Food Safety News

The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.

Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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Spices USA Inc. of Hialeah, FL is recalling Tasty-Sawa cinnamon because of elevated lead levels.

According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on March 12, 2024, and is ongoing.

The recalled products were distributed in the U.S in Florida, Georgia, and North Carolina and in Trinidad and Tobago and Guyana.

Recalled product:

Tasty-Sawa Cinnamon Ground, Net Wt. 55.11 lbs, paper bag (bulk), 

• Country of Origin Vietnam
• Product Quantity: 394 bags/21713.34 Lbs
• Code Information: Lot No: VN/OFD/1D/0623

Consumers should not use this product. Recalled products should be thrown out or returned to their place of purchase.

About lead poisoning
Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the only apparent sign of lead exposure. Additional signs and symptoms of lead exposure are more likely with acute exposure to higher levels of lead or chronic exposure to lead. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age/ body weight. 

If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system may occur. This can result in learning disorders, developmental defects, and other long-term health problems. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.

Exposure to large amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount of and duration of lead exposure and age of the person exposed.

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Naturz Organics USA LLC of North Brunswick, NJ is recalling certain Naturz Organics Organic Pea Protein bags because of possible Salmonella contamination.

According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on March 18, 2024, and is ongoing.

The recalled products were distributed to one consignee in Wisconsin

Recalled product:

Naturz Organics Organic Pea Protein,

• Item Code NO-OPP-80, 
• Net Weight 20 KG 
• Bulk product packaged in paper bags
• Product Quantity: 19,200 kg
• Code Information: Lot #NO-OPP8020231114 Production Date: 2023-11-14 
• Best Before Date: 2025-11-13

Consumers should not use this product. Recalled products should be thrown out or returned to their place of purchase.

About Salmonella infection
Food contaminated with Salmonella bacteria does not usually look, smell, or taste spoiled. Anyone can become sick with a Salmonella infection. Infants, children, seniors, and people with weakened immune systems are at higher risk of serious illness because their immune systems are fragile, according to the CDC.

Anyone who has eaten any of the recalled products and developed symptoms of Salmonella infection should seek medical attention. Sick people should tell their doctors about the possible exposure to Salmonella bacteria because special tests are necessary to diagnose salmonellosis. Salmonella infection symptoms can mimic other illnesses, frequently leading to misdiagnosis.

Symptoms of Salmonella infection can include diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating contaminated food. Otherwise, healthy adults are usually sick for four to seven days. In some cases, however, diarrhea may be so severe that patients require hospitalization.

Older adults, children, pregnant women, and people with weakened immune systems, such as cancer patients, are more likely to develop a severe illness and serious, sometimes life-threatening conditions.

Some people get infected without getting sick or showing any symptoms. However, they may still spread the infections to others.

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Pennsylvania Department of Agriculture v. Amos and Rebecca Miller is advancing in the Court of Common Pleas of Lancaster County, Pennsylvania.

In the latest round of arguments, the attorneys for the Millers, Bradford L. Geyer and Robert E. Barnes, have put forth their view of what the Pennsylvania Department of Agriculture (PDA) is attempting to do to the Millers. They produce and sell unpasteurized, raw milk and other agriculture products that have been found to be in violation of state law.

It is not something the state will likely agree with, but it does show how far apart the Millers and their state are from one another.

“The PDA asks this court to do precisely what the court told all parties and the public the court would not do, usurp the legislature and amend the law, “ the defense brief opens. “The PDA goes even further: it also demands the court amend the United States Constitution. The court has already rejected this same argument made by the PDA in their opposition to Defendants’ motion for modification, and they cite no new fact or argument to reverse the court’s decision.”

“The PDA seeks this court’s license to usurp Congress as well as the state legislature,” it continues. “The law is clear: it only applies to sales to Pennsylvania customers within the state. By contrast, the language the PDA wants to add — “from the Commonwealth” & “regardless of where customers reside” — does not exist in the statute. Nor could it exist Constitutionally.”

“The food laws govern access to Pennsylvania customers because that is what the legislature chose to do and what the Constitution allows them to do; the laws do not regulate producers, processors, or possessors of food intended for export to out-of-state markets,” it argues.  “Consider the absurd havoc created by the PDA’s amendment of the law they ask this court to do — anyone traveling through Pennsylvania with food intended for sale outside the state is now subject to PDA jurisdiction and restrictions, such that someone traveling from West Virginia through Pennsylvania to another state with food intended for sale outside Pennsylvania can be stopped, searched, seized, fined, enjoined, penalized, and imprisoned. Food producing, processing, and transporting facilities for export outside Pennsylvania — of which thousands of people employed in Pennsylvania — would now be banned overnight and wake up criminals. This is not what the legislature authorized nor what the Constitution allows. Contrary to PDA’s claims, food intended for export is already regulated by Congress, as the Defendants’ half-decade of litigation reflects.”

“The PDA goes even further—it would redefine the word “sells” to include mere “exchange” or “delivery” regardless of intent to sell or actual sale… it continues. “The PDA’s judicially engrafted amendment of the law would make every potluck meal, every Thanksgiving lunch, every Christmas dinner, and every Easter brunch illegal in Pennsylvania. This is precisely why the legislature limited the scope of the law. Agriculture Secretary Redding may think the legislature gave him the power to be the Food Pope of Pennsylvania – no one can eat any food anywhere until and unless Pope Redding blesses it first—but the legislature did no such thing, nor could it Constitutionally.”

“The PDA asks this court to make up a new law that would also violate the Supremacy Clause, the Commerce Clause, the Right to Travel Clause, the Privileges and Immunities Clause, and the Due Process Clause of the United States Constitution. The Fourth and Fifth Amendments prohibit state seizure of property without due process of law, probable cause, or just compensation. The right to travel, privileges and immunities, and the due process clause assure access to traditional foods essential to health and consumed with the informed consent of a willing consumer. The PDA’s permitted scope of police power is to protect Pennsylvania consumers concerning Pennsylvania-made products, not Tennessee consumers from themselves.

The PDA would make criminals of all those who produce, process, or possess food intended exclusively for export to out-of-state markets. People produce, process, and possess food products unlicensed by PDA at Pennsylvania farms, processors, shippers, transporters, and distributors for daily export. PDA would make them all criminals merely because the food product at some point is within Pennsylvania’s borders. Congress governs interstate commerce, not the PDA. The Constitution says so. The FDA preempts the PDA, and the PDA does not get to roleplay the FDA or replace the FDA if the PDA does not like the law; appeal to Congress, not the courts.

The defense attorneys also say, “Of note—the PDA’s testing showed no e-coli, and the leading raw milk safety expert in the nation testified that the raw milk products of defendants were safe for human consumption at the evidentiary hearing. Despite extensive testing, invasive surveillance, and access to a global database, the PDA could provide not a single witness who consumed the Defendants’ food products to testify otherwise. As every PDA official confessed under cross-examination, no customer of the defendants has ever complained about any food product of the defendants despite the millions of food products distributed to tens of thousands of Americans over decades. The only harm would come from people denied access to defendants’ products.”

