Food Labs May Have Misled FDAMay 28, 2008 | Parker Waichman LLP
In a May 1 letter to 10 laboratories, the House Committee on Energy and Commerce writes that the labs may have been encouraged by importing companies to withhold tainted food samples in order to enable foods to reach United States consumers. The committee asked 50 multinational food companies for a variety of recall- and food-import records dating as far back as 2000.
The letter suggests labs may have discarded test results indicating failures of Food and Drug Administration (FDA) standards at the encouragement of importing companies. "We're gathering information from both the FDA and private industry about the labs almost being complicit in helping importers game the system," said Representative Bart Stupak (Democrat-Michigan), chairman of the Oversight and Investigations subcommittee investigating the labs and food companies. "Someone told us you pay for the result you want to get from the labs." The letter restates Stupak's suspicion that testing on some samples was repeated until the food passed.
The letter also states that in other cases, when food failed tests at one lab, importers would simply hire another lab to continue testing until a positive result was received. "This repeated testing is done without alerting FDA that potentially dangerous food has been imported into this country—a practice which we find deplorable," the letter states.
The letter asks about those cases when food proven to be contaminated with chemicals or life-threatening bacteria such as E. coli, salmonella, or listeria. "We wish to assess the extent of microbiological and/or chemical contamination occurring during the processing of food and the extent to which controls have failed to prevent or eliminate contamination in food," the committee wrote. The second request included companies such as Kraft Foods, Inc., Sara Lee Corporation, and the Wm, Wrigley Jr. Company.
When the David Eisenberg, CEO of Anresco Laboratories of San Francisco—a private lab—told the committee, this February, that private labs don't always tell the FDA when tests reveal contamination in imported foods, food testing in such labs came into question. Eisenberg said that the FDA "requires that we sign a laboratory director's statement that we're submitting all work that we've done on a sample." "If the importer tells us not to submit the information to the FDA, the FDA never sees it," Eisenberg testified. "Sometimes they want to keep a clean record on their item with the FDA.” Eisenberg later admitted a review of his company's records revealed it withheld samples from the FDA at a company's request an average of three times each month and that labs break no laws by withholding such information. "We are employed by the imported-food manufacturer, we are not employed by the FDA and the FDA has no authority over private labs that are generating imported-food test results, so we have to follow the advice of our customer."
FDA assistant commissioner for food protection, Dr. David Acheson, said the role of private labs is to determine if importers comply with requirements outlined in FDA alerts for certain goods, but acknowledged the test results belong to the companies. "They're not required to send us the whole bundle of testing that they have done."