Largest ever monetary criminal penalty in food safety matter

Family Dollar Stores LLC pleaded guilty Monday to holding food, drugs, medical devices, and cosmetics under unsanitary conditions related to a rodent infestation at the company’s West Memphis, AR, distribution center.

At the same time, criminal information unsealed in federal court in Little Rock, AR, charged Family Dollar with one misdemeanor count of causing FDA-regulated products to become adulterated while being held under insanitary conditions.

The company, a subsidiary of Dollar Tree Inc., entered into a plea agreement that includes a sentence of a fine and forfeiture amount totaling $41.675 million, the largest-ever monetary criminal penalty in a food safety case. The plea agreement also requires Family Dollar and Dollar Tree to meet robust corporate compliance and reporting requirements for the next three years. U.S. Magistrate Judge Jerome T. Kearney presided over the company’s guilty plea and sentencing at Monday’s hearing.

“When consumers go to the store, they have the right to expect that the food and drugs on the shelves have been kept in clean, uncontaminated conditions,” said Acting Associate Attorney General Benjamin C. Mizer.  “When companies violate that trust and the laws designed to keep consumers safe, the public should rest assured: The Justice Department will hold those companies accountable.”

“Companies distributing and selling food, drugs, medical devices, and cosmetics must ensure that these products are being held in safe and sanitary conditions,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will continue to work closely with the FDA to investigate and prosecute those who put public health at risk by failing to meet this important obligation.”

“Consumers trust that products purchased from retail stores such as Family Dollar are safe,” said U.S. Attorney Jonathan D. Ross for the Eastern District of Arkansas. “It is incomprehensible that Family Dollar knew about the rodent and pest issues at its distribution center in Arkansas but continued to ship unsafe and unsanitary products. Knowingly selling these types of products places the public’s health at risk and erodes the trust consumers have in the products they purchase. Products shipped and sold are required to be safe for consumers, and the safety of Arkansans and others is extremely important to this office. Let me be clear, if you conduct business in Arkansas and allow the shipment or sale of unsafe and insanitary products, you will be held accountable.”

“U.S. consumers rely on the FDA to ensure that their food is safe and wholesome,” said Special Agent in Charge Charles L. Grinstead of the Food and Drug Administration’s Office of Criminal Investigations (FDA-OCI) Kansas City Field Office. “When companies put themselves above the law and distribute food that has been held under extremely unsanitary conditions, putting the public’s health at risk, we will see that they are brought to justice.” 

In pleading guilty, the company admitted that its Arkansas distribution center shipped FDA-regulated products to more than 400 Family Dollar stores in Alabama, Missouri, Mississippi, Louisiana, Arkansas, and Tennessee. According to the plea agreement, the company began receiving reports in August 2020 of mouse and pest issues with deliveries to stores. By the end of 2020, certain stores reported receiving rodents and rodent-damaged products from the warehouse. The company admitted that by no later than January 2021, some of its employees were aware that the unsanitary conditions caused FDA-regulated products held at the warehouse to become adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).

According to the plea agreement, the company continued to ship FDA-regulated products from the warehouse until January 2022, when an FDA inspection revealed live rodents, dead and decaying rodents, rodent feces, urine, and odors, and evidence of gnawing and nesting throughout the facility. According to the plea agreement, subsequent fumigation of the facility resulted in the reported extermination of 1,270 rodents. On Feb. 18, 2022, the company voluntarily recalled all drugs, medical devices, cosmetics, and human and animal food products sold since Jan. 1, 2021, in the 404 stores serviced by the warehouse.

The FDA-OCI investigated the case.

Senior Litigation Counsel Patrick Runkle, Trial Attorney Alisha Crovetto of the Civil Division’s Consumer Protection Branch, and Assistant U.S. Attorneys Julie Peters and Cameron McCree for the Eastern District of Arkansas prosecuted the case.

Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.

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Dollar Tree Distribution Inc. is recalling certain products purchased from Family Dollar because of potential exposure to rodents.

This recall comes after last month’s FDA warning to consumers to throw out products from Family Dollar stores in a number of categories, including human food, because of a severe rodent infestation in a distribution facility in Arkansas.

“More than 1,100 dead rodents were recovered from the facility following a fumigation at the facility in January 2022. Additionally, a review of the company’s internal records also indicated the collection of more than 2,300 rodents between March 29 and Sept. 17, 2021, demonstrating a history of infestation,” according to the FDA’s public warning.

The products were distributed to Dollar Tree stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.

The recall includes food products, cosmetic products, dietary supplements and pet food and treats purchased from Family Dollar retail stores.

A full list of recall products can be found below:

# Product Description Recall Number Classification Code Information Product Quantity Reason for Recall
1

Food products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee

F-0810-2022

Class II

All food products purchased from Family Dollar retail stores located in AL, AR, LA, MS, MO, and TN from January 1, 2021 to present

Unknown

Potential exposure to rodents and rodent activity in the distribution center.

2

Cosmetic products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee, including but not limited to skin and eye care products, baby oil, lipstick, shampoo, baby wipes

F-0811-2022

Class II

All cosmetic products purchased from Family Dollar retail stores located in AL, AR, LA, MS, MO, and TN from January 1, 2021 to present

Unknown

Potential exposure to rodents and rodent activity in the distribution center.

3

Dietary supplements purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee, including but not limited to vitamins, herbal and mineral supplements

F-0812-2022

Class II

All dietary supplements purchased from Family Dollar retail stores located in AL, AR, LA, MS, MO, and TN from January 1, 2021 to present

Unknown

Potential exposure to rodents and rodent activity in the distribution center.

