Food Safety News

The CDC is reporting that more than 380 children are now involved in an outbreak of lead poisoning traced to pouches of cinnamon applesauce.

The outbreak was first announced in October 2023 after the Food and Drug Administration received information in September from North Carolina officials about children with elevated levels of lead in their blood. Traceback work showed a common source — cinnamon applesauce sold in pouches.

The implicated applesauce was made in Ecuador by Austrofoods. The cinnamon in the applesauce pouches was supplied by Negasmart to Austrofoods. Officials found the lead in the cinnamon was 2,000 times the amount considered safe. Elevated levels of chromium was also found in the product.

The U.S. Centers for Disease Control and Prevention is investigating 97 confirmed cases, 253 probable cases, and 35 suspected cases for a total of 385 cases from 42 different states.

The U.S. Food and Drug Administration is reporting that it is investigating 90 cases with the age range for the patients from less than one to 53 years old with the median age being 1 year old. There could be some overlap so the CDC and FDA numbers should not be added together.

Three brands of cinnamon applesauce pouches have been recalled. They are Wanabana, Schnucks and Weis. The pouches were sold individually nationwide. Some of the Schnucks pouches were sold in variety packs.

The FDA and CDC are recommending that parents not use the applesauce and through it away or return it to the place of purchase. The applesauce has a very long shelf life, so officials are urging the public to check their homes for the recalled products.

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.

About chromium exposure
Symptoms of chromium exposure from eating contaminated food may be nonspecific. Some people might not experience any symptoms. Ingestion of chromium exceeding dietary recommendations may result in abdominal pain, nausea, vomiting, diarrhea, anemia, renal and hepatic dysfunction.

Norovirus has been determined to be the suspected cause of a large outbreak at Airbus in France in late 2023, according to public health officials.

The Loire-Atlantique regional health agency (ARS) believes norovirus was behind almost 700 people falling sick at the Airbus Atlantic Christmas lunch in mid-December. Findings are based on the clinical symptoms in patients and the time it took for them to appear.

Sick people reported suffering from nausea, vomiting, and diarrhea after the event in Montoir at the company’s restaurant. Testing of food leftovers was negative for norovirus. No detail was given on whether patients or food handlers had been tested.

The varied menu is said to have included a cheese plate, a starter with scallops, a foie gras terrine, beef in sauce, and a lobster dish.

Norovirus can quickly and easily spread through sick people and contaminated surfaces or through contaminated food and water. A person usually develops symptoms 12 to 48 hours after being exposed. Most people with norovirus illness get better within 1 to 3 days, but they can still spread the virus for another few days.

Seasonal spike linked to shellfish

Meanwhile, France has reported a number of outbreaks linked to bivalve mollusks with several shellfish areas closed since December 2023.

In Loire-Atlantique, a norovirus outbreak with 40 infections after eating oysters was recorded in December. In Ille-et-Vilaine, several cases of food poisoning were linked to oysters in January and the same situation occurred in Gironde in December.

Norovirus in oysters from France caused 15 people to fall sick in Sweden and two cases in Finland in January. In Denmark, 32 illnesses were recorded in December.

In France, actions after an outbreak include oyster bed closures for 28 days and weekly norovirus testing until the production area tests negative.

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A petition filed last year with USDA’s Food Safety and Inspection Service (FSIS) is among the first to generate a comment in 2024.

Animal Partisan, one of the nation’s many animal activist organizations, authored the petition.

Petition 23-07, requests that FSIS issue a notice to convey that: 1) State government officials are not categorically pre-empted from enforcing state anti-cruelty laws by the Federal Meat Inspection Act, the Humane Methods of Slaughter Act, or the Poultry Products Inspection Act, and 2) FSIS personnel should cooperate with state government officials in the enforcement of state anti-cruelty laws and improve clarity and frequency of communication to those officials.

The Animal Partisan Petition has been pending since it was filed on Sept. 2, 2023. It mainly asks FSIS to publish a notice clarifying that federal law does not necessarily prevent state government officials from bringing animal cruelty charges when farmed animals are abused in slaughter plants.

The Washington D.C.-based Animal Welfare Institute filed new comments in support of Petition 23-07 on Jan. 23, 2024.  It says the Animal Partisan petition is a  simple request and would require relatively little of the agency, yet it could significantly improve the welfare of animals at slaughter.”

The Animal Welfare Institute  claims that “all too often, while they await slaughter and during the slaughter process, these animals are severely mistreated.”

“USDA records describe live birds having their heads, legs, feathers, and wings ripped off,” it continues.  “Animals are kicked, dropped, beaten, and held for hours or days without protection from severe weather.”

“Some of these incidents may violate state animal cruelty laws; yet, the USDA does not refer these cases to state law enforcement officials, It adds. “Further, some local officials incorrectly believe that federal law prevents them from ever charging slaughter plants or personnel with animal cruelty, and the USDA has not dispelled that misguided notion.”

Petition 23-07 was assigned to the FSIS Office of Policy and Program Development for review.

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The demand for food away from home has witnessed a surge in recent years, making restaurants a crucial source of food-related illness outbreaks. 

A new study, conducted by researchers with the University of Illinois in Urbana-Champaign and Purdue University, has delved into the intricacies of these outbreaks, shedding light on the media and stock market responses to both single-state and multistate incidents. The focus of the research is on Chipotle Mexican Grill, a prominent restaurant chain that faced eight outbreaks between 2015 and 2018.

The study begins by highlighting a startling statistic – over 60 percent of foodborne illness outbreaks in the United States occur at restaurants, and 97 percent of these outbreaks are limited to a single state. Despite the prevalence of such incidents, there is a gap in the understanding of restaurant outbreaks, especially when it comes to single-state occurrences.

Chipotle cases provide a unique lens through which to examine these outbreaks. The study analyzes the media and stock market responses to each of Chipotle’s eight outbreaks, differentiating between single-state and multistate events. The research emphasizes the importance of understanding the financial impact of outbreaks on businesses, given that food away from home constitutes a significant portion of total food expenditures in the U.S.

The results of the study reveal a shift in the dynamics of reporting and market response to single-state outbreaks before and after Chipotle’s multistate E. coli outbreaks. Notably, multistate outbreaks led to swift stock price declines for Chipotle, resulting in a decline of market capitalization of approximately $1.75 million. However, the impact of single-state outbreaks was contingent on their timing rather than their severity.

Before the worse multistate outbreaks, single-state incidents at Chipotle garnered minimal media coverage and inflicted no financial losses. In contrast, after the multistate events, single-state outbreaks resulted in national media attention and substantial financial impacts, indicating a significant change in perception.

The research draws attention to the efficient market hypothesis, suggesting that stock prices should reflect the value of information contained in outbreak announcements. Chipotle’s publicly traded status allows for a clear evaluation of the financial impact through stock price changes, enabling insights into how price discovery takes place.

