Warning issued on dog treats.....

Warning issued on dog treats
FDA looks into reports of tainted jerky from China


FORT LAUDERDALE, FLA. — Federal regulators said Friday they are investigating potential contaminants in dog treats made in China, as the nation's leading veterinarian association posted a warning to pet owners that the products might be making animals sick.

The American Veterinary Medical Association, which represents 75,000 vets, issued the statement prompted by members' reports of numerous unusual cases of dogs suffering from a rare kidney ailment after consuming the treats. Most were chicken flavored.

"We want people to know what we are hearing, to pay attention and to monitor their pet's health," said association spokesman Michael San Filippo. "We can't stay quiet, putting our fingers in our ears and ignoring the situation."

While the association stopped short of advising pet owners not to buy Chinese-made dog treats, San Filippo said: "I would be leery, especially if it was something I had not given my pet before."

Sept. 17th, 2007

Vets warn of China-made jerky treats

Veterinary organizations are warning dog owners that their pets could be at risk of illness from some jerky treats made in China.

Six months ago, tainted pet food made from Chinese ingredients sickened and killed dogs and cats and led to a massive recall.

In the last few weeks, dog owners and veterinarians have noticed cases of dogs becoming sick after eating Chinese-made jerky treats. Symptoms include vomiting, diarrhea and lethargy. No deaths have been reported.

The number of reported cases is low, but the American Veterinary Medical Association, the American College of Veterinary Internal Medicine and Cornell University's College of Veterinary Medicine are all tracking the problem.

The AVMA has posted an alert on its website. It hopes to gather information quickly from members on whether there is a problem, and if so, how large it is, spokeswoman Sharon Granskog said.

Affected dogs show maladies that a typical clinic might see just once or twice a year, said Richard Goldstein, a veterinary kidney specialist and professor at Cornell University's College of Veterinary Medicine. He described them as "Fanconi-like syndrome" symptoms. Fanconi's syndrome is an inherited disease that affects the kidney's ability to function.

But suddenly, veterinarians have seen "three in one week," Goldstein said. The contamination appears to be causing damage to a specific area of the animal's kidneys, based on tests of affected dogs, he said.

The AVMA is advising owners to "use their best judgment." Only non-brand-name jerky treats from China have been implicated.

The Food and Drug Administration is aware of consumer complaints related specifically to chicken jerky treats and is actively investigating the matter, spokesman Michael Herndon said. The agency is testing numerous samples of jerky treats for pets for chemical and microbiological contaminants, including melamine, the industrial chemical that led to the pet-food recall earlier this year. Thus far, it has not detected any contaminants.

No other types of pet treats have been implicated. No list of brand or product names of the affected treats is currently available. The Pet Food Institute, an industry organization, is not aware of any problems with pet treats, spokesman Kurt Gallagher said.



Food and Drug Administration spokesman Mike Herndon said the agency is trying to determine whether the jerky treats pose a threat but has not singled out individual brands or requested any recalls.

Veterinary investigators advised pet owners not to panic. Initial tests of the most likely toxic ingredients — including melamine, a component in plastics that was behind the massive Menu Foods recall earlier this year — have come back negative, "and we are continuing to investigate," Herndon said.

Dr. Richard Goldstein, associate professor of veterinary medicine at Cornell University and part of the team assisting the FDA in its investigation, said most of the affected dogs are small breeds that had developed renal problems. Symptoms include vomiting, lethargy and lack of appetite.

"If people have a dog that has exhibited these symptoms in the past few months and they were (being fed) treats, they should take the dog to their vet and make the vet aware of the treat history," he said.

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FDA-CVM initiatives span individualized medicine to aquaculture research

FDA-CVM initiatives span individualized medicine to aquaculture research

Certain Collies and other breeds of herding dogs as well as hounds are sensitive to the avermectin class of drugs. In fact, ivermectin-sensitive Collies are bred for this trait because before the Food and Drug Administration's Center for Veterinary Medicine approves new avermectin products, it requests that they be tested in these dogs.

If the product is found toxic when administered to ivermectin-sensitive Collies, the safety margin is considered inadequate for the drug to be used even in the general dog population.

A genetic mutation is responsible for ivermectin sensitivity. It affects dogs that are homozygous-recessive for a deletion in multidrug-resistance gene 1, which encodes for P-glycoprotein.

The CVM's approach toward this MDR-1 defect is an example of how the agency is refining the use of drugs on the level of individual patients.

Individualized medicine, or pharmacogenomics, is an area where CVM Director Stephen F. Sundlof predicts much progress. This field of research focuses on variations in the molecules that interact with medicines moving through the body. Dr. Sundlof and CVM Deputy Director Bernadette M. Dunham spoke with AVMA News recently about the agency's future directions and recent challenges.

"Whereas the human drugs and biological centers within the FDA really have the lead on (pharmacogenomics), a lot of the things they're learning about specific genes and their impact on disease and how drugs result in differences based on the genetic makeup of the person or the animal—all of that is going to come to the Center for Veterinary Medicine," Dr. Sundlof said.

