Form Table of Contra& drugs in the context of dog and cat foods (1) that provided nutrients in support of the animal's total required daily nutrient needs, (2) that were distributed only through licensed veterinarians and (3) with respect to which manufacturers restricted labeling claims. However, noting an increase in the number of dog and cat foods labeled as being intended for use in the diagnosis. cure. mitigation. treatment or prevention of disease, and noting that animal health may suffer when such products arc not subject to pm-market FDA approval and are provided in the absence of a valid veterinarian-client-patient relationship. the FDA recently issued a list of specific factors it will consider in determining whether to initiate enforcement action against products that satisfy the definitions of both an animal food and an animal drug, but which do not comply with the regulatory requirements applicable to animal drugs. We currently produce products, such as cat food with hairball management. that undergo FDA pm-market inspection. While we believe that we market our products in accordance with the applicable FDA regulatory requirements. the FDA may classify some of our products differently than we do and may impose more stringent regulations applicable to animal drugs, such as requirements for pre-market approval and compliance with GMPs for the manufacturing of pharmaceutical products. We intend to produce more products that we anticipate will be subject to FDA pm-market inspection. including new products to the Therapeutic market segment. Under Section 423 of the FFDCA. the FDA may require the recall of an animal feed product if them is a reasonable probability that the product is adulterated or misbranded and the use of or exposure to the product will cause serious adverse health consequences or death. In addition, pet food manufacturers may voluntarily recall or withdraw their products from the market In 2010„ we voluntarily issued a =all