The study underscores the importance of investing in outbreak prevention, particularly for restaurants. It also emphasizes that outbreaks at restaurants, often stemming from factors like sick workers or improper food handling, are preventable with the right training and policies.

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Pennslvania Attorney General Michelle Henry, with the state Department of Agriculture, has now sued Amos and Rebecca Miller and their various farms and related businesses in the Lancaster County Court of Common Pleas to shut him down with a permanent state injunction. 

Two recent E. coli illnesses reported by other states’ health departments are suspected to have originated from Miller’s Organic Farm raw milk or raw milk products. 

Additionally, samples of raw milk and raw milk products collected by the Pennsylvania Department of Agriculture recently tested positive for Listeria. These bacteria pose serious health risks, especially to young children, older people, and people with weakened immune systems.

The AG filed the 357-page complaint with exhibits on Jan. 23 after years of attempts by state and federal officials to bring the Miller into compliance with basic food safety law. The filing outlines violations of Pennsylvania’s Milk Sanitation Law, Food Safety Act, Retail Food Facility Safety Act, Unfair Trade Practices, and Consumer Protection Law. 

The alleged violations include failing to obtain licenses and permits, selling illegal raw milk products, and selling raw and raw milk products outside of Pennsylvania. The two recent E. coli illnesses reported by departments of health in New York and Michigan are suspected to have originated from Miller’s Organic Farm raw milk or raw milk products.

“For years, this business has brushed off efforts to bring its commercial farm operation into compliance with the law — as all commercial farms are required to do,” Attorney General Henry said. “We cannot ignore the illnesses and potential harm posed by distributing these unregulated products. We have long had food safety laws in this Commonwealth to protect the public from harm. Pennsylvanians should know what is in the products they and their families are consuming.”

Efforts to bring the farm into compliance date back several years. In 2019, in a case involving violations of federal meat and poultry handling laws, a federal court ordered Miller’s Organic Farm to comply with Pennsylvania licensing requirements and all applicable food codes. After multiple findings of contempt for failure to follow that order, Miller and his attorney agreed to a consent decree in August 2023, which remains in effect today, in which he affirmed his “independent responsibility for complying with relevant provisions of the laws of the Commonwealth of Pennsylvania.”

The lengthy complaint also names  Miller’s Organic Farm, its owners, and all related businesses as additional defendants.

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An assessment of controls at companies in the dairy sector in Ireland has found the system works well overall but there are several areas that need improvement.

The audit covered official controls by a Department of Agriculture, Food and the Marine (DAFM) division in the dairy production chain. Eleven businesses were audited between August and November 2022.

The Food Safety Authority of Ireland (FSAI) audits the effectiveness and appropriateness of the controls implemented by other agencies.

Following onsite audits at two companies, one small scale and one very small, the audit team found that official controls were not effective and the assessment of compliance against food law was not adequate. Compliance notices were issued to both firms by the DAFM unit.

At one very small company, no food safety management system and associated records were available on the audit day. The business could partially demonstrate one-step forward traceability but not one-step-back traceability, as EU legislation requires.

Cheese issues
In one region, following an increase in controls, a series of non-compliances with food law had been identified by DAFM at one company between 2021 and 2022. Following these checks, compliance notices were issued. At the time of the audit, four such notices remained in place.

As a result of official controls carried out on downgraded cheese, a RASFF alert was made regarding the unauthorized placing on the market of cheese unfit for human consumption, which originated from this firm.

During an audit, non-compliance with food law was identified, resulting in almost 4.5 tons of cheese deemed unfit for consumption and disposed of as a Category 2 Animal By-Product (ABP). The cheese processor was also requested to review all stock within the establishment. This resulted in 42 tons of product disposed of as Category 2 ABP.

Subsequent audits in another region by FSAI identified more product being stored and or consolidated for this company, these products were also judged to be unfit to eat and were disposed of in the same way.

Official controls were effective in identifying non-compliance but actions taken to address the issues did not prevent further occurrences, said auditors.

Findings from 11 audits by the FSAI team resulted in enforcement action taken by the DAFM division on four firms and the continuation of pre-existing actions on a fifth.

Auditors found the trading activities of one large multi-site manufacturer were not registered or approved by the DAFM unit, so it was not subjected to official controls. DAFM had contacted the firm about registration at the time of the audit.

Assessing DAFM performance
The audit team reviewed the risk rating and official control program for 2021 and 2022. On numerous occasions, non-compliances were noted. Not all establishments under the remit and supervision of the DAFM division were risk-assessed in 2021, and eight controls were missed. The 2021 official control plan was outdated and did not identify all sites requiring planned checks.

Not all storage and distribution sites were risk-assessed or approved for the re-packaging of cheese in 2021 and 2022. Cheese re-packing has ceased in all three sites since September 2022.

There were three missed official controls in 2021 for the handling and re-packaging of cheese, and three controls were not identified in the 2022 plan.

Auditors also found scores assigned to certain parameters were inaccurate, resulting in a change to the risk rating of three establishments.

In 2021, there were 241 planned controls and 537 reactive controls. Reactive checks were performed at four sites concerning the 11 missed planned official controls.

In one region, auditors noticed that one very small-scale plant did not receive the required frequency of food safety and process hygiene sampling controls as outlined in the 2021 sampling plan. DAFM explained that due to COVID-19 and reduced production, sampling frequency was halved for this firm. During an onsite inspection, the FSAI found that this company had not performed any product testing in line with EU regulations and relied on official control sampling to verify compliance with food safety requirements.

Concerns were raised by the audit team about the long periods, up to three years in one case, in which establishments remained approved or registered despite having either ceased operations or having approval or registration proposed for suspension or canceled. Since early 2022, additional resources have been allocated to improve the management and control of suspensions and revocations.

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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.

Click on table to enlarge. Use link above to go to FDA page with links to specific alerts.

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A connection between extraintestinal infections and food is possible, but it is hard to prove a direct link, according to a Dutch agency.

Extraintestinal infections arise outside the intestines, especially in the urinary tract and bloodstream. An infection can occur because bacteria from feces have entered the urinary tract. There is increasing evidence that food can cause them.

The National Institute for Public Health and the Environment (RIVM) searched scientific literature to see whether there was a connection. The agency found indications, but no hard evidence, that food is a direct cause of these infections.

E. coli can cause both gastrointestinal and urinary tract infections. However, the E. coli strains associated with urinary tract infections differ from those behind gastrointestinal cases.

RIVM found extraintestinal pathogenic E. coli (ExPEC) appears to cause the most urinary tract and bloodstream infections in the Netherlands. So, scientists focused their search for a link between infections caused by ExPEC and food.

It is difficult to demonstrate whether bacteria that cause urinary tract infections come from food. To do this, it must be checked whether the bacterial strain in humans is the same as in food or animals. It then needs to be investigated whether people ate this food before developing an extra-intestinal infection. This kind of research takes a lot of time and money, said RIVM.

Looking at the evidence
Scientists first looked at which pathogens lead to urinary tract and bloodstream infections in the Netherlands using 2019 and 2022 data. E. coli was the top pathogen, while Klebsiella pneumoniae and Enterococcus faecalis were found less often.