# Product Description Recall Number Classification Code Information Product Quantity Reason for Recall
1

Pet food and treats purchased from Family Dollar retail stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee that are packaged in material other than glass or metal can

Not Yet Classified

All food products purchased from Family Dollar retail stores located in AL, AR, LA, MS, MO, and TN from January 1, 2021 to present

Unknown

Potential exposure to rodents and rodent activity in the distribution center.

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The FDA is warning consumers in several states to throw out products in a number of categories, including human food, because of a severe rodent infestation in a distribution facility in Arkansas.

The implicated states are Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. No recalls have been initiated for the products, but the Food and Drug Administration is working with the company to initiate a recall of the affected products.

“More than 1,100 dead rodents were recovered from the facility following a fumigation at the facility in January 2022. Additionally, a review of the company’s internal records also indicated the collection of more than 2,300 rodents between March 29 and Sept. 17, 2021, demonstrating a history of infestation,” according to the FDA’s public warning.

This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. 1, 2021, through the present. Some examples of these products include human foods, including dietary supplements, vitamin, herbal and mineral supplements; cosmetics skincare products, baby oils, lipsticks, shampoos, baby wipes; animal foods such as pet food, pet treats, wild bird seed; medical devices including feminine hygiene products, surgical masks, contact lens cleaning solutions, bandages, nasal care products; and over-the-counter (OTC) medications including pain medications, eye drops, dental products, antacids and other medications for both adults and children.

Impacted products originated from the company’s distribution facility in West Memphis, AR.

Following a consumer complaint, the FDA began an investigation of the Family Dollar distribution facility in West Memphis, AR, according to the FDA warning. In January 2022. Family Dollar ceased distribution of products within days of the FDA inspection team’s arrival on-site and the inspection that concluded on Feb. 11.

Conditions observed during the inspection included live rodents, dead rodents in various states of decay, rodent feces and urine, evidence of gnawing, nesting and rodent odors throughout the facility, dead birds and bird droppings, and products stored in conditions that did not protect against contamination.

The FDA’s Associate Commissioner for Regulatory Affairs Judith McMeekin, Pharm.D., said: “No one should be subjected to products stored in the kind of unacceptable conditions that we found in this Family Dollar distribution facility. These conditions appear to be violations of federal law that could put families’ health at risk. We will continue to work to protect consumers.”

Consumers are advised not to use impacted products. The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded. Food in non-permeable packaging, such as undamaged glass or cans that are all metal, may be suitable for use if thoroughly cleaned and sanitized. Consumers should wash their hands immediately after handling any products from the affected Family Dollar stores.

Consumers who recently purchased affected products should contact a health care professional immediately if they have health concerns after using or handling impacted products. Rodent contamination may cause Salmonella infections and other infectious diseases, which may pose the greatest risk to infants, children, pregnant women, the elderly and immunocompromised people.

Following a consumer complaint, the FDA began an investigation of the Family Dollar distribution facility in West Memphis, Arkansas, in January 2022. Family Dollar ceased distribution of products within days of the FDA inspection team’s arrival on-site and the inspection concluded on Feb. 11. 

Conditions observed during the inspection included live rodents, dead rodents in various states of decay, rodent feces and urine, evidence of gnawing, nesting and rodent odors throughout the facility, dead birds and bird droppings, and products stored in conditions that did not protect against contamination. 

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As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.


Dollar Tree Inc.
Chesapeake, VA

Dollar Tree Inc. of Virginia is on notice from the FDA for the unsanitary conditions of their distribution center, including a rodent infestation.

In a Nov. 8, 2022, warning letter, the FDA described a Jan. 11 through Feb. 11, 2022, inspection of Dollar Tree Inc.’s Family Dollar Distribution Inc. in West Memphis, AR.

The FDA’s inspection revealed that the firm had serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations, and resulted in the issuance of an FDA Form 483. 

The firm initiated a voluntary recall of certain products regulated by the FDA that were stored and shipped to 404 stores from Family Dollar Distribution Inc., in West Memphis, Arkansas from Jan 1, 2021, through March 18, 2022, due to the presence of rodents and rodent activity at the Family Dollar Distribution Center.

In the firm’s May 6, 2022, response letter, they stated that they are permanently closing the West Memphis facility.

Some of the significant violations are as follows:

Adulterated Human Foods and Dietary Supplements

The inspection of the firm’s facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods. These violations cause the firm’s human food and dietary supplement products to be adulterated in that their products consist in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food and in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. 

1. The firm did not take effective measures to exclude pests from their holding areas and to protect against contamination of food on the premises by pests as required. Specifically, FDA investigators observed evidence of rodent activity, including live rodents, dead rodents in various states of decay, rodent excreta pellets (REPs) in numbers too numerous to count (TNTC), gnaw marks in food and food packaging, nesting material, and odors indicative of rodent infestation throughout the entire facility including areas where human food, including dietary supplements, are routinely stored. Below are some examples of the observations made by the investigators: 

• Four rat carcasses on the conveyer belt along the south wall of the facility by aisles (redacted) and (redacted)

• Significant gnawings, REPs TNTC, and a strong odor of rodent urine and excreta on a pallet containing (redacted) cases of mixed nuts stored in rack location (redacted). Multiple bags of product were gnawed open, and product was spilling out of cases onto lower levels of the pallet. Gnawings and spilled product could be seen from the top (redacted) layer down to the 3rd layer of the pallet. 

• REP and (redacted) hair on top of a pallet of Vitamin C 1000 mg dietary supplements.

• Approximately 15 REPs on a pallet of flour located in rack location (redacted). Eleven of the (redacted) cases stored on the pallet contained product with gnawings. While investigators unstacked the pallet, two mice exited from gnawed-open product bags stacked on the bottom layer of the pallet and ran west under the north end of aisle (redacted).

