FDA, Smucker don’t agree on which dog foods are problem

The Food and Drug Administration alerted pet owners Friday about potential pentobarbital contamination in several brands of dog foods manufactured by The J.M. Smucker Co.

The warning came after a media outlet reported the results of a study that found low levels of pentobarbital in some samples of Gravy Train canned dog food. The drug is used to euthanize animals.

Based on the testing results provided to FDA, the agency has made a preliminary evaluation that the level of pentobarbital found in the samples is “unlikely to post a health risk for pets.”

However, the presence of pentobarbital at any level in pet food is a violation of the Federal Food, Drug and Cosmetic Act, and FDA therefore is investigating the potential source and route of contamination.

Smucker responded to the findings of the private study by initiating a voluntary business-to-business withdrawal of certain Gravy Train, Kibbles ’N Bits, Ol’ Roy and Skippy branded canned dog food from retailer warehouses.

According to FDA, the list of affected products (shown below) includes all lots of the specified products manufactured from 2016 through the present. The products were distributed to retailers across the USA.

A comparison of the FDA list to a list of 27 products provided to Food Safety News Thursday by a Smucker spokesperson reveals significant differences.

While all 18 products on the FDA list were included in the Smucker information, several Gravy Train, Skippy and Kibbles ’N Bits products named by the company were absent from the FDA list.

“Out of a desire to inform consumers quickly, earlier this week we published a list of products that included the ingredient that could have contained extremely low levels of pentobarbital, regardless of whether the products were manufactured during the withdrawal timeframe. The FDA chose to focus on products made within a specific timeframe,” a Smucker spokesperson told Food Safety News.

FDA is aware of these differences and has requested clarification from Smucker regarding the status of the additional products, according to a statement added to the agency’s consumer alert notice several hours after its initial release.

Although Smucker has not initiated a consumer-level product recall, as of Friday, Target, Walmart, PetSmart and the Department of Defense Commissary Agency (DeCA) have alerted their customers to the product withdrawals.

FDA advice to retailers, consumers
Retailers should remove the withdrawn pet food from their shelves and/or websites and contact the manufacturer for further instructions. If retailers have records to identify consumers who have purchased the withdrawn product, the FDA encourages those retailers to contact the consumers to alert about the product withdrawal.

Consumers should not feed their pets the withdrawn lots of canned dog food. Consumers who purchased these products should safely dispose of the cans and/or contact the Sucker company for information about returning the products.

Consumers who think their pets may be ill from eating food contaminated with pentobarbital should contact their veterinarians immediately.

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

In addition to certain Skippy and Kibbles ‘n’ Bits dog foods, the Smucker Co. is pulling Gravy Train and Ol’ Roy brands.

Canned dog food listed by the FDA as being included in the market withdrawal are:

Gravy Train with T-Bone Flavor Chunks, 13.2-ounce can, UPC 7910052541
Gravy Train with Beef Strips, 13.2-ounce can, UPC 791052542
Gravy Train with Lamb & Rice Chunks, 13.2-ounce can, UPC 7910052543
Gravy Train with Chicken Chunks, 13.2-ounce can, UPC 7910034418
Gravy Train with Beef Chunks, 13.2-ounce can, UPC 7910034417
Gravy Train with Chicken Chunks, 22-ounce can, UPC 7910051645
Gravy Train with Beef Chunks, 22-ounce can, UPC 7910051647
Gravy Train Chunks in Gravy with Beef Chunks, 13.2-ounce can, UPC 7910034417
Kibbles ‘N Bits 12-can Variety Pack – Chef’s Choice American Grill Burger Dinner with Real Bacon & Cheese Bits in Gravy, Chef’s Choice Bistro Tender Cuts with Real Turkey Bacon & Vegetables in Gravy, 12 pack of 13.2-ounce cans, UPC 7910010377, 7910010378
Kibbles ‘N Bits 12-Can Variety Pack – Chef’s Choice Bistro Hearty Cuts with Real Beef, Chicken & Vegetables in Gravy, Chef’s Choice Homestyle Meatballs & Pasta Dinner with Real Beef in Tomato Sauce, 12 pack of 13.2-ounce cans, UPC 7910010382, 7910048367, 7910010378
Kibbles ‘N Bits 12-Can Variety Pack – Chef’s Choice Homestyle Tender Slices with Real Beef, Chicken & Vegetables in Gravy, Chef’s Choice American Grill Burger Dinner with Real Bacon & Cheese Bits in Gravy, Chef’s Choice Bistro Tender Cuts with Real Beef & Vegetables in Gravy, 12 pack of 13.2-ounce cans, UPC 7910010380, 7910010377, 7910010375
Kibbles ‘N Bits Chef’s Choice Bistro Tender Cuts with Real Beef & Vegetables in Gravy, 13.2-ounce can, UPC 7910010375
Kibbles ‘N Bits Chef’s Choice Bistro Tender Cuts with Real Turkey, Bacon & Vegetables in Gravy, 13.2-ounce can, UPC 7910010378
Kibbles ‘N Bits Chef’s Choice Homestyle Tender Slices with Real Beef, Chicken & Vegetables in Gravy, 13.2-ounce can, UPC 7910010380
Ol’ Roy Strips Turkey Bacon, 13.2-ounce can, UPC 8113117570
Skippy Premium Chunks in Gravy Chunky Stew, 13.2-ounce can, UPC 79100502469
Skippy Premium Chunks in Gravy with Beef, 13.2-ounce can, UPC 7910050250
Skippy Premium Strips in Gravy with Beef, 13.2-ounce can, UPC 7910050245

