Pet Food Recall Showed ‘FDA at Its Finest,’ CVM Director Tells FDA Alumni

Dr. Stephen Sundlof, Director of FDA’s Center for Veterinary Medicine, was the featured speaker at the FDAAA luncheon June 8 in Rockville, Md.

The recent recall of contaminated pet food showed “FDA at its finest,” Center for Veterinary Medicine Director Stephen Sundlof, D.V.M., Ph.D., told 45 FDA alumni and guests at a June 8 FDAAA luncheon in Rockville, Md.

Sundlof, the featured speaker at the gathering, recounted what he said “may be the largest recall FDA has ever had to deal with, at least in terms of complexity,” and even conducted a science experiment to show how the contaminants proved so deadly to countless dogs and cats.

The public response to the recall “overwhelmed all the systems FDA has,” Sundlof said. The recall included nearly 200 brands of pet food and millions of packages of individual servings. More than a dozen companies have recalled pet food products and the situation even came to include human food after it was found that contaminated pet food scraps were used in feed for pigs, chickens and fish.

Between March 16, when Toronto, Canada-based Menu Foods announced the first recall, and Memorial Day, FDA complaint coordinators had received more than 18,700 calls about the problem products. By comparison, FDA receives no more than 6,000 complaints about all the products it regulates in a year, Sundlof said. The complaint coordinators had to deal with the “emotional baggage” of pet owners who were “absolutely irate at FDA or totally distraught. We handled it about as well as we could,” he said.

The center director recounted in detail the facts of the investigation, beginning March 15 when FDA first learned from Menu Foods about the impending recall. He described the massive mobilization of field inspectors, who were on site the next day at the company’s plants in Kansas and New Jersey, and laboratory personnel, who by the end of the month had determined that the principal contaminant was melamine, found in wheat gluten imported from China. At the peak of the investigation, more than 400 FTEs (full-time equivalents) were involved. “One district office added nine people just to handle calls,” Sundlof added.

However, “the problem got worse,” Sundlof explained, as another firm notified FDA in April that it had found melamine in rice protein concentrate it had imported from China. “It was a typical case of fraud,” Sundlof explained, since melamine causes nitrogen levels to rise, making the feed ingredients appear to have more protein than they really did, enhancing their economic, if not nutritional, value.

CVM Director Steve Sundlof conducts a “science experiment” to show how two pet food contaminants combine and crystallize, causing kidney blockages that led to illness and deaths in countless dogs and cats.

Sundlof explained that it was not the melamine by itself that was sickening and killing dogs and cats across the country. A second contaminant, cyanuric acid, was also detected in the feedstuffs, and Sundlof donned his lab coat and safety goggles and took test tubes in hand to conduct his science experiment to show his audience how the two chemicals combined in so lethal a fashion. The veterinarian emptied one test tube, which contained melamine, into the other, which contained cyanuric acid, and the audience gasped as it saw white crystals form instantaneously. It was the presence of such crystals in the urine of the affected pets that blocked their kidneys, leading to sickness and, in many cases, rapid decline and death.

Sundlof marveled at the fact that “a couple of companies and a couple of nefarious individuals” on the other side of the globe could cause such a public health problem for the United States. He likened the food safety system in China today to the public health environment in the United States prior to the passage of the Pure Food and Drugs Act in 1906. “It’s kind of like going back 100 years, before there was a food and drug law. It’s kind of a Wild West of food production,” he explained. “This really has been a wakeup call for FDA in terms of the U.S. food supply, with products coming from countries that don’t have a strong food safety system.”

One immediate result of the recall was FDA Commissioner Andrew von Eschenbach’s decision to create the positon of assistant commissioner for food protection in the Office of the Commissioner. On May 1, David Acheson, M.D., who had been serving as chief medical officer and director of the Office of Food Defense, Communication and Emergency Response in the Center for Food Safety and Applied Nutrition, was named to that position.

In his new position, Dr. Acheson will “provide advice and counsel to the Commissioner on strategic and substantive food safety and food defense matters,” according to the FDA press release announcing the appointment. He will “work with individual FDA product centers, as well as the Office of Regulatory Affairs to coordinate FDA's food safety and defense assignments and commitments. In addition, Dr. Acheson will serve as the commissioner's direct liaison to the Department of Health and Human Services…and to other U.S. departments and agencies on food safety and food defense related inter-agency initiatives.”

Despite the heavy toll the investigation took on Agency resources, Sundlof praised the way employees responded. “FDA – man, in a crisis, it’s the best. Everyone knows what to do and they’re doing it. It’s just astounding to see it work like that.”

For more about the pet food recall and related issues, visit FDA’s special Web page at http://www.fda.gov/oc/opacom/hottopics/petfood.html.

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