FDA WARNING_LETTER - Cell Vitals

On November 24, 2014, the FDA issued a Warning Letter to Cell Vitals, specifically addressing products promoted on their website, www.cellvitals.com, reviewed in September 2014. The FDA determined that Cell Vitals' "ReLuma Advanced Stem Cell Facial Moisturizer," "ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser," and "ReLuma Stem Cell Eye Cream" are promoted for uses that classify them as unapproved new drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act).

The violations stem from drug claims made on the website, indicating the products are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or function of the human body. Examples of such claims include stimulating fibroblast cell growth, increasing collagen/elastin, anti-bacterial/anti-cancer properties, reducing melanin production, repairing UV exposure effects, preventing muscle contraction, anti-inflammatory effects, healing, and repairing DNA damage.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Marketing new drugs without an approved New Drug Application (NDA) violates section 505(a) of