Attorneys for the Millers also quote RFK Jr. and Rep. Congressman Thomas Massie to support their clients.

Robert E. Barnes, a Los Angeles-based attorney, said the Amos Miller case could be in the state courts for as long as two or three years.

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According to recently released figures, the number of Campylobacter cases in England decreased in 2022.

Reported infections fell from 55,642 in 2021 to 54,461 cases in 2022, a decrease of 1,181.

Data comes from the UK Health Security Agency’s (UKHSA) Second Generation Surveillance System and the Gastrointestinal Infections and Food Safety (One Health) (GIFSOH) division’s eFOSS (electronic foodborne and non-foodborne outbreak surveillance system).

Overall, 54 percent of cases were male, and the most affected age group was the 50 to 59-year-old category, accounting for 15 percent of laboratory reports.

The region that reported the most Campylobacter lab reports was the South East, with 9,540; however, the region with the highest rate per 100,000 population was the North East.

The number of monthly lab reports followed the same trend as in past years, peaking in June.

Under a quarter of Campylobacter samples in England were speciated by laboratories. With more than 11,000, most were Campylobacter jejuni, followed by Campylobacter coli with 1,243.

One Campylobacter jejuni outbreak affected 13 people, with four lab-confirmed cases, and was caused by chicken served in a restaurant, café, pub, hotel, or catering service setting.

In 2022, 30 European countries reported 140,241 confirmed cases of campylobacteriosis and 35 deaths. Germany had the most cases, with almost 43,500, with Spain second with more than 20,800 infections.

Developing interventions
Meanwhile, a University of Reading researcher has been awarded a grant to study the UK’s most common bacterial cause of food poisoning.

Aidan Taylor, a lecturer in Microbiology, will investigate Campylobacter. The bacteria has developed resistance to some antibiotics, meaning new methods are needed to fight it.

The Academy of Medical Sciences awarded funding as part of grant money that it will share with 54 biomedical and health researchers. Taylor’s work will receive £121,000 ($153,000).

Taylor said the technology he will use to fight the bacteria works by disrupting its genes. 

“Transposons are jumping genes that insert themselves into other genes to create a library of mutant bacteria. Antibiotic treatments are then used on this mutant library, and we measure which ones survive and which ones do not, meaning we can see which genes are necessary for survival,” he said.

“Developing interventions for Campylobacter will allow us to reduce the number of infections in humans, saving the suffering of many thousands of people, reducing pressure on the NHS and the financial burden on the taxpayer.” 

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— ADVERTORIAL —

By Roger Hancock, CEO of Recall InfoLink

Recently, kielbasa, frozen dumplings, queso fresco, charcuterie meats, and other foods have been recalled. In fact, the FDA issued 46 food and drink recalls in January 2024 alone, a 31 percent increase from 2023’s fourth-quarter monthly average. While food recalls are nothing new, there are growing concerns about their frequency and how they’re being managed.

So far this year, foods have been contaminated by listeria, Salmonella, lead, foreign objects, and non-food grade oil. Labeling errors – such as mislabeling of allergens – are contributing to frequent recalls.

Compounding the problems:

• Individual companies act in isolation. Our industry must shift from an individual company process to a supply chain processtohelp spread information wider and faster, track contaminated products’ paths, and recall them more efficiently.
• There’s no standardization of data or recall processes. Disparate data and processes cause confusion and delays during time-sensitive recalls. Standardizing data and processes will better protect foods, people, and businesses.
• Companies aren’t practicing in ways that actually prepare them. Companies need to shift from mock recalls to recall simulations. Many companies do practice recalls, but not necessarily in ways that will actually prepare them properly.Without simulations that mirror a real recall scenario, companies can’t identify and address process gaps – or feel confident that their employees and supply chain know what to do during a recall.
• Supply chain connectivity can be limited. This industry is still highly manual, and many food businesses are not yet leveraging technology. Manual systems (and incomplete or inaccurate data) continue to be the primary issues limiting supply chain connectivity and impeding smooth recalls. When companies avoid adopting tech tools, it keeps them caught in outdated systems instead of using more effective, tech-enabled processes.

The Industry Needs a Paradigm Shift 

We need a new paradigm for the recall process that unites supply chains into Recall Ready Communities that use standard data and shared simulation exercises. Over the last 30 years, despite efforts from industry and regulatory agencies, effective recall response has not kept pace with huge advances in technology and distribution. Our industry lacks a Recall Ready Community approach, where everyone in the supply chain works collaboratively with a shared approach.

Currently, recalls are conducted by individual companies, with practice and execution being done individually. For example, mock recalls are generally static tabletop exercises that don’t strengthen the collaboration between supply chain partners towards the common goal of quickly removing contaminated products.  

Then, when actual recalls happen, businesses are unprepared to act collaboratively to take action. Instead, crisis mode kicks in, leading to inaccuracies, communication challenges, delays, and confusion. Without proper coordination, companies are unable to effectively, efficiently protect consumers and food businesses as quickly as possible. When food companies lack experience conducting recalls collaboratively with supply chain partners – and lack proper standards for sharing information – it translates into unnecessary risks to consumers, compliance challenges for the industry, and added costs (potentially upwards of billions of dollars). 

Additionally, the way consumers receive information has changed dramatically in recent years. They’re using new technologies and trying to manage an enormous amount of information coming at them constantly. Therefore, food businesses must develop compelling, succinct, action-oriented recall information and disseminate it in ways that people will receive, notice, and act on it. 

Shifting to a Recall Ready Community approach will take companies, food associations, regulators, etc. all joining together to modernize food recalls. 

The Path Forward

Change needs to happen on a national and global scale, with the industry implementing high-level conceptual changes. The most pressing problems – like a lack of standardized data used across the industry and the fact that tech solutions aren’t ubiquitous – must be resolved before we’ll see impact down to the consumer.

In a world where Recall Ready Communities exist, recalls will be a supply chain activity that enables best practices. Companies will use proper standards, collaborative processes, powerful tech solutions, and recall simulations to quickly execute effective recalls. Without these critical changes, gaps will remain, companies will stay stuck in antiquated and disjointed processes, and there will continue to be major flaws in the way recalls are handled.

Moving forward, the industry must shift its way of thinking – and acting – around recalls. A group of industry representatives is working together, along with the FDA and regulatory bodies, to transform and standardize the recall process.

For now, we must understand that the existing fragmented approach to recalls is no longer effective in today’s interconnected world. By embracing a new Recall Ready Community paradigm, the supply chain can collaborate to ensure accurate information flow, timely actions, and enhanced protection for consumers and food businesses alike. The industry must galvanize, collaborate, train, and practice, ensuring a future where recalls are conducted swiftly, thoroughly, and accurately.  

