Inadequate Classification leads to Warning Letter

The US Food and Drug Administration (FDA) has reviewed the website of Mother Stem Institute and its process for obtaining and processing adipose tissue, which is prepared for autologous use as "stem cells". The company processes the adipose tissue into Stromal Vascular Fraction (SVF) and isolates cellular components using enzymatic digestion. These SVF products are administered intravenously and the website claims that they can treat a variety of diseases, including Alzheimer's, diabetes and autoimmune diseases.

The FDA classifies the SVF product as a drug under the FD&C Act because it is used to treat disease and affects the structure or function of the body. It is also considered a biological product under the Public Health Service Act because it is used to prevent, treat or cure disease. It also falls under the definition of "Human Cell, Tissue, or Cellular or Tissue-based Product" (HCT/P) and is therefore subject to the corresponding regulations (21 CFR Part 1271). Since the processing of adipose tissue by enzymatic disruption and isolation of the cellular components alters the original structural properties, this manipulation is considered more than minimal, resulting in stricter regulation. 

As a result, Mother Stem Institute does not have a valid licence to market this biological product and the product is not approved for use in a clinical trial. In addition, the product is considered a mislabelled drug as it does not contain sufficient instructions for safe use by laypersons. The misclassification of the drug has now led to a Warning Letter from the FDA.

The incorrect classification of organic products is by no means an isolated incident. This has already led to Warning Letters in the past. Differences in the classification of ATMPs between Europe and the USA complicate the authorisation process. For example, exosomes are only ATMPs in Europe if they are used in modified form in gene therapy. Whereas in the USA, exosomes are classified as ATMPs even if they are not modified, depending on the intended use. In this case, discussions should always be held with the FDA or the responsible authority in advance. For Europe, the EMA offers support with the "Reflection paper on classification of advanced therapy medicinal products". The authorisation process is not easy for any biological product, so it helps to be informed through training or timely contact with the competent authority.