FDA WARNING_LETTER - Ortho Molecular Products Inc - April 05, 2012

The FDA conducted an inspection of Ortho Molecular Products Inc.'s facility in Stevens Point, Wisconsin, from April 3-5, 2012. The inspection included collecting labeling samples for products like Candicid Forte, Inflamma-bLOX, and Lipitrol, and a review of their website, www.orthomolecularproducts.com, in October 2012.

The FDA determined that nine products—Candicid Forte, Inflamma-bLOX, Lipitrol, Mucosagen, Prostatrol Forte, Resvoxitrol, Paracid Forte, VascuPak HTN, and Lithium Orotate—are promoted with therapeutic claims that classify them as unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of claims include "eliminate Candida and its related effects" for Candicid Forte, "Designed for Prostatitis" for Inflamma-bLOX, and "lowers total cholesterol, LDL-C" for Lipitrol. These products are not generally recognized as safe and effective for their intended uses and lack FDA approval.

Furthermore, these products are deemed misbranded under section 502(f)(1) of the Act because they are intended for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for laypersons. The introduction