While improved quality assurance and control programs have helped reduce food safety risks, recalls are still happening frequently, and the industry must be better equipped to manage them. The steps that the industry – and individual companies – should follow aren’t new, but they must be improved to improve speed, accuracy, and thoroughness of recalls and to better protect foods, consumers, and brands.

About the author: Roger Hancock, CEO of Recall InfoLink is one of the world’s foremost experts on recalls, with experience that spans the retail, tech, data, regulatory, and supply chain. Recall InfoLink, makes recalls faster, easier, and more accurate across the supply chain to protect consumers and brands. As the only company focused entirely on recalls, Recall InfoLink’s solutions drive immediate action, streamline the recall process, and simplify compliance. Recall InfoLink helps brands become Recall Ready by standardizing data, collaborating with their supply chains, and practicing recall simulations.

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The Coca-Cola Company of Auburndale, FL, is recalling Powerade products because of the potential presence of a foreign metal object in the product, specifically a stainless-steel ring.

According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on Feb. 27, 2024, and is ongoing.

The recalled products were distributed to 760 consignees in South Carolina and Florida.

Recalled product:

Powerade Zero Fruit Punch – 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack

• Product Quantity: 149 cases
• Code Information: Lot Codes 0013098209, 0013111742, 0013111657, 0013119902 
• Expiration date: NOV1124AME

Powerade Zero Mixed Berry – 20 oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack.

• Product Quantity: 387 cases
• Code Information: Lot Codes 0013098209, 0013111742, 0013111657, 0013119902 
• Expiration date: NOV1124AMC

Powerade Mountain Berry Blast – 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack

• Product Quantity: 366 cases
• Code Information: Lot Codes 0013098209, 0013111742, 0013111657, 0013119902 
• Expiration date: NOV1124AMG and NOV18AMA

Consumers should not use this product. Recalled products should be thrown out or returned to their place of purchase.

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Pepsico Inc. of Purchase, NY, is recalling certain Schweppes Zero Sugar Ginger Ale cases because an internal investigation discovered that product labeled as Zero Sugar contains full sugar product.

For some people with certain underlying conditions, too much sugar can lead to serious health problems.

According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on March 9, 2024, and is ongoing.

The recalled products were shipped to Maryland, Pennsylvania and West Virginia.

Recalled product:

Schweppes ZERO SUGAR GINGER ALE CAFFEINE FREE 7.5 FL OZ (221 mL) 

• PRODUCED UNDER THE AUTHORITY OF DR. PEPPER/SEVEN UP, INC., 5301 LEGACY DRIVE, PLANO, TX 75024 
• UPC 0 78000 02965 9
• Product Quantity: 233cs/6/4 pk cases (24 pk)
• Code Information: May 20 24 MAY20240520VS02164 – MAY20240550VS02164

Recalled products should be thrown out or returned to their place of purchase.

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Waiakea Bottling Inc., located in Hilo, HI,  is recalling certain Waiakea Hawaiian Volcanic Water Naturally Alkaline Electrolytes Deep Well Water because of consumer complaints of floating particles.

According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on Nov. 28, 2023, and is ongoing.

The recalled products were distributed in Pennsylvania, Maryland, New Jersey, Michigan, Texas, Florida, North Carolina, Georgia and Colorado.

Recalled products:

Waiakea Hawaiian Volcanic Water Naturally Alkaline Electrolytes Deep Well Water 

• 1.0 Liter (33.8 FL OZ) 
• Distributed by Waiakea Inc. PO Box 1595 Hilo, HI 96721 
• UPC 8 56652 00600
• Product Quantity: 3850 cases

Code Information:

• WB123275 entire coding on the bottles and cases 
• WB123276 time stamp was before 5:59 am, but contained a box coding of WB123275

Consumers should not use this product. Recalled products should be thrown out or returned to their place of purchase.

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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.

Living Tree Community Foods Inc.
Berkeley, CA

A food firm in California is on notice from the FDA for violations of various federal regulations, including: Hazard Analysis and Risk-Based Preventive Controls regulation, Current Good Manufacturing Practice, Unapproved New Drugs and Misbranded Drugs, and Misbranded Foods.

In a March 4 warning letter, the FDA described a Feb. 13 through March 17, 2023, inspection of Living Tree Community Foods’ manufacturing facility located in Berkeley, CA. The FDA also reviewed the firm’s labels and website, www.livingtreecommunityfoods.com, on Oct. 11, 2023.

The FDA’s inspection revealed that the firm was not in compliance with federal regulations and resulted in the issuance of an FDA Form 483. 

Some of the significant violations are as follows

Hazard Analysis and Risk-Based Preventive Controls:

1. The firm’s hazard analysis did not appropriately evaluate all known or reasonably foreseeable hazards to determine whether there are hazards requiring a preventive control for their RTE nut and seed butters, as required.

Specifically, the firm manufactures 25 different RTE nut & seed butters using a variety of tree nuts (almonds, Brazil nuts, pecans, walnuts, pine nuts, cashews, hazelnuts, pistachios, macadamia, and coconuts) and seeds (sesame seeds, pumpkin seeds, sunflower seeds, and hemp seeds). Their hazard analysis for “RTE Living Tree Community Foods alive & organic Walnut Butter, organic Milk of Paradise Cashew & Macadamia Butter, and alive & organic Sesame Tahini,” included in their  “Food Safety Plan For Nut and Seed Butters, Muesli, Bars, and oils Version 2” dated March 21, 2020, did not identify biological, chemical, and physical hazards associated with these products and with tree nuts/seeds as significant hazards which require a preventive control at receiving, storage, slicing nuts and seeds, holding in bin, mixing (redacted by the FDA) /cooling, and/or packaging steps.

A. The firm’s hazard analysis considered “Presence of pathogenic bacteria” associated with their seeds and tree nut ingredients at their receiving step, but they determined that the hazard was not significant. However, vegetative pathogens such as Salmonella have been associated with these tree nuts and seeds food products. Therefore, the pathogen of Salmonella is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in their circumstances would identify pathogens as a hazard requiring a preventive control in these ingredients. The hazard may be controlled during their processing or at their supplier. Their process does not apply a process preventative control such as a lethal treatment to any of their incoming raw materials and ingredients used in production of their RTE nut and seed butters. The firm’s manager stated that all tree nuts and seeds used to manufacture their RTE nut and seed butter products are received raw, but only their almonds and cashews receive a treatment at the supplier to reduce pathogens. The firm told FDA investigators that their firm did not identify pathogens (pathogenic E. coli and/or Salmonella) as a significant hazard requiring a preventive control for tree nuts and seeds because these hazards can be controlled by their existing prerequisite programs as listed in their hazard analysis. These prerequisite programs include “Approved Supplier Program,” “Good Manufacturing Practices” and “Receiving and Storage Practices.” However, these written programs did not have procedures in place to verify that the supplier is controlling pathogens that may be present in raw materials to mitigate the hazard.

