California Stem Cell Supplier Cited for False Advertising
The FDA hit California-based Chara Biologics with an untitled letter for unapproved claims related to its CharaCore stem cell product.
The FDA’s Office of Compliance and Biologics Quality rapped the company for promoting CharaCore as a treatment for autism in children and traumatic brain injury in young adults although it is not approved for those indications.
The company’s website included testimonials suggesting that children and young adults on the treatment made dramatic improvements, the letter noted.
The agency also noted a post on the company’s Facebook page, which described the product as to be used in patients with “various chronic conditions” such as lupus and psoriasis.