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

Gravy Train, Ol’ Roy, other brands recalled for euthanasia drug

Smucker Co. downplays phenobarbital amid ‘withdrawal’ of four dog food brands

The J.M. Smucker Co. has voluntarily withdrawn certain shipments of 27 different pet food products following media reports of pentobarbital contamination in some of its Gravy Train dog food.

Pentobarbital is a tranquilizer that is often used as a euthanizing agent to put down sick or fatally injured animals.

A consumer-level product recall has not been initiated. As of Wednesday afternoon neither Smucker nor any government agencies had revealed whether any of the implicated dog food made it to retail shelves where the public has access to buy it.

Smucker’s spokesperson provided Food Safety News a list of the recalled dog food, which it has requested retailers remove from their warehouses. The list of recalled dog food provided by Smucker is as follows:

Gravy Train 13.2 oz. with T-Bone Flavor Chunks – UPC: 7910052541
Gravy Train 13.2 oz. with Beef Strips – UPC: 7910052542
Gravy Train 13.2 oz. with Lamb and Rice Chunks – UPC: 7910052543
Gravy Train 13.2 oz. with Beef Chunks – UPC: 7910034417
Gravy Train 13.2 oz. with Chicken Chunks – UPC: 7910034418
Gravy Train 13.2 oz. Chunks in Gravy Stew – UPC: 7910051933
Gravy Train 13.2 oz. Chicken, Beef & Liver Medley – UPC: 7910051934
Gravy Train 13.2 oz. Chunks in Gravy with Beef Chunks – UPC: 7910034417
Gravy Train 22 oz. with Chicken Chunks – UPC: 7910051645
Gravy Train 22 oz. with Beef Chunks – UPC: 7910051647
In addition to certain Skippy and Kibbles ‘n’ Bits dog foods, the Smucker Co. is pulling Gravy Train and Ol’ Roy brands.