The firm maintains an “Approved Supplier Program” whereby they request the supplier to complete an “Approved Supplier Questionnaire” (redacted by FDA) and (redacted by FDA), thereafter. Their 2022 Supplier List showed they have (redacted by FDA) approved suppliers; however, they only have completed questionnaires for 3 current suppliers and 1 previous supplier. Furthermore, they have only signed off on 1 of the 4 completed questionnaires as approved by their firm. The other 3 questionnaires did not include an approval decision. Further, the “Approved Supplier Questionnaire” asks about Food Safety Plans and third-party audits, but they do not review the third-party audit reports or verify supplier controls through an onsite audit.

B. The firm’s hazard analysis in their “Food Safety Plan for Nut and Seed Butters, Muesli, Bars, and oils Version 2” did not consider the hazard of allergen cross contact as a potential food safety hazard at their slicing, or mixing steps to evaluate whether it requires a preventive control. The firm considered “allergen cross contamination” at the packaging/filling processing step; however, they determined that the hazard was not significant. The firm manufactures nut and seed butters using shared equipment on the same day. Their shared equipment includes the (redacted by FDA) slicing machine at the slicing step, the (redacted by FDA) machines at the mixing step, and the jar filling machine at packaging. They identified prerequisite programs of “Allergen Control Program,” “Cleaning Program,” and “Good Manufacturing Practices” at these steps; however, they do not include monitoring, corrective actions, verification procedures and recordkeeping to ensure allergen cross-contact controls are implemented within their facility. Furthermore, they do not have adequate controls in place as evidenced by the following:

a. On Feb. 16,2023, FDA investigators observed a significant amount of food debris and black residue on the food contact surfaces of the cleaned and ready-to-use (redacted by FDA) slicing machine in areas such as where the slicing head sits, underneath the belt cover and on the back leg. This machine is used to slice sesame seeds, almonds, pistachios, pecans, and walnuts. The machine was last used on Feb. 14, 2023 to slice walnuts, and their “(redacted by FDA) Housekeeping Schedule” dated Feb. 14, 2023 indicated that the slicer was cleaned after use, and it was verified cleaned by their manager.

b. On March 8, 2023, FDA investigators observed food residue build-up on the area where the slicing head sits while their employee was using the same (redacted by FDA) to slice sesame seeds. The food residue appeared to be residue from previous use. Their manager identified the product run on the machine as almonds from the week of Feb. 27, 2023. Further, their manager stated they do not remove this section of the machine during cleaning.

c. On March 8, 2023 FDA collected a sample of their Walnut Butter, lot (redacted by FDA). One sub-sample was analyzed using both the (redacted by FDA) and the (redacted by FDA). This subsample displayed response characteristics of 7 and 9ppm (in (b)(4)), and 5 ppm sesame according to the (redacted by FDA), and the (redacted by FDA), respectively. The firm sliced sesame seeds on their (redacted by FDA) machine from Feb. 2, 2023 until Feb. 08, 2023. They cleaned their (redacted by FDA) machine on Feb. 8, 2023, and then used the machine to slice the walnuts on Feb. 9, 2023, which were used in Walnut Butter, lot, (redacted by FDA). These findings indicate that they did not adequately clean their (redacted by FDA) machine to prevent sesame from being present in their Walnut Butter.

C. The firm did not identify and evaluate the hazard of undeclared allergens due to an incorrect label as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. A knowledgeable person manufacturing/processing food in their circumstances would identify undeclared allergens as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for labeling to ensure that all food allergens that are present in the food are included on the label. FDA notes that their pre-requisite “Allergen Control Program” stated that their firm will control undeclared allergens through (redacted by FDA). However, it does not include monitoring, corrective actions, and verifications procedures to control undeclared allergens. Further, your firm does not keep records of label review.

D. The firm’s hazard analysis included in their  “Food Safety Plan for Nut and Seed Butters, Muesli, Bars, and oils Version 2” considered mycotoxins associated with their seeds and tree nuts as a potential food safety hazard to evaluate whether it requires a preventive control; however, they determined that the hazard was not significant based on ingredient and supplier history. Tree nuts and seeds are known to be associated with aflatoxins. Therefore, contamination with mycotoxins is a known or reasonable foreseeable hazard. A knowledgeable person manufacturing/processing food in their circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients.

Current Good Manufacturing Practice:

1. The firm’s equipment and utensils were not designed and were not of such material and workmanship as to be adequately cleanable and were not adequately maintained to protect against contamination, as required. Specifically,

• On Feb. 16, 2023, FDA investigators observed an approximately inch long cut on the food contact surface of the (redacted by FDA) mixer bowl. This mixer is one of the (redacted by FDA) mixers used in mixing their RTE nut and seed butters.
• On Feb. 16, 2023, our investigators observed a large section of an off-white-colored lid gasket on one of the (redacted by FDA) mixer bowls with signs of wear and tear; these areas appeared to be blackened through accumulation of food residue over time.

2. The firm did not take reasonable precautions and measures to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) after each absence from the workstation and at any other time when hands may have become soiled or contaminated, as required. Specifically, on March 8, 2023, FDA investigators observed an employee at the (redacted by FDA) machine removing one of the gloves he was wearing and throwing it into the trash bin by lifting the dirty trash can lid with his barehand. The employee did not wash his hands prior to donning new gloves. The employee continued to open sesame seed bags and pour them into (redacted by FDA). Then he took these (redacted by FDA) to the (redacted by FDA) to pour the sesame into the machine. Later in the (redacted by FDA), the same employee touched the same trash can lid with cleaned hands as he was throwing away the paper towel he used to dry his hands after washing them. He then donned a new pair of gloves without re-washing his hands and continued to complete his work at the (redacted by FDA). Following both instances, FDA investigator observed the employee’s gloved hands touching the inside of the (redacted by FDA). These (redacted by FDA) are re-used for storing the sesame meal afterwards with no further cleaning.

Unapproved New Drugs and Misbranded Drugs

The FDA reviewed the firm’s website where they take orders for their product Sesame Tahini in Oct. 2023. The webpage: https://www.livingtreecommunityfoods.com/product/tahini-alive-and-organc?v=3 has a link to the webpage https://www.naturalnews.com/026409_tahini_calcium_cancer.html.

The claims on the firm’s websites establish this product is a drug under section because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the website claims that provide evidence that their product is intended for use as a drug include:

– “Tahini contains B vitamins…” “recent studies have also shown that vitamin B can help protect against one of the most deadly forms of cancer, pancreatic cancer, but only when consumed in food it is because of this that you will now find tahini for sale in most health shops.”

– “[H]igher total calcium intake is associated with a decreased risk of digestive system cancers … findings show that high calcium intake was associated with a reduced overall cancer risk especially amongst women. This is where tahini can come in as just 35 grms [sic] of tahini can contain almost 35% of your recommended daily calcium intake.” 