The literature study analyzed articles on infections by ExPEC related to food, published from 2010 to February 2023. Poultry meat appeared to be the most significant potential source but this was based on indirect clues, said researchers. The role of eggs, raw milk, and fruit and vegetables is minimal, but there are only a limited number of studies.

The variable incubation period of extraintestinal pathogens, because they can live in the intestines without causing disease, makes it challenging to demonstrate a relationship with food.

Outbreaks of ExPEC have been described where there may have been a link to food but the source was not confirmed. Also, there was often incomplete data collection or reporting in these outbreak investigations.

Although similar strains appear to occur in animals and humans, there is no quantitative evidence of transmission of ExPEC through food and urinary tract infections with food as a direct source.

Ways to demonstrate the relationship between food and extraintestinal infections include detecting identical, or almost identical, strains in patients and food or animals and showing an epidemiological link between consumption of contaminated food products and extra-intestinal infections.

To gather more evidence, scientists said a database could be set up involving sequencing and analyzing ExPEC strains from clinical isolates, farm animals, and food. Based on this sequence data, any clusters can be monitored and investigated. Data could also be used for source attribution studies.

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–OPINION —

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Ranking Member Frank Pallone Jr. (D-NJ), Subcommittee on Health Chair Brett Guthrie (R-KY) and Ranking Member Anna G. Eshoo (D-CA), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Ranking Member Kathy Castor (D-FL) wrote to Food and Drug Administration Commissioner Robert Califf to request a briefing regarding the possible intentional contamination of applesauce pouches.

BACKGROUND: 

• On Nov. 9, 2023, the FDA announced that WanaBana USA had voluntarily recalled three applesauce brands—Weis, WanaBana, and Schnucks—“due to reports of elevated levels of lead.” Subsequently, on January 5, 2024, the FDA announced that its testing of the applesauce pouches and cinnamon collected from the manufacturing facilitiy had also found chromium. applesauce
• In a statement, the FDA’s Deputy Commissioner for Human Foods, Jim Jones, indicated that recent lead contamination in applesauce pouches may have been an intentional, economically motivated act by a foreign supplier of cinnamon for the recalled products. 
• As of Jan. 8, 2024, the FDA had received 87 confirmed complaints/adverse event reports linked to the recalled product. 
• The Centers for Disease Control and Prevention (CDC) reported a total of 321 cases from 38 different states. 
• Of those 321 cases, reports suggest more than 60 children under the age of six in the United States have tested positive for lead poisoning. 
• Children in this age range are more susceptible to lead poisoning, which makes the Committee’s concerns about intentional product adulteration along the global supply chain particularly urgent. 

KEY LETTER EXCERPT: 

“Though the FDA has in the past elevated concerns about unacceptably high levels of lead in some baby food, recent events raise whether more can be done to prevent and detect illicit food contamination. Therefore, the Committee urgently requests a detailed briefing on the FDA’s suspicion of intentional lead contamination in applesauce pouches, particularly the steps undertaken for its investigation and measures for future prevention. It is crucial to understand the FDA’s strategies for detecting and addressing intentional contamination in the food supply chain given the limited authority your agency has over contaminated cinnamon from abroad, which was identified as the potential source of this issue.” 

The bipartisan Committee leaders requested a briefing no later than February 2, 2024, and requested that the following topics should be covered: 

• A timeline of events leading to the discovery of lead contamination in the three applesauce brands listed above. 
• How did the FDA determine that the adulteration of raw cinnamon may have been intentional? 
• How is the FDA collaborating with international partners, particularly Ecuadorian authorities, to investigate this issue thoroughly? 
• How is the FDA collaborating with domestic partners, including state departments of health, to investigate this issue thoroughly?  
• What steps have been taken to determine if other foods have been contaminated as a result of this supply chain vulnerability? 
• How, if at all, does the FDA’s process for detecting lead contamination in food products differ for foods produced domestically from food produced abroad?  
• Since 2020, what has the FDA done to identify lead-contaminated foods and prevent them from reaching shelves?  
• Since 2020, how many recalls has the FDA issued related to lead contaminated foods? Of those, please specify how many were related to contamination products manufactured in America and how many were related to contamination abroad.   
• What are the FDA’s capabilities within its existing authorities to enhance monitoring and inspection processes to better detect and prevent intentional acts of lead contamination along the supply chain, including internationally, and what plans does the FDA have to use those authorities? 
• What additional resources or authorities are needed to better detect and prevent intentional acts of lead contamination along the supply chain, including along international supply chains?
• Will the FDA commit to providing the Committee with rolling updates on the status of the investigation, including findings related to the suspected international contamination? 

CLICK HERE to read the full letter.

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It was only a matter of time. Colorado raw milk rules are among the most restrictive in the
West, but that isn’t likely to last. With bipartisan sponsors, Senate Bill (SB) 24-0434 is off and running in the Colorado Legislature.  Colorado’s governor, as a congressman, was a prominent Food Freedom Caucus member.

Under current law, if you own a cow or goat that produces raw or unpasteurized milk, you may drink it, but you cannot sell it in Colorado. Cow shares are recognized as ownership. But that’s about it.

Instead, Colorado is considering joining its surrounding Western states by allowing raw milk dairies to sell directly to consumers. This is the one-step short of allowing retail sales of raw milk,  It’s where the law stops in Wyoming, Oregon, Montana, Nebraska, Kansas, Oklahoma and Texas.

Utah, Idaho, Washington, Arizona, New Mexico, Nevada and California do permit raw milk sales in all sorts of retail stores.

SB 24-043 legalizes the sale of raw milk from cows or goats in Colorado when sold directly to consumers, either at the dairy, at the consumer’s residence, or at a farmer’s or roadside market. The raw milk dairy making such sales must be registered with the Department of Public Health and Environment (CDPHE) and meet certain handling and labeling requirements.

The Colorado Department of Agriculture (CDA) shares jurisdiction for those handling and labeling requirements and will make the raw milk rules in consultation with CDPHE.

CDA may investigate raw milk producers and apply civil penalties through civil actions against any producers who violate the raw milk program’s requirements.

The bipartisan sponsors, Sen. Dylan Roberts, D-Summit County, and Sen. Byron Felton, R-Sterling, say that while opening raw milk sales directly to the consumer, their bill considers food safety.  Rules violations could result in fines totaling $500 per container.

Under the bill, raw milk must be labeled with the dairy’s name and production date and a warning that the product “may increase your risk of foodborne illnesses,” including a higher risk for children, pregnant women, and older people.”  The bill also requires that raw milk be kept below 40 degrees F during transport.

For decades, the State of Colorado has warned the public about the dangers of raw milk.   That will likely end with this bill or if Polis silences his CDPHE scientists during hearings and debates on SB 24-043.

