PetSmart and other stealthy pet food recalls

Not all food-safety recalls are announced via a corporate news release and posted on-line.

In some cases, news of a recall is shared only by telephone, email, letter or some other private means.

Nevertheless, all recalls that come under the jurisdiction of the FDA eventually find their way into the FDA’s Weekly Enforcement Report.

A survey of Enforcement Reports for 2020, conducted last week by eFoodAlert, turned up several recalls for which no public notice was issued.

The Smaller Fry

Boesl Packing Company recalled one batch of K9 Kraving Dog Food Beef and Vegetable Raw Dog Food due to Listeria monocytogenes contamination. The recall was initiated on July 22, 2019 and classified six months later as a Class I recall on January 23, 2020. The product was shipped to one customer in North Carolina. The customer was notified by telephone.

G & C Raw, LLC recalled one batch of G&C Raw Ground Turkey due to possible presence of Listeria monocytogenes. The recall was initiated on May 20, 2019 and was eventually classified as a Class I recall on January 23, 2020. The recalled items were distributed only in Michigan and consignees were notified by email.

Grassland Beef recalled two varieties of Dr. Siegel’s S. A. F. E. Petfood, Ground Beef due to possible presence of E. coli O157:H7. The recall was initiated on October 20, 2020 and Classified as a Class I recall on November 23, 2020. The recalled products were shipped directly to consumers nationwide and to one retail location in Florida.

Stella & Chewy’s, LLC recalled one batch of Stella & Chewy’s Raw Blend, Kibble + Wholesome Grains Red Meat Recipe, with Pumpkin & Quinoa due to potential Salmonella contamination. The recall was initiated on October 14, 2020 and classified as a Class I recall on October 28, 2020. The product was distributed in four states and consignees were notified by telephone.

Texas Tripe recalled multiple products in which Listeria monocytogenes and/or Salmonella were detected. The recalls were initiated in July 2019 and classified as Class I on January 23, 2020. FDA was sufficiently disturbed at the magnitude of the problem and the lack of a public recall notice to issue its own caution to pet owners on August 14, 2019.

Woody’s Pet Food Deli recalled one batch of Raw Chicken, Homemade Cat and Dog Food, with supplements, due to Salmonella contamination. The recall was initiated on August 30, 2019 and classified as Class I on January 23, 2020. Product was distributed in Minnesota and Colorado, and customers were notified by telephone.

The Major Leagues

The J.M. Smucker Company recalled several cat food products in December 2019, and one additional product on July 2, 2020, due to excessive levels of choline chloride.

The public recall notice for the 2019 recall stated only that the recall was due to “ingredients believed to not meet the Company’s quality and safety standards.”

Only the July 2020 recall advised the public that an excessive level of choline chloride was behind the recalls.

PetSmart Inc. recalled Authority Savory Blends Turkey Formula Cat Food and Authority Savory Blends Chicken Formula Cat Food (all lot codes) on November 11, 2020, due to elevated levels of the mycotoxin, Zearalenone. The products were distributed nationwide.

According to a spokesperson for the FDA, there is no established action level for Zearalenone in pet foods or animal feeds, and no adverse events relating to the recalled products have been reported to the agency. The PetSmart recall was classified as Class II, since Zearalenone is not considered to be as significant a health risk as certain other mycotoxins, such as aflatoxin.

The Bottom Line

Stealth recalls are not limited to veterinary products, pet treats and pet foods. Some recalls of human food also never enter the public spotlight, for a variety of reasons.

To keep up to date on all FDA-overseen recalls, whether publicized or not, check the FDA’s Weekly Enforcement Report page, which is updated every Wednesday.

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.

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.