FDA investigates Smucker-owned Big Heart over pentobarbital

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

An investigation into pentobarbital adulteration in canned, wet pet food manufactured by Big Heart Pet Brands Inc. remains “open and ongoing” according to a spokesperson for the U.S. Food and Drug Administration.

Big Heart is a wholly owned subsidiary of The J.M. Smucker Company Inc.

On Feb. 16, FDA alerted pet owners to the possible presence of pentobarbital in certain canned dog foods, including Gravy Train, Kibbles ’N Bits, Ol’ Roy and Skippy products, after a media outlet reported having found the chemical in several samples of Gravy Train canned, wet dog food.

Upon learning of the findings, Smucker initiated a product withdrawal pending the outcome of an internal investigation. The withdrawal was upgraded to a voluntary recall after the company verified the presence of pentobarbital in its finished products and in beef tallow, an ingredient common to all of the affected products.

Pentobarbital is a barbiturate used to euthanize animals. FDA considers a pet food to be adulterated if it contains even a trace amount of the drug.

On Feb. 23, FDA initiated an inspection of the Big Heart manufacturing facility in Bloomsburg, PA. The inspection was conducted jointly with the Pennsylvania Department of Agriculture (PDA) and was completed on March 12th.

According to information contained in the Establishment Inspection Report (EIR), obtained by Food Safety News in response to a Freedom of Information Act request, Big Heart produces dog food under contract for third-parties in addition to manufacturing the Gravy Train, Ol’ Roy, Kibbles ’N Bits, and Skippy dog food brands as well as several brands of cat food.

A spokesperson for FDA, citing the ongoing status of the investigation, declined to comment on whether any of the private-labeled products were evaluated for possible pentobarbital contamination. Nor would the spokesperson comment on whether FDA conducted its own independent analysis of any ingredients or finished products as part of its investigation.

Big Heart did not test any other ingredients for pentobarbital once it found the chemical in the beef tallow ingredient.

All of the beef tallow used in the adulterated pet food was obtained from a single supplier.

Big Heart notified its supplier of the test results and followed up with an inspection of the supplier’s facility. Concluding that the supplier did not have adequate controls over its supply chain, Big Heart management switched to a different tallow supplier. In addition, the company reconfigured some product formulas to eliminate beef tallow.

A class action lawsuit filed in Northern California on May 1 against Big Heart Pet Brands Inc. alleges that the tallow was supplied by MOPAC, an eastern Pennsylvania rendering facility belonging to JBS USA Holdings Inc.

JBS operates two facilities in eastern Pennsylvania, one in Souderton and the other in Elizabethville. FDA declined to comment on whether either or both of these facilities were included in the investigation.

According to information contained in Establishment Inspection Reports obtained in response to a Freedom of Information Act request, the Elizabethville location manufactures poultry feed.

JBS Souderton is a rendering operation. It receives bovine, porcine and avian trimmings, bone, hides, offal, and blood from its nearby slaughter/meat packing facility and from other slaughter facilities, and also receives used cooking oil and yellow grease from restaurants.

Souderton produces a number of animal feed ingredients, including tallow, blood-meal, feather-meal, bone-meal and animal protein.

During the February-March inspection of Big Heart, FDA and PDA investigators were denied access to several documents, according to the EIR.

On instruction from the Smucker corporate headquarters, Big Heart management refused to furnish PDA and FDA investigators with qualitative or quantitative product formulae and refused to permit them to review either the company’s consumer complaint files or its Standard Operating Procedures for retaining samples.

The Plant Director, Dave Brookover, also declined to sign, or even to read, an FDA Affidavit (FDA Form 463a) setting out the information supplied by him during the course of the inspection. On instructions from the corporate office, Brookover left the room when the FDA investigator recited the contents of the Affidavit.

Some companies have specific policies on what they will or will not share with FDA, a spokesperson for the agency explained, adding that the nature and number of refusals were not out of the ordinary and did not obstruct the investigation.

Consumers’ cases against Gravy Train maker consolidated

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

A class action lawsuit was filed May 1 in Northern California against Big Heart Pet Brands Inc. on behalf of consumers and businesses who bought pentobarbital-contaminated dog food manufactured by the company.

Big Heart is owned by the J.M. Smucker Co. 

The lawsuit, referred to as a master consolidated complaint, consolidates four similar actions filed in February and March against the company.

The complaint accuses Big Heart of several counts, including negligent misrepresentation, violation of California’s Consumers Legal Remedies Act, false advertising, negligence, breach of express warranty, breach of implied warranty, fraud and deceptive and unfair trade practices.

Plaintiffs are seeking an order preventing Big Heart from selling the contaminated dog food, a mandatory corrective advertising campaign, full restitution and an unspecified amount of actual, statutory and punitive damages.

The pentobarbital problem came to light in February, when a Washington, D.C.-television station’s investigation into potential pentobarbital contamination in canned, wet dog food revealed the presence of the drug in several Gravy Train products. Veterinarians use large doses of the fast-acting drug to euthanize animals.