The raw milk bill could become law as early as 90 days after the Colorado Legislature adjourns.   The bill is subject to a referendum to voters, although such action isn’t likely.  CDA oversight and registration of raw milk producers will require an additional full-time employee and cost $125,970 by FY 2025-26.  The fiscal note on the bill figures that CDA will collect $126,000 annually from registering 200 raw milk producers.

Since 1987, the U.S. Food and Drug Administration (FDA) has prohibited the sale of raw milk across state lines. Regardless of state laws, most state agriculture and health departments recommend against consuming raw milk or products made from it because of the danger of contamination by E. coli, Salmonella, Listeria and other pathogens.

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The European Commission has changed the level of inspections on various imported products, including decreases related to ethylene oxide and increases in pesticide residues.

The revised legislation sets the rate of official controls and special conditions for food and feed of non-animal origin imported into Europe. Rules are modified every six months.

Decisions are based on reports in the Rapid Alert System for Food and Feed (RASFF) and information from documents, identity, and physical inspections by EU countries in early 2023.

Checks on sesame seeds for Salmonella from India have been tightened to 30 percent of consignments. However, controls for ethylene oxide will be relaxed from 50 percent to 30 percent of shipments.

Ethylene oxide amendments
Instant noodles containing spices and seasonings or sauces from South Korea have had a higher rate of official controls because of the risk of contamination by ethylene oxide since December 2021. Findings by member states show better compliance, so the control level of 20 percent of consignments entering the EU has been reduced to 10 percent.

Stricter checks on food supplements containing botanicals from South Korea and peppers (other than sweet) from Uganda due to ethylene oxide have been removed.

The frequency of identity and physical checks on cumin seeds from Turkey for pyrrolizidine alkaloids has been increased to 30 percent.

Guar gum from India has been subjected to increased official controls because of the risk of contamination by pentachlorophenol and dioxins since February 2015. National inspections show improvement in compliance, so the level of controls has been reduced from 50 percent of consignments entering the EU to 30 percent.

Peanuts, also known as groundnuts, from the U.S., will still be checked at a frequency of 20 percent for aflatoxins. Vanilla extract controls for pesticide residues also remain unchanged at 20 percent.

The majority of updates feature pesticide residues. Increased oversight has been put on seem and helmet beans from Bangladesh, yard-long beans from India and Sri Lanka, granadilla and passion fruit from Thailand, durian from Vietnam, vine leaves from Egypt, and rice from Pakistan. However, controls have been relaxed for mint from Israel.

Oversight related to Chernobyl

The EU Commission has also updated rules covering import conditions of food and feed from other countries following the accident at the Chornobyl nuclear power station in 1986.

Conditions apply to products containing or derived from wild mushrooms and wild fruits of the genus Vaccinium, such as cranberries and blueberries, several other mushroom types, and some juices and waters.

Mixtures of nuts and dried fruits, jams, fruit jellies, marmalades, fruit or nut purée and fruit or nut pastes, mixtures of juices, flavored waters, and certain foods with several ingredients containing the affected mushrooms and fruits are also covered by the rules.

Certain foods with wild mushrooms or wild berries might also contain ingredients of animal origin, so physical controls should only be performed at the border control post, said the EU Commission.

The maximum permitted levels of radioactive contamination in terms of cesium-137 is 370 Bq/kg for milk and milk products and food for infants and young children. It is 600 Bq/kg for all other covered products.

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Researchers have raised questions about the threat Yersinia enterocolitica poses to public health in the food chain.

The study, involving the Quadram Institute, University of East Anglia, and the UK Health Security Agency (UKHSA) found diverse populations of Yersinia enterocolitica on foods.

The number of yersiniosis cases is low, but it is likely there is underreporting. Not everyone with gastroenteritis reports it; such patients aren’t routinely screened for Yersinia.

Yersinia enterocolitica was isolated from 37 of 50 raw chicken, 8 of 10 pork and salmon samples, and 1 of 10 leafy green samples collected at retail in the UK in 2021.

The percentage of food contamination was higher than in past studies looking at Campylobacter and Salmonella, but Yersinia enterocolitica causes fewer reported infections than these bacteria.

Another study, published in the journal Eurosurveillance in 2023, estimated thousands of Yersinia enterocolitica infections may go undiagnosed in England annually.

In the new work, researchers used multiple methods to determine the diversity of Yersinia enterocolitica in different foods and if it contributed to human infections.

According to the study published in the International Journal of Food Microbiology, understanding the types of Yersinia enterocolitica found on food samples is essential for outbreak investigations.

Potential role in infection
From the 80 food samples, 207 Yersinia enterocolitica isolates were recovered and their genomes sequenced. Isolates from food belong to 38 sequence types (ST).

The 207 genomes from food were compared with 747 public Yersinia enterocolitica genomes. Of the 207 food-derived isolates recovered in the study, 205 were biotype 1A. Biotype 1A is considered non-pathogenic because it lacks virulence genes, but outbreaks with this biotype have been reported.

Of the 80 food samples tested, 41 contained isolates that belonged to the same ST that had previously been isolated from UK human sources.

Just because highly similar Yersinia enterocolitica biotype 1A isolates were found in clinical and food specimens does not mean they were the agent responsible or that the isolate originates from that food type, said researchers.

“Effective source attribution of Yersinia enterocolitica will require improved detection and reporting of Yersinia enterocolitica from humans, and surveillance of food with sufficient isolates taken to capture the diverse populations present; this will also help determine the clinical significance of biotype 1A.”

Findings suggest that food samples were contaminated with a diverse population of Yersinia enterocolitica at a single point or at multiple points with different strains. 

“The large amount of diversity found amongst samples has implications for outbreak analysis, as sampling a single Yersinia enterocolitica isolate from a food sample will unlikely represent the diverse population present and could result in potential sources of infection being missed,” said scientists.

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All the following stem from the temporary January closure of a popular restaurant called DaVinci’s at 150 Mill Street in Lewiston, Maine:

—Tonight, the Lewiston City Council will likely notify Commissioner Jeanne M. Lambrew of Maine’s Center for Disease Control and Prevention, terminating the City’s agreement with the state for City inspection services of restaurants within the City.

—The Lewiston City Council will also likely approve a supplemental FY24 budget adjustment to rescind the funding for the Certified Sanitation Inspector/Code Enforcement Officer who did those restaurant inspections for the remainder of the fiscal year.

—The City of Lewiston has already placed Planning and Code Enforcement Director Dave Hediger on immediate administrative leave, which is part of the “continued fallout,” according to local media, over the recent temporary closure of DaVinci’s.

—The person whose position and funding are being eliminated is  Louis Lachance, the city’s long-time restaurant inspector who holds the sanitation inspector position, getting the axe tonight.

No official record explaining why DaVinci’s was closed has been made public.  Closures only occur when something is causing a severe threat to human health.

DaVinci’s co-owner Craig Tribuno told local media that someone had reported seeing a cockroach in the restaurant’s kitchen.  From Social Media posts, the closure appears to have begun on Jan. 8, and the re-opening came a week later on Jan. 15.

