Confusing product recall adds to US cyclospora outbreak uncertainty

Explosive diarrhea infection detected in 41 states with at least 72 sickened by new, as yet unknown source of parasite

Confusion abounds in the cyclospora outbreak that has sickened thousands in at least 41 states, as officials identify a new cluster of cases and more potential products come under scrutiny.

The recall of products during this outbreak of explosive diarrhea has been an unusual one, complicated by poor communication, politicization and the delay of a new regulatory rule could have helped trace the cyclosporiasis outbreak faster.

At least 72 people have been sickened by another as-yet unknown source of cyclospora, and the Food and Drug Administration (FDA) is now tracing back to the potential contamination source, according to an update from the agency on Wednesday.

It joins another investigation, still ongoing, that led to shredded iceberg lettuce from Taylor Farms, a mega-producer based in the US with facilities in Mexico.

Officials in North Carolina also identified parsley and cilantro, in addition to lettuce, as potentially linked to the state’s 561 confirmed cases.

“The amount of cases we’re having right now is incredibly high, and it’s clear that there’s multiple outbreaks happening all at once,” said Katelyn Jetelina, science communicator and founder of Your Local Epidemiologist. “The news of another cluster isn’t too surprising to me. What is is how little information was given. The communication just continually is falling short, which is leaving all of us on the outside to put these puzzle pieces together.”

With all clusters of cases, “the key question is whether the source can stop,” said Joshua Sharfstein, a public health professor at Johns Hopkins University and former principal deputy commissioner at the FDA.

If there was a confined burst of contamination, the outbreak could end soon; but if the soil or water is still contaminated, “then there’s a risk of ongoing contamination, and that’s kind of what FDA has to worry about,” he said. And “the ability to say all the downstream products – that has traditionally been very hard”.

A new regulation was supposed to help with all of that.

Last year, the FDA proposed the Food Traceability Rule in order to more quickly track and identify foods at high risk of being contaminated by foodborne pathogens – including iceberg lettuce.

“This is exactly the sort of gap that the food traceability list is meant to close,” Jetelina said.

The new regulation was required by the Food Safety Modernization Act of 2011, and it was finally set to go into effect in January.

“Probably the most important thing about that law was that companies like Taylor Farms have to recognize the risk and have these processes to address it,” Sharfstein said.

But food suppliers asked for more time, and it is now planned to take effect in early 2028.

These epidemiological investigations are particularly important since cyclospora is so difficult to detect in produce. Without the updated rule, traceback investigations can take days or weeks – which can allow an outbreak to spread even more.

The recall from Taylor Farms has been plagued with confusion and reversals. Last Thursday, businesses supplied by Taylor Farms learned they should not use the lettuce before the FDA’s announcements, according to reporting by Consumer Reports. Executives also met with the White House and the FDA to distance themselves from the cyclospora outbreak, according to reporting by the New York Times and Bloomberg .

On Friday, the FDA warned against eating shredded iceberg lettuce served at Taco Bell locations in Indiana, Kentucky, Michigan, Ohio and West Virginia – but the agency did not identify the producer at that point, noting only that they were located in Mexico.

Taylor Farms posted to Facebook on Friday afternoon that none of their salads or kits were associated with the outbreak, the Times also reported; the post appears to be deleted now, with no posts visible on their page since 8 July. The Taylor Farms website still said there were no active recalls. “In the rare event a product does not meet these standards, we take immediate action to remove affected items from distribution and notify our customers,” the website said.

The recall was posted later that evening, noting that the potentially contaminated lettuce had been shipped as recently as Thursday.

The voluntary recall said that 27 states might be affected by the contaminated lettuce. And it took the unusual approach of not listing brand names, instead using internal product numbers – which appear to correspond with products sold in stores such as Walmart and potentially restaurants such as Subway. That greatly complicated the ability of stores, restaurants and customers to know which products were involved in the recall.

“The actual recall notice from Taylor Farms was incredibly weird, because you had to decode it,” Jetelina said.

On Saturday, the FDA added an update: lettuce that was not part of the recall had tested positive for cyclospora. But on Sunday, the FDA deleted that line and said the test was a false positive. The recall still existed, FDA officials told journalists on Monday – despite confusing messaging from the supplier.

“Today, FDA apologized to us,” a statement on the Taylor Farms website read on Sunday, despite no public information about an apology. The farm added that “at this moment, FDA has not identified a single positive product test result for Cyclospora.” On Monday, the producer clarified that the recall was still in effect and that they were no longer sourcing iceberg lettuce from central Mexico for this growing season.

Cyclospora is notorious for being difficult to detect in produce; it’s much easier to find in the feces of humans, in whom the parasite thrives. It’s also possible for contamination of all sorts to be temporary in produce, which means investigators sometimes never have laboratory confirmation of which product or products spurred an outbreak. But there are other ways to identify contaminated products, like epidemiological investigations, Sharfstein said.

A spokesperson for Taylor Farms told the Guardian they were undertaking an independent investigation of its central Mexico facility, but did not answer questions about executives’ meeting with the White House and FDA, or provide clarity on when they first learned their product might be contaminated.

“When questions were raised about the source of the recent cyclospora outbreak, we immediately removed all potentially implicated product from the marketplace, and out of an abundance of caution we issued an even broader recall of all iceberg lettuce sourced from the region,” the spokesperson said.

US officials “remain focused on protecting the American people”, said Emily Hilliard, a spokesperson for the US Department of Health and Human Services. The administration has “mounted a robust, science-based response to this cyclosporiasis outbreak, working closely with health departments in all 50 states, rapidly identifying known sources, and ensuring Americans have the information they need to protect themselves,” she added.

Last year, Taylor Farms donated $1m to Maga Inc, a Trump-affiliated Super Pac, according to financial records obtained by Wired.

Potential political interference was also concerning, making it more difficult to trust what’s coming from officials and companies, Jetelina said. “Trust is everything. And trust is not declared; it’s demonstrated.”

She pointed to Taco Bell, which was “incredibly cooperative” and worked quickly to pull potentially affected products and trace them back to the supplier, Jetelina said. “I was very impressed with how quickly they owned this and came out and communicated and acted,” which she contrasted with a “more uncooperative” Taylor Farms, which appears to be slow-walking the response. “And the question is why, and why isn’t there more pressure from the federal government?”

Mega-producers can meet a lot of demand for food, Sharfstein said. “But if there is a problem, that problem can be pretty widespread.”

With cyclospora, washing doesn’t really help that much, unlike E coli or salmonella. “So we are relying on the regulatory and public health system to protect us,” Sharfstein said.

“You could call it the explosive diarrhea rule,” he added. “When you’re not having explosive diarrhea, you don’t realize that the regulatory and public health systems are protecting you. When you do have explosive diarrhea, you’re like, ‘What’s going wrong? And we need to invest in systems to keep us from getting exposed to diarrhea.’”