FDA warns Darwin’s in follow-up to sick cat complaint

The US Food and Drug Administration (FDA) has issued a stern warning to Arrow Reliance Inc. (doing business as Darwin’s Natural Pet Products), following what the agency referred to as an “inadequate” response to violations of the Food Drug and Cosmetics Act (FD&C Act) documented during an August-September 2022 inspection.

The inspection was carried out in response to a consumer complaint received by the FDA, in which the consumer reported that a Darwin’s cat food had caused illness in three kittens. The consumer provided documentation that a stool sample from one of the kittens tested positive for Salmonella.

Background

On July 8, 2022, the FDA was contacted by a consumer who complained that Darwin’s cat food had made her three kittens ill.

The FDA collected unopened packages of the suspect food from the consumer and found Salmonella in two samples.

With the Salmonella-positive results in hand, the FDA urged Darwin’s to initiate a recall of the contaminated products.

The company refused, and the FDA advised Darwin’s that the agency would issue a public caution.

On July 29, 2022, Darwin’s filed a request in federal court for a temporary restraining order to prevent the FDA from releasing information about the contaminated products to the public.

The court rejected the company’s request, and on August 5, 2022, the FDA finally was able to issue a caution to pet owners, advising them not to feed certain Darwin’s cat foods to their pets due to Salmonella contamination.

On August 23, 2022, the FDA began an inspection of Darwin’s manufacturing facility and, on September 30, 2022, handed a completed list of Inspectional Observations (FDA Form 483) to the company.

The company’s Director of Quality replied to the list of observations on October 14th.

What Darwin’s claims

Darwin’s claims that its Salmonella-contaminated raw pet foods are not adulterated, because (a) the microbe is not an “added substance,” and (b) it is up to the FDA to demonstrate that the Salmonella is present at a level that makes it “ordinarily injurious” to the intended consumer.

In its filing for the temporary restraining order, the company made reference to USDA enforcement policies for Salmonella and questioned why it should be acceptable for the pathogen to be present in raw poultry, beef and other meats for human consumption, but not in pet food.

Unresolved issues

1. Adulterated Animal Food

The FDA collected and analyzed unopened samples from the complainant.

One of the samples contained Salmonella Typhimurium, a serotype well known to cause both human and animal illness.

A second sample contained both Salmonella Typhimurium and Salmonella Kentucky, another serotype known to cause disease.

A third sample collected during the inspection of Darwin’s manufacturing facility also yielded Salmonella Typhimurium.

Because Salmonella can cause serious–sometimes fatal–illness in humans and in animals, the FDA considers the presence of the microbe at any level to be hazardous if the food is meant to be consumed without cooking.

Therefore, the three lots of Salmonella-contaminated cat food were adulterated within the meaning of the FD&C Act, according to the Warning Letter.

2. Use of an Unapproved Food Additive

In 2021, the FDA expressed its concern to Darwin’s regarding the company’s use of peroxyacetic acid (PAA) as an additive to control pathogens in its raw pet foods, as the chemical was not “generally recognized as safe” (GRAS) for the intended use.

During the 2022 inspection, the FDA observed that PAA was still being added to the pet foods, and that the company had increased the level of PAA to a concentration significantly higher than the recognized maximum safe level for its use in any food.

The FDA was unable to find any scientific data to indicate that the concentration of PAA incorporated into Darwin’s pet foods was safe for dogs or cats to consume.

The agency also reviewed documentation of a third-party lab study, undertaken on Darwin’s behalf, to validate the ability of PAA to control pathogens in the company’s raw pet foods. The FDA concluded that the level of pathogen control demonstrated during the study was inadequate to ensure a pathogen-free state in the company’s finished products.

3. Food Facility Registration

Under the FD&C Act, Darwin’s is required to register with the FDA as a “food facility.”

The company has long insisted that it supplies its products directly to customers and, as a “retail food establishment,” is exempt from this mandate.

However, Darwin’s ships the majority of its products to customers through third-party warehouses rather than directly from its manufacturing facility. Therefore, the company does not meet the definition of “retail food establishment” under the FD&C Act.

What happens next?

The company was given fifteen (15) working days to respond to the issues raised in the Warning Letter.

In the absence of a satisfactory response, the FDA may undertake legal action, including the possibility of seizure of products and/or seeking an injunction against the company.

Want to learn more about pathogens and other problems in commercial pet food?

Pre-order the digital edition of TOXIC today for automatic delivery on June 22, 2023.

Available from Amazon, Apple, Barnes & Noble, Kobo, and Smashwords.