• Approximately 30 REPs in and around a pallet containing (redacted) cardboard cases with twelve 5.6-ounce pouches of Chicken Flavor Rice & Pasta Blend product stored in rack location (redacted). This pallet also had nesting material and tunneling in between the bottom layers 1 and 2 of the pallet and at the top ((redacted)) layer. Approximately 20 of the cases on the pallet contained significant rodent gnawings.

• Four rats crossing aisle (redacted) from east to west near the south side of the aisle and two more rats crossing aisle (redacted) from west to east near the south side of the aisle. Food is stored along the entirety of the floor levels of aisles (redacted).

• At least 5 rats were noted in rack location (redacted), which is in the northeast corner of one of the two food storage areas in the facility. Rats were climbing through the pallet in this rack location and climbing up rack scaffolding to reach upper levels.

• A strong foul odor/stench of dead and decaying rodents, rodent pellets, and evidence of rodents nesting in and around the Inventory Control Center (ICC) and the breakroom, which is located directly north of food aisles (redacted). According to firm management, the General Manager closed the ICC and breakroom in Oct. 2021 because of complaints related to strong odors associated with dead rodents. Inspectors observed that the ICC was cleared out and closed off, and a putrid odor continued to permeate the room. The breakroom above the ICC was closed and rodent nesting materials were in front of the entrance.

• Apparent bird droppings were observed on chocolate protein shakes and Vitamin C supplement drops and on the floor near the northeast side of the small food storage racks by the shipping area ((redacted) and (redacted), respectively). 

• Two dead birds were observed within the facility. One bird was caught in netting hung from the roof above pallets of breakfast cereals. The second was observed on the east side of the mezzanine level under part of the old conveyor system.

In addition to visual observations, FDA documented the following findings: 

• FDA collected several samples during the inspection. These samples included human food products and an animal food product, product packaging, and a filth sample. These samples were submitted to FDA labs for analysis. FDA’s analysis found the presence of urine, gnaw marks in the packaging, rodent hairs, and/or REPs in these samples. Further, the filth sample included REPs and nesting materials collected from all four corners and the center of the warehouse (including the center of each of the two food areas), demonstrating the rodent population was throughout the facility.

• FDA conducted a review of the firm’s pest control records. Reports from their pest control company documented the capture of between 16 and 107 rodents for all months of 2020 and Jan.– June of 2021. In addition, the firm’s maintenance team conducted additional monitoring and tracking of rodent captures made in large bait boxes and glue traps placed by their pest control company along the pick-slot level of aisles (redacted). Between the dates of March 29, 2021 to Sept. 17, 2021, the firm documented over 2,300 rodent captures. Following a facility fumigation between Jan. 16 – 20, 2022, approximately 1,100 rodent carcasses were “harvested” or removed from their facility by firm employees and their pest control company.

• According to internal emails reviewed during the inspection, the firm was contacted by stores as far back as Dec. 8, 2020, sharing their observations of rodent activity in deliveries of food products from the distribution center. Specifically, throughout 2021, retail stores serviced by the West Memphis distribution center emailed complaints of receiving food products gnawed by rodents, nesting materials inside of packages, and case containing both live and dead rodents from the distribution center. 

2. The firm did not maintain buildings, fixtures, and other physical facilities of their plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated as required. Specifically, unsanitary conditions were observed throughout their facility demonstrating that sanitation and cleaning operations were not conducted in a manner that protects against contamination of food. These unsanitary conditions provided food sources and pest harborage areas for rodents and other pests. In addition, inadequate maintenance to parts of the facility allowed for potential pest entry and harborage areas within the facility. The following are examples of insanitary conditions that were observed:

• Investigators observed spilled breakfast cereal, spilled Chicken Flavor Rice & Pasta Blend product, spilled all-purpose flour, spilled popcorn, and spilled sunflower seeds. All products had REPs mixed in with spilled product. Fluorescing stains were observed in and around the packaging for spilled flour and popcorn.

• Accumulations of trash and debris in multiple locations, including the old conveyor system located in the mezzanine level and in the “Junk Yard” portion of the warehouse, which contains maintenance equipment. 

• Open packages of baby wipes were observed in the warehouse with fluorescent stains indicative of urea or urine. 

• Following the fumigation of the facility, the inadequate sanitation practices became more apparent as dead pests were observed in various states of decay throughout the facility. These observations included, but are not limited to:

o Multiple dead rodents found near slots (redacted) and #(redacted).

o Dead rodents along the north wall, near the ICC and breakroom, on March 7, 2022. One was caught in a snap trap zip tied to a metal beam next to dock door (redacted) and the other was behind a metal beam against the outer wall. 

o A dead bird below part of the old conveyor system on March 7, 2022.

The following are examples of inadequate maintenance conditions that were observed:

• Gaps were found along the top of the compactor that is meant to create a seal between the compactor and the exterior wall of the facility. Additionally, holes were observed in the compactor sidewall ranging from an estimated 1 inch to 12 inches on both the north and south facing sides allowing for potential pest entry. The compactor has a (redacted) door for access from the inside of the firm that is left open during business hours. While this door is open, the gaps and holes present the potential for pest entry into the facility. 

• Multiple dock doors were observed to have gaps allowing for potential entry of pests into the facility. More specifically, receiving doors (redacted) and (redacted) had gaps up to 3 inches in length and 1 inch in height around the doors, and receiving doors (redacted), (redacted) and (redacted) were observed to have gaps at least 2 inches in height and 6 inches in length. Shipping doors (redacted) and (redacted) were observed to have approximately 2-inch gaps running the entirety of each side of the dock plates. 

• The firm began the decommissioning of a conveyor system. Parts of the decommissioned system were left in the mezzanine level where cobwebs, dirt, dust, and debris has built up under and around these parts. This equipment became a harborage area for rodents as evidenced by the observation of a dead rodent that was seen in between the conveyor belts of the “Upper West Side Belt” and investigators noting a foul odor indicative of dead and decaying animals in another section of what would be the “Upper Southside Belt.”

