(DTC) advertising of suspect goods and services has burgeoned because of the
Internet. Despite very limited approval for use, DTC stem cell–marketed
“treatments” have emerged for an array of conditions, creating global public
health and safety risks. However, it remains unclear whether such use of stem
cells is subject to drugs or biologics regulations. To address this gap,
regulatory agencies should be given clear authority, and the international
community should create a framework for appropriate stem cell use. In addition,
consumer protection laws should be used to scrutinize providers.