Darwin’s Response to FDA Public Caution Statement

The other side of the story.

Below is the Darwin’s response to the FDA caution statement issued yesterday 3/26/19. This was received directly from Darwin’s Pet Food (and will be issued in a public press release).

Darwin’s Natural Pet Products Disputes FDA Warning
FDA offers no scientific rationale for zero-tolerance policy

SEATTLE March 27, 2019 – Today Darwin’s Natural Pet Products disputed an FDA warning regarding pathogens in its raw pet food. The FDA tested three lots of Darwin’s poultry meals, produced in October and November of last year, and claimed to find the presence of Salmonella in them. Darwin’s stated that the warning was inappropriate, as there is no inherent public health risk, and that customers were already aware of the situation as a result of the company’s own communications. Further, the FDA informed Darwin’s that it was issuing the warning because Darwin’s refused to turn over customers’ personal contact information which the FDA demanded to receive.

“We dispute both the recent FDA warning and as well as its policy.” said Gary Tashjian, Darwin’s Natural Pet Products president. “The public warning is inappropriate because we’ve already notified our customers directly via email about this situation on two occasions. More importantly, our customers have told us that this food was consumed by their pets long ago, with no medical issues reported. The facts show that there is no safety risk here.”

Darwin’s sells its meals directly to pet owners, and as a result of that direct relationship with its customers, the company keeps track of customer comments and complaints and can tell quickly if there are problems with its meals by looking for patterns in those calls. Since the product was produced and sent to customers almost four months ago, past experience, supported by customer feedback, indicates that all of this product had already been consumed without any evidence of problems.

Salmonella is inherent in raw poultry products and is unlikely to pose danger to most pets, or to humans when properly handled. Because of this, the USDA, which regulates meat and poultry for human consumption, allows for some presence of Salmonella in raw poultry. All of Darwin’s
ingredients, which are USDA-approved, meet these standards for human consumption. The FDA, however, which regulates pet food, maintains a zero-tolerance policy which disallows any presence of Salmonella, even in quantities too low to cause harm to either humans or pets.

“We find ourselves in the same situation as many other raw pet food companies have found themselves over the past year – having to decide whether to issue a recall for products that we believe are safe for pets, but which do not meet the standards set by the FDA,” said Tashjian. “We believe that the FDA has failed to demonstrate any scientific basis for establishing standards for pet food that are more stringent than the USDA sets for food intended for human consumption. Darwin’s believes that the FDA’s policy is misguided.”

In this instance, the FDA’s test records raised questions as to whether Salmonella was present in the food at all. Moreover, the FDA failed to provide Darwin’s with “split samples” (i.e., retained samples of the tested product) to enable the company to perform its own independent tests to confirm the FDA’s findings – even though the FDA is required by law to do so.

“For all of these reasons, we do not believe that the facts support a recall of these products, which is why we have refused to do so,” said Tashjian. “We also believe that the FDA’s demands for our customers’ personal information infringes on their right to privacy, and is inappropriate under the circumstances.”

Darwin’s encourages its customers and anyone who raw feeds their pet to contact the company for more details about how the company came to this decision. A special toll-free number has been set up for inquiries: 866-832-8319 (Monday-Friday from 6am to 6pm, and Saturday 7am-3pm Pacific Time).

End of Darwin’s statement.

Personal opinion: From personal experience, I can say with confidence this sentence from the Darwin’s response is absolutely true: “We believe that the FDA has failed to demonstrate any scientific basis for establishing standards for pet food that are more stringent than the USDA sets for food intended for human consumption.” I have personally seen email after email from multiple different parties that asked FDA for scientific basis of their zero tolerance for pathogenic bacteria in raw pet food (such as which strains of Salmonella cause pet illness? and how many bacteria of each strain of Salmonella that is known to cause illness does it take to actually cause illness?). The FDA has NEVER given anyone a response. I’ve also asked FDA for the scientific evidence of the safety of rendered sick and dead animals used in pet food (allowed by FDA in pet food with no warning to the pet owner). The FDA response: “We could not find the requested records.” How can the FDA properly regulate pet food if their internal rules are not based on sound scientific evidence? They can’t.

As to Darwin’s statement that FDA did not provide the company with split samples – this is the same complaint numerous other raw pet foods that were forced to recall has stated. Providing a split sample is a legal requirement of any regulatory body. Government agencies are required by law to provide the company a split sample of the product they tested. Ignoring this legal requirement with some styles of pet food is NOT the proper way to regulate.

We aren’t asking for special exceptions to be made for raw pet food. Instead we are asking for uniform enforcement of law (actual law, not FDA policies) – uniform enforcement of law across all styles of pet food. FDA’s internal policies that allow the pet feed industry to utilize illegal wastes from the processing of human food while at the same time holding raw pet food to standards above that of human food is NOT uniform enforcement of law.

Direct your emails to FDA at AskCVM@fda.hhs.gov

My thanks to Darwin’s Pet Food for their transparency in this issue with me and the public.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
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