3. The firm did not keep grounds around the plant in a condition that would protect against the contamination of food as required. Specifically, they did not properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests, as required. For example, throughout the inspection, FDA investigators observed the following conditions:

• Large amounts of trash (including food trash), wood from pallets, and debris were piled below dock doors and along the shipping and receiving area walls of the facility.

• Piled-up trash extending approximately 2 feet out from the walls of the facility. 

• Large amounts of food trash and dirt piled below and surrounding the compactor that appeared to have spilled from a breach in the side panel of the compactor.

• Throughout the inspection, piles of food next to or spilling out of the large open-top dumpsters located on the west side of the shipping dock.

Additional Considerations

The corporation received a Warning Letter (ent to Greenbrier International Inc. doing business as Dollar Tree) on Nov. 6, 2019, for the receipt and delivery or proffered delivery of adulterated drugs. Of particular concern, the Warning Letter detailed FDA evidence that Dollar Tree, parent company of Family Dollar, distributed drugs that were manufactured at a facility where rodent feces were found throughout. In light of these two separate incidents involving significant rodent infestations in their supply chain, the FDA recommends that Family Dollar take steps to evaluate whether there are additional issues with rodent infestation in their drug supply chain. 

The FDA reviewed the firms written responses but do not see a need to discuss their responses further in light of their decision to close the facility.

If the firm plans to resume the preparing, packing or holding of FDA regulated articles for distribution at this facility, the FDA requests that they notify the FDA of their plans in writing. 

The full warning letter can be viewed here.

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The Dollar General Corporation’s “dollar stores” are sometimes used by researchers as a poverty indicator and this year a corner of those  more than 18,000 locations in the continental United States were called out for rodents and other sanitation problems.  And a federal grand jury has joined these investigations.

Dollar Stores with problems were connected with the Family Dollar distribution center in West Memphis, AR. This includes Dollar Tree stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. This is the area where Dollar Tree Distribution Inc. recalled all food and certain other products because of potential exposure to rodents.

In response to the recent  inspections, the Eastern District of Arkansas has reportedly issued a federal grand jury subpoena for more information from Dollar. The grand jury is seeking information on the pest and sanitation issues that led to last month’s recall of drugs, cosmetics, human food and animal foods from 404 stores in six U.S. states.

Dollar has confirmed it has received the subpoena and said it  it incurred a $34.1 million loss because of the recall.

The February recall came after January’s ’s FDA warning to consumers to throw out products from “Family Dollar” stores in a number of categories, including human food, because of a severe rodent infestation in the West Memphis distribution facility.

“More than 1,100 dead rodents were recovered from the facility following a fumigation at the facility in January 2022. Additionally, a review of the company’s internal records also indicated the collection of more than 2,300 rodents between March 29 and Sept. 17, 2021, demonstrating a history of infestation,” according to the FDA’s public warning.

The inspection reports from the Arkansas Department of Health (ADH) and the U.S. Food and Drug Administration (FDA) that are the basis for the public health warning and product recall are now public documents.

Those documents describe the West Memphis facility as a multiple food storage warehouse and distribution center, used since 1994. Dollar Tree  bought the warehouse and distribution center about 4 years ago. Family Dollar Distribution is based in Matters, NC.

Before the current rodent infestations, the West Memphis facility was last inspected by FDA in 2017. No “significantly objectiveable conditions” were found at that time. Pest control  records review found “no abnorml pest activity” during the previous year.

Reports from 2022 inspections are much more concerning. Some of the findings include:

  • The company did not exclude pests from its food plant to protect against contamination of food.
  • Specifically, during this inspection we observed rodent evidence, including live rodents, dead rodents of various states of decay, rodent excreta pellets (REFs), gnawings, nesting and odors indicative of rodents throughout the entire facility, including areas where human food is routinely stored…
  • The inspection team observed a live rat possibility chasing live mouse from east to west across the aisle.
  • Significant gnawings and the strong odor of rodent urine on pallets of mix nuts were also documented.
  • There were numerous REPs on equipment and floors.
  • Grounds around the facility were not in a condition to protect against the contamination of  food.
  • Rubber seals around piping and wiring had holes.
  • Animal food was not property stored to protect against contamination.
  • Measures were not being taken to exclude pests from the facility.
  • Buildings were not in a clean and sanitary condition.

A half dozen FDA personnel helped conduct the inspection, which ran from Jan.11, 2022 to Feb. 11, 2022.

Dollar has been in the grocery business since 2003. It added the low-cost Asian market a year later when it opened a sourcing office in Hong Kong.

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An Ohio family infected with the dangerous E. coli O157:H7 bacteria did not consume all of a multi-pound chub of ground beef that was a possible source of their illnesses, and what was left of the beef was found in their freezer by Butler County Health Department investigators.

When the Ohio Department of Agriculture found that the meat tested positive for O157:H7, it set off Tuesday’s national recall of approximately 131,300 pounds of ground beef from Tyson Fresh Meats Inc. in Emporia, KS.

Four children from the Ohio family became ill between Sept. 8 and 11 after eating the ground beef, and one was hospitalized for about 10 days. Butler County Health Director Pat Burg said the child has since been released.

Meanwhile, the Health Department is setting up a hotline to field questions and to determine if there are any other victims of the recalled, contaminated beef.

Packaged and sold under the Kroger, Butcher’s Beef and generic brands, the recalled ground beef carried a “best before or freeze by” date of Sept. 12, 2011.  None of the beef remains in stores, but because it was sold in three and five pound chubs (chubs are packaged tubes of ground meat), the recalled ground beef could be in home freezers.

