FDA Update

Consumer Inquiries: 888-INFO-FDA

April 22, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) is investigating an imported shipment of rice protein concentrate which has been found to contain melamine.

The rice protein concentrate may have been used as an ingredient in some pet foods. FDA’s investigation of the rice protein is being carried out by specialists in FDA headquarters and in eight FDA district offices. Thus far, the following has been established:

• The suspect shipment of rice protein concentrate was imported and offloaded during the week of April 2, 2007, by Wilbur-Ellis, an importer and distributor of agricultural products, including rice protein concentrate, with headquarters in San Francisco, CA. The source of the product is identified as Binzhou Futian Biological Technology in China.
• The shipment consisted primarily of rice protein concentrate in white bags, but also included one pink bag that was labeled, in part, with the word “melamine.”
• On April 15, Wilbur-Ellis notified FDA’s Center for Veterinary Medicine about the suspect shipment. On April 16, FDA launched a nationwide investigation tracing eight import entries identified as being shipped from the Chinese firm since July 2006. FDA testing revealed melamine in both the white and pink bags.
• Wilbur-Ellis has initiated a recall of all suspect rice protein concentrate it had imported and distributed; see http://www.fda.gov/oc/po/firmrecalls/wilburellis04_07.html.
• As a result of notification by Wilbur-Ellis, Royal Canin USA and C.J. Foods voluntarily recalled certain products; see http://www.fda.gov/oc/po/firmrecalls/royalcanin04_07.html and http://www.fda.gov/oc/po/firmrecalls/bluebuffalo04_07.html.

FDA investigators have obtained records showing distribution to five pet food manufacturers in seven locations. Investigators are currently inspecting all five manufacturers and collecting additional samples, as appropriate.

FDA has confirmed the presence of melamine in finished pet food products containing rice protein concentrate. Those products, and others within the same product line, are currently under recall by Natural Balance Pet Foods and are labeled as: Venison and Brown Rice canned and bagged dog foods; Venison and Brown Rice dog treats; and Venison and Green Pea dry cat food; see http://www.fda.gov/oc/po/firmrecalls/naturalbalance04_07.html.

If FDA’s investigation determines that additional pet food products have been manufactured from the suspect rice protein concentrate, FDA will expect manufacturers to initiate voluntary actions to remove these products from the marketplace. FDA will continue to communicate its findings promptly.

In a related development, the California Department of Food and Agriculture (CDFA) issued a press release on April 19, 2007, stating that CDFA laboratory testing had detected melamine in urine from hogs at the American Hog Farm in Ceres, CA. For further information, see
http://www.cdfa.ca.gov/exec/pa/pressreleases/PressRelease.asp?PRnum=CDFA07-038.

Due to the involvement of animal feed, FDA is working with CDFA on this development.

FDA continues to work comprehensively to protect the nation’s pet food as well as to conduct a full investigation to determine any impact on the human food supply. The agency is now sampling all rice protein concentrate from China and continues to sample all wheat gluten imported from China, and it is ready to increase its surveillance of other products, if necessary. To search for the latest list of recalled products, which will be updated when new information is received, please see http://www.accessdata.fda.gov/scripts/petfoodrecall/.