This is a great question and is often misunderstood. In the United States, products used in what are commonly referred to as “stem cell therapies” are generally regulated by the FDA as drugs under the 351 pathway.

Under this pathway, these products require clinical trials and FDA approval before they can be marketed or offered outside of an approved clinical trial. However, there is a separate and well-established regulatory pathway, known as the 361 pathway, which allows for the use of certain human tissue products in medical practice today, including perinatal tissues.

These 361-regulated products include those sourced from umbilical cord and related birth tissues. They contain both structural and cellular components naturally present in these tissues, including stem cells, and are regulated based on their role in supporting the body’s tissue environment.

When handled in accordance with FDA Section 361 guidelines, they can be used legally by physicians without going through the drug approval process.