Pathways for Regulating the Direct-to-Consumer Stem Cell Industry in the United States

The direct-to-consumer (DTC) stem cell industry is a novel industry in the United States offering experimental stem cell treatments to patients with little regulatory oversight. The rapid expansion of this industry over the last decade has drawn attention from a number of stakeholders, and there is heated debate about how the industry should be regulated in order to maintain patient safety and treatment efficacy while also promoting innovation. Since 2009, the U.S. Food and Drug Administration (FDA) has been the main regulatory agency within the DTC stem cell industry, but it has been criticized for not taking stricter action. To develop a better understanding of the regulatory landscape in the DTC stem cell industry, this study provides a thorough analysis of five effective regulatory pathways: Food & Drug Administration (FDA), Federal Trade Commission (FTC), litigation, state legislation, and state medical boards. The operation of these pathways as regulatory agencies separately and together provide a clearer picture of future regulation in the DTC stem cell industry.