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Immune & Genetics Protocols, LLC was warned for marketing Immune Bio Green Cell as an unapproved new drug in violation of the Food, Drug, and Cosmetic Act. The company made disease claims on its website and social media stating the product could treat, mitigate, or prevent conditions including autism, asperger syndrome, diabetes type 2, and cancer-related side effects, thereby establishing the product as a drug requiring FDA approval before marketing. These claims—including assertions that the product could "attack malignant cells" and "activate the regeneration of pancreatic cells"—were made without the required new drug application or evidence of safety and effectiveness. The company was selling the unapproved product directly to consumers through its website at biogreencell.com.