Tribune said the closure cost the restaurant $80,000, and he wanted assurance from the City that it wouldn’t happen again. Neither he nor City elected officials said what led to the closure or what the $80,000 bought

No restaurant inspection reports have been made available for this incident, but earlier reports for DaVinci’s are posted on the City’s code enforcement website.   And DaVinci’s failed a 2019 inspection conducted by Lachance.

A failed inspection is one with more than three critical violations or more than 10 non-critical violations.  A failing establishment gets re-inspected within 30 days or less. All critical violations must be corrected within ten days. 

DaVinci’s 2019 violations were extensive but did not require the restaurant’s closing.    Closures under the 2013 Maine Code occur only when a food service establishment is found to pose an imminent health hazard to public health. DaVinci passed its re-inspection in 2019, and the last regular inspection was in early 2022.

With a population of not more than 40,000, Lewiston has been one of three cities contracted by Maine to do restaurant inspections. It has about 175 establishments.  Ironically,  the Lewiston City Council signed its current agreement with the state only last Nov. 14.

But just 69 days later, the Lewiston City Council will likely trigger the 30-day termination clause, meaning Maine CDC is on its own.

A city building inspector, writing on Facebook, said:  “The message being received is that if I do my job well, I might no longer have a job.  Imagine going to work with that feeling.”

Immediate action by the non-partisan government could not be taken against Lachance because a union contract covered him.  However, if his position and funding Are eliminated after tonight’s council meeting, those details might not count for much.

Hediger, the planning and code enforcement director, has worked for Lewiston for 25 years.  Lachancee said Hediger is “the hardest working employee at the city.”

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The number of E. coli, Salmonella, Campylobacter, and Listeria infections has gone up in Ireland, according to 2022 data from the Health Protection Surveillance Centre (HPSC).

During the COVID-19 pandemic, reporting rates for giardiasis, listeriosis, norovirus, rotavirus, salmonellosis, shigellosis, and toxoplasmosis in Ireland decreased compared to pre-pandemic levels. Still, rates for campylobacteriosis, cryptosporidiosis, E. coli, and yersiniosis increased or remained unchanged. In 2022, most of these diseases returned to or remained at pre-pandemic levels.

A 2021 cyber-attack at the Health Service Executive (HSE) also affected data validation and collection, reporting of enhanced data variables, and outbreak notification.

Campylobacter and Salmonella stats
In 2022, 3,617 Campylobacter cases were recorded. The incidence rate increased by 13 percent compared with 2021, after a rise of 23 percent between 2020 and 2021. Rates in 2021 and 2022 were the highest recorded in recent years and remained largely unaffected by the pandemic, apart from a slight decrease in 2020. In 2022, reporting rates were above the EU average.

The highest incidence rate was among those younger than 5, with males accounting for 61 percent of cases in this age group. The rate increased across all age groups 2022 except among 5-9 and 10-14-year-olds. The highest number of notifications was reported in June, with 474.

Ireland had between zero and three outbreaks a year from 2019 to 2022. In 2022, outbreaks ranged in size from two to 11 cases, with a median of three people ill.

342 Salmonella infections were recorded in 2022, and 142 people were hospitalized. The reporting rate in Ireland remained lower than the EU average.

The incidence rate decreased in 2020 and 2021 during the pandemic. In 2022, it almost doubled from 2021 but was similar to pre-pandemic rates.

The highest incidence rate was among less than one to 4 year olds. Salmonella Typhimurium, including monophasic Salmonella Typhimurium and Salmonella Enteritidis, were the most common serotypes 2022. Other frequently seen types included Newport, Poona, Mbandaka, and Infantis. Salmonella Enteritidis was more likely among travel-associated cases, but it was Salmonella Typhimurium among domestic infections.

In 2022, 99 patients reported being infected outside Ireland. Spain, Portugal, and Turkey were the most common countries among travel-associated cases.

Seventeen outbreaks were reported in 2022, up from 11 and six in 2020 and 2021. Three were national incidents, including 16 cases that were part of the Ferrero Kinder chocolate multi-country outbreak. Another Salmonella Typhimurium outbreak affected 27 people, but the source was not found.

E. coli and Listeria figures
980 E. coli cases were recorded in 2022, and 322 people were hospitalized. The notification rate remained higher than the EU average. In 2022, only the rate in Denmark was higher than in Ireland.

Key risk factors for infection include private well water, animal/environmental exposures, and attending a childcare facility. Food and international travel play minor roles, said HPSC.

Four deaths occurred among cases in 2022; the infection did not cause two, while the cause of death was not known for the other two. All people who died were older than 60.

In 2022, the incidence rate for E. coli increased by 3 percent compared to 2021. The highest rate was among less than one to 4-year-olds, followed by those more than 65 years old.

The top serogroup among culture-confirmed cases was O26 on 232 occasions, followed by O157 164 times. Other common serogroups were O145, O146, O103, and O91. Infections caused by E. coli O26 were more common earlier in the year, peaking in June, while those caused by O157 were more common later in the year.

Twenty-four cases of hemolytic uremic syndrome (HUS) were reported. Ten were O26, and six were O157, while O103, O145, O5, and O55 caused one case each.

Seventy-eight E. coli outbreaks were notified, with 208 people ill, compared to 62 outbreaks in 2021.

There were 18 cases of listeriosis in Ireland in 2022. Notifications decreased to six in 2020 but returned to usual levels in 2021 and 2022. Notification rates in 2022 were half the average rate in Europe.

In 2022, the highest incidence occurred in people older than 65 years old. There were also two cases in the less than 1 to 4-year age group. There was one pregnancy-related listeriosis notification each year in 2022, 2021 and 2020.

Ireland also recorded three cases each of Clostridium perfringens and Bacillus cereus and two of botulism in 2022. A total of 17 Yersinia infections were reported. Hepatitis A fell from 82 cases in 2021 to 66 in 2022.

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Updated figures for antimicrobial resistant (AMR) E. coli, Campylobacter, and Salmonella on chicken and turkey meat in the United Kingdom have been released.

A survey covered 306 fresh raw chicken and 302 turkey meat samples collected at retail in the UK from January to December 2022. A report was produced by the Animal and Plant Health Agency (APHA) under contract from the Food Standards Agency (FSA). Findings continued monitoring E. coli and Campylobacter and produced new baseline prevalence data on AMR Salmonella in chicken and turkey.

The prevalence of Extended Spectrum Beta Lactamases (ESBLs) and AmpC E. coli in chicken and turkey meat was 12 percent. The prevalence of ESBLs in E. coli from chickens was similar to the 2020 survey of 13 percent. For Turkey, there was no change from the 2020-21 survey.

Mcr-1 colistin-resistant E. coli was detected in 1 percent of both meat samples. Seven of the eight positives came from imported meat. It was the second time that MCR-1 had been found in E. coli in chicken and turkey meat on retail sale in the UK.

