FDA Warns Darwin’s: Clean Up Your Act or Face The Regulatory Music

A damning FDA warning letter sent to Darwin’s Natural Pet Food this week tells the raw pet food company clean up its act or face the regulatory music. The company is being given fifteen days to shape up or ship out after the agency has repeatedly warned the company about significant pet food safety fails.

This news follows on the heels of a full-on FDA investigation of the company in February. The FDA took the unusual step of publicizing a blistering report on the company and warn the public of an ongoing pattern of contaminated pet food sold by Darwin’s.

Darwin’s pet food company has fielded hundreds of serious complaints, some dating back almost two years ago. The complaints include reports of pet illnesses associated with the raw pet food, descriptions of sharp pieces of bones in the food, difficulty swallowing and digesting the bone fragments, off-color and foul-smelling pet food in leaky packaging. Federal and state food inspectors repeatedly found multiple violations at Darwin’s pet food plant and testing found the pet food contaminated with pathogenic bacteria. Repeated testing discovered the pet food was contaminated with Salmonella, Listeria, and Shiga toxin-producing Escherichia coli O128.

WHAT COMPLAINTS?

But Gary Tashjian, president, and owner of Darwin’s told the inspectors his company hadn’t received any specific complaints regarding Salmonella, E. coli or Listeria, according to a draft report from the inspectors. Unfortunately, that claim came back to bite him in the behind when inspectors found the company logged 332 complaint entries, including complaints of foreign material, spoiled and leaking packages, and pet illnesses and deaths. Tashjian said in an email to his distributors “We have not received any reports [of illnesses] from customers regarding these meals, and are taking these steps out of an abundance of caution.” An abundance of caution.

SALMONELLA KILLS

The saddest story is of a poor little kitten that suffered and died after being fed Darwin’s Salmonella tainted cat food. Salmonella was isolated from both the sick kitten and from an unopened package from the same lot of the raw cat food consumed by the kitten. The kitten’s necropsy indicated a severe systemic Salmonella infection, and Salmonella was isolated from the kitten’s liver. Scientific analysis showed that the Salmonella found in the kitten liver was identical to the Salmonella isolated from the same lot of Darwin’s raw cat food the kitten ate, indicating that the food more than likely caused the illness and death of the kitten.

NO, IT DOESN’T

If you hear Tashjian tell it, Salmonella doesn’t kill pets: “Most animal-health experts agree that pets are generally not affected by pathogens like Salmonella or E. coli unless they are already ill with some other condition,” said Tashjian. Later, in a statement released by the company, Tashjian firmly denied there to be a problem with Salmonella stating, “…most dogs’ and cats’ digestive systems are able to process pathogens such as Salmonella without harm (we are aware of a single case of a pet being affected, which involved a dog who was already will with other conditions).”

REPEATED VIOLATIONS

The agency’s warning letter gives a running tally of the number of times the government caught the company selling contaminated pet food:

November 29, 2017, pet food tested positive for Salmonella;
November 27, 2017, pet food tested positive for Salmonella and Listeria monocytogenes;
November 29, 2017, pet food tested positive for Salmonella;
December 21, 2017, a nationwide Class I recall (based on Salmonella and Listeria monocytogenes posing acute, life-threatening hazards to health) for the pet food lots that tested positive for Salmonella and Listeria monocytogenes;
February 1, 2018, pet food tested positive for Salmonella;
February 6, 2018, pet food tested positive for Salmonella;
February 13, 2018, a nationwide Class I recall (Salmonella poses an acute, life-threatening hazard to health) was initiated after FDA notified Darwin’s of the pet food sample results;
March 19, 2018, pet food tested positive for Salmonella;
March 20, 2018, pet food tested positive for Salmonella and Shiga toxin-producing Escherichia coli O128;
March 16, 2018, pet food tested positive for Salmonella;
March 16, 2018, another pet food tested positive for Salmonella;
March 26, 2018, a nationwide Class I recall (Salmonella poses an acute, life-threatening hazard to health) was initiated after FDA notified Darwin’s of the pet food sample results;
Even though sources of meat in two pet food products were different, the analysis indicated that the Salmonella strains are identical, suggesting pathogen contamination in Darwin’s facility;
FDA has concerns about the use of bacteriophages because the agency is unaware that they are generally recognized as safe (GRAS).

