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.

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