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. RESULTS: The study identified types of perinatal interventions companies advertised, geographic locations of clinics selling such products, types of companies operating in this space, diseases and injuries such businesses claim to treat, prices companies charge for such interventions, brand names of advertised perinatal cell products and identities of suppliers. CONCLUSIONS: A substantial number of US businesses market unapproved perinatal stem cell products for various indications. This widespread commercial activity occurred following the conclusion of a period of enforcement discretion by the FDA and suggests the need for more robust and comprehensive regulatory responses to businesses selling unapproved perinatal stem cell products.

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. Thirty-six of the businesses marketed their stem cell and exosome products as treatments for Long COVID, six advertised them as "immune boosters," five claimed to treat patients in the acute infection phase, and two claimed their products were preventive. The least expensive product cost $2,950, the most expensive was $25,000, and the average listed cost for patients was $11,322. The promotion of these products is concerning because they have not been approved by national regulators and do not appear to be supported by convincing safety and efficacy data.