Darwin’s recurring pet food safety violations indicate a pattern of problems that the company apparently has the inability to control or lack of interest in doing so.

FAILURE TO ACT RESPONSIBLY

The agency stated the obvious, that it the responsibility of the company to ensure that they are not producing an unadulterated product. The FDA also warns that “unlike other human and pet foods which are heat-treated or are intended to be cooked, raw pet food has the potential to pose a significant risk to human and animal health because raw pet food is produced with minimal processing and is intended to be handled by humans and fed to animals without cooking, which would kill potentially harmful pathogens.”

FIX IT OR FORGET IT

The FDA has put Darwin’s on notice: Take prompt action to correct the violations, and establish and implement procedures that will prevent these and other violations in the future. If Darwin’s can’t pull that off, then the FDA warns the company that a “Failure to implement lasting corrective actions may result in FDA taking further regulatory action, such as seizure and injunction, without further notice.”

A CASE STUDY

Darwin’s warning letter serves as an example of what can happen if a pet food company fails to produce a safe product. In particular, this is a warning to other raw pet food manufacturers that the agency has a specific concern for foods that do not undergo a kill-step. With every new raw pet food recall, and subsequent bad press reports validate the government’s criticism of the raw pet food sector, further solidifying their rationale in focusing their efforts on pet food that is more likely to be contaminated than a pet food that has undergone a kill-step over one that has not. Essentially, reports like this paint a bigger target on raw pet food’s back.

HEALTH RISKS ASSOCIATED WITH CONTAMINATED FOOD

Pathogenic bacteria can cause serious infections in people who handle contaminated food. It can also contaminate surfaces, containers, and utensils, which can spread the bacteria to foods, hands, and anything coming into contact with the contaminated items.

PET FOOD SAFETY TIPS

Do not feed your pet any food that appears to be spoiled, off-color, off-odor, or otherwise defective.
Take special care to avoid any drippings from thawed food that could contaminate your work surfaces.
If your pet is suffering from diarrhea, be extra careful about washing your hands before handling or preparing food.
Be aware that you can infect yourself with Salmonella or Listeria by spreading microscopic amounts of the bacteria from the contaminated food to your mouth.
If you get Salmonella or Listeria on your hands or clothing, you can’t see it or smell it, but you can spread the bacteria to other people, objects, and surfaces.
Thoroughly wash your hands with soap and water for at least 20 seconds.
Thoroughly clean and disinfect all surfaces and objects that come in contact with pet food.

WHAT TO DO IF YOU A PROBLEM

People who think their pets have become ill after consuming contaminated raw pet food should contact their veterinarians. Veterinarians who wish to have dogs tested for Salmonella or other pathogenic bacteria may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.

If you believe your pet has become ill from consuming a pet food, please provide the FDA with valuable information by reporting it electronically through their Safety Reporting Portal or call your local FDA Consumer Complaint Coordinator.

If you and your veterinarian think a pet food or treat is the source of a problem – save it – because your state agricultural or veterinary diagnostic lab may want to do testing. Find out how to report a pet food complaint to the FDA. If you have any questions about this process or need my help with anything else, please don’t hesitate to write me at molliemorrissette@poisonedpets.com. I’m happy to help.

SINCE YOU’RE HERE …

… I have a teensy weensy favor to ask. Believe it or not, Poisoned Pets’ independent, investigative journalism takes a lot of time, money and hard work to produce. And I do it all on a tattered shoestring, but I do it because I believe this work matters – because it might save your pets life.

If everyone who reads my reporting, who likes it, and helps fund it, the future of Poisoned Pets would be much more secure. For as little as $1, you can support Poisoned Pets – and it only takes a minute. Please donate – even if it’s a tiny amount – to help Poisoned Pets.

MORE ABOUT DARWIN’S