On March 15, 2007, a pet food manufacturer alerted FDA to the deaths of 14 cats and dogs due to kidney failure. Further investigation revealed the deaths were caused by melamine contamination of the wheat gluten used in the pets’ food, leading to a major pet-food recall.
On Feb. 6, 2008, FDA’s Office of Criminal Investigations announced federal grand jury indictments of two Chinese nationals and the businesses they operate, as well as a U.S. company and its president and chief executive officer, for their roles in a scheme to import products purported to be wheat gluten into the United States that were contaminated with melamine.
The federal grand jury charged the following companies and individuals with a 26-count indictment: Xuzhou Anying Biologic Technology Development Co., LTD. (XAC), a Chinese firm that processes and exports plant proteins to the United States; Mao Linzhun, a Chinese national who is 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 exports products from China to the United States; and Chen Zhen Hao, president of SSC and a Chinese national.
Also indicted were ChemNutra, Inc., a Las Vegas corporation that buys 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, is the controlling owner and president of ChemNutra; Stephen Miller is an owner and CEO of ChemNutra.
The indictments charge 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.
The indictments allege that the products purported to be wheat gluten were misbranded because the labels incorrectly represented that the purported wheat gluten had a minimum protein level of 75%.
The indictments allege that more than 800 tons of purported wheat gluten, totaling nearly $850,000, was imported into the United States between Nov. 6, 2006, and Feb. 21, 2007. According to the indictments, SSC falsely declared to the Chinese government that those shipments were not subject to mandatory inspection by the Chinese government prior to export.
ChemNutra contracted with SSC, a Chinese registered export broker, to purchase food-grade wheat gluten, according to the indictment. SSC then entered into a separate contract with XAC to supply the wheat gluten it needed to fulfill its contract with ChemNutra.
Melamine can be used to create products such as plastics, cleaning products, glues, inks and fertilizers. Under certain conditions, melamine mixed with wheat gluten can make the product appear to have a higher protein level than is actually present. Melamine has no approved use as an ingredient in human or animal food in the United States. Wheat gluten is a natural protein derived from wheat or wheat flour, which is extracted to yield a powder with high protein content. Pet-food manufacturers often use wheat gluten as a thickener or binding agent in the manufacture of certain types of pet food.