Campylobacter and Salmonella results
The prevalence of Campylobacter in chickens was 48 percent, but only 5 percent in turkeys. High levels above 1,000 colony-forming units per gram (CFU/g) were detected in 17 chicken samples. The highest was 25,700 CFU/g in whole chicken. Campylobacter jejuni was detected in 143 chicken samples, Campylobacter coli in 17 samples, and both species were found 15 times.

Ciprofloxacin and tetracycline resistance was common in chicken and turkey Campylobacter isolates. Resistance to ciprofloxacin is a concern as it is one treatment option for campylobacteriosis in people. Resistance to chloramphenicol, erythromycin, and gentamicin was not detected.

Salmonella was found in six chicken and two turkey samples. No isolates were ESBL- or carbapenemase-producers. Salmonella Paratyphi B variant Java was isolated from a chicken breast with meat origin from the Netherlands. Other isolates were Agona four times and Infantis, London, and Mbandaka all once. Except for one Agona isolates in a turkey breast from the UK, all were from chicken of UK origin.

• Multidrug resistance (MDR) was observed in a Salmonella Agona isolate from a turkey breast, which showed resistance to ampicillin, gentamicin, and tetracycline. Another Salmonella Agona isolates from a chicken leg was resistant to ampicillin. As ampicillin, sulfamethoxazole, and tetracycline have been commonly used in veterinary medicine, the findings are not unexpected.

E. coli, Campylobacter, Salmonella, and AMR were detected in chicken and turkey samples. However, they were raw meat intended to be cooked. Proper cooking will destroy microorganisms and reduce the risk for consumers.

Food handler knowledge
Meanwhile, another survey found four in five UK food handlers had heard of antimicrobial resistance (AMR). Half of respondents said they knew at least a little about it, and over a quarter stated they knew much about AMR.

Participants were 500 workers who handled food or touched surfaces likely to be in contact with food. They completed a survey between June and July 2022. Workers were shown a list of eight statements about AMR and one about antibiotics, of which some were true and others false. 

Findings suggested that food handlers’ levels of awareness and understanding of AMR were lower than those of consumers.

“It appears that some food handlers aren’t aware of the key food handling/preparation activities that can limit the spread of AMR,” said a survey report.

Food handlers more commonly identified meat, poultry, and seafood as sources of AMR over salad and fruits. About three in 10 incorrectly believed that washing chicken before cooking can protect against the spread of AMR.

Managerial food service staff and kitchen staff had similar levels of awareness across most areas.

Women and older respondents had higher levels of knowledge in terms of correctly categorizing statements and when identifying correct sources of and ways to protect against the spread of AMR.

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The FDA’s largest reorganization in history, involving about 8,000 employees, is far more than just “moving some boxes around.”  The proposed changes and updates to an FDA-wide reorganization plan have been out for external reviews and clearances since Dec. 13, 2023, and implementation should occur sometime during 2024.

A “Unified Human Food Program(HFP)” functional risk model is at the center of the reorganization. FDA will manage public health risks  through three areas of focus:

• nutrition, microbiological food safety, and chemical safety. Its strategic management functions leverage data to better prioritize activities and resources based on risk.

• surveillance strategy, risk-informed decision framework, and resource management for HFP and related field activities. So-called cross-cutting functions are the “tools” supporting risk management priorities.

• integrated food safety system partnerships, laboratory operations and applied science, compliance and enforcement, policy, and communications and engagement.

The Reagan Udall Foundation in 2022 evaluated FDA food programs, finding outside criticisms were justified and required fixing.

FDA Commissioner Robert Califf, who took over the agency for a second time on Feb. 17, 2022, ordered work to begin that May on the FDA-wide reorganization plan.  Califf previously served as Commissioner of Food and Drugs from February 2016 to January 2017. 

The Alliance for a Stronger FDA recently gathered FDA staff who helped draft the reorganization plan. They included:

• Deputy Commissioner Janet Woodcock, 

• Chief Scientist Namandje Bumpus, 

• Deputy Commissioner for Human Food Jim Jones, 

• Acting CFSAN Director Donald Prater.

*Deputy Commissioner for Operations Jim Sing

*Commissioner for Regulatory Affairs Michael Rogers, M.S.

The reorganization was submitted for review by the Department of Health and Human Services (HHS), which houses the FDA. Others might get involved, from the Office of Management and Budget (OMB) to the various public employee unions.

Janet Woodcock, the former acting FDA Commissioner, emphasized how far-reaching the reorganization will affect nearly every FDA unit.  The authors of the plan say it not only improves the human food program but also overall efficiency.

A new Office of Inspections and Investigations (OII) is at the center of changes.

The reorganization itself was said to be “budget neutral.”

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— OPINION —

If you recall, two weeks ago, I launched my column, “The Litigated Dish,” with the goal of addressing the Internet’s most frequently asked food safety questions. I kind of veered off topic last week when I discussed the most startling recent foodborne illness outbreaks, but I’m back on track. 

We already delved into one of the top Google searches: the top foodborne pathogens. 

Another super popular question is whether foodborne illness is contagious. 

This question, however, is quite broad because – which foodborne illness? There are several bacteria, viruses, and parasites that can cause foodborne illness. I thought I would put together a neat little table of some of the pathogens I frequently encounter, their food sources, and whether they are contagious.

Hope it helps.

PathogenCommon food sourcesContagious?NorovirusProduce, shellfish, and any food contaminated by someone who is infected with the virusYes, highly contagious. Some people may be contagious for as long as two weeks after recovery. SalmonellaA wide variety of foods, including raw and undercooked eggs, undercooked meat and poultry, produce, and pet foodYes. You can get a Salmonella infection from another person or even from your pet. If you have been infected, you can spread Salmonella for as long as you carry the bacteria in your bowel, which may be months after you stop having any symptoms.E. coliUndercooked ground beef, unpasteurized milk and juices, produce and sprouts, contaminated water, animals and their environment, feces of infected peopleYes, contagious for at least as long as the person has diarrhea, and sometimes longer. E. coli bacteria can be spread from humans and animals. C. perfringensMeat, poultry, gravies, and food cooked in large batches and held at an unsafe temperatureNo.CampylobacterUndercooked poultry, raw milk, untreated waterNot usually, but it can happen if the infected person does not thoroughly wash their hands after using the bathroom. Infected people will continue to pass the bacteria in their feces for a few days to a week or more.ListeriaUnpasteurized dairy products, deli meats, smoked fish, pates or meat spreadListeria is not contagious from person to person, but the bacteria may be passed from mother to fetus during pregnancy or directly to the newborn at the time of birth.Botulism (C. botulinum)Improperly prepared home-canned foodsNo.Staphylococcus aureusCooked foods high in protein (e.g., cooked ham, salads, bakery products, dairy products) that are held too long at room temperatureNo. But people who carry Staph can contaminate food if they don’t wash their hands before touching it. If food is contaminated with Staph, the bacteria can multiply in the food and produce toxins that can make people ill.ShigellaSalads, untreated water, and any food handled by someone who is infected with the bacteriumYes, highly contagious. Shigella foodborne outbreaks are most often associated with contamination by a sick food handler.Vibrio spp.Raw or undercooked seafood, particularly shellfishNo.Hepatitis ARaw or undercooked shellfish, produce, unclean water, and any food contaminated with an infected food handlerYes, highly contagious.It can be spread from close, personal contact with an infected person, caring for someone who is ill, or using drugs with others. Hepatitis A is very contagious, and people can even spread the virus before they feel sick.CyclosporaProduceUnlikely.Cronobacter sakazakiiLow-moisture, dry foods, like powdered infant formula, powdered milks, starches, and herbal teasUnknown. Experts do not know if it spreads from person to person.