Kibbles ‘N Bits 13.2 oz. Burger Bacon Cheese and Turkey Bacon Vegetable Variety 12-Pack – UPC: 7910010377; 7910010378
Kibbles ‘N Bits 13.2 oz. Beef, Chicken, Vegetable, Meatball Pasta and Turkey Bacon Vegetable Variety Pack – UPC: 7910010382; 7910048367; 7910010378
Kibbles ‘N Bits 13.2 oz. Beef, Chicken, Vegetable, Burger Bacon Cheese and Beef Vegetable Variety Pack – UPC: 7910010380; 7910010377; 7910010375
Kibbles ‘N Bits 13.2 oz. Wet Variety Pack – UPC: 791001037; 7910048367
Kibbles ‘N Bits 13.2 oz. Chef’s Choice Bistro Tender Cuts with Real Beef & Vegetable in Gravy – UPC: 7910010375
Kibbles ‘N Bits 13.2 oz. Chef’s Choice Bistro Tender Cuts with Real Turkey, Bacon & Vegetable in Gravy – UPC: 7910010378
Kibbles ‘N Bits 13.2 oz. Chef’s Choice Homestyle Tender Slices with Real Beef, Chicken & Vegetables in Gravy – UPC: 7910010380
Skippy 13.2 oz. Premium Select Cuts in Gravy with Beef & Bone Marrow – UPC: 7910071860
Skippy 13.2 oz. Premium Select Cuts with Burgers & Cheese Bits – UPC: 7910050243
Skippy 13.2 oz. Premium Chunks in Gravy with Smoky Turkey & Bacon – UPC: 7910050246
Skippy 13.2 oz. Premium Chunks in Gravy with Beef & Chicken – UPC: 7910050247
Skippy 13.2 oz. Premium Chunks in Gravy 3 in 1 Chicken, Beef & Liver – UPC: 7910050248
Skippy 13.2 oz. Premium Chunks in Gravy Chunky Stew – UPC: 7910050249
Skippy 13.2 oz. Premium Strips in Gravy with Chicken – UPC: 7910050244
Skippy 13.2 oz, Premium Chunks in Gravy with Beef – UPC: 7910050250
Skippy 13.2 oz. Premium Strips in Gravy with Beef – UPC: 7910050245
Ol’ Roy 13.2 oz Turkey Bacon Strips – UPC: 8113117570

Smucker initiated the product withdrawal following a Feb. 8 media report of low levels of pentobarbital contamination in some Gravy Train products.

The contamination was detected during the course of a study commissioned by WJLA, a Washington D.C. area station, according to a spokesperson from the Clean Label Project, which conducted the study for the news station. Gravy Train was the only brand of pet food included in the study that was found to contain pentobarbital.

The study was undertaken in response to the 2017 discovery of pentobarbital in brands of canned/wet dog food manufactured by Evanger’s Dog & Cat Food Co. Inc., an adulteration that resulted in illnesses of several pets and at least one death.

Beginning in October 2017, Clean Label Project obtained 99 retail samples of various brands of canned/wet dog food for pentobarbital analysis by Ellipse Analytics, a Denver laboratory.

The samples were analyzed to determine both the presence and the amount of pentobarbital in the dog foods, using test methods consistent with FDA protocols. According to Smucker, the amounts of pentobarbital found in their product “…do not pose a threat to pet safety.”

An FDA spokesperson told Food Safety News that the agency’s “…preliminary evaluation of the testing results of Gravy Train samples indicates that the low level of pentobarbital present in the withdrawn products is unlikely to pose a health risk to pets.

“However, pentobarbital should never be present in pet food and products containing any amount of pentobarbital are considered to be adulterated,” said the FDA spokesperson.

All of the products included on Smucker’s retailer recall list came from the same manufacturing facility. The company has narrowed its investigation to “…a single supplier and a single, minor ingredient…” used at that facility.

Jaclyn Bowen, the executive director of Clean Label Project expressed a lack of surprise at the pentobarbital findings.

“At Clean Label Project, we believe that sometimes what’s not on the label is what’s most important,” she said.

“Clean Label Project’s 2017 Pet Food Study revealed high levels of heavy metals, BPA, and acrylamide in some of the nation’s best selling pet food. The presence of pentobarbital in Gravy Train does not come as a surprise and the Evanger’s recall was not a one-off, rather the tip of the iceberg of an industry that needs to significantly improve its food safety and quality through testing.”

Smucker encourages pet owners with questions or concerns about this situation to contact the company by telephone 800-828-9980 or via email at: http://www.bigheartpet.com/Contact/ContactUs.aspx.

This story first appeared on Food Safety News and is reposted here with permission.

Evanger’s proposes donating recalled pet food. FDA says ‘no’

The United States Food and Drug Administration (FDA) has vetoed a proposal by Evanger’s Dog and Cat Food Co. to donate recalled pet food to animal shelters after conducting random spot-checks for pentobarbital.

The proposal was revealed in a June 29, 2017 Warning Letter issued by FDA, and released on its website Tuesday morning (July 4, 2017) under the agency’s standing policy to post recent Warning Letters on a weekly basis.

The letter addressed to Holly N. Sher and Joel A. Sher, President and Vice President, respectively, notifies them that FDA found “…serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations” during an investigation that included supplier traceback, facility inspection, and analysis of samples collected by FDA.

