In a recent Federal case against the FDA, the Stem Cell Clinics marked the use of the Stromal Vascular Fraction (SVF) must be exempted as it regulated misbranding and adulteration provision. The clinics could not also confer with the pre-requisites of cGMP for drugs, according to the court.

The heated argument still persists between the two entities whether to exempt SVF as regulated human cells, tissues, or cellular or tissue-based products (HCT/Ps). However, the clinics argued that their products should be exempt from regulation, but Ungaro found that such an exemption “does not and cannot apply.”