FDA Warning Letter: Unauthorised Distribution of Fecal Microbiota Transplant Products

The FDA reviewed MG Infusions' website and found that the company was distributing fecal microbiota transplant (FMT) products in various forms, such as capsules and enemas infusions, in the US. These products were offered to treat or prevent a variety of diseases or conditions. For example, on the homepage under the title 'What is FMT', statements were made such as:

"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."

"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."

"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."

"FMT is used to help people with C.Diff [sic], C.diff related ulcerative colitis, and other harmful intestinal bacteria."

These statements indicate that MG Infusions' products are intended to mitigate, treat, or prevent disease, which classifies them as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Because they are not generally recognised as safe and effective for the indicated uses, they are also considered 'new drugs' under the FD&C Act. In addition, these products are defined as biological products under the Public Health Service Act (PHS Act) because they are intended to prevent, treat or cure diseases in humans.

Under the FD&C Act, no new drug may be introduced into interstate commerce in the United States without an FDA-approved New Drug Application (NDA). Similarly, under the PHS Act, it is illegal to distribute a biologic product without a Biologics Licence Application (BLA) issued by the FDA. However, MG Infusions does not have an approved NDA nor a BLA for the FMT products it offers, which is a violation of these regulations.

The FDA emphasised that manufacturing FMT products without a valid BLA is a violation of the Act and that such products may not be introduced into interstate commerce. The Warning Letter urged MG Infusions to take immediate action to correct the violations and indicated that failure to comply could result in further regulatory action, including product seizure or injunctions.

The FDA emphasised the importance of protecting public health and the need for all companies that manufacture or distribute biological products to comply with regulatory requirements to ensure the safety, effectiveness and quality of their products. Had MG Infusion correctly classified the products in advance, this Warning Letter would not have been issued. Read the complete Warning Letter to MG Infusions on the official FDA website.