Local law firm fights FDA's raw pet food policy - Colorado Springs Business Journal

Local law firm fights FDA's raw pet food policy - Colorado Springs Business Journal

By Faith Miller

You wouldn’t know it from watching Yeager jump up and down as his “dad” prepares his breakfast at the office, but the 2-year-old standard poodle wasn’t always so happy.

Yeager used to suffer frequently from digestive problems, according to owner Joseph O’Keefe, a trial lawyer and recent transplant from Pennsylvania. Now, Yeager is doing much better — and O’Keefe thinks that’s thanks to Answers Pet Food, which O’Keefe is representing in a case challenging the Federal Food and Drug Administration.

The case that O’Keefe and his firm, Dickson Law Group, are fighting could have consequences for raw pet food manufacturers across the nation. They represent a relatively small but fast-growing sector of the pet food industry that caters to pet parents willing to pay top-dollar for diets they believe are closer to what nature intended for their furry friends.

That belief runs contrary to the recommendations of many major veterinary organizations that point to scientific studies that show health risks associated with the diet.

But like many proponents, O’Keefe and his wife say they have “witnessed the difference with Yeager,” since he started on a raw diet from Answers. “He’s not gagging and barfing stuff up. He’s out hiking more and more with us. He’s just a much healthier dog.”

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Answers Pet Food, a Pennsylvania-based raw pet food manufacturer, argues that its food is of a higher caliber than other products on the market, and that it provides more nutritional value than the typical processed food. The FDA, however, has repeatedly butted heads with the company over safety violations. In the latest round, the FDA requested the food be pulled from shelves due to salmonella contamination.

Interestingly, O’Keefe isn’t arguing that Answers doesn’t contain salmonella; he’s arguing that the FDA is incorrectly enforcing its guidelines on salmonella.

Federal law requires the FDA to quantify contaminants and create allowable tolerances. But O’Keefe claims the agency doesn’t test the amount of salmonella in pet food products, or determine which strain it is; it just checks for its presence.

(The FDA didn’t respond to our requests for comment, but its website said: “Federal law requires all pet food to be free of pathogens, including Salmonella. Pet food manufacturers must effectively manage sourcing of ingredients, processing and packing to control pathogens.”)

Answers President Keith Hill said the FDA has asked the company to recall its product when salmonella is detected.

“We have a recall strategy, and we would be the first party to recall any of our products if there was any indication that the product would present a possibility of a health risk to the pet or the human,” Hill said.

But a recall didn’t happen after the company’s most recent run-in with the FDA in January, when Nebraska regulators found salmonella in its Straight Beef Formula for Dogs.

Answers requested a sample of the product, and found that the salmonella content was too small to quantify, according to a January statement from the company. A subsequent, larger quantity from Nebraska tested negative, and Answers suspects the original sample was cross-contaminated.

Answers refused to recall the product — so the FDA published a warning letter advising consumers not to purchase it because the food had tested positive for salmonella. Hill said that warning unfairly threatened Answers’ bottom line and reputation.

“There’s irreparable harm that’s done by these kinds of actions, by shaming you in the public,” he said.

Hill said if food was truly dangerous, the FDA should have simply issued a mandatory recall. The department can “order the recall of certain food products when the FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals,” according to the FDA’s website.

While the FDA didn’t respond to our inquiry by press time, Hill has his own theory of why the FDA didn’t take that route: “Because they don’t have the science to back it up, and they didn’t follow the procedure in the law to get to that point to be able to do a mandated recall.”

The FDA isn’t just concerned about Answers’ product. Its Center for Veterinary Medicine study, conducted from 2010 to 2012, found that out of 196 raw pet food samples, 15 tested positive for salmonella and 32 tested positive for Listeria monocytogenes.

“Based on the study’s results, CVM is concerned about the public health risk of raw pet food diets,” reads a statement on the FDA’s website.

The FDA warns salmonella contamination can lead to salmonellosis, a food-borne illness that causes around 19,000 hospitalizations and 380 deaths in the U.S. each year for humans, according to the Centers for Disease Control and Prevention.

Cases of salmonellosis in dogs and cats are uncommon, and those numbers are declining, the FDA said. In a survey conducted between 2012 and 2014 that tested 3,000 stool samples from dogs and cats, the FDA found fewer than 1 percent of cats and 2.5 percent of dogs tested positive for salmonella. But an infected pet or contaminated product can spread the disease to humans.

Jacqueline Hill, vice president of operations at Answers, and Keith Hill’s wife, has a degree in microbiology and said she became interested in raw diets while working in the veterinary industry. Around 2010, when Answers first put product on the market, Hill said many raw pet food companies were beginning to use a pasteurization process to make sure products wouldn’t be recalled for containing pathogens.

“That kind of freaked me out, because I wanted to make sure that there was a truly raw diet available to the end user,” she said, touting the digestive benefits of such a diet.

Instead of pasteurizing or cooking its product, Answers uses a fermentation process, which favors the growth of healthy bacteria. It “actually enhances the nutrition of the food, which to me is a win-win,” Hill said.

But the FDA isn’t alone in objecting to a raw diet for pets. The American Animal Hospital Association, for example, advises against it in an online position statement endorsed by the American Association of Feline Practitioners and the National Association of State Public Health Veterinarians.

“Based on overwhelming scientific evidence, AAHA does not advocate nor endorse feeding pets any raw or dehydrated nonsterilized foods, including treats that are of animal origin,” the statement said.

The FDA recommends that pet owners who feed their pet a raw diet not “kiss” their pet around its mouth or let it lick their face, especially right after the dog has eaten.

Central to Answers’ case is an accusation that the FDA has not followed the proper rulemaking process for creating guidelines on salmonella, and instead refers to a so-called Non-Binding Compliance Policy Guide to unlawfully crack down on raw pet food companies.

In a complaint filed in Colorado district court, Dickson Law Group, on behalf of Answers, names the Food and Drug Administration, Association of Feed Control Officials, Colorado Department of Agriculture, and United States Department of Health and Human Services, along with several state officials (who enforce FDA policy) as defendants.

Answers seeks to restrain the defendants from “enforcing their rules and/or guidance policies in that the presence of any amount of Salmonella in pet food renders that pet food adulterated in which such rules and/or guidance policies do not meet the requirements, criteria and procedures of the Food, Drug and Cosmetic Act.”

O’Keefe said Chief Judge Philip Brimmer has told him to be ready to bring the case to trial within 60 days.

According to Keith Hill, there are currently no restraints on the company continuing to manufacture and distribute. But Answers is taking a proactive stance.

“If we don’t address this issue now, what ends up happening is the FDA will continue to put out warning letters,” Hill said. “They will continue to threaten [us] with legal and monetary consequences.”

Note: This story first appeared at csindy.com.