Tag: romaine

FDA stonewalls on source of deadly 2024 romaine lettuce outbreak

The US Food and Drug Administration (FDA) has declined to identify the source of E. coli O157:H7-contaminated romaine lettuce that sickened 89 people across 15 states in November 2024.

Seven of the outbreak victims developed hemolytic uremic syndrome (HUS), and one person died. Thirty-six individuals were hospitalized.

Outbreak cases were reported from Arkansas (2), Colorado (1), Illinois (7), Indiana (8), Kansas (1), Kentucky (1), Missouri (50), Montana (1), North Dakota (2), Nebraska (3), Ohio (8), Pennsylvania (1), South Dakota (1), Tennessee (1), and Wisconsin (2).

Information about the outbreak investigation was obtained from the FDA in response to a Freedom of Information Act (FOIA) request filed by eFoodAlert.

The US Centers for Disease Control and Prevention (CDC) identified seven subclusters in the multistate outbreak, including events linked to a Missouri-based caterer, and Ohio school, an Indiana restaurant, an Illinois restaurant, and an Illinois event catered by a different Missouri-based caterer.

Ninety-five percent (95%) of victims who responded to questionnaires reported consuming leafy greens prior to illness. Romaine lettuce was consumed by 88% of the outbreak victims who were able to remember the exact type of leafy green consumed.

The FDA was notified of the outbreak by the US Centers for Disease Control and Prevention on November 25, 2024. Traceback investigations by the FDA ultimately identified a single processor and a single grower as the source of Romaine lettuce supplied to all of the events that formed part of the outbreak.

What FDA found

On January 15, 2025, the FDA’s Coordinated Outbreak Response and Evaluation (CORE) team supplied the following traceback summary to the CDC:

A traceback investigation was initiated in response to a E. coli O157 outbreak with leafy greens as the suspected vehicle. Each case included in the traceback investigation reported consumption of leafy greens prior to illness onset. Based on information available at the points of service (POS), the traceback focused on iceberg and romaine lettuce. The investigation consisted of [redacted] traceback legs representing twenty-eight cases and [redacted] POS. The [redacted] traceback legs identified [redacted] distribution centers, [redacted] broker, [redacted] processors, [redacted] grower, and [redacted] ranch. The traceback investigation determined that a sole processor sourced romaine lettuce from [redacted] grower that would have been available at all points of service during the timeframe of interest. Additionally, romaine lettuce supplied to [redacted] POS was traced back to a common ranch and lot. Through analysis of records, [redacted] lot of romaine lettuce were implicated, resulting in confirmation of romaine lettuce as the vehicle.

The following traceback diagram included in the full CORE report illustrates the supply chain involved in the outbreak.

During the course of its investigtion, the FDA collected a total of twelve (12) environmental and water samples, but did not recover the outbreak strain from any of them.

The CORE report does not indicate whether the samples were collected at the grower or at the processor of the romaine lettuce.

Information withheld

The FOIA request filed by eFoodAlert sought “complete CORE investigation report and any documents related to this outbreak investigation, including Establishment Inspection Report(s), FDA Form 483(s), if issued, results of lab analyses, correspondence between FDA and CDC relating to this investigation.”

We received ONLY the CORE investigation Executive Summary and two emails.

We did NOT receive the requested results of lab analyses.

We did NOT receive a copy of any Establishment Inspection Report (either for the grower or the processor), which would have provided the identity of the establishment(s).

According to the CORE report, no [adverse] observations were noted (ie., no FDA Form 483 issued).

The CDC never posted a public notice for this outbreak.

The FDA chose not to release the name of the grower or the processor because “…there was no product remaining in commerce.”

Why this matters

The victims of this outbreak have a right to know the source of the product that made them ill, and have the right to seek compensation.

The restaurants and caterers who purchased the produce deserve to know the source of the contaminated romaine lettuce so that the can choose to use different suppliers in future.

