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Report scrutinizes FDA’s work in 2007 pet food recall

Agency supports assessment, works to make improvements

September 10, 2009
By Jennifer Fiala

More than two years after the largest pet-food recall in history, federal investigators maintain that the Food and Drug Administration (FDA) did not do its job properly. 

What’s more, FDA lacks the statutory authority to impose recalls and penalize companies for recall violations — a lack of power that worked against the agency in 2007, as officials attempted to crack down on melamine-laced pet food products now linked to the deaths and illnesses of thousands of dogs and cats. 

The assessment comes from the Office of Inspector General’s (OIG) audit of FDA’s role in the 2007 pet food recall, a scandal that involved 60-million containers of pet food in the United States, most manufactured by Menu Foods Limited and sold under 95 brand names. The report, requested by Iowa Sen. Tom Harkin, chairman of the Senate Committee on Agriculture, Nutrition and Forestry, makes a series of recommendations for strengthening FDA’s recall authority and improving its effectiveness in monitoring food recalls. 

The 2007 pet food crisis, with recalls spanning from March 16 to April 26, has been labeled one of North America's largest consumer-product recalls. Approximately 89 percent of the products in 16 recalls were manufactured by Menu Foods, the largest maker of wet and dry pet food in North America. 

One major problem with FDA's regulatory system, writes Inspector General Daniel R. Levinson, is that “The ultimate responsibility for removing the contaminated pet food rested with Menu Foods and its distributors and retailers." 

“Nevertheless, FDA’s lack of authority, coupled with its sometimes lax adherence to its recall guidance and internal procedures and the inadequacy of some of those procedures, limited FDA’s ability to ensure that contaminated pet food was promptly removed from retailers’ shelves,” the report contends.

The OIG audit highlights deficiencies in FDA’s system to alert and protect the public from contaminated food products by revisiting the 2007 recall in which high levels of melamine were found in wheat flour imported from China. Since the pet food crisis, the public has called on FDA to do a better job of inspecting imported food ingredients and has expressed concern about an apparent lack of regulation that many believe led to the deaths of so many pets. 

Last year, consumers advocacy groups further criticized FDA when the agency found “trace levels” of melamine in baby formula yet maintained that levels of the industrial chemical were low enough that such formula was still safe to consume. These alleged missteps are highlighted in the Feb. 4 Journal of the American Medical Association, in which an article takes aim at FDA for not quickly establishing limits for melamine found in food products as well as the agency’s apparent lack of testing for the chemical even after news surfaced that melamine-tainted milk sickened more than 50,000 Chinese children and led to four deaths. 

During the pet food crisis, FDA’s Dr. Renate Reimschuessel, a veterinarian and biologist, discovered that melamine and related chemicals, when absorbed into the bloodstream, formed crystals in the kidneys of animals, causing damage that often resulted in serious illness and death. Previously, scientists had rejected the idea that melamine was contaminating pet food because they thought that the chemical was non-toxic. 

FDA has responded to the OIG report by supporting all of its recommendations and agreeing, at least in principle, with its critique of the agency. Signed by FDA’s Principle Deputy Commissioner Joshua M. Sharfstein, the response begins by describing the 2007 recall as a “complex and multi-faceted investigation that involved not only recalls, but also development of new regulatory science and novel approaches to public health protection efforts.” 

He admits that FDA’s “limited resources” were no match for a recall of unprecedented size and scope.

“FDA’s experience in this incident also has provided the agency with important lessons that will apply in the future, including implementing processes to improve coordination with states in the context of large recalls.” 

One such development could be the FDA’s new Reportable Food Registry, built as mandated by the Food and Drug Administration Amendments Act of 2007 (FDAAA).

The electronic portal went live Sept. 8, and is designed to allow industry to alert FDA quickly when there is a reasonable probability that an article of food will cause serious adverse health consequences. According to FDAAA, which amends the Federal Food, Drug and Cosmetic Act, U.S. facilities that manufacture, process or hold food for consumption now are required to report food- or feed-product safety incidences via the portal within 24 hours after determining that their products might sicken or kill animals or people. 

Failure to report is a felony violation. 

In addition, the United States Department of Agriculture and the United States Department of Health and Human Services announced yesterday that the agencies launched a new site designed to provide the latest on food safety and recall information, which will include pet-food products. 

The new food safety Web site allows consumers to sign up to receive news alerts from across all government agencies that deal with food safety. According to FDA Commissioner Margaret Hamburg, the site also will be a “clearinghouse for information on the latest FDA rules and guidance.”

VIN News Service commentaries are opinion pieces presenting insights, personal experiences and/or perspectives on topical issues by members of the veterinary community. To submit a commentary for consideration, email

Information and opinions expressed in letters to the editor are those of the author and are independent of the VIN News Service. Letters may be edited for style. We do not verify their content for accuracy.


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