The recalled products include:

— Five pound chubs of Kroger-brand ground beef, 73 percent lean/ 27 percent fat, with a product code of D-0211 QW, shipped to distribution centers in Tennessee and Indiana.

-Three pound chubs of Butcher’s Beef brand ground beef, 73 percent lean/27 percent fat, ID code D-0211 LWIF, shipped to distribution centers in North and South Carolina for retail sale.

— Three pound chubs of generic label ground beef, 73 percent / 27percent fat, ID code D-0211 LWI, for distribution in Delaware, Florida, Georgia, Illinois, Indiana, Missouri, New York, Ohio, Tennessee, Texas and Wisconsin for retail sale.

There is an ink jetted number “245D” printed along the package seams.

The product was produced by Tyson on Aug. 23. Kroger has said it will have in-store signs notifying customers of the recall and will notify its loyalty card holders of the recall by email or telephone. Cashier receipts will also include the recall information.

The Butcher’s Beef brand meat went to Food Lion stores in North Carolina, South Carolina, Georgia, Florida, Virginia and West Virginia, and to Bottom Dollar Food stores in North Carolina, Food Lion said in a news release.

For the USDA’s retail distribution list check here.

Tyson’s recall is the second largest of 2011 for E. coli O157:H7 contamination. Earlier this year, eight other companies recalled a total of 312,268 pounds of meat. So far, the largest recall for E. coli contamination was 228,596 pounds of meat called back by Cincinnati’s Tri State Beef.

  

By Darin Detwiler

In reflecting on the evolution of food safety over the past three decades, we observe a landscape marked by significant and escalating legal actions against companies responsible for outbreaks and violations.  The effectiveness of these penalties, especially monetary fines, in preventing future lapses in food safety, merits a deeper examination.

  • Jack-in-the-Box: This 1993 multi-state E. coli outbreak sickened over 700 people across four states, resulted in over 170 hospitalizations and took the lives of four children. became a critical turning point in the U.S. for food safety awareness, regulation, and policy. However, the absence of state or federal charges against the company or its executives sent a message to the industry that, at that time, regulatory and legal frameworks might not sufficiently penalize or hold corporations accountable for lapses in food safety, potentially underestimating the importance of stringent food safety protocols and oversight. 
  • Jensen Farms:  This2011 Listeria monocytogenes outbreak tied to cantaloupe resulted in at least 147 illnesses across 28 states, with 33 deaths.  Today, this event is still the worst foodborne illness outbreak in the United States. The court sentenced the two owners each to five years’ probation, six months home detention, $150,000 in restitution and 100 hours of community service. 
  • DeCoster’s Eggs: The 2010 Salmonella outbreak led to one of the largest recalls in U.S. history, involving approximately 550 million eggs, as well as a nationwide public health crisis, affecting thousands. The 2014 trial and 2015 sentencing came with a $6.8 million dollar fine and saw the owners sentenced to prison, marking a rare instance where corporate executives faced jail time for negligence in food safety practices. The significance of the DeCosters’ egg outbreak and the subsequent sentencing lies in its establishment of a precedent for holding food company executives criminally responsible for food safety violations. This case underscored the seriousness with which the U.S. justice system began to treat food safety violations, signaling to the industry that leadership could be held personally accountable for the safety of their products, thus elevating the importance of rigorous food safety management within corporate culture.
  • Peanut Corporation of America (PCA): This 2008-2009 Salmonella outbreak traced to PCA’s products resulted in nine deaths and hundreds of illnesses across 46 states, leading to one of the largest food recalls (over 3,900 different types of products) in U.S. history. The 2014 trial and 2015 sentencing marked a stark escalation in the consequences for food safety failures, with numerous convictions and lengthy prison sentences for the executives involved. This case exemplified the judicial system’s growing resolve to treat food safety negligence as a grave legal and ethical breach.
  • ConAgra Grocery Products: This 2002 Listeria Outbreak, linked to contaminated peanut butter, marked a significant food safety incident. The outbreak resulted in widespread public health concerns, and, like the PCA incident, involved an extensive and lengthy investigation over the next five years. This incident led to one of the largest product recalls of its kind at the time, encompassing millions of jars of peanut butter sold under various brand names.  In 2015, ConAgra Grocery Products LLC agreed to plead guilty to federal charges related to the outbreak and was sentenced to pay an $11.2 million settlement, which included an $8 million criminal fine—the largest ever in a U.S. food safety case up to that point. 
  • Chipotle Mexican Grill: Multiple multi-state outbreaks between 2015 and 2018 involved multiple incidents of foodborne illnesses, involving various pathogens such as E. coli, Norovirus, and Salmonella linked to Chipotle. The subsequent federal fine of over $25 million dollars (the largest ever in a U.S. food safety case up to that point) underscored the importance of operational practices in ensuring food safety. This case also highlighted the reputational damage (stock values took 15 NYSE quarters of trading to recover) and financial penalties companies could face, even without criminal charges.
  • Blue Bell Creameries: The 2015 Listeria ice cream recall would result in Blue Bell pleading guilty (and paying criminal penalties totaling $17.25 million) to two counts of distributing adulterated food products in violation of the 1938 Federal Food, Drug, and Cosmetic Act 21 U.S.C. ch. 9 § 301 et seq. The court later sentenced the company to pay an additional $2.1 million to resolve civil False Claims Act (1863) allegations regarding ice cream products manufactured under insanitary conditions (and sold to federal / military facilities).  At the time, the $19.35 million in fine, forfeiture, and civil settlement payments constituted the second largest-ever amount paid in resolution of a food safety matter. This case further illustrated the increased financial and operational consequences for companies failing to adhere to food safety standards, emphasizing the role of top leadership in preventing such crises.
  • Family Dollar Stores LLC, a subsidiary of Dollar Tree Inc.: Most recent event involved egregious sanitation violations, including a severe and widespread rodent infestation, noted between 2020 and 2022, at Family Dollar Store’s West Memphis, AR, distribution center. The issues were so pronounced that they prompted a recall of all FDA-regulated products that came through that center from January 2021-February 2022, impacting over 400 stores across six states. The company entered into a plea agreement that includes a fine and forfeiture amount topping $41 million dollars – representing the current zenith of accountability.  Soon after this agreement, the company announced their decision to close over 1,000 stores. This case not only showcases the continued escalation of direct financial repercussions but also highlights the broader impact on food security and access in affected communities.

