Stem Cell Therapy Makers’ Product Claims in FDA’s Crosshairs

The FDA continues to take aim at bad actors among developers of stem-cell therapies, issuing a formal warning letter and 20 advisory letters to companies that may be selling unapproved stem-cell products.

Many companies are wrongly telling consumers their products aren’t subject to FDA regulation, especially in the case of therapies developed from cells taken from the patient’s own body, the Food and Drug Administration said.

But even therapies using a patient’s own cells can present risks when those cells have undergone more than a minimal manipulation, the FDA said.

The FDA’s announcement comes about halfway through a period of ...