FDA WARNING_LETTER - Immune & Genetics Protocols, LLC - March 30, 2021

On March 30, 2021, the FDA issued a Warning Letter to Bio Green Cell following a review of their website and social media, which market the product Immune Bio Green Cell. The FDA determined that claims made for Immune Bio Green Cell establish it as an unapproved new drug under sections 201(g)(1)(B) and 201(p) of the Food, Drug, and Cosmetic Act, as it is intended for the cure, mitigation, treatment, or prevention of diseases such as Autism, Diabetes Type 2, Crohn's, Cancer, Lupus, and HIV, and is not generally recognized as safe and effective. Introducing such a product into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act. Furthermore, the product is deemed misbranded under section 502(f)(1) because it fails to bear adequate directions for its intended uses, as the conditions it purports to treat are not amenable to self-diagnosis or treatment by a layperson. The introduction of this misbranded drug into interstate commerce also violates section 301(a). The letter also noted misleading statements on the company's website and Facebook page claiming USDA approval and FDA laboratory registration, which the FDA refutes. Additionally, the FDA has no record of the facility's registration, which is required for facilities manufacturing or holding dietary supplements (foods) under Section 415 of the Act. Bio Green Cell must respond within 15 working days detailing corrective actions and prevention measures, or face potential legal action including seizure and injunction.