US businesses engaged in direct-to-consumer marketing of perinatal stem cell interventions following the Food and Drug Administration's enforcement discretion era.

Background Aims: The goal of this study was to analyze online marketing representations made by 300 US businesses selling allogeneic perinatal stem cell products. The study was conducted after a period of enforcement discretion by the US Food and Drug Administration (FDA).

Methods: Data mining and content analysis were used to identify, analyze and categorize marketing claims made on the websites of 300 businesses selling perinatal stem cell interventions.

Businesses marketing purported stem cell treatments and exosome therapies for COVID-19: An analysis of direct-to-consumer online advertising claims.

We identified 38 businesses advertising purported stem cell interventions and exosome products for COVID-19. These companies operated or facilitated access to 60 clinics. More than 75% of these clinics were based in the United States and Mexico.

Regulatory claims made by US businesses engaged in direct-to-consumer marketing of purported stem cell treatments and exosome therapies.

This study investigated whether US businesses engaged in direct-to-consumer online marketing of purported stem cell therapies and stem cell-derived exosome products made claims concerning the regulatory status of these interventions. We used data mining and content analysis of company websites to examine regulatory-related representations made by US businesses marketing stem cell treatments and exosome therapies. More than two thirds of such businesses did not make explicit representations about the regulatory status of their marketed products.

Safety and efficacy claims made by US businesses marketing purported stem cell treatments and exosome therapies.

Examining websites of US businesses engaged in direct-to-consumer advertising of putative stem cell treatments and exosome therapies, this study investigated the marketing claims such companies make about the purported safety and efficacy of these products. Data mining and content analysis of company websites were used to identify and analyze safety and efficacy claims. Of the 978 businesses analyzed, less than half the companies made identifiable claims about the safety and efficacy of their advertised stem cell and exosome products.