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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.

Lone Star Botanicals Inc.

Tyler, TX

A food firm in Texas is on notice from the FDA after an inspection at its food manufacturing facility found violations of various federal regulations, including unapproved new drugs and misbranded drugs, hazard analysis and risk-based preventive controls, and misbranded foods.

In a Nov. 6, 2023 warning letter, the FDA described an April 17-21, 2023 inspection of Lone Star Botanicals Inc.’s food manufacturing facility in Tyler, TX.

The FDA’s inspection found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation.

They determined that the ready-to-eat (RTE) seasoning products manufactured in the firm’s facility are adulterated as they were prepared, packed, or held under insanitary conditions where they may have become contaminated with filth or rendered injurious to health. 

After the inspection, FDA investigators issued a Form 483 (FDA-483), Inspectional Observations.

Some of the significant violations are as follows:

Unapproved New Drugs and Misbranded Drugs

FDA reviewed the firm’s website at the Internet address https://drbotanicalhealth.com/ in July 2023 and Oct. 2023 and has determined that they take orders there for their Dr. Botanicals Health products Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, Marine Collagen, Organic Cordyceps Mushroom Based Superfood Powder, Organic Acai Plant Based Superfood Powder, Organic Inulin Prebiotic Fiber Superfood Powder, Organic Chaga Mushroom Based Superfood Powder, Organic Maca Plant Based Superfood Powder, Organic Reishi Mushroom Based Superfood Powder, and Organic Rhodiola Rosea Plant Based Superfood Powder. 

In addition, FDA reviewed the firm’s product labels collected during the inspection for their Dr. Botanical Health products Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, and Organic Cordyceps Mushroom Based Superfood Powder, as well as their Dr. Botanical Health Product Brochure, which directs consumers to their website https://drbotanicalhealth.com/ to purchase their products. The claims on their website, product labels, and product brochure establish that the products are drugs 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 products are intended for use as drugs include:

• Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder

o “Anti-inflammatory”
o “It’s known to help reduce anxiety ….”
o “It…reduces anxiety and depression ….”
o “Ashwagandha powder can help reduce inflammation ….”

• Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder

o “Helps Fight Colds & the Flu”
o “It’s often used as a folk remedy for…the common cold and flu … helping allergies and sinus infections, treating diarrhea ….”
o “It also has anti-inflammatory properties, which makes it useful for treating allergies and sinus infections … scientifically proven to be effective at treating colds and flu, particularly at the onset of a cold or flu.”
o “Various studies have shown that it can be effective as a natural remedy for preventing and treating colds and flu … Not only can elderberry help prevent colds and flu, but it can also be used to treat allergies, including hay fever, and sinus infections. It’s thought to be particularly effective against allergies and sinus infections ….”

• Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder

o From the list of hyperlinked “Tags” on the product page:
    “anxiety”
    “depression”
o “Rich in medicinal properties, Lion’s Mane mushrooms are thought to guard against dementia, reduce mild depression and anxiety, and help speed up recovery from injuries to the nervous system. Our extract powder can also help to regulate diabetes ….”
o “The lions mane mushroom contains a variety of compounds… [that] have anti-inflammatory, anti-cancer…properties.”
o “Lion’s mane mushrooms have been used medicinally for…skin diseases…reduce inflammation…. They are also used to help treat skin conditions such as psoriasis and eczema, as well as mental health conditions such as depression and anxiety.”

• Dr. Botanical Health Marine Collagen

o “Stabilizes blood sugar”
o “Reduces inflammation”
o “This powerful supplement is proven to stabilize blood sugar…reduce inflammation….”
o “[I]t can…reduce inflammation….”

• Dr. Botanical Health Organic Cordyceps Mushroom Based Superfood Powder

o From the list of hyperlinked “Tags” on the product page:
    “anti-inflammatory”

Examples of some of the claims on their product labels that provide evidence that their products are intended for use as drugs include:

• Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder

o “Contains Anti-Tumor Properties”
o “Anti-Inflammatory”

• Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder

o “Contains Ant-Inflammatory Properties”
o “Helps Fight Infections Like Cold & Flu”
o “Fights Harmful Bacteria”

• Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder

o “Helps Combats [sic] Depression, Anxiety & Stress”
o “Anti-Inflammatory”

• Dr. Botanical Health Organic Cordyceps Mushroom Based Superfood Powder

o “Anti-Inflammatory”

Examples of some of the claims on their Dr. Botanical Health Product Brochure that provide evidence that their products are intended for use as drugs include:

• Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder

o “Ashwagandha. …reduces anxiety and depression ….”

• Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder

o “The phytochemicals found in elderberries are known to fight infection, particularly in the respiratory system. High in antioxidants, it lowers cholesterol ….”

• Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder

o “Medicinally, Lion’s Mane mushrooms are thought to protect from dementia, reducing mild depression and anxiety, and increase recovery from nervous system injuries.”

• Dr. Botanical Health Marine Collagen

o “Marine Collagen is a powerful supplement proven to…reduce inflammation….”

• Dr. Botanical Health Organic Cordyceps Mushroom Based Superfood Powder

o “The benefits of this adaptogen also extends to fighting inflammation.”

• Dr. Botanical Health Organic Acai Plant Based Superfood Powder

o “Acai also helps lower cholesterol levels ….”

• Dr. Botanical Health Organic Inulin Prebiotic Fiber Superfood Powder

o “It is known for aiding in…constipation, diarrhea, and diabetes!”

• Dr. Botanical Health Organic Chaga Mushroom Based Superfood Powder

o “The health benefits of these mushrooms…include…lowering cholesterol, blood sugar and blood pressure…and fight unhealthy inflammation.”

• Dr. Botanical Health Organic Maca Plant Based Superfood Powder

o “Maca may also help…lower blood pressure ….”

• Dr. Botanical Health Organic Reishi Mushroom Based Superfood Powder

o “[T]hese mushrooms lower cholesterol, reduce allergic reactions ….”

• Dr. Botanical Health Organic Rhodiola Rosea Plant Based Superfood Powder

o “[T]his herb has been traditionally used to reduce anxiety, depression ….”

