Consumer Reports has asked the FDA’s deputy commissioner to respond to its concerns about the agency’s response to this summer's Cyclospora outbreak linked to Taylor Farms lettuce from Mexico.
In the letter to Donald Prater, the consumer organization cited “critical vulnerabilities” in the U.S. food safety oversight. The investigation into the Cyclospora outbreak — which sickened almost 13,000 people, hospitalizing 560 and killing two — raised questions about the Food and Drug Administration’s fulfillment of its public health mandate, according to the organization.
Consumer Reports requested that Prater respond by Nov. 6.
“Throughout this investigation, the FDA’s response has been hindered by notable delays and a lack of transparency, ultimately exposing consumers to unnecessary risk,” the letter states.
“Although initial evidence pointed to shredded iceberg lettuce from Taylor Farms de Mexico as a source of contamination, FDA investigators took nearly a month to launch environmental sampling and on-site inspections in Mexico. Additionally, the recall classification was delayed for over a month, creating widespread public confusion.”
The group states that public messaging during the outbreak was inconsistent, which led to financial losses and unnecessary food waste involving U.S. grown fresh produce. Consumer Reports also called into question the FDA’s failure to disclose what actions were being taken during its investigation, including when it conducted foreign inspections and when and where samples were collected.
“To restore public trust and ensure accountability, the FDA must address the systemic inefficiencies, communication breakdowns, and regulatory leniency that have hindered this response,” Consumer Reports wrote.
The group requested responses from Prater on the following questions:
- What factors delayed the FDA’s deployment to Mexico to conduct an on-site investigation?
- In a separate outbreak, it was reported that the FDA was unable to access a particular facility due to safety concerns. If the FDA cannot conduct on-site safety inspections at certain foreign food facilities due to security concerns, why are imports from these facilities still permitted to enter the U.S. market?
- Which specific FDA personnel were deployed, and did the team comprise an appropriate balance of inspectors, investigators, and subject matter experts?
- Given FDA’s authority to issue Import Alerts, why has an import alert not been issued on iceberg lettuce from Central Mexico when it meets the criteria for one?
- What accounts for the one-month delay in classifying this as a Class I recall?
- How was information communicated and shared between federal agencies and state public health partners during this outbreak investigation?
- Did the consolidated communications functions under the department’s shared services approach negatively impact the FDA’s ability to communicate to the public about the outbreak?
- What is the estimated staffing allocation within the Human Foods Program dedicated to foodborne illness outbreak response, compliance and enforcement, and after event prevention efforts?
Statement apart from the letter
Prior to sending its letter to Prater, Consumer Reports issued a public statement about the outbreak and investigation, citing comments from a food safety expert.
“There’s a fair amount of additional work that needs to come together to really give us a more complete picture of what happened this year and how best to approach next year,” says Craig Hedberg, PhD, a professor at the University of Minnesota who studies how to make foodborne illness outbreak investigations more effective.
One of the main problems during the outbreak investigation was the ability to trace contaminated lettuce, according to Consumer Reports. A rule mandated in 2011 addressed that problem, but action by Congress in the summer of 2025 delayed its implementation.
“The Food Safety Modernization Act of 2011 anticipated this problem. A provision known as the traceability rule requires companies handling high-risk foods like leafy greens, fresh-cut fruits, and raw cheese to keep detailed records of how those foods move through the supply chain and hand them over within 24 hours of an FDA request. The FDA itself has said the rule would allow for ‘faster identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths,’ “ Consumers Reports’ statement said.
The rule was supposed to take effect in January 2026, 15 years after the law ordering its existence was signed. But in March 2025, the FDA pushed that deadline back two and a half years to July 2028, in order, it said, to give companies more time to comply. Congress later codified the delay.
“Had the rule been in place, it would have made it easier to trace the outbreak back to the source more quickly,” said Brian Ronholm, CR’s director of food policy, who previously served as the deputy under secretary of food safety at the Department of Agriculture.
Ronholm said that FMI, a trade group that represents the consumer food supply chain, lobbied Congress to delay the rule’s implementation. “Basically, Congress decided to put consumers at risk because a small part of the food industry claimed 15 years wasn’t enough time to prepare,” Ronholm said.
