Human Microbes, a company promoting the value and sale of fecal microbiota transplants (FMT), has received an FDA Warning Letter listing a litany of regulatory violations, including lack of an FDA-approved BLA.

Showcasing a video labeled “We want your poop,” the website — humanmicrobes.org — touts the unauthenticated potential benefits of FMT capsules, enemas and infusions to treat a variety of conditions that include obesity, mental illness, multiple sclerosis, autism and diabetes.

As FMT is highlighted on the website as a “lifesaving treatment” and advertised as having “shown promising results in clinical trials,” the products in treatment are thus classified as “drugs” and “new drugs” under the Federal Food, Drug, and Cosmetic (FD&C) Act, the letter says. The Warning Letter confirms that the organization — to lawfully market a drug that is also a biological product — must have an FDA-approved BLA confirming the product is safe, pure and potent.

Read the FDA warning letter here.

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