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Human Microbes was warned for marketing fecal microbiota for transplantation (FMT) products as treatments for numerous diseases and conditions—including C. difficile infection, IBS, IBD, Parkinson's disease, autism, diabetes, depression, and bipolar disorder—without proper FDA approval, thereby violating the Federal Food, Drug, and Cosmetic Act by selling unapproved new drugs. The company made disease treatment and prevention claims on its website and YouTube channel without having obtained required biologics licensing, and offered these products for sale internationally across the United States, Canada, and other countries.