The FDA and the US direct-to-consumer marketplace for stem cell interventions: a temporal analysis

Regen Med. 2018 Jan;13(1):19-27. doi: 10.2217/rme-2017-0115. Epub 2018 Jan 12.


Hundreds of businesses in the US currently advertise a wide range of non-US FDA-approved stem cell interventions. Here we present a novel systematic temporal analysis of US companies engaged in direct-to-consumer marketing of putative stem cell treatments. Between 2009 and 2014, the number of new US stem cell businesses with websites grew rapidly, at least doubling on average every year. From 2014 to 2016, approximately 90-100 new stem cell business websites appeared per year. In contrast, from 2012 to the present, regulatory activity in the form of FDA warning letters has been limited. These data point to a problematic disconnect between a rapidly expanding US direct-to-consumer stem cell industry and limited FDA oversight of this marketplace. More consistent, timely and effective FDA actions are urgently needed.

Keywords: FDA; adipose stem cells; amniotic stem cells; bone marrow stem cells; direct-to-consumer advertising; patient safety; stem cell clinics.

MeSH terms

  • Cell- and Tissue-Based Therapy / economics
  • Cell- and Tissue-Based Therapy / standards*
  • Humans
  • Stem Cells*
  • United States
  • United States Food and Drug Administration*