JBS knowingly distributed pentobarbital-adulterated products

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

JBS Souderton Inc. continued to distribute pentobarbital-adulterated products to customers even after receiving formal notification of pentobarbital contamination, according to a warning letter issued on April 23 by the Food and Drug Administration.

The warning letter to JBS Souderton Inc., which does business as MOPAC, was sent more than one year after pentobarbital was first discovered in beef tallow from the company’s Souderton, PA, facility.

Pentobarbital is a barbiturate used by veterinarians to euthanize animals, including companion animals, horses and cattle. According to the FDA, pet foods containing even a trace amount of pentobarbital are considered adulterated. It is against federal law to release “adulterated” products into the stream of commerce.

JBS was the supplier of beef tallow to Big Heart Pet Brands Inc. and to Champion PetFoods, among others.

Big Heart is a wholly owned subsidiary of The J.M. Smucker Company Inc. Champion is a Canadian pet food company whose U.S. production facility is in Auburn, KY. It manufactures Acana and Orijen brands of dry dog food.

In February 2018, a media outlet reported having found pentobarbital in several samples of Gravy Train canned, wet dog food. Smucker initiated a product withdrawal of the implicated products pending the outcome of its internal investigation.

Concurrently, FDA alerted pet owners about the possible presence of pentobarbital in the several dog food brands, including Gravy Train, Kibbles ’N Bits, Ol’ Roy and Skippy.

Smucker converted its withdrawal into a full-blown recall once company officials had confirmation of the presence of pentobarbital in its finished product and in samples of beef tallow supplied by JBS.

As part of its investigation into the Big Heart, FDA and the Pennsylvania Department of Agriculture conducted a joint inspection of JBS beginning March 13, 2018.

According to the warning letter, FDA found pentobarbital in four out of nine samples collected at the JBS facility. Upon further analysis, three of the samples were found to contain pentobarbital at levels ranging from 61.8 +/-19 to 277 +/-70 nanograms per gram (ng/g), well above the minimum detection concentration of 4 ng/g.

The four pentobarbital-contaminated products were delivered to customers from November 2017 through March 2018.

Samples collected from JBS and from its customers’ facilities and analyzed by Pennsylvania officials found levels of pentobarbital as high as 680 ng/g.

The list of Inspectional “Observations” in the FDA’s Form 483, provided to JBS management on Oct. 17, 2018, contained two items:

JBS did not visually verify loads of raw materials with what the hauler stated that they brought in. This led to tallow, manufactured at [the JBS] facility, to be adulterated with pentobarbital.
JBS did not have an effective system for evaluating incoming raw materials to ensure that these ingredients are suitable for use in human products and animal feeds.

JBS officials informed the FDA on April 17, 2018, that the company had completed cleaning all of its conveyances, conduits, cookers and centrifuges, and some of its storage tanks to remove any pentobarbital-contaminated product. In a May 30, 2018, letter, JBS management indicated the company would complete the cleaning process within an additional 30 days.

The company officials also reported having identified and talked with all of its suppliers that may have presented a risk for entry of euthanized animals into the rendering plant, and obtained a guarantee from each supplier that they would not provide euthanized animals. JBS also indicated it would continue to conduct random tests of tallow products for pentobarbital.

On July 27, 2018, the FDA took a follow-up sample from one of the JBS storage tanks. Upon analysis, the sample was found to contain trace amounts of pentobarbital.

On Aug. 8, 2018, the FDA inquired what actions JBS planned to take in response to the pentobarbital finding.

The company declined to recall the product. Instead, JBS offered to ask animal food producing customers that received animal food products to remove any products deemed positive for pentobarbital and to have their tanks cleaned.

JBS described its product withdrawals and attempted withdrawals of pentobarbital-contaminated product from its customers in a Nov. 26, 2018, letter to the FDA.

In its warning letter, the FDA noted that it was unable to asses the effectiveness of the corrective actions in the absence of a voluntary recall or other documentation demonstrating all contaminated products were removed from the marketplace.

As reported by Food Safety News in November 2018, Champion PetFoods retrieved pet foods the contaminated tallow from its third-party distributors. The company declined to initiate a retail-level recall, even though some of the product had reached the store/consumer level. The refusal was based on laboratory test results on retained samples of those finished products that did not reveal pentobarbital.

JBS was given fifteen working days to notify the FDA in writing of the specific steps it has taken to correct the violations listed in the warning letter, or to provide a time frame within which the corrections will be completed.

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.