The firm’s product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug.” With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA. The FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

Misbranded Foods

1. The firm’s Sesame Tahini, Walnut Butter, Macadamia Butter and Milk of Paradise Cashew & Macadamia Butter products are misbranded in that the nutrition information (e.g. Nutrition Facts label) does not comply with requirements. For example, the nutrients declared in the nutrition label are not in accordance with regulation, and the format is not in accordance with regulation. In addition,

o The firm’s Walnut Butter label bears nutrient content claims for various nutrients such as fatty acids, protein, phosphorus, vitamin B, and vitamin D. However, the Nutrition Facts label fails to meet requirements which include declaring phosphorus, vitamin B, and vitamin D, the percent daily value of protein, and polyunsaturated and monounsaturated fat respectively.

o The firm’s Sesame Tahini website labeling bears the claim “source of zinc.” However, the Nutrition Facts labels fails to declare zinc as required. Their Macadamia Butter and Milk of Paradise Cashew & Macadamia Butter products bear a nutrient content claim for protein. However, the Nutrition Facts labels fail to include the percent daily value of protein as required.

2. The firm’s Macadamia Butter, Milk of Paradise Cashew & Macadamia Butter, and Walnut Butter products are misbranded because the product labels bear nutrient content claims but do not meet the requirements to make the claims. In addition, even if their Sesame Tahini product was not an unapproved new drug and misbranded drug, it is misbranded.

The full warning letter can be viewed here.

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New Zealand Food Safety has advised people not to consume a brand of unpasteurized, raw fruit juice as the company behind the products was not registered.

The agency said it had become aware of an unregulated manufacturer and seller of raw fruit juice. Without controls during processing, pathogens can enter the product making it unsafe, particularly for children, those who are old, pregnant or have reduced immune systems.

Recalled juice from Our Fruit Box has limited labeling or branding and may be sold in 20 liter plastic containers labeled ‘OFB’ and in unlabeled bottles of different shapes and sizes.

Current information suggests the juice was sold through informal sellers, door-to-door through businesses, local markets and on the firm’s website. Products are available in various flavors and are advertised as being available frozen, partially frozen, or defrosted. There have been no reports of associated illness to date.

Vincent Arbuckle, New Zealand Food Safety’s deputy director-general, said the juice had not been through the required checks to make sure it was safe to consume.

“The company making these juices has not been registered under the Food Act, so consumers cannot be certain that risks have been properly identified and managed,” he said.

“The product is a raw fruit juice and for that reason food safety controls are crucial. Without proper controls during processing of food, pathogens can enter the product. If you have bought this product – either labelled OFB or Our Fruit Box, or with limited or no identifying labelling or branding – do not consume it and throw it out.”

Recent outbreaks
Meanwhile, unrelated Campylobacter, Clostridium perfringens, histamine, and norovirus outbreaks were recorded in the country in February.

A Campylobacter outbreak in Canterbury involved 12 people. Cases were part of a group of visiting foreign students attending a course at a local institution. Unpasteurized milk consumed at a dairy farm was identified as the likely source.

An outbreak of Clostridium perfringens affecting five people was reported from the Capital, Coast and Hutt Valley district. Patients attended a private lunch at a restaurant. The source was partially precooked lamb which was reheated at the venue.

Two outbreaks of histamine (scombroid) fish poisoning occurred in the Auckland region, involving seven cases. Sick people had eaten kahawai at two separate restaurants. Both incidents were linked to the same supplier.

An outbreak of norovirus was reported from the Whanganui district with 277 cases. Patients were students and staff from two schools which share the same campus. Illness was associated with lunch at the cafeteria but investigations to find the source are ongoing.

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Michigan State University’s Online Master of Science (MS) in Food Safety Program (MSU OFS) is set to host an event June 11-13, 2024, featuring prominent figures in the field—Frank Yiannas and Bill Marler. The event aims to ignite conversations on tools, strategies, and behavior-based science essential for creating a robust food safety culture in the workplace.

Founded in 2002, the MSU OFS was established in response to a market research study conducted in 2000, revealing a critical need for individuals educated in the multifaceted aspects of safeguarding the food supply. The program addresses the concerns of the food industry, government, and public health, providing a fully online format to accommodate both individuals and employers.

Frank Yiannas

Frank Yiannas, a former Deputy Commissioner for Food Policy and Response, is set to share insights gained during his leadership role in implementing the FDA Food Safety Modernization Act (FSMA). With a diverse background encompassing leadership roles at Walmart and the Walt Disney Company, Yiannas has been globally recognized for pioneering blockchain for transparent food traceability.

Bill Marler

Bill Marler, the publisher of Food Safety News, is an accomplished personal injury lawyer and national expert on foodborne illness litigation. Marler, who began representing foodborne illness victims in 1993, brings a wealth of experience and knowledge to the event.

Frank Yiannas’s presentation will focus on creating a behavior-based food safety management system, drawing from his expertise in supply chain innovation, outbreak response, and product recall activities. Attendees will receive copies of Yiannas’s books, “Food Safety Culture: Creating a Behavior-Based Food Safety Management System” and “Food Safety = Behavior: 30 Proven Techniques to Enhance Employee Compliance.”

Bill Marler’s guest lecture will provide valuable insights into foodborne illness litigation, adding a legal perspective to the discussions. His pivotal role in representing victims of the Jack in the Box E. coli O157:H7 outbreak in 1993, resulting in a landmark settlement, positions him as a leading authority in the field.

Registration
The event offers three registration types, catering to different professionals. The Executive registration, priced at $3,200, is open to industry professionals, covering most meals, hotel accommodations, and transportation on designated days. The Alumni/Non-Profit registration, priced at $2,200, is available for MSU OFS alumni and non-profit professionals with similar coverage.

Notably, the registration fee for both categories includes copies of Frank Yiannas’s books, enhancing the learning experience for participants. Cancellation policies are in place, with a $400 fee for cancellations on or before May 24 and forfeiture of the entire registration cost for cancellations after that date.

Food safety professionals from various sectors, including industry, regulatory bodies, academia, and the military, are encouraged to participate in this exceptional opportunity to learn from two leading experts in the field. Detailed event information, including venue specifics and schedules, will be provided after registration.

To secure your spot and register for the event, click here.

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A study in Turkey has found nearly 40 percent of chicken products sampled contained Salmonella.

Researchers investigated prevalence, antibiotic resistance, and genomic diversity of Salmonella in raw poultry meat products across Turkey.

A total of 293 samples were collected, including chicken breast, skinned drumstick, skinned chicken chop, wing, chicken offal, and chicken patty.

Samples came from different retail stores in Kayseri during 2019. They were collected at two-week intervals in all seasons of the year and were sourced from various brands and production facilities in the same week.

Results, published recently in the International Journal of Food Science and Technology, revealed 112 samples contained Salmonella, with five and one of the isolates identified as Salmonella Enteritidis and Typhimurium, respectively. Scientists said findings underscore the importance of continued monitoring and control measures in the poultry industry.

