A federal court on Monday ruled in favor of the US Food and Drug Administration (FDA) in a case over whether unapproved stem cell products can be considered adulterated and misbranded.
US District Judge Ursula Ungaro of the Southern District of Florida ruled that stromal vascular fraction (SVF) cells can be a drug and subject to the Federal Food, Drug, and Cosmetic Act’s (FDCA) adulteration and misbranding provisions. US Stem Cell Clinic LLC of Weston, FL and US Stem Cell, Inc. of Sunrise, FL failed to comply with the requirements of current good manufacturing practices (CGMP) for drugs, the court found.
By siding with FDA, the court ruling marked a new win in the agency’s campaign to crack down on stem cell clinics offering stem cell treatments that are unproven and could potentially cause serious patient harm.
At the center of the debate between FDA and the clinics is the question of whether the SVF cells are exempt from being regulated as human cells, tissues, or cellular or tissue-based products (HCT/Ps)…