Heat is used to eliminate microbes and other contaminants from final product
Discussions around TB-500 typically include careful assessment of patient history, physical demands, and tolerance for regenerative therapies, with ongoing monitoring when used under medical supervision
FDA routinely conducts similar, web-based inspections, which are well suited to reveal a products intended use often the determining factor in whether a product is a drug. See 21 CFR 201.128 (intended use can be derived from a broad array of objective factors, including labeling claims, advertising matter, or oral or written statements.) See also 21 USC 321(g) (defining drug based on, inter alia, its intended use)
Supports conditions like leaky gut, gastric ulcers, and inflammatory bowel