These escalating consequences from past outbreaks to the present day signal a clear trend (see graphic) towards greater accountability and, more so, stricter financial penalties for food safety failures.  Future cases will likely see even more stringent financial penalties, but will they include more significant operational impacts and personal accountability for corporate executives?

The substantial fines imposed on companies like Chipotle and Family Dollar Stores represent attempts to penalize and deter unsafe practices. However, these financial penalties must not be the end-all solution. Some may infer that the increase in corporate financial penalties has become the new industry tactic to avoid prosecution and prison time. True deterrence will come from a holistic approach that includes not just fines but also rigorous enforcement of the Responsible Corporate Officer (RCO) Doctrine, ensuring that individuals in positions of authority cannot evade personal accountability for violations of public welfare laws. 

History show us that fines, even those exceeding tens of millions of dollars, have not eradicated negligence. As fines grow larger, we must consider if they alone are sufficient to deter malfeasance or if they inadvertently allow wealthy corporations to bypass meaningful consequences. Consumers will feel the impact, both in terms of food safety and higher prices, if these fines become merely a cost of doing business for entities whose decisions are driven more by profit than by ethical considerations for consumer health and safety. 

  • The next big failure in food safety is not a matter of if, but when, and it will likely result from a combination of ignored warnings (perhaps even those related to ESG), systemic vulnerabilities, and unanticipated challenges. As food technology advances and the global supply chain expands, the complexity of maintaining food safety standards increases. 
  • This next big failure is likely to emerge not just from a gap in food safety practices but from a systemic undervaluation of rigorous ethical standards and a culture of compliance. The potential for failure grows not necessarily from a lack of knowledge or technology but from a failure to prioritize safety over profit at every level of decision-making.
  • This future landmark event may result not only in unprecedented penalties but could also drive a transformative shift in how food safety is integrated into the core values and operations of companies. 

Fines and legal actions will always be reactive measures – their impact never undoing the true burden to consumers forever harmed. In this era of rapid technological advancement and increasingly global supply chains, the next failure in food safety is preventable not by fear of financial loss but through a steadfast commitment to the principles of public health and safety.

To ensure that the next landmark in food safety is not a failure but a success story of prevention, we must focus on a foundation of ethical leadership and accountability that permeates every level of the food industry. Proactive, ethical decision-making that places consumer welfare at the forefront must be ingrained in every decision, from daily operations to strategic planning. To support this, the courage to prioritize food safety must be cultivated, validated, and even celebrated. 

Let us learn from the past not to predict failure but to pave the way for a future where food safety failures become historical anomalies, not recurring headlines. To prevent becoming the next cautionary tale, companies across the food industry must prioritize food safety as a central pillar of their corporate responsibility. 

By learning from past mistakes and embracing innovation in risk management, the food industry can aim not just to react to crises, but to prevent them. In doing so, the food industry will protect not only its consumers but also its own future.

About the author: Darin Detwiler is a food safety academic, advisor, advocate, and author.  For nearly 30 years, he has played a unique role in controlling foodborne illness.  After losing his son, Riley, to E.coli in 1993 Jack in the Box outbreak, the Secretary of Agriculture invited Detwiler’s collaboration on consumer education.  He was twice appointed to the USDA’s National Advisory Board on Meat and Poultry Inspection, represented consumers as the Senior Policy Coordinator for STOP Foodborne Illness, served on Conference for Food Protection councils, and supported the FDA’s implementation of FSMA. Detwiler is a professor of food policy and corporate social responsibility at Northeastern University.  He is chair of the National Environmental Health Association’s Food Safety Program. 

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In response to the problem with elevated levels of lead in cinnamon in children’s applesauce and recalls of products in the fall of 2023, the FDA initiated a review of ground cinnamon and has issued warnings.

During the review the Food and Drug Administration found elevated levels of lead in several products. The products are not targeted toward children, but are used as ingredients in foods that consumers may make and serve to children.

“Consistent with the agency’s Closer to Zero initiative, which focuses on reducing childhood exposure to lead, the agency is recommending voluntary recall of the products listed below because prolonged exposure to the products may be unsafe. Removing the ground cinnamon products in this alert from the market will prevent them from contributing elevated amounts of lead to the diets of children,” according to the FDA warning.

The FDA’s targeted survey checked ground cinnamon products from discount retail stores and analyzed the samples for chromium as well as lead.