Gravy Train is manufactured by Big Heart.

Mark Johnson, one of the plaintiffs named in the class action suit, owned 13 border collie and Australian shepherd mixes, which he used as herding dogs for his cattle. All of Johnson’s dogs developed kidney failure within a few hours after eating a Gravy Train product and had to be put down on Jan. 14 and 15, according to the complaint. 

There is no mention in the complaint of a confirmed cause of the kidney failure, or of any laboratory analyses being carried out either at necropsies on the dogs or on the dog food.

The presence of pentobarbital at any level in animal food renders the product adulterated, according to the US Food and Drug Administration (FDA).

Oral exposure to pentobarbital causes primarily neurological symptoms including drowsiness, dizziness, excitement, loss of balance, jerky eye movements, and, in the most severe cases, coma and death. Kidney failure is not one of the reported manifestations of oral pentobarbital poisoning.  

An investigator from the FDA’s Philadelphia district office visited Big Heart’s Bloomsbury manufacturing facility five times between Feb. 23 and March 12, 2018, according to information obtained by Food Safety News in response to a Freedom of Information Act (FOIA) request.

At the end of the inspection, the investigator cited the presence of pentobarbital in a retained sample of tallow from February 2017 and in a sample from the company’s current inventory of tallow. The tallow is among ingredients used in the manufacture of Gravy Train, Kibbles ‘n Bits, Skippy and Ol’ Roy canned, wet dog food brands.

On Feb. 16, FDA alerted consumers to the potential contamination issue and advised the public that Smucker was withdrawing from the market a wide range of canned, wet dog food products.

The withdrawal was upgraded to a Class III voluntary product recall on March 2.

A Class III recall is one in which the “… product is violative and use of or exposure to the product is not likely to cause any adverse health consequences,” according to FDA’s Regulatory Procedures Manual.

Although the concentration of pentobarbital found in the tallow was included in the investigator’s completed Form 483 (Inspectional Observations), the information was redacted from the copy supplied to Food Safety News.

According to information contained in the class action complaint, the retained sample of tallow contained pentobarbital at a level of 529 parts per billion (ppb). Levels of the drug in the current inventory ranged from 802 ppb to 852 ppb.

The tallow was allegedly supplied by MOPAC, an eastern Pennsylvania rendering facility belonging to JBS USA Holdings Inc.

When asked to confirm the reported levels of pentobarbital in the tallow samples, a spokesperson for FDA declined to comment. An FOIA request for the lab reports and for the Notice of Inspection (Form 482) was turned down on April 20, with the explanation that they were “not available” at the time. 

It is standard procedure for an investigator to issue a Form 482 Notice of Inspection at the outset of any inspection. No explanation was given as to why this document was unavailable.

FDA has issued no updates on the status of its investigation or of the product recalls since the March 2nd recall notice.

Smucker confirms euthanasia drug in popular dog food brands

Recall includes Gravy Train, Kibbles ’N Bits, Skippy, Ol’ Roy; FDA’s investigation, testing ongoing

Phote Illustration

The FDA has posted notice of a voluntary recall by The J.M. Smucker Company Inc. of canned dog food after the company confirmed pentobarbital in tallow used to manufactured the affected products.

In all, the recall covers more than 107 million cans of dog food in several flavors sold under the Gravy Train, Kibbles ’N Bits, Skippy and Ol’ Roy brands. Big Heart Pet Brands distributed the Gravy Train, Kibbles ’N Bits and Skippy dog food to retailers nationwide. Walmart Stores Inc. distributed the Ol’ Roy dog food.

Initially, the Food and Drug Administration FDA had agreed to allow Smucker to issue a “product withdrawal,” pending the results of lab tests. Once pentobarbital contamination was confirmed by the company itself, Smucker agreed to a voluntary recall.

Pentobarbital is a chemical sedative used by veterinarians to euthanize animals. The presence of it at any level in a pet food is illegal, and renders the product adulterated under federal law.

The recalled dog food is sold in individual cans and multi-can packs. Smucker products included in the recall are:

The recalled dog food is sold in individual cans and multi-can packs. Smucker products included in the recall are:

