The US Food and Drug Administration has upgraded a July recall of produce from Taylor Farms de Mexico to a Class I risk classification.
The federal regulatory agency designated the recall as Class I on Thursday, indicating "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The Food and Drug Administration is the federal agency responsible for protecting public health by regulating food safety, pharmaceuticals, and medical devices across the United States. A Class I classification is the highest risk level assigned by the agency during product recalls.
The classification applies to more than 236,000 cases of 21 products, including chopped iceberg lettuce, iceberg lettuce salad kits, shredded iceberg lettuce, lettuce blends including iceberg and romaine, and garden salad mixes.
The original recall was issued on July 17 due to possible contamination with the cyclospora parasite, which causes cyclosporiasis.
Record parasite outbreak across US states
Cyclosporiasis is a gastrointestinal infection that leads to sudden and painful diarrhea. The infection is caused by a microscopic single-celled parasite that infects the small intestine, typically when consumers ingest food or water contaminated with fecal material.
The United States is now reporting record locally acquired numbers of the infection, at least 17,180 confirmed cases, with nearly 12,000 more cases still under investigation.
There have been 922 hospitalizations and two deaths. Forty-eight states and Washington, DC are reporting cases.
The recalled products were distributed to 27 states, including Alabama, Arkansas, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin.
A full list of specific products can be found in the FDA's updated enforcement report.
Restaurant link and false positive test
The outbreak of cyclospora was first identified in July and linked to shredded lettuce served at certain Taco Bell locations. Taco Bell, a major American fast-food chain specializing in Mexican-inspired food items, then stopped using lettuce in its menu items.
Shortly after, produce supplier Taylor Farms voluntarily recalled iceberg lettuce grown in Mexico that the CDC and FDA said was linked to the outbreak.
The Centers for Disease Control and Prevention is the primary national public health institute of the United States, responsible for tracking and responding to disease outbreaks.
However, it was then revealed that the positive test result for cyclospora in a sample of Taylor Farms lettuce was a false-positive. The company has stated that no further testing of its products has detected the pathogen.
Company statement and FDA conclusions
Taylor Farms, a major producer and distributor of fresh-cut vegetables headquartered in Salinas, California, addressed the recall in a public statement. In a statement at the time, Taylor Farms said: "No Taylor Farms branded salads or kits are associated with this cyclospora outbreak."
The company expressed concern for affected consumers, adding: "As a family-owned and operated company, we are deeply concerned for those who became ill, their families, and the many Americans whose trust in the safety of their fresh produce has been shaken. That trust is something we’ve worked for decades to earn, and we are committed to doing everything in our power to restore that confidence."
Outlining its removal of produce, the company stated: "Based on information provided yesterday by the FDA, Taylor Farms de Mexico is voluntarily removing all iceberg lettuce sourced from central Mexico. No Taylor Farms branded salads or kits are associated with this outbreak. No Taylor Farms branded salad kits contain iceberg lettuce."
Taylor Farms noted: "While the FDA traceback is indicating a specific independent farm, which represents less than 1 percent of the US’s iceberg lettuce supply, as the potential source of the outbreak, we have removed all iceberg lettuce from the region indefinitely."
Despite this, Acting FDA Commissioner Kyle Diamantas said in an interview with CNBC earlier this month that the FDA is "very confident that the iceberg lettuce from central Mexico was the culprit."
Diamantas added that the FDA "remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market."
Public health status and consumer uncertainty
Following the regulatory updates, the Department of Health and Human Services followed up in a social media post: "Cyclospora: contained, American food: safe." The Department of Health and Human Services is the cabinet-level executive department responsible for protecting the health of all Americans and providing essential human services.
And the CDC's cyclosporiasis surveillance page says it is investigating multiple clusters of the infection, "including the large multistate outbreak linked to processed iceberg lettuce from Central Mexico."
No other possible source of the cyclosporiasis outbreak has been named or confirmed, leaving consumers confused over what is safe to eat and what isn't, despite reassurances from health leaders.
