FDA WARNING_LETTER - Jaba Labs - February 28, 2011

The FDA issued a Warning Letter to JabaLabs, LLC following a February 2011 review of their websites, http://www.stemcellfacecream.com and http://www.synovialabs.com. The agency determined that the products StemCellin Intensive Emulsion, StemCellin Deep Wrinkle Serum, and Faitoz-25 are promoted with claims that cause them to be unapproved new drugs under sections 201(g)(1)(C) and 201(p) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(g)(1)(C) and § 321(p)]. The websites featured numerous claims, such as "Lose your wrinkles! without painful injections," "Accelerates collagen and elastin production," "Reverses chronological aging," and "Activates your own skin stem cells," along with personal testimonials. These claims establish the products' intent to affect the structure or function of the human body, thus classifying them as drugs. Since these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" and cannot be legally marketed in the U.S. without prior FDA approval, as required by section 505(a) of the Act [21 U.S.C. § 355(a)]. JabaLabs, LLC is required to take prompt action to correct these violations and respond within fifteen working days, detailing corrective steps and providing documentation. Failure to comply may lead to enforcement actions, including seizure or injunction. The letter emphasizes the firm's responsibility for ensuring all products and labeling adhere to FDA regulations.