FDA finds Salmonella in three lots of Darwin’s raw dog food; cautions pet owners


This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission

The U.S. Food and Drug Administrations (FDA) cautioned pet owners not to feed certain Darwin’s Natural Pet Products raw dog foods after finding Salmonella in the products.

FDA collected and analyzed unopened packages from the products in response to a consumer complaint.

The products were manufactured by Arrow Reliance, Inc. (Arrow), a company based in Tukwila, Washington and doing business as Darwin’s Natural Pet Products.

The products that are affected by FDA’s alert to pet owners are:

  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs: 5309(11)181019, manufactured on October 19, 2018
  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs: 5375(11)181106, manufactured on November 11, 2018
  • Darwin’s Natural Pet Products Natural Selections Turkey Recipe with Organic Vegetables for Dogs: 5339(11)181026, manufactured on October 26, 2018

Arrow has taken steps to remove these products from the marketplace, but has not issued a public notification, according to the FDA. The agency is concerned that the company’s customer notifications may not be effective, and is working with Arrow on recalling the remaining products from these lots.

In a statement released on its website today, Darwin’s expressed its disappointment in FDA’s decision to issue a public warning. The company also asserted its belief that its products do not pose any danger to either humans or pets, and stated that it had received no medical reports of illnesses attributable to these meals.

Animals infected with Salmonella may suffer symptoms that include vomiting, diarrhea (sometimes bloody), fever, loss of appetite and decreased level of activity. An infected animal may not exhibit any symptoms but may still shed the bacteria in its feces, passing the infection to human companions.

Salmonella can cause illness and death in humans and in animals. People infected with Salmonella may develop diarrhea, fever and abdominal cramps. The elderly, the very young, and individuals with weak immune systems are more prone to suffering severe symptoms, including secondary infections in other organs.

What consumers should do

  • If you have purchased one of the affected products, discard it in a secure container to prevent children, pets or wildlife from accessing it. * If you have had one of the affected products in your home, you should clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Clean up the pet’s feces in yards or parks where people or other animals may become exposed. Remember to thoroughly wash your hands after handling the recalled product or cleaning up potentially contaminated items and surfaces.
  • If you or a member of your household becomes ill, contact your health care provider.
  • If you think your pet has become ill after consuming contaminated pet food, contact your veterinarian. Veterinarians who wish to have pets tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.
  • The FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators

Human Salmonella illness linked to raw pet food


This story by Phyllis Entis was first published in Food Safety News and is reposted here with permission.

A confirmed case of Salmonella Infantis illness has been linked to a raw pet food manufactured by Arrow Reliance, Inc., dba Darwin’s Natural Pet Products (Darwin’s), according to updated information released by the U.S. Food and Drug Administration (FDA).

The infected individual is one of 92 people infected with a multidrug-resistant Salmonella Infantis outbreak since the beginning of 2018 according to the Centers for Disease Control and Prevention (CDC).

The individual reported having become ill after household pets ate raw ground chicken pet food manufactured by Darwin’s. According to a spokesperson for CDC, this individual did not report any pet illnesses.

The Salmonella Infantis outbreak has spread over 29 states and hospitalized 21 individuals.

Outbreak victims reported eating various brands and types of chicken products. A single, common supplier of either raw chicken products or live chickens has not been identified, according to CDC.

The outbreak strain has been recovered from samples of raw chicken products, from live chickens, and from raw chicken pet food.

According to a spokesperson for FDA, the outbreak strain is likely related to the Salmonella strain recovered from an adult dog that had recurring diarrhea as a result of consuming contaminated raw chicken dog food manufactured by Darwin’s.

The raw pet food fed to the infected dog also tested positive for Salmonella.

Darwin’s initiated a total of five voluntary recalls between October 17, 2016, and March 26, 2018, after being informed that Listeria monocytogenes, Salmonella, and E. coli O128 were found in some of the company’s raw pet food products.

CDC is reminding pet owners that Salmonella and other pathogenic bacteria in raw pet food can make pets sick. Household members also can become infected by handling the raw food or when caring for an infected pet.

FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.

Darwin’s QA program evolves in response to FDA enforcement measures


The following story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission.

Arrow Reliance Inc., dba Darwin’s Natural Pet Products, is taking steps to correct multiple violations of the Federal Food, Drug, and Cosmetic Act discovered during an investigation of Darwin’s raw pet food manufacturing facility in December 2017 and January 2018.

The Food and Drug Administration detailed the problems in a warning letter April 2.

A redacted copy of Darwin’s response letter was obtained by Food Safety News in response to a Freedom of Information Act request.

The investigation was triggered by a series of product recalls announced by the company in late 2017 due to Salmonella contamination in samples of Darwin’s raw frozen pet foods, following customers’ complaints of a kitten death and other ill pets. The joint investigation was carried out by the FDA and the Washington State Department of Agriculture (WSDA).

The FDA warning letter, and the Establishment Inspection Report that preceded it, highlighted several issues, including:

  • Bacterial pathogens (Salmonella, Listeria monocytogenes and/or E. coli O128) present in samples of various Darwin’s Natural Selections and ZooLogics brands of raw pet food;
  • The identical strain of Salmonella was recovered from both the dead kitten and a sample of food that had been fed to the kitten;
  • The protocol used by Darwin to reduce pathogen contamination through the application of bacteriophages had not been validated;
  • Failure to conduct operations under cGMPs (current Good Manufacturing Practices)
  • Raw materials not thawed under conditions that would minimize potential for growth of undesirable pathogens;
  • Animal food contact surfaces not made of appropriate materials or maintained to protect animal food from becoming contaminated; and
  • Equipment and utensils not used appropriately to avoid adulteration of animal food with contaminants.

In its response to the FDA warning letter, Darwin officials reported conducting a risk assessment to identify the root cause or causes of contamination. Based on the results of their assessment, the company concluded that the primary source of their contamination problem was pathogens present in some raw materials. 

To address that issue, Darwin has adopted new approaches to reducing or eliminating pathogens in those raw materials, including:

  • Requiring all meat suppliers and produce suppliers to use a pathogen-reducing treatment (details redacted) prior to shipping raw materials;
  • On-site audits of meat suppliers and primary produce supplier;
  • Pathogen testing conducted by an independent testing lab of a number of inbound raw materials;
  • Additional “interventions” that are being evaluated (details redacted) for possible inclusion in the company’s processes to further reduce pathogen levels;
  • Increasing the dosage of bacteriophages to match the manufacturer’s “standard” recommended dosage and tested a revised method of application; and
  • Conducting validation tests, which were carried out by an independent testing lab, to confirm the effectiveness of the higher bacteriophage dosage and revised application method.

According to Darwin’s response letter, in 2016, the company hired a Quality Assurance (QA) manager who developed the company’s first formal Standard Operating Procedures (SOPs) and Sanitation Standard Operating Procedures (SSOPs) and expanded the company’s sanitation and environmental testing programs. Prior to 2016, the sanitation and quality assurance functions were handled by the production department.

In response to the violations detailed in the FDA warning letter, the company expanded its QA team, adding an assistant manager and technicians. It also conducted a comprehensive review and update of its Good Manufacturing Practices (GMPs) conducted training sessions for employees, and corrected other issues raised by FDA and WSDA inspectors during the inspections initiated in December 2017 and completed in January 2018.

When asked to comment on the remedies outlined in Darwin’s response letter, a spokesperson for FDA said “… we aren’t able to share … any information about discussions with firms regarding their responses to warning letters.”

FDA’s investigation remains open, according to the agency spokesperson.