MG Infusions

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your website indicates that you sell fecal microbiota for transplantation (FMT) in various forms (e.g., capsules and enema infusions; hereafter “your products”) in the United States for the treatment or prevention of various diseases or conditions. For example your website states the following: - Homepage, under a title of “What is FMT”***1*** o “FMT, also called fecal microbiota transplant, and known as a stool transplant is the process of transplanting fecal bacteria from a healthy individual into a recipient as a treatment for Clostridium difficile infection (C.diff [sic]), C.diff related ulcerative colitis, irritable bowel syndrome, and many others.” o “Finding a healthy and reliable donor can be challenging for people going through this struggle, but with the help from mginfusions hundreds to thousands of people have already been helped on the road back to a strong and healthy life.” o “Ideally both forms of administration [capsules and enema infusions] have proven to show significant benefits in removing any types of harmful pathogens, such as c.diff [sic] and ulcerative colitis.” - “About Me” page, under a title of “Donor Information” o “FMT is used to help people with C.Diff [sic], C.diff related ulcerative colitis, and other harmful intestinal bacteria.”