According to data from the Ministry of Health, the most frequent Salmonella serotype in Turkey between 2012 and 2016 was Salmonella Enteritidis. 

Thirty-five of 90 chicken breast samples were positive, as well as 30 of 80 skinned drumstick and 17 of 42 skinned chicken chops. Salmonella was also found in a dozen wing samples, thirteen of 27 offal samples and five of 22 chicken patty samples. Three of five Salmonella Enteritidis isolates belonged to chicken chop samples with skin.

Need for monitoring and past incident
Multilocus sequence type ST11 was the only detected type among Salmonella Enteritidis isolates, while Salmonella Typhimurium belonged to the S19 MLST type. All six isolates carried at least one antimicrobial resistance gene.

Antibiotic resistance analysis revealed that all isolates were sensitive to Meropenem and Aztreonam, while the most resistant antibiotics were Doxycycline and Trimethoprim-sulfamethoxazole. 

Researchers said whole genome sequencing revealed distinct clones and antibiotic resistance patterns.

“The data obtained in the study reveal the continued importance of Salmonella monitoring for the poultry industry across different regions of Turkey to maintain food safety. The microbiological and epidemiological risks observed in mass production can be minimized, particularly by integrating epidemiological and molecular findings with an effective strategy.”

In July 2023, the UK Health Security Agency (UKHSA) said almost 250 Salmonella infections had been linked to travel to Turkey since the start of that year. Between January and July, there were 241 confirmed cases of Salmonella Enteritidis.

Of cases with available travel information, people reported staying in different hotels in Turkey and most ate a variety of foods at their hotel resort as part of an all-inclusive holiday package.

Whole genome sequencing (WGS) revealed some clusters were related, which indicates a likely common source of infection. As of late July 2023, the source of infection had not been found.

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The FDA commissioner is scheduled to testify at a hearing before the U.S. House of Representatives Committee on Oversight and Accountability next week.

Commissioner Robert Califf is the only witness scheduled for the hearing, which is set for 1 p.m. EDT on April 11. The hearing will be open to the public and will be live streamed online at https://oversight.house.gov/.

The agenda includes discussion of the infant formula crisis that followed a recall by Abbott Laboratories in 2022 that was related to a deadly outbreak of cronobacter infections. General food safety concerns are also listed as part of the hearing’s focus.

“The Oversight Committee has highlighted several crises occurring on the FDA’s watch which have negatively impacted the lives and health of American people and families,” said committee chairman James Comer, R-KY.

“From a botched response to a nationwide infant formula crisis, failure to regulate safe tobacco products, failure to prepare for and address critical drug shortages, and more, we have identified how dysfunction at the FDA could be worsening many of these preventable crises. 

“We will hold the Commissioner accountable for what the FDA is doing to address ongoing crises, how they are conducting inspections to prevent nationwide crises in the future, and how they intend to ensure the FDA is first and foremost protecting American consumers. Subcommittee Chairwoman McClain has been at the forefront of the Oversight Committee’s efforts to bring transparency to the FDA and we look forward to continuing that work at this hearing.”

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The Food and Agriculture Organization of the United Nations (FAO) and food manufacturer Mars have renewed their partnership on food safety.

Maximo Torero, FAO’s chief economist, and Dr. Abigail Stevenson, chief science officer for Mars, signed a Memorandum of Understanding (MoU) to promote better understanding and application of Codex Alimentarius food standards.

FAO and Mars will work on enhancing mycotoxin management in maize value chains through modeling approaches and strengthen information-sharing on emerging food safety threats, technologies, and trends.

“Strong science to support food safety decisions and strong public-private cooperation for food safety are increasingly important to ensure sustainable and resilient agrifood systems,” said Torero.

Mars’ partnership with FAO began in 2015. The two parties exchange knowledge and information to support science-based decision-making and strengthen food safety through capacity building.

“This is a great opportunity to share our technical knowledge and scientific expertise in mycotoxin management and develop scientific publications which help to ensure safe food for all,” said Stevenson.

There are plans for FAO and Mars to help develop guidance for increased uptake of Codex standards and codes of practices by the private sector, in areas such as food allergen management and the identification of best practices for mycotoxin control and mitigation in maize value chains.

FAO said activities with Mars will boost the agency’s capacity for early warning, risk reduction and management of health risks. 

WHO and BfR partner
Elsewhere, the World Health Organization (WHO) and German Federal Institute for Risk Assessment (BfR) have also agreed to collaborate for the next decade.

The cooperation will focus on food safety, global networking for risk assessment, risk communication, capacity building, and sustainability in the food chain.

BfR and WHO intend to use risk assessment methods to address current and future challenges to food safety and nutrition. The aim is to develop a risk-benefit assessment that integrates nutrition, safety, and sustainability.

Another focus is capacity building for risk assessment and recommendations on food safety and nutrition in low- and middle-income countries.

Francesco Branca, director of WHO’s Department of Nutrition and Food Safety, said: “There is an urgent need to strengthen the capacity of low- and middle-income countries to understand and respond to food system challenges and improve food safety and nutrition. The BfR’s experience and capabilities will improve and expand the WHO’s actions.”

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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.
• Dollar General: Most recent event involved egregious sanitation violations, including a severe and widespread rodent infestation, noted between 2020 and 2022, at Dollar General’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 Figure 1.) 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 Dollar General 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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With states like California, Illinois, and New York questioning the safety of certain food additives and some other chemicals used in food, the public is wondering if a food is safe to eat if it contains chemicals.

The Food and Drug Administration gave one of Its long essay questions that answered that question this week. The agency did not specifically refer to pesticides or herbicides but did refer to “chemicals added to food.”

“All our food — like everything in the world — is made up of chemicals,” FDA said. “The presence of a chemical alone doesn’t determine whether a food is safe to eat. To assess the safety of chemicals in food, scientists at the U.S. Food and Drug Administration and others worldwide look at information about the chemical’s safety, how much of a chemical is in the food, and how much a person eats or drinks. It’s the amount that counts.”

The FDA continued:

Our food is chemicals: Facts, science and safety
What does it mean that food is made up of chemicals? Chemicals exist in whole foods and provide nutrition, such as potassium in bananas. The water, protein, fats, and carbohydrates we need for a healthy, balanced diet are chemicals, too.

Some chemicals are added to food for nutritional benefits, like milk fortified with vitamins A and D, or to protect food from spoiling or to prevent pathogens (germs) that could make people sick. Chemicals also add flavor and enhance food in other ways.

Some chemicals, like environmental contaminants, get into food when crops absorb them from the soil or air. Some contaminants are naturally present in the environment and are hard to eliminate, while others are in the environment because of industrial emissions and other human-made pollution.

Chemical exposure through food: It’s the amount that counts
A basic principle in science is that any chemical has the potential to be harmful at a certain level. That means a person would have to eat or drink enough to reach the harmful level. For some chemicals, that level is very low, and for others, the level is higher.