Lax testing practices resulted in vitamin D overdoses in Hill’s and Sunshine Mills pet food

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

Toxic levels of vitamin D in Hill’s Pet Nutrition (Hill’s) canned pet foods and Sunshine Mills (Sunshine) dry pet foods could have been prevented, had both companies followed their own food safety plans.

According to information obtained by Food Safety News in response to Freedom of Information Act (FOIA) requests, Hill’s identified Vitamin Premix as a ‘high risk’ chemical hazard and required that the ingredient “…be analyzed and be within acceptable limits prior to unloading … into the manufacturing facility.”

The company was unable to provide analytical test results for Vitamin Premixes during a February 2019 inspection.

The inspection was undertaken by the U.S. Food and Drug Administration (FDA) in response to the January 31, 2019 Hill’s recall of canned pet foods due to excess levels of vitamin D.

Tests conducted on a retained sample of the premix revealed a level of vitamin D that was roughly 30 times the target range for this ingredient. As of February 11, 2019, the company acknowledged having received 85 consumer complaints reporting pet deaths.

The number of complaints received by the company has increased substantially since that date, according to information supplied to FDA by Hill’s in response to FDA’s inspection observations.

FDA declined to comment on the number of pet deaths. According to an agency spokesperson, FDA is still in the process of verifying details of the complaints it has received, and considers it would be “…premature to release a number until the cases have been vetted to ensure they are all related to recalled product and are indeed cases of vitamin D toxicity.”

Hill’s cited a manufacturing error on the part of its vitamin premix supplier as the cause for the excessive vitamin D levels in its canned pet foods. The company is reevaluating and strengthening its specifications, including requiring a Certificate of Analysis for each incoming shipment of vitamin and trace mineral premixes.

In December 2018, FDA issued an alert to pet owners regarding a series of dry dog food recalls for excessive vitamin D levels. As reported by Food Safety News, FDA received a total of six dog illness reports associated with the recalled products.

The dry dog foods were manufactured by Sunshine Mills and sold under several brand names.

An ordering error by a Sunshine employee caused the wrong Vitamin D ingredient to be shipped to the company.

According to FDA, Sunshine did not follow its own written procedures for receiving ingredients. The company neither obtained a Certificate of Analysis for the ingredient, nor conducted its own testing to determine whether the Vitamin D it received was the correct concentration for use in dog food.

The error resulted in a level of Vitamin D in the finished dog foods of as much as 70 times the target amount.

Sunshine was notified on October 23, 2018 about a consumer complaint reporting an ill dog that had eaten one of the company’s dry dog foods. Sunshine investigated the complaint and concluded on November 2nd that it was valid.

FDA requires validated complaints to be reported within 24 hours; however, Sunshine did not submit a ‘reportable food report’ to FDA until six days later, on November 8, 2018.

Although the sources of elevated vitamin D were different in these two situations, the course of events was similar.

Both Hill’s and Sunshine took delivery of an ingredient that was substantially higher in vitamin D than specified for the purpose.
Both Hill’s and Sunshine had written procedures in place for receiving raw materials, and these procedures mandated testing for vitamin D concentration.
Neither Hill’s nor Sunshine carried out the lab analysis mandated in their written procedures.
Neither Hill’s nor Sunshine required a Certificate of Analysis for their Vitamin D ingredient or premixes.
Had Hill’s and Sunshine followed their own written procedures, the incorrect vitamin D ingredient concentration would have been found before the ingredient was used.

FDA’s investigation into Hill’s is ongoing, according to an agency spokesperson.

FDA offers the following information regarding vitamin D toxicity to pet owners and veterinarians.

If your pet is having symptoms of vitamin D toxicity, contact a veterinarian immediately. Provide a full diet history to your veterinarian. You may find it helpful to take a picture of the pet food label, including the lot number.
Don’t feed the recalled products to your pets or any other animal. Contact the company listed on the package for further instructions or throw the products away in a way that children, pets and wildlife cannot access them.
Consumers can report suspected illness to the FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. It’s most helpful if you can work with your veterinarian to submit your pet’s medical records as part of your report. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.
The FDA encourages veterinarians treating vitamin D toxicity to ask their clients for a diet history. We also welcome case reports, especially those confirmed through diagnostics. You can submit these reports electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.
Veterinarians should also be aware that vitamin D toxicity may present as hypercalcemia, similar to dogs that have consumed rodenticide. In these cases, FDA suggests that veterinarians confirm diet history to verify whether the dog has been eating any of the recalled products.

For a comprehensive list of Hill’s Pet Nutrition canned pet foods recalled due to excessive Vitamin D, please visit Hill’s Pet Nutrition recalls: Country-by-country breakdown on eFoodAlert