Regenerative Solutions Marketing Unapproved Drugs: FDA

The CBER Office of Compliance and Biologics Quality says Regenerative Solutions of New Jersey, Edison, NJ, is marketing exosome products from Kimera Labs for numerous diseases or conditions, including treating Covid-19. A 4/10 untitled letter says the products are administered by various routes, including intravenously.

The letter quotes statements from the firm’s Facebook page relating to treating Covid-19 with exosome products and also says that Regenerative Solutions markets the products for other diseases or conditions such as chronic obstructive pulmonary disease, spinal cord injury, Parkinson’s disease, Alzheimer’s disease, lupus, and multiple sclerosis.

FDA says the products would be regulated as drugs and require a valid BLA or IND. The letter reminds Regenerative Solutions that it is responsible for ensuring that all of its products fully comply with the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.