Chapter 5 Center for Veterinary Medicine Contents Animal Feed.5-2 Animal Drugs .5-5 BSE Enforcement Activities.5-8 Illegal Drug Residues .5-9 Turtles .5-11 Enforcement Statistics.5-14 Center for Veterinary Medicine Fiscal Year 2008 _ The Warning Letters presented in this chapter were chosen to provide examples of the types of Warning Letters issued for violations of FDA laws and regulations. The hyperlinks provided may change and to locate the archived Warning Letters go to:http:/www.fda.gov/foi/warning.htm. Animal Feed Several Indicted for Importing Contaminated Ingredients Used in Pet Food _ Efforts of FDAs criminal investigations result in successful indictment of feed importer On February 6, 2008, the Food and Drug Administration (FDA), Office of Criminal Investigations (OCI), announced that two Chinese nationals and the businesses they operated, along with a U.S. company, its president and chief executive officer (CEO) were indicted by a Federal grand jury in separate but related cases. The indictments were related to a scheme to import products purported to be wheat gluten that were contaminated with melamine into the United States (U.S.). These products were domestically used to make pet food. Xuzhou Anying Biologic Technology Development Co., LTD. (XAC), a Chinese firm that processed and exported plant proteins to the U.S.; Mao Linzhun, a Chinese national who was the owner and manager of XAC; Suzhou Textiles, Silk, Light Industrial Products, Arts and Crafts I/E Co. LTD. (SSC), a Chinese export broker that exported products from China to the U.S.; and Chen Zhen Hao, president of SSC and a Chinese national, were all charged in a 26-count indictment returned by a federal grand jury in Kansas City, Missouri. Also indicted were ChemNutra, Inc., a Las Vegas, Nevada corporation that bought food and food components from China to sell to U.S. companies in the food industry, along with ChemNutra owners Sally Qing Miller and her husband, Stephen S. Miller, who were charged in a separate, but related, 27- count indictment. Sally Qing Miller, a Chinese national, was the controlling owner and president of ChemNutra; Stephen Miller was an owner and CEO of 5-2 Center for Veterinary Medicine Fiscal Year 2008 _ ChemNutra. The indictments charged all seven defendants with delivering adulterated food that contained melamine, a substance which may render the food injurious to health, into interstate commerce; introduction of a misbranded food into interstate commerce; and other charges. On March 15, 2007, a pet food manufacturer alerted FDA to the deaths of 14 cats and dogs, several reported by consumers and several that died during routine taste trials conducted by the company. The animals were reported to have developed kidney failure after eating pet food that had been manufactured with the purported wheat gluten. To view the full text of the Press Release go to: http:/www.fda.gov/bbs/topics/NEWS/2008/NEW01792.html Animal Food Products Seized at Petco _ Under FDA direction, U.S. Marshals seized various animal food products at the PETCO Animal Supplies Distribution Center located in Joliet, Illinois, on June 19, 2008. All FDA-regulated animal food susceptible to rodent and pest contamination located at the facility was seized because these products were being held under insanitary conditions. During an FDA inspection of the PETCO distribution center in April 2008, widespread and active rodent and bird infestation of the premises was observed. The FDA reinspected the facility in May 2008 and found continuing and widespread infestation, which was determined to be a direct result of the companys continuing failure to adequately control and prevent pests at the facility. The Federal Food, Drug, and Cosmetic Act (the Act) prohibits animal feed from being stored in filthy and insanitary conditions, just as it does for human food. The distribution center provided pet food products and supplies to PETCO retail stores in 16 states including Alabama, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Min