The ground cinnamon products subject to the FDA’s warning are:

DistributorRetailersBrand Names(s)Lots/CodesLead Concentration (ppm)
La Fiesta Food Products
La Miranda, CA
La Superior SuperMercadosLa Fiesta250332.73
Moran Foods, LLC
Saint Ann, MO
Save A LotMarcumBest By: 10/16/25 10DB 04/06/25 0400B13.20   2.70
MTCI
Santa Fe Springs, CA
SF SupermarketMKNo codes2.99
Raja Foods LLC
Skokie, IL
Patel BrothersSwadKX212232.12
Greenbriar International, Inc.
Chesapeake, VA
Dollar Tree   Family DollarSupreme TraditionBest By: 09/29/25 09E8 04/17/25  04E11 12/19/25 12C2 04/12/25 04ECB12 08/24/25 08A_ _ 04/21/25 04E5 04/21/25 04E5  2025-09-22 09E20 (Missouri)3.37 2.26 2.03 2.34 3.14 3.12 2.88 3.13
El Chilar
Apopka, FL
La Joya Morelense  (Baltimore, MD)El ChilarF275EX1026 (Maryland) D300EX1024 (Maryland)3.40 2.93

The FDA is advising consumers to throw away and to not buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. The FDA has been unable to reach MTCI to share test findings and therefore has been unable to request that the company initiate a recall. The FDA will post updates with communications from firms that voluntarily agree to recalls.

Contamination thought to be intentional
This past week the FDA confirmed that lead chromate is the source of lead and chromium in cinnamon applesauce marketed for children and imported from Ecuador.

Leaders at the FDA continue to believe the contamination was intentional.

The Food and Drug Administration had already confirmed that applesauce samples had as much as 2,000 times the amount of lead considered safe.

Three brands of cinnamon applesauce pouches were recalled in November of 2023 because of lead contamination: Wanabana, Schnucks, and Weis. The FDA also found elevated levels of chromium in the recalled applesauce.

“People who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium and should inform their healthcare provider so they can monitor health and provide supportive care, as needed,” according to the FDA.

“Historically, lead chromate has been illegally added to certain spices to increase their weight and color, increasing the monetary value of the adulterated spices. FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration.”

The FDA has limited regulatory power over foreign ingredient suppliers who do not directly ship their products to the United States. Consequently, the FDA cannot take direct action against Negasmart, the supplier of the cinnamon to the Ecuadorean applesauce manufacturer Austrofoods, or Carlos Aguilera, the processor of the cinnamon sticks. 

“Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador is the likely source of contamination and is not in operation at this time,” according to the U.S. FDA.

Children impacted by cinnamon applesauce with elevated levels of lead
According to the Centers for Disease Control and Prevention there are now 468 patients spread across 44 states.

The implicated cinnamon applesauce products — Wanabana, Schnucks and Weis — were recalled in the fall of 2023. They have long shelf life and consumers may still have them on hand, so FDA continues to urge people to check their homes for these products.

“Cases are reported to the CDC through state health departments. State health departments receive reports of potential cases from various sources, and then follow up to determine whether the case definition is met. In order to be considered in CDC’s case count, the person must have had a blood lead level of 3.5 ug/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit purée product after November 2022,” according to the CDC’s outbreak update.

The Food and Drug Administration is also logging patients in the outbreak. As of Feb. 27 the FDA was reporting that its patient count was holding steady at 90. The FDA and CDC use different ways of tracking patients, so there may be some overlap with the counts. The FDA reports that the vast majority of the patients are 1 year old or younger.

The investigation
The FDA and officials in Ecuador — where the applesauce was produced — continue to investigate the situation. Some of the tests of cinnamon used to make the implicated applesauce showed 2,000 times the amount of lead considered safe.

Earlier this month, the U.S. Food and Drug Administration revealed the name of the company that supplied tainted cinnamon used to make applesauce marketed for young children in the United States. On Feb. 6, officials in Ecuador reported to the FDA that Carlos Aguilera of Ecuador was the processor of ground cinnamon used in making applesauce sold in pouches in the United States.

The cinnamon supplier sold the tainted spice to Negasmart, which sold the cinnamon to Austrofoods, the end producer of the applesauce. The FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses.

According to the U.S. Food and Drug Administration, the cinnamon supplier is currently not in business. The FDA’s deputy commissioner for human foods, Jim Jones, has said he believes the cinnamon was intentionally contaminated. Adding lead to spices and other products can increase the product’s weight and, therefore, its value.

“The FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing before export. Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera,” according to a statement from the agency.

“FDA does not indicate that this issue extends beyond these recalled products and does not have any confirmed reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.”

According to health officials in Ecuador, unprocessed cinnamon sticks used in recalled products were sourced from Sri Lanka. They were sampled by Ecuadoran officials and found to have no lead contamination.

About lead poisoning
Parents and caretakers should consult a healthcare provider and ask for blood tests if they suspect a child may have been exposed to the recalled cinnamon applesauce products. 

Short-term exposure to lead could result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. 

Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss. 

Permanent consequences can lead to developmental delays and brain damage.

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— OPINION —

In the aftermath of the groundbreaking plea agreement with Family Dollar Stores LLC, entailing a fine and forfeiture totaling $41.675 million for storing food, drugs, medical devices, and cosmetics in unsanitary conditions, we are starkly reminded of the imperative for stringent regulatory enforcement within the domain of food safety. This agreement, representing the largest-ever monetary criminal penalty in the context of food safety, serves as a vivid indicator of the justice system’s intensifying resolve in addressing such transgressions. This occasion necessitates reflection on historical incidents where the lack of such decisive actions had catastrophic outcomes, emphasizing the critical need for prompt and determined interventions.

The 1993 E.coli outbreak linked to Jack in the Box restaurants stands as a harrowing instance. This tragedy, which resulted in the death of my son, Riley, along with three other children and afflicted more than 700 individuals across several states, was a direct result of the company’s non-compliance with state-mandated minimum cooking temperature regulations. Astonishingly, the incident led to no state or criminal charges against the company for these fatalities. Had the judiciary imposed penalties comparable to those seen today, it might have sent a formidable message to the industry, potentially preventing subsequent food safety failures.

In recent years, we have witnessed significant legal actions, including:

·       In 2023, Kerry Inc. agreed to a $19.228 million fine and forfeiture for manufacturing ready-to-eat breakfast cereal under unsanitary conditions. 

