U.S. Regulation of Stem Cells as Medical Products

Premarketing approval by the federal government should ensure not only safety, but efficacy as well. A recent decision by a U.S. District Court judge could have profound implications for the increasing number of U.S. clinics that advertise putative “stem cell treatments” for a wide range of clinical, rejuvenation, and aesthetic applications. In United States v. Regenerative Sciences LLC et al., the court upheld the authority of the Food and Drug Administration (FDA) to require the premarketing approval of human stem cell–derived products that meet any of several broad criteria ( 1 ). The court concluded that the cultured autologous mesenchymal stem cell–based product at issue in the case is subject to FDA regulatory oversight, as it meets criteria for classification as a biological drug, and its manufacture, distribution, and sale constitute interstate commerce. Although the court described the decision, which has been appealed, as “a close question,” this new ruling reaffirming FDA authority has prompted heightened interest in the regulation of stem cells as medical products.