FDA Issues Warning Letter To Cell Vitals

A warning letter has been issued to Cell Vitals, Irvine, CA, after the FDA reviewed its website in September 2014.

Based on the review, FDA says ReLuma Advanced Stem Cell Facial Moisturizer, ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser, and ReLuma Stem Cell Eye Cream appear to be promoted for uses that cause these products to be drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and § 321(g)(1)(C)]. 
 
The FDA letter was dated Nov. 24, 2014.
 
FDA wrote,  “This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct the violations associated with your products. Failure to promptly correct these violations may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.” 
 
FDA requested that the company contact the agency in writing within fifteen working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur.