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

Aim: 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. Methods: 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. Results: More than two thirds of such businesses did not make explicit representations about the regulatory status of their marketed products. Businesses that made claims about the regulatory status of the stem cell and exosome products they sold used range of representations concerning the legal standing of these interventions. Conclusion: The absence of information addressing the regulatory status of stem cell interventions and exosome products and the use of what appeared to be inaccurate information concerning the regulatory status of numerous products likely complicates efforts by customers to make informed health-related decisions.

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

Aim: 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. Methods: Data mining and content analysis of company websites were used to identify and analyze safety and efficacy claims. Results: 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. We also explored how companies framed the stem cell and exosome products they promoted. Representations ranged from assertions that such products are unproven and investigational to claims they constituted cures. Most advertising frames fell between these poles. Conclusion: Some businesses include in their marketing representations claims about the safety and efficacy of advertised products. Businesses that did not make such assertions use other techniques to attract prospective clients.