In its response to the Evanger’s proposal to donate recalled pet food, FDA said that finding the contents of individual cans of food from recalled lots to be negative for pentobarbital would not provide “…sufficient assurance that the remaining units are not adulterated.”

After stating that FDA’s own testing confirmed the pentobarbital contamination not to be homogeneous throughout an entire lot, the agency declined Evanger’s proposal and recommended destruction of all remaining recalled product.

The Warning Letter is the most recent development in an investigation of Evanger’s that began in early January with the reported illness of five dogs in a single household and the death of one of the dogs. Lab tests conducted on the gastric contents of the dead dog and on the remains of Evanger’s Hunk of Beef au Jus canned dog food that had been fed to all five of the animals, revealed the presence of a ‘large quantity’ of pentobarbital in both samples.

FDA opened its investigation immediately upon becoming aware of the incident. A team of inspectors began an on-site inspection of Evanger’s manufacturing facility in Wheeling, Illinois on January 10, 2017.

On February 14, 2017, the inspection team furnished Evanger’s management with a Form 483, listing a series of Inspectional Observations, including:

• Pentobarbital found in a sample of Evanger’s Hand Packed Hunk of Beef au Jus, 12 oz. can (Lot #1816E06HB13)
• Pentobarbital found in a sample of Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs, 12 oz. can (Lot #2415E01ATB12; BEST DEC 2019)
• Condensate dripping throughout the facility, including into open cans in-process and onto totes of raw meat
• Pitted, cracked and damaged floors
• Peeling paint, mold throughout the facility and a live ‘fly-like insect’ in the hand-packing area during processing
• Inadequate temperature controls

In addition to the two pentobarbital-positive samples cited in the February 14th Form 483, FDA has found pentobarbital in the following five production lots of Evanger’s dog food:

• Braised Beef Chunks, lot code 2016E08BBW11 Best Aug 2020.
• Hunk of Beef Au Jus, lot code 1816E14HBC18 Best June 2020.
• Hunk of Beef Au Jus, lot code 1816E02HB12 Best June 2020.
• Hunk of Beef Au Jus, lot code 1316E23HB09 Best Jan 2020.
• Hunk of Beef Au Jus, lot code 1816E03HB17 Best June 2020.

On March 3, 2017, Evanger’s voluntarily recalled all cans of Evanger’s Braised Beef Chuncks, Evanger’s Hunk of Beef Au Jus and Against the Grain Pulled Beef with Gravy manufactured between December 2015 and January 2017.

In correspondence dated 2/4/2017, 2/21/2017, 4/4/2017, 5/18/2017 and 5/23/2017, Evanger’s addressed FDA’s Inspectional Observations, and proposed a series of corrective actions. In addition to the proposed donation of recalled product, the following actions, listed in the Warning Letter, are those FDA found to be inadequate or unacceptable.

Evanger’s discontinued doing business with the meat supplier alleged by the company to be the source of the adulterated meat.

Evanger’s was unable to supply any documentation or evidence that the indicated supplier was the only one who supplied the contaminated raw materials. Therefore, FDA was unable to evaluate whether or not this was an adequate response.

Evanger’s suggested that if pentobarbital were to be present in any of its ground loaf products, it would be “…well within the range that FDA had previously deemed not to be a health or safety concern in pet foods.”

FDA disagrees that grinding would dilute any pentobarbital to safe levels, and points out that there is zero tolerance for pentobarbital in pet food.

Evanger’s proposed random pentobarbital tests of finished products prior to shipment as a way to ensure that raw materials are not adulterated.

FDA considers this to be an inadequate and unreliable way to ensure the safety of the finished product. FDA’s own testing has demonstrated pentobarbital contamination is not uniformly distributed throughout all cans in a production lot. Also, the agency disagrees that finished product testing can mitigate the risk of pentobarbital in the raw material.

Evanger’s now requires new and current suppliers to provide letters of guarantee for their products.

FDA points out that a letter of guarantee may not provide adequate assurance of product safety, and recommends conducting site audits and/or reviews of supplier procedures in addition to the letter of guarantee.

As is customary, the Warning Letter concludes with a requirement that Evanger’s must furnish a written reply within fifteen working days, spelling out the steps it has taken or will take to correct the violations and prevent them from occurring again.

The complete text of the Warning Letter can be found on the FDA website.

This article first appeared in Food Safety News and is reposted here with permission.