By: Matt Fischer
The U.S. Food and Drug Administration (“FDA”) has implemented a tiered, risk approach to the regulation of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). HCT/Ps, essentially stem cell business, that meet certain criteria under 21 CFR 1271 are only subject to limited regulation and have no requirement to obtain full premarket approval. An analysis of recent warning letters and inspectional data reveals that the FDA continues to crack down on health care providers and manufacturers offering to use adipose stromal vascular fraction (“SVF”) products to treat a wide variety of conditions. The common conclusion by the FDA: SVF products are more than minimally manipulated and not intended for homologous use meaning that pre-market approval is required.
At the beginning of 2018, the FDA issued its first stem cell business warning letter of the year to American Cryostem Corporation. According to the letter and 483 inspection report, this company was not a direct to consumer clinic but processed tissue into SVF, further expanded the tissue, and shipped the final product to physicians for injection. The FDA determined that the product did not meet the minimal manipulation criterion because the processing altered the original characteristics relating to the tissue’s utility for reconstruction or repair. The agency also found the product was intended to treat a variety of illnesses (e.g., ALS, stroke, Parkinson’s) according to the company’s website; therefore, the homologous use criterion was also not met.
However, American Cryostem is not alone. In August 2017, the FDA sent a warning letter to U.S. Stem Cell Clinic, a direct to consumer clinic, indicating that the SVF process did not meet the requirements in order to avoid premarket approval. The same position was taken by the FDA in similar letters against Irvine Stem Cell Treatment Center and Miami Stem Cell Treatment Center in 2015.
Looking at the big picture, the FDA’s position is clear at this point or at least somewhat of a line in the sand has been made. Given last November’s notice of increased scrutiny from the agency, the focus on these types of offerings to treat a myriad of conditions with one product will likely continue.