The US Direct-to-Consumer Marketplace for Autologous Stem Cell Interventions

Hundreds of businesses and clinics in the United States are engaged in direct-to-consumer marketing of unproven and unlicensed stem cell–based interventions. This essay provides an overview of this marketplace, examines advertising techniques companies use to draw clients and legitimate marketing claims, and summarizes the roles the Food and Drug Administration (FDA) and other agencies are supposed to play in regulating the direct-to-consumer marketplace for stem cell interventions. The essay also reviews federal regulations, describes how many businesses selling purported "stem cell treatments" appear to violate these standards, and considers ethical issues and harms associated with widespread promotion of unapproved stem cell products.