Hazard Analysis and Risk-Based Preventive Controls:

1. The firm did not prepare, or have prepared, and implement a food safety plan. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs). Their food safety plan must also include the following:

1) The written hazard analysis;
2) The written preventive controls;
3) The written supply-chain program;
4) The written recall plan;
5) The written procedures for monitoring the implementation of the preventive controls;
6) The written corrective action procedures; and
7) The written verification procedures.

However, the firm did not have a food safety plan with any of the required elements. For example, they did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control. Also, they did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated or misbranded. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system. The firm must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system. Specifically:

a. The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their facility manufactures RTE seasoning products that contain allergens (such as milk) which are processed using the same utensils on the same production day as products that do not contain milk. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in their circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label.

The firm do not have controls in place for allergen cross-contact or perform and document the review of labels for proper declaration of allergens. For example, they do not identify ingredients used in the seasonings that contain allergens to prevent allergen cross-contact during manufacturing. The John Paine’s Steak Beast Unleashed All Purpose Rub, Net. Wt. 12oz. bears a label that contains an allergen statement that reads in part: “***Contains Dairy.***”; however, the ingredient list for this product did not include butter powder as an ingredient, which contains a major allergen, milk.

b. For their RTE seasoning products, they did not identify and evaluate contamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it is hazard requiring a preventive control. The firm’s facility manufactures RTE seasoning products which are exposed to the environment during blending and filling. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling. In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control .

The firm does not have appropriate controls in place for contamination with environmental pathogens. They stated that they use Mrs. Meyer’s Clean Day Multi-Surface Concentrate as the main cleaning solution for cleaning all areas of the facility including food-contact surfaces. This is labeled as a household cleaner, not for use on food-contact equipment in a food manufacturing facility. They further stated that they do not use any sanitizers at their facility, such as for food-contact surfaces.

c. The firm did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their facility manufactures RTE seasoning products made from onion powder, garlic powder, white pepper, paprika, cayenne pepper and celery powder which have been associated with vegetative bacterial pathogens such as Salmonella. A knowledgeable person manufacturing/processing food in their circumstances would identify bacterial pathogens as a hazard requiring a preventive control. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as Salmonella, must establish and implement a risk-based supply-chain program for those raw materials and ingredients. The supply-chain program must include using approved suppliers and conducting supplier verification activities.

The firm does not have an appropriate supply-chain program in place. For example, they do not approve suppliers or conduct appropriate supplier verification activities for the manufacturing of John Paine’s Steak Beast Unleashed All Purpose Rub (Lot: JPUL230216004), which consists of salt, brown sugar, onion powder, garlic powder, white pepper, black pepper, paprika, cayenne pepper, celery powder, and hickory smoke seasoning. Salmonella in RTE seasoning products is a hazard that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled. The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter.

d. The firm did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their facility manufactures and repackages RTE seasoning products made from white pepper, cayenne pepper, and paprika. These ingredients have been associated with mycotoxins. A knowledgeable person manufacturing/ processing food in their circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients. The supply-chain program must include using approved suppliers and conducting supplier verification activities. The firm does not have this program in place.

Misbranded Foods

1. The firm’s John Paine’s Steak Beast Unleashed All Purpose Rub product is misbranded in that the finished product label fails to declare the major food allergen “milk.”

2. The firm’s John Paine’s Steak Beast Beasty Bird is misbranded in that the product label fails to bear the common or usual name of the food. The statement of identity “Beasty Bird” is not provided by law or regulation, is not the common or usual name of a food, and is not appropriately descriptive.

3. The firm’s John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded because the products bear or contain an artificial coloring but do not bear labeling stating that fact. Specifically, the formulation for Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub lists “color – orange” as an ingredient, and the Beasty Bird formulation lists “color – red” as an ingredient. However, none of the product labels declare the artificial color in the ingredient statements. Note that if these color additives are certified, they must be declared.

4. The firm’s John Paine’s Steak Beast Beasty Bird, Unleashed All Purpose Rub, Steak Seasoning, and Pork Rub products are misbranded in that the products are fabricated from two or more ingredients and each ingredient is not declared on the label in descending order of predominance by weight in the finished food.

5. The firm’s John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded in that they fail to list the name and place of business of the manufacturer, packer or distributor.

6. The firm’s John Paine’s Steak Beast products (Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, Unleashed All Purpose Rub), and Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products are misbranded in that the nutrition information (e.g., Nutrition Facts label, “NFL”) is not in accordance with the requirements. 

7. The firm’s John Paine’s Steak Beast products (Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub) are misbranded because the labels fail to declare the net quantity of contents on the principal display panel.

8. Even if the firm’s Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products were not unapproved new drugs and misbranded drugs, they are misbranded because the product labels bear nutrient content claims, but the products do not meet the requirements to bear such claims. A claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product.

The full warning letter can be viewed here.

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The European Union has launched a campaign in the United States to promote food and beverage products.

The communication campaign highlights the safety, quality, and authenticity of European products.

The EU is the third largest supplier of agricultural and agri-food products to the United States after Mexico and Canada.

Product categories featured include cheeses, olive oil, fruits and vegetables, chocolate and confectionery products, pasta and bakery products, wine, beer, and spirits.

The EU has several quality schemes, including Protected Designation of Origin (PDO) and Protected Geographical Indication (PGI), to protect the names of specific products and to promote their features. Items are tied to these origins and cannot be reproduced elsewhere. For PDO-designated products, every part of the production, processing and preparation process must take place in the specific region, while PGI is less strict.

Use of pesticides, herbicides, additives, flavorings, and enzymes is regulated in the 27 EU member states. There are strict health and safety standards across the supply chain – from field to the consumer – covering areas from pesticides to packaging, disease prevention and hygiene.

More information can be found at events in March such as Charleston Wine + Food and South by Southwest in Texas or Vinexpo in New York in June, and the American Cheese Society conference in Buffalo in July.

State aid to Czech Republic
Meanwhile, the European Commission has approved two Czech schemes with a budget of around €1.46 billion ($1.6 billion) to help prevent the spread of certain poultry and pig diseases.

Czech Republic notified the EU Commission of plans to support farmers in preventing the diseases and adopting biosecurity measures. The aim is to stop the spread of avian influenza, Salmonella and poultry campylobacteriosis, and porcine brucellosis, porcine reproductive and respiratory syndrome, and salmonellosis.

Measures will run until December 2029 and are open to small, medium and large farmers in the Czech Republic who put in place steps for disinfection, extermination of insects and rats and other biosecurity measures.

Aid will be direct grants to support the additional costs of cleaning of farm premises and equipment, treatment of feed and water and veterinary interventions. It will cover up to 50 percent of eligible costs.

“These €1.46 billion Czech schemes will ensure the production of healthy and safe food. They will support farmers in adopting measures to prevent the spread of certain animal diseases, and will contribute to achieving the EU agricultural objective of ensuring long-term food security, without unduly distorting competition,” said Margrethe Vestager, executive vice-president in charge of competition policy.

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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.

Click on table to enlarge. Use link above to go to specific FDA page with links to specific alerts.

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