·       In 2020, Chipotle Mexican Grill Inc. agreed to pay $25 million to settle criminal charges related to at least five foodborne illness outbreaks that sickened more than 1,100 people between 2015 and 2018.

·       Also in 2020, Blue Bell Creameries L.P. agreed to pay a total of $19.35 million after having pled guilty to two misdemeanor counts of distributing adulterated ice cream products– stemming from their shipping of contaminated products linked to a 2015 listeriosis outbreak.

·        In 2015, ConAgra Grocery Products agreed to a plea agreement totaling $11.2 million after having pled guilty in the salmonella case involving Peter Pan peanut butter in a 2006-2007 salmonella outbreak.

These cases and others illustrate a trend toward acknowledging the severe nature of these violations and the paramount importance of public health. The evolution of legal and regulatory responses reflects a growing recognition of the necessity for accountability and the efficacy of punitive measures in averting future violations.

The sentencing of officials from the Peanut Corporation of America (PCA) in 2015, where I witnessed the proceedings, represents a milestone in judicial responses to food safety infractions. The severe penalties imposed in this case (a sentence length far greater than the three-month sentencing seen in the trial of the owners of DeCosters Eggs) testify to the judiciary’s potential to instigate significant industry-wide changes, ensuring that consumer health and safety are prioritized. 

The prison sentences in the PCA case, along with the large settlements and fines in recent cases, serve not merely as a deterrent but as a catalyst for establishing comprehensive food safety cultures within organizations. The escalating fines highlight the increasing financial, operational, and reputational risks companies face that disregard their fundamental obligation to ensure product safety. This trend toward harsher penalties mirrors a broader societal call for corporate accountability, especially concerning public health.

This shift is a clarion call to the industry: lapses in food safety, propelled by negligence or disregard for established protocols, will not be tolerated. For companies that have embarked on rigorous efforts to safeguard consumer health, these developments affirm their endeavors to protect every plate. For others, it should serve as a wake-up call, compelling them to evaluate the costs of doing nothing. ALL food industry entities must prioritize implementing exhaustive safety measures, engage in vigilant oversight, and cultivate a culture that places consumer safety at its core.

While the recent legal actions signify substantial progress in the crusade for food safety, they also serve as poignant reminders of the tragedies that could have been averted through earlier and more decisive interventions. The movement toward more severe penalties for food safety violations is a positive evolution, signaling a commitment to holding companies accountable and preventing future outbreaks. This momentum must be sustained, ensuring that the lessons learned from past incidents propel continuous improvement in food safety standards and practices across the industry, thereby safeguarding the health and well-being of the public.

About the author: Darin Detwiler is a food safety academic, advisor, advocate, and author.  For more than 30 years, he has played a unique role in controlling foodborne illness, including service on the USDA’s National Advisory Board on Meat and Poultry Inspection, representing consumers at NGOs, serving on Conference for Food Protection councils, and supporting the FDA’s implementation of FSMA.  Detwiler is a Professor of food policy and corporate social responsibility whose research and insights have appeared on television, such as Netflix’s 2023 documentary “Poisoned,” and in print, including his book “Food Safety: Past, Present, and Predictions.” In addition to his current role as the Chair of NEHA’s Food Safety Program Committee, his leadership capacities include the FDA Foods Coalition and numerous advisory and editorial boards, and he has long consulted on food safety issues with industry in the U.S. and abroad. Detwiler is the recipient of the International Association for Food Protection’s 2022 Ewen C.D. Todd Control of Foodborne Illness Award and their 2018 Distinguished Service Award for dedicated and exceptional contributions to reducing risks of foodborne illness.

The number of children affected by extremely high levels of lead in cinnamon applesauce pouches continues to grow.

The Centers for Disease Control and Prevention are now reporting a total of 287 patients, up from its count on Dec. 22 when 251 patients from 34 states had been reported to the agency.

The Food and Drug Administration had received reports of 82 reports of children with lead poisoning as of Dec. 26. The agencies use different reporting methods so their numbers may overlap in some cases and should therefore not be added for a total.

The outbreak has been traced to three brands of cinnamon applesauce, Wanabana, Schnucks and Weis. All three were produced by Astrofoods in Ecuador and all three used cinnamon from the supplier Negasmart. The recalled cinnamon applesauce pouches were made with cinnamon containing as much as 2,000 times the recommended amount of lead. These products have a long shelf life. Consumers should check their homes and discard these products.

The cinnamon in the applesauce has been found to be the problem by U.S. and Ecuadorian officials. The U.S. Food and Drug Administration is testing other products and only the recalled cinnamon applesauce is showing elevated levels of lead. 

Recalled products still on store shelves
WanaBana apple cinnamon fruit puree pouches are sold nationally individually and in three-packs and have been available through multiple retailers, including Amazon and other online outlets, as well as Dollar Tree and Family Dollar/Dollar Tree combination stores.

The FDA found, as of Dec. 13, recalled WanaBana Apple Cinnamon Puree products still on the shelves at several Dollar Tree stores in multiple states. 

As of Dec. 19, the FDA also received a report that recalled WanaBana Apple Cinnamon Puree products may still be on shelves at Family Dollar/Dollar Tree combination stores. Consumers should not purchase these products.

Schnucks-brand cinnamon-flavored applesauce pouches and variety packs were sold at Schnucks and Eatwell Markets grocery stores. They have been removed from store shelves

Weis-brand cinnamon applesauce pouches are sold at Weis grocery stores and have been removed from store shelves.

About lead poisoning
Parents and caretakers should consult a healthcare provider and ask for blood tests if they suspect a child may have been exposed to the recalled cinnamon applesauce products. 

Short-term exposure to lead could result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. 

Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss. 

Permanent consequences can lead to developmental delays and brain damage.

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