Let’s apply that to sodium as an example. Sodium is essential for maintaining blood pressure and for properly working nerves, muscles, and other body tissues. Too much sodium can raise blood pressure to unhealthy levels, which is a significant risk factor for heart disease and stroke. The Dietary Guidelines for Americans, 2020-2025, recommends limiting sodium intake to 2,300 mg daily for people 14 years and older and even less for those 13 years and younger. That’s why the FDA issued guidance to help the food industry make reasonable reductions in sodium across a wide variety of foods.

Determining safe amounts: The science behind FDA food chemical safety
The FDA evaluates and monitors chemicals in FDA-regulated food to ensure they don’t pose a health risk.

Scientifically assessing safe amounts of chemicals in food requires extensive calculation and consideration. This applies to chemicals used in packaging, added to food, contaminants from the environment, and chemicals that can form when raw foods are cooked and processed.

The FDA has different ways to scientifically assess the safe amount of a chemical in food by comparing the amount someone is likely to consume daily with other safety data. For example, the FDA determines an Acceptable Daily Intake when evaluating a chemical as a food additive, such as aspartame. That’s the amount safe to consume daily throughout a person’s lifetime. The FDA intentionally determines an Acceptable Daily Intake at a level that includes a safety margin that ensures the amount people eat daily is much lower than the level known to have a possible adverse health effect. The difference between the safe level and the harmful level is called the safety margin, a term used worldwide by scientific experts working to protect consumers from the harmful effects of too much of any chemical.

Here are some of the many factors FDA scientists weigh when looking at food chemical safety:

• The chemical, why it is in the food, and what’s known about its safety.
• The amount of the chemical in food.
• The amount and types of food include the chemical a person would likely eat or drink.
• Groups of people who may be particularly sensitive such as children, pregnant people, and older people.

One way the FDA monitors our food supply to help keep it safe is through the Total Diet Study, which is a routine survey that began more than 60 years ago. FDA researchers buy food from the same retail outlets that people buy food from, then prepare the food as people typically would to provide realistic estimates of the nutrients and contaminants in food. The information the FDA gets from this study and other monitoring programs guides us and informs our public health initiatives, such as working to get the levels of environmental contaminants children may be exposed to Closer to Zero.

While the FDA and industry share the responsibility of ensuring food is safe, it is the manufacturer’s responsibility to make sure they market food that meets the FDA requirements that apply. The FDA will act when chemicals are in food at unsafe amounts.

Points to consider when reading about chemicals in food

Reading or hearing about chemicals in food, when combined with words like “toxic,” “extremely dangerous,” and “cancer-causing,” may be scary, especially if you aren’t getting all the facts.

Here are a few points to help you navigate information about chemicals in food:

• More complete information from a credible medical and scientific source would likely explain how much of the chemical is in the food, how much of the food someone eats or drinks, and whether the chemical is present at a level that is harmful to people.
• Chemical names may sound complicated, but that does not mean they are unsafe. Some may be ingredients you are familiar with. For example, tocopherols are vitamin E, sodium chloride is salt, and dihydrogen monoxide is water.
• Some chemicals safely used in food may have other non-food uses. Vinegar, for example, is used as a household cleaner and in small amounts in food. A chemical must meet the FDA’s safety standards if used in food.

Making food choices

Eating various nutrient-dense foods can help reduce exposure to any one chemical. Whether you cook from scratch or buy some prepared or packaged items, remember:

• Eat various vegetables, fruits, whole grains, lower-fat dairy, protein food, and certain oils.
• Eat and drink fewer foods and beverages high in saturated fat, sodium, or added sugars.

Food choices are yours to make. The FDA wants to help ensure you have sound information to make the best choices for you and your family.

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The FDA has been investigating certain supplements since September and has found some tejocote root products to be substituted with toxic yellow oleander, which can cause serious reactions and death.

Most of the products are sold online. As of April 4, the Food and Drug Administration had received reports of “adverse events” from people who ingested products labeled as tejocote root. At least one serious event has been reported in relation to Green ELV Nutrition brand Elv Control Herbal Supplement capsules. The capsules have been added to the FDA’s list of products that have been found to have toxic yellow oleander.

“The agency is reminding consumers to avoid these products (certain tejocote root products) because they contain toxic yellow oleander and can cause neurologic, gastrointestinal and cardiovascular adverse health effects that may be severe, or even fatal,” according to the FDA’s warning.

Some of the products have been recalled, but seven suppliers have refused to recall their products. Therefore, the FDA is concerned that products containing toxic yellow oleander remain on the marketplace. The FDA is evaluating additional regulatory pathways to remove all identified products from the marketplace. The agency has the authority to force recalls but it has not imposed such recalls on the identified firms. 

The complete list of products can be found in the chart below.

Some products may have tejocote listed as Crataegus mexicana root or Brazil seed. 

“Yellow oleander is a poisonous plant native to Mexico and Central America and a toxic substance of concern to public health officials. In other words, the tested products that were labeled as tejocote or Brazil seed are actually toxic yellow oleander,” according to the FDA’s warning.

Recommendations

• The FDA is advising consumers to stop using and dispose of these products.
• The FDA advises consumers who have taken any of these products of concern to contact their health care provider immediately.  Even if these products have not been used recently, consumers should still inform their health care provider about which product they took, so that an appropriate evaluation may be conducted.
• Call 9-1-1 or get emergency medical help right away if you or someone in your care has serious side effects from these products.
• Contact your healthcare provider if you or someone in your care recently ingested these products and have health concerns.
• Consumers can also contact the state poison control center.

Who to contact

Health care professionals, patients and consumers are encouraged to report complaints and cases of exposure and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

To report a complaintor adverse eventsuch asillness or serious allergic reaction, you can

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to FDA.

SELLING
FIRMBRANDWEBSITE
PURCHASED FROMPRODUCTRECALL
STATUSWorld Green Nutrition Inc. / AlipotecGreen ELV Nutrition brand Elv Control Herbal Supplement (capsules)Amazon.com Independent Distributor (Alipotec)Recall InitiatedAlipotec South TXWorld Green Nutrition, Inc.ALIPOTEC ELV Mexican Tejocote Rootalipotecus.comRecall InitiatedAmazon.comnwl NUTRA Mexican Tejocote RootAmazon.comSeller declined to recall, removed listingsGlobal Mix Inc. EVA NUTRITION Mexican Tejocote RootEva-nutrition.comDeclined to recallSunset Sales + ELV King All Natural Tejocote RootELV King Tejocote Root Raiz de TejocoteAmazon.comDeclined to recall, removed listingsALIPOTEC RAIZ DE TEJOCOTEALIPOTEC Tejocote Root Dietary Supplement Piecesalipotectejocote.comFDA unable to contact firmNatural Supplements, LLCScience of ALPHA Mexican Tejocote RootTejocotemexican.comDeclined to recallH and NaturalH & Natural Tejo Root Raiz de TejocoteH & Natural Brazil SeedHandnatural.comRecall InitiatedBackstage CTC SellerALIPOTEC Tejocote Root Raiz de TejocoteAmazon.comRecall Initiatedby sellerAmazon.comALIPOTEC Tejocote Root Dietary Supplement PiecesNutraholics ELV Tejocote Root Dietary Supplement Pieces Nutraholics ELV Nutraking Mexican Tejocote Root Supplement Pieces ALIPOTEC Tejocote RootAmazon.comDeclined to recall, removed listingsGlobal Mix, Inc.Niwali Raiz de TejocoteScience of Alpha Mexican Tejocote RootEtsy.comDeclined to recallInnovacion Natural, LLC ALIPOTEC Tejocote Root Dietary Supplement PiecesInnovacionnatural.comFDA unable to contact firmPastor-Villareal, Inc.  Tejocotex Tejocote Root Amazon.comDeclined to recall, removed listingsFDA’s investigation is ongoing. Additional products may be added to the list.

