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Claims that go beyond what the pre-clinical literature actually demonstrates should be treated with caution

Vegetarian dietary patterns increase risk of Vitamin B12 deficiency because plant foods do not naturally contain sufficient B12

TB-500 has not been approved for medical use by the FDA or other regulatory agencies

It supports red blood cell production, which is vital because red blood cells carry oxygen to keep the body working properly

Cancer Res 73(3):10971106 Zhao Q et al (2018) Single-cell transcriptome analyses reveal endothelial cell heterogeneity in tumors and changes following antiangiogenic treatment

Once FDA establishes the intended use, FDA can review its own records to determine that the company is not registered with FDA and/or has no drug approval, at which point the product is an unapproved new drug. Adulteration and misbranding violations follow in line, both of which are based on statutes carrying civil and criminal penalties