FDA WARNING_LETTER - Process Managers LLC - December 27, 2011

An FDA inspection of Process Managers, LLC, conducted in December 2011, revealed that the firm's "CalDensity®" and "Want A Snack™" products, marketed for animal consumption, are unapproved new animal drugs. The FDA determined that claims on the company's websites (caldensity.com and wantasnack.com) establish the products' intended use in the mitigation, treatment, or prevention of disease in animals, classifying them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. These products are also considered new animal drugs under section 201(v) because they lack general recognition of safety and effectiveness. As neither product has an approved new animal drug application or index listing, they are deemed unsafe under section 512(a) and adulterated under section 501(a)(5) of the Act. The introduction of such adulterated drugs into interstate commerce is prohibited by section 301(a). Despite the firm's January 2012 response claiming removal of questionable language, violative claims persisted. Process Managers, LLC, must promptly correct these violations and notify the FDA in writing within fifteen working days, providing documentation of corrective actions. Failure to comply may result in enforcement actions, including product seizure or injunction.