FDA WARNING_LETTER - Gialive SA de CV - January 28, 2015

From January 26-28, 2015, the FDA inspected Gialive SA de CV's manufacturing facility in Aguascalientes, Mexico. The inspection and review of product labeling and the firm's website (www.gialive.com) revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

Several dietary supplements, including AC-H, AC-M, ASD Complex, BLZ, CPX, CV, DC, NT, OM-3 Golden, and RG, are promoted with claims such as "promotes the creation of essential neurotransmitters to reduce or prevent muliesclerosis [sic], high levels of cholesterol." These claims cause the products to be unapproved new drugs under Section 201(g)(1)(B) and 201(p) of the Act, as they are not generally recognized as safe and effective for their intended uses. Introducing these products into interstate commerce without FDA approval violates Sections 505(a) and 301(d) of the Act. Furthermore, these products are misbranded under Section 502(f)(1) because they are intended for conditions not amenable to self-diagnosis, and thus lack adequate directions for layperson use.

Even if the CV product were not deemed a drug, it is adulterated under Section 402(g)(1) due to non-compliance with Current Good Manufacturing Practice (CGMP