‘Revolution’ Quelled? FDA Warns Firm For ReLuma Stem-Cell Claims

Claims promoting Cell Vitals’ ReLuma skin-care line render the products unapproved drugs, FDA asserts in a Nov. 24 warning letter. Marketed as “A Revolution in Stem Cell Skin Care,” the firm’s products feature cytokines and growth factors harvested from adult stem cells that send “grow and divide” signals to aging skin cells, the company says.

Irvine, Calif.-based Cell Vitals may have to rein in its claims for ReLuma skin-care products, touted as containing cell-signaling protein molecules derived from adult stem cells, following FDA’s Nov. 24 warning letter to the firm.

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