In humans, for example, pharmacogenomics is minimizing the adverse effects of a chemotherapy drug called Camptosar (irinotecan). Variations in a human gene that produces a specific enzyme can influence a patient's ability to metabolize Camptosar. If given standard doses, about half of the 10 percent of North Americans who have this genetic variation will develop severe, potentially fatal neutropenia. A molecular assay has been developed, however, to identify patients with the variant.

"The dog and cat genomes have already been mapped out," Dr. Sundlof noted. "As we understand more about how drugs work at a genetic, molecular level, we will be able to approve products based on the genetic makeup of an animal."

Continuing with the technology update, Dr. Dunham said, "A budding area that we are moving into more and more is biotechnology, and that's going to encompass a lot of the scenarios that will come from cloning and, potentially, transgenic animals.

"Nanotechnology is another portion of new technology which, down the road, will probably be impacting how some drugs are formulated and delivered."

Educational outreach, also a CVM priority, has encompassed issues such as nonsteroidal anti-inflammatory drugs and involved collaboration with the AVMA and American Animal Hospital Association. The address of the CVM Web page on NSAID is www.fda.gov/cvm/nsaids.htm.

The CVM's newest office, Minor Use and Minor Species Animal Drug Development, is directed by Dr. Dunham. In the July 26 Federal Register, the FDA issued final regulations (www.fda.gov/cvm/CVM_Updates/finalruledrugs.htm) on Designation of New Animal Drugs for Minor Uses or Minor Species, in response to the Minor Use and Minor Species Animal Health Act of 2004. The MUMS act established new regulatory procedures that provide incentives to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and for uncommon diseases in major animal species. The final rule on designation, which will take effect Oct. 9, 2007, can be viewed online at www.gpoaccess.gov/fr/.

In all, approximately 75 veterinarians are on staff with the CVM, most of them working from the Rockville, Md., area northwest of Washington, D.C. These FDA veterinarians direct field staff—generalists who inspect facilities ranging from pet food companies to pharmaceutical production plants.

Several veterinarians are on staff at the CVM research office in Laurel, Md., midway between Washington, D.C., and Baltimore. The Laurel facilities are geared toward food animals, with housing for cattle, swine, chickens, turkeys, sheep, goats, and various aquatic species. Highly functional, the site includes a surgical suite, necropsy facility, operating feed mill, and milking barn.

Research on a variety of fish is conducted at the aquaculture facility. One current project is related to the massive pet food recall earlier this year.

"One of the (fish studies) that we are conducting in response to the pet food outbreak is creating what we call incurred residues," Dr. Sundlof said, "that is, feeding melamine, cyanuric acid, and other components to food-producing animals, including fish, to see how and where that product accumulates and how rapidly it is eliminated."

This research is important because during the pet food contamination, some of the recalled product was fed to food-producing animals. Dr. Sundlof said questions were asked by the Department of Agriculture and others about the safety of animals entering the food supply.

Dr. Sundlof said FDA received an unprecedented number of phone calls from the public in the midst of the pet food crisis. During the first three weeks, the FDA received 12,000 calls about pet food—more than the agency normally receives in two years for all the products it regulates.

An import alert is in place for all vegetable protein products (eg, wheat gluten and corn gluten) entering the United States from China. Dr. Sundlof said that these products are subject to "detention without physical examination," meaning they can enter the United States only with documentation that the product has been analyzed and is free of any contaminated ingredients.

"A lot of our efforts in the future are going to be directed at making sure the pet food industry as well as the human food industry is sourcing its materials from reputable vendors or suppliers that can vouch for, and stand behind, the safety of their products," he said.

Dr. Dunham added that the tragedy highlights trade issues and will lead to better communication, transparency, and, therefore reassurance that strict quality standards are met and that "everybody's aboveboard." She said, "It has been a big eye-opener as to how things are happening around the world. It's truly a global village that we live in."

During the recall, the agency found that simply putting the information on its Web site was not sufficient. Dr. Sundlof explained that a substantial number of Americans, especially seniors, do not access the Internet. In the future, the FDA will endeavor to reach all of the public.

He added, "If this had been a human food outbreak, the Centers for Disease Control and Prevention would have been out there talking to people who believed they were infected, talking to their physician, and doing a thorough epidemiologic investigation. Anything that could fill that void would have been helpful to us in this case, and I believe would be helpful in the future."

The CVM is in preliminary discussions with interested parties such as the American Association of Veterinary Laboratory Diagnosticians about such a program.

Asked whether the CVM has adequate staff and budget to fulfill its mission, Dr. Sundlof said the agency has not been handicapped to the extent some other parts of the FDA have. "It's no secret that the total number of inspectors has been going down at the same time that we're seeing a great increase in imported products that need inspection. But as far as CVM is concerned, we're doing fairly well," he said.

Specific expertise is needed to cover everything from pre-market drug reviews to post-market surveillance. Dr. Dunham said, "In one sense, our mission is quite diverse, and we try to take the most highly qualified people who apply so we have the best of the best in those positions."

Many FDA veterinarians have acquired additional skill sets that enhance their value to the agency, such as master's or PhD degrees or board certification. According to Dr. Sundlof, "We don't have a problem attracting highly qualified people. People really like working here at CVM."

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