Darwin’s Natural Pet Products silent recall surpassed 11 tons of raw dog food

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

On February 7, 2019, in a move announced only via email to its direct customers, Arrow Reliance, doing business as Darwin’s Natural Pet Products (Darwin’s), recalled 11.7 tons of raw dog food.

The recall was first divulged to the public on March 26, 2019, by the US Food and Drug Administration (FDA) via a news release cautioning pet owners to avoid feeding the recalled products.

According to the FDA Enforcement Report issued on April 3, 2019, the recall encompassed:

Natural Selections Turkey and Vegetable Meals for Dogs, frozen, raw dog meals, packaged in 2 lbs. thermo-formed sealed plastic package, divided into 8 oz. portions. Lot #5339, manufactured on 10/26/18 (listed as 5339(11)181026 on the label)
Natural Selections Chicken and Vegetable Meals for Dogs, frozen, raw dog meals, packaged in 2 lbs. thermo-formed sealed plastic package, divided into 8 oz. portions. Lot # 5309, manufactured on 10/19/18 (listed as 5309(11)181019 on the label)
•Natural Selections Chicken and Vegetable Meals for Dogs, frozen, raw dog meals, packaged in 2 lbs. thermo-formed sealed plastic package, divided into 8 oz. portions. Lot # 5375, manufactured on 11/6/18 (listed as 5375(11)181106 on the label)

Although Darwin’s claimed to have notified all of its affected customers via email of the Salmonella contamination, Food Safety News has learned that at least one customer did not receive the initial notification.

When FDA is concerned as to the effectiveness of a company’s recall action, the agency has the authority to request distribution information in order to audit the recall, as detailed within the agency’s Investigations Operations Manual.

According to a Product Information Update posted on the company’s website on March 27, 2019, Darwin’s declined to furnish distribution information to FDA, citing their customers’ right to privacy.

Darwin’s ships its products directly to end users, and does not use third-party distributors, wholesalers or retailers.

In its March 27th update, Darwin’s further claimed that FDA’s March 26th news release was in retaliation for the company’s refusal to share customer contact information.

When asked to respond to this allegation, an FDA spokesperson told Food Safety News, “The FDA’s first priority is to protect public health. In accordance with this mission, we want to ensure that anyone who may have purchased or used violative product is informed of the issue and the health risk, so that they can take appropriate steps to protect themselves and their pets. In the absence of an adequate public notification by the firm, or confirmation from the firm that it has promptly and effectively communicated the recall to all customers, the agency may issue its own public notification.”

Commenting on Darwin’s characterization of the company’s message to its customers as a warning, not a recall, the spokesperson added, “The FDA considers the actions taken by Arrow Reliance to remove the violative product from the marketplace to meet the regulatory definition of a recall.”

Finally, Darwin’s reiterated a past claim that Salmonella is not a concern for healthy animals, citing “information from experts” on FDA’s website.

The citation in question was a research article that concluded, in part, “This study suggests an overall decline in the prevalence of Salmonella-positive dogs and cats over the last decades and identifies consumption of raw food as a major risk factor for Salmonella infection.” (emphasis added).

The same study determined that almost half of the Salmonella-positive animals did not suffer from diarrhea.

Salmonella-infected animals are still capable of passing the bacteria in stool and infecting their human companions or other animals.

Salmonella-contaminated pet foods have caused illness in both pets and humans in the past. Most recently, a raw turkey meat pet food was linked to cases of Salmonella illness that were part of a nationwide outbreak of multidrug-resistant Salmonella Reading infections.

FDA recommendations to consumers

If you have Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs (5309(11)181019 and 5375(11)181106) or Darwin’s Natural Pet Products Natural Selections Turkey Recipe with Organic Vegetables for Dogs (5339(11)181026), stop feeding it to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it.
Consumers who have had this product in their homes 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. Consumers should thoroughly wash their hands after handling the recalled product or cleaning up potentially contaminated items and surfaces.
People who think their pets have become ill after consuming contaminated pet food should first contact their veterinarians. 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.

Incident timeline

December 27, 2018, FDA received a pet illness complaint from a consumer, citing Darwin’s product. FDA obtained three intact packages of Darwin’s raw dog food from the consumer and found Salmonella in all three.
On or about the week of January 28, 2019, FDA notified Darwin’s of their findings and recommended a voluntary recall. Darwin’s notified by email those customers who had received product from one or more of the contaminated lots but declined to issue a public recall notice.
February 7, 2019, Darwin’s posted a Product Information Update on their website, acknowledging the incident.
March 26, 2019, FDA issued a caution to pet owners, informing the public of Darwin’s Salmonella contamination.
March 27, 2019, Darwin’s issued a second Product Information Update, rebutting FDA’s public statement.

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