  • Gravy Train With Lamb & Rice Chunks, packaged in metal cans with Net WT 13.2 OZ; UPC: 7910005430 on flat case and 7910052543 on cans. Best By range 10 25 19 thru 02 09 2021; Code range: 6299 through 8040, each with the suffix plant number 803.
  • Gravy Train; With T-Bone Flavor Chunks; packaged in metal cans with Net WT 13.2 OZ; UPC: 7910005410 on flat case and 7910052541 on cans. Best By range 10 25 19 thru 02 09 2021; Code range: 6299 through 8040, each with the suffix plant number 803
  • Gravy Train With Beef Chunks; packaged in metal cans with Net WT 22 OZ and UPC: 7910051647 on flat case and 7910051647 on cans; or with Net WT 13.5 OZ and UPC: 7910052457 on flat case and 79100034417 on cans. Best By range 10 25 19 thru 02 09 2021; Code range: 6299 through 8040, each with the suffix plant number 803
  • Gravy Train With Chicken Chunks; packaged in metal cans; Net WT 22 OZ with UPC: 7910051645 on flat case and 7910051645 on cans; and Net WT 13.2 OZ with UPC: 7910052458 on flat case and 7910034418 on cans. Best By range 10 25 19 thru 02 09 2021; Code range: 6299 through 8040, each with the suffix plant number 803
  • Gravy Train With Strips In Gravy; packaged in metal cans with Net WT 13.2 OZ; UPC: 7910005420 on flat case and 7910052542 on cans. Best By range 10 25 19 thru 02 09 2021; Code range: 6299 through 8040, each with the suffix plant number 803
  • Ol’ Roy Dog Food Strips in Gravy With Turkey & Bacon; packaged in metal cans with Net Wt 13.2 OZ; UPC: 7910017570 on flat case and 8113117570 on cans. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021
  • Kibbles ‘n Bits brand Dog Food; Chef’s Choice Homestyle Tender Slices With Real Beef, Chicken & Vegetables in Gravy; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052489A on flat case and 7910010380 on cans. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021
  • Kibbles ‘n Bits brand Dog Food; Chef’s Choice Bistro Tender Cuts With Real Turkey, Bacon & Vegetables; packages in metal cans with Net Wt. 13.2 OZ; UPC: 7910052488A on flat case and 7910010378 on cans. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021
  • Kibbles ‘n Bits brand Dog Food; Chef’s Choice Bistro Tender Cuts With Real Beef & Vegetables In Gravy; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052486A on flat case and 7910010375 on cans. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021
  • Skippy Premium Chunks in gravy; Chunky Stew; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052469 on flat case and 7910050249 on cans. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021
  • Skippy Premium Chunks in gravy; With Beef; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052508 on flat case and 7910050250 on cans. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021
  • Skippy Premium Strips in Gravy; With Beef; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052509 on flat case and 7910050245 on cans. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021
  • Kibbles ‘n Bits 12 Can Variety Pack; Chef’s Choice Bistro, containing 4 cans of Hearty Cuts with Real Beef, Chicken & Vegetables In Gravy; Chef’s Choice Homestyle, 4 cans of Meatballs & Pasta Dinner with Real Beef in Tomato Sauce; Chef’s Choice Bistro, and 4 cans of Bistro Tender Cuts With Real Turkey, Bacon & Vegetables in Gravy; packaged in metal cans with 12 – 13.2 OZ Cans per case; Total Net Wt 9 LB 14 OZ; Variety Pack paper box UPC: 7910027750; These packages are not meant for individual can sales and are sold as a 12 can Variety Pack. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021
  • Kibbles ‘n Bits 12 Can Variety Pack; containing 4 cans of Chef’s Choice Bistro, Hearty Cuts with Real Beef, Chicken & Vegetables In Gravy; 4 cans of Chef’s Choice Homestyle, Meatballs & Pasta Dinner with Real Beef in Tomato Sauce; and 4 cans of Chef’s Choice Bistro, Bistro Tender Cuts With Real Turkey, Bacon & Vegetables in Gravy; packaged in metal cans with 12 – 13.2 OZ Cans per case; Total Net Wt 9 LB 14 OZ; Variety Pack paper box UPC: 7910027750. These packages are not meant for individual can sales and are sold as a 12 can Variety Pack. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021
  • Kibbles ‘n Bits 12 Can Variety Pack; containing 6 cans of Chef’s Choice American Grill, Burger Dinner With Real Bacon & Cheese Bits In Gravy; and 6 cans of Chef’s Choice Bistro, Tender Cuts With Real Turkey, Bacon & Vegetables In Gravy; packages in metal cans with 12 – 13.2 OZ cans per case; Total Net Wt 9 LB 14 OZ; Variety Pack paper box UPC: 7910027685. These packages are not meant for individual can sales and are sold as a 12 can Variety Pack. Code range: 6299 through 8040, each with the suffix plant number 803; Best By range 10 25 19 thru 02 09 2021

Excluded from Friday’s voluntary recall are a number of products reported previously by Food Safety News to have been withdrawn from the market, based on information obtained directly from the company. FDA has not yet resolved this discrepancy, an agency spokesperson said.

Test results are still pending on finished product samples collected by FDA, and the agency is continuing its investigation.

What consumers should know
Pets should not be fed any of the recalled products. Consumers should safely dispose of the recalled cans of pet food and/or contact the company or the place of purchase for information about returning the products.

Pets that consume a food containing pentobarbital can experience drowsiness, dizziness, excitement, loss of balance, nausea, inability to stand and nystagmus, which causes the eyes to move back and forth in a jerky manner. Consuming high levels of pentobarbital can cause coma and death. However, low levels of pentobarbital are unlikely to pose a health risk to pets, according to FDA.

People who think their pets have become ill after consuming pet food contaminated with pentobarbital should contact their veterinarians.

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.

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