Finally, deterrence is—or should be—a weapon in the food safety arsenal. If a grower, processor, or manufacturer of any food product knows that they will be identified by name in the event that their product is the source of a foodborne disease outbreak, they will be more likely to take steps to avoid supplying contaminated product to the public.

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Retailers remove Romaine lettuce from their stores

Retailers across the USA and Canada are removing Romaine lettuce and products containing Romaine lettuce from their stores in response to alerts issued today by the US Food and Drug Administration (FDA), the US Centers for Disease Control and Prevention (CDC) and the Public Health Agency of Canada (PHAC).

Epidemiological evidence in both countries has linked consumption of Romaine lettuce to an outbreak of E. coli O157:H7 illnesses in eleven US states and two Canadian provinces.

Traceback investigations are in progress to determine the source of the contaminated Romaine.

The following US supermarket chains and food stores have alerted customers to the illness outbreak and, in many cases, have removed all products containing Romaine from their stores:

The following Canadian supermarket chains and food stores have alerted customers to the illness outbreak and, in many cases, have removed all products containing Romaine from their stores:

Do not consume any romaine lettuce or any product containing romaine lettuce. Please follow the live links to your retailer’s web page for a complete list of affected products sold by that retailer.

What you don’t see CAN hurt you

More than 500 customers of McDonalds have become infected with a nasty little parasite that goes by the name Cyclospora. Twenty-four people have been hospitalized, according to CDC.

Cyclospora is a single-cell, microscopic parasite that is transmitted through contaminated food or water. The most common symptom of infection is watery diarrhea. Other symptoms may include loss of appetite, weight loss, cramping, bloating, increased gas, nausea, vomiting, low-grade fever and fatigue.

Symptoms appear, on average, 7 days following initial infection (incubation period ranges from 2 days to more than 2 weeks) and can persist for several weeks. Cyclospora infections are not usually life-threatening.

outbreak_mapMC_8.23.18
Geographic distribution, courtesy of CDC

Confirmed cases have been reported by fifteen states and by New York City (which boasts a larger population that many of the states). Consumers in Connecticut, Florida, Iowa, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Ohio, South Dakota, Tennessee, Virginia, Wisconsin, and New York City.

According to CDC, the largest numbers of illnesses occurred in Illinois (273), Iowa (99) and Missouri (52). Multiple cases also were reported in neighboring states. Outbreak victims in Connecticut, New York City, Tennessee, and Virginia purchased salads while traveling in Illinois; the Florida patient purchased a salad while traveling in Kentucky.

Most of the reported cases materialized in late June and early July.

The parasite was recovered from a packaged romaine lettuce/carrot mix supplied to the restaurant chain by Fresh Express.  The investigation is ongoing and FDA is currently reviewing distribution and supplier information for both the romaine and the carrots.

FDA offers the following suggestions for restaurants, food service facilities and consumers.

What Do Restaurants and Retailers Need To Do?

Based on current information available Cyclospora may be resistant to routine chemical disinfection methods such as those using chlorine. However, restaurants and retailers should still follow basic food safety practices:

  • Retailers, restaurants, and other food service operators should always practice safe food handling and preparation measures. It is recommended that they wash hands, utensils, and surfaces with hot, soapy water before and after handling food. Wash and sanitize display cases and refrigerators where potentially contaminated products were stored.
  • Wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store potentially contaminated products.
  • Wash hands with warm water and soap following the cleaning and sanitation process.
  • Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross-contamination.

What Do Consumers Need To Do?

Consumers who have symptoms of cyclosporiasis should contact their health care provider to report their symptoms and receive care. Most people infected with Cyclospora develop diarrhea, with frequent, sometimes explosive, bowel movements. Other common symptoms include loss of appetite, weight loss, stomach cramps/pain, bloating, increased gas, nausea, and fatigue. Vomiting, body aches, headache, fever, and other flu-like symptoms (relapse).