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Bacterial populations remain stable despite cleaning efforts in ready-to-eat food facilities, according to researchers.

Scientists from the Quadram Institute and UK Health Security Agency (UKHSA) are working on how Listeria persists in ready-to-eat (RTE) food production environments.

Researchers hope that understanding how Listeria survives in these environments could inform better laboratory testing of cleaning methods. Funding came from the Biotechnology and Biological Sciences Research Council.

In 2019, six people died in a Listeria outbreak caused by contaminated ready-to-eat sandwiches served in several hospitals across the UK. A recent inquest at Manchester Crown Court found Beverley Sowah, 57, and Enid Heap, 84, died after eating contaminated chicken mayo sandwiches.

Despite well-implemented strategies to disinfect facilities and control microbial risks, Listeria can breach food safety barriers and cross-contaminate products. This is particularly dangerous in RTE foods where consumers will not destroy bacteria by heating the food before eating it.

Researchers wanted to understand the potential sources of cross contamination and the factors that contribute to the survival of Listeria monocytogenes in such environments.

The team sampled the floor of a RTE food factory that had detected Listeria monocytogenes in non-food contact areas of the plant. They sampled different sites: a preparation area, where ingredients were kept at 4 degrees C (39.2 degrees F), and a production area where food was assembled and packaged, kept at 10 degrees C (50 degrees F). They sampled the sites over 10 weeks, before and after cleaning.

Listeria and supporting microbes
Culturing and genetic analysis on samples was done to identify which bacteria were present and in what proportions. Results showed the populations of bacteria that coexist with Listeria monocytogenes were stable over time and have adapted to conditions on the factory floor, including food safety controls. 

“As Listeria monocytogenes is supported by a stable community of other bacteria, we may now need to develop new strategies to alter the whole bacterial population to effectively eliminate the pathogen,” said Maria Diaz from the Quadram Institute.

Overall bacterial populations, and proportions of bacteria were stable before and after cleaning.

“The populations are very stable, and cleaning is not shifting the composition – it’s not letting one bacterium grow over another. After cleaning, the bacteria reduce in numbers and the bacterial load is lower, making cross contamination less likely,” said Diaz.

There was a difference between areas of the site at different temperatures; suggesting that bacterial populations are adapted to different environments in the facility. It also indicates that bacteria in the factory are established populations and not introduced from outside sources – as despite movement of staff between them, the populations remained stable.

Diaz will present her data at the Microbiology Society Annual Conference, which is scheduled from April 8 to 11 at Edinburgh International Convention Centre.

Meanwhile, in September 2024, the Quadram Institute is hosting the 21st International Symposium on Problems of Listeria and Listeriosis.

The meeting will bring together the Listeria research community and other food and health stakeholders to discuss new discoveries and opportunities to understand and control the pathogen.

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Audits in Luxembourg and Hungary have found positives in the system for meat controls but also areas that need addressing in both countries.

The DG Sante audit in Luxembourg in May 2023 assessed the official controls related to slaughter hygiene and meat inspection requirements. The visit found official controls are delivered at the established frequency and generally cover the relevant aspects.

Weaknesses included the inability to impose fines. This is a longstanding issue, identified in previous audits, that limits the efficiency of official controls, especially when food businesses do not resolve non-compliances by the deadlines imposed.

A solution to the national legislation not providing the possibility for the authority to impose fines has been in preparation for several years and a draft bill was being studied at the time of the audit. This new law proposal foresees administrative sanctions for all the legislation that could be applied following the first official control.

Issues going undetected
The Luxembourg Veterinary and Food Administration (ALVA) was created in 2022 and is responsible for official controls at slaughterhouses.

Auditors said the guidance and procedures available to official veterinarians (OVs) were limited in some areas, which does not ensure that all the points are supervised and results in problems around consistency of controls.

Supervision and identification of training needs are not adequate and, as a result, some OVs were not able to identify certain operational hygiene non-compliances or enforce their correction.

The audit team saw evidence of OVs not identifying some non-compliances, so not enforcing them, and examples of unsatisfactory action when the company did not provide a solution by the agreed date. In some cases, the only measures taken by the authority was to extend the deadline. In several cases, the actions taken to ensure the firm resolved a non-compliance did not consider the root cause of the issue.

Auditors observed that the line speed, the layout of inspection points and the positioning of official staff made it difficult to inspect the lower parts of the beef carcass for contamination in two red meat sites.

They also found that sampling programs were not fully in line with legislation and one establishment did not have a procedure in place to explain what to do in case of positive Salmonella results.

Hungary findings
The audit in Hungary in September 2023 found the overall system could provide reassurances that official controls for red meat and poultry meat were delivered as intended but there were also several weaknesses and five recommendations were made.

Of 430 red meat approved slaughterhouses in the country, 18 applied the derogation of the timing of post-mortem inspection (PMI) and 96 where PMI is carried out under the responsibility of the official veterinarian (OV).

During preparation for the audit, authorities found that some sites were not in compliance with EU legislation as their annual throughput was above the permitted threshold for these derogations. Authorities took action to address this issue during the audit.

Frequency of official inspections in slaughterhouses is decided following a risk analysis carried out by the National Food Chain Safety Office (NÉBIH). This does not take into account an operator’s past record based on previous official controls and their level of compliance, said auditors.

In response, Hungarian officials said checklists at slaughterhouses will be renewed and any deficiencies will be weighted so that the following year’s inspection plan can account for the previous year’s non-compliances, the outcome of official controls and the level of compliance.

The current system does not provide the authority with a reasonable level of confidence that controls at establishment level are carried out correctly, uniformly and consistently and that non-compliances are identified and corrective action taken when necessary, found the report.

In some establishments, a number of non-compliances identified by the audit team had not been recognized by the resident OVs during their daily presence at the slaughterhouse nor identified during the annual inspection, so no enforcement had been applied to resolve the issues.

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