www.fdanews.com/articles/195075-florida-stem-cell-supplier-draws-untitled-letter-for-false-claims
Florida Stem-Cell Supplier Draws Untitled Letter for False Claims
December 9, 2019
The FDA hit Florida stem-cell supplier RichSource Stem Cells with an untitled letter for unapproved claims relating to its RICHGEN stem cell product.
The FDA’s Office of Compliance and Biologics Quality (OCBQ) rapped the company for claiming that RICHGEN was “clinically proven to provide an effective option for treating various conditions,” like cancer and diabetes.
The website also included patient testimonials for the product as treatments for asthma, knee and spine pain, and arthritis, the letter noted.