FDA WARNING_LETTER - Cogent Solutions Group LLC - November 10, 2009

This FDA Warning Letter, issued to Cogent Solutions Group, L.L.C. on May 12, 2010, follows a November 2009 inspection and review of product labels and websites for "Runovia," "Trixsyn," and "Hyaluronex." The FDA determined that all three products are unapproved new drugs due to therapeutic claims for disease diagnosis, cure, mitigation, treatment, or prevention in humans or animals, violating section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. Specifically, "Runovia" is an unapproved new drug under section 201(p) and 505(a) for human use. "Trixsyn" and "Hyaluronex" are unapproved new animal drugs under sections 201(v) and 512(a), making them unsafe and adulterated under section 501(a)(5), and their interstate commerce unlawful under section 301(a). Additionally, "Runovia" is a misbranded dietary supplement under sections 403(i)(1), 403(s)(2)(B), and 403(q)(5)(F) of the Act, and 21 CFR 101.3(a), (g), 101.36, and 101.4(g). Misbranding issues include failure to identify as a "dietary supplement," non-compliant nutrition information formatting (type size, title, subheading placement), and incorrect placement of the "Other ingredients" list. The firm is required to promptly correct these violations, investigate their causes, and prevent recurrence. Failure to comply within fifteen working days may result in enforcement actions like seizure or injunction, and impact federal contracts.