeutic use, violated the Federal Food, Drug, and Cosmetic Act. The FDA and Federal Trade Commission jointly reviewed the company's marketing materials across multiple platforms in August 2021.