Consumer Reports has given FDA Deputy Commissioner Donald Prater until Nov. 6 to answer for the agency's handling of this summer's Cyclospora outbreak, which sickened nearly 13,000 people, hospitalized 560 and killed two.

In a letter delivered this week, the consumer organization cited "critical vulnerabilities" in U.S. food safety oversight and said the investigation into contaminated lettuce from Taylor Farms de Mexico raised direct questions about whether the FDA fulfilled its public health mandate.

"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.

What delayed the response?

According to Consumer Reports, early evidence pointed to shredded iceberg lettuce from Taylor Farms de Mexico as the contamination source, yet FDA investigators took nearly a month to begin environmental sampling and on-site inspections in Mexico. The recall classification took more than a month, which the group says created widespread public confusion.

The organization also criticized inconsistent public messaging that produced financial losses and unnecessary food waste involving U.S.-grown fresh produce — collateral damage that hit domestic growers even as suspicion centered on Mexican product. The FDA did not disclose when it conducted foreign inspections or when and where it collected samples, the letter adds.

"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 posed eight questions to Prater, including:

• What factors delayed the FDA's deployment to Mexico for on-site investigation?
• Why has no Import Alert been issued on iceberg lettuce from Central Mexico when it meets the criteria for one?
• What accounts for the one-month delay in classifying the event as a Class I recall?
• Did consolidating communications functions under the department's shared services approach hurt the FDA's ability to inform the public?
• What is the estimated staffing allocation within the Human Foods Program for outbreak response, compliance, enforcement and post-event prevention?

Another question references a separate outbreak, in which the FDA reportedly could not access a facility due to safety concerns. If inspectors cannot enter certain foreign facilities, the group asked, why do imports from those facilities still enter the U.S. market?

What does this change for operators and suppliers?

The answer may hinge on a traceability rule that never took effect. The Food Safety Modernization Act of 2011 required companies handling high-risk foods — leafy greens, fresh-cut fruits, raw cheese — to keep detailed supply chain records and turn them over within 24 hours of an FDA request. The FDA itself said the rule would allow for "faster identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths."

The rule was set to take effect in January 2026, 15 years after the law was signed. In March 2025, the FDA pushed the deadline back two and a half years, to July 2028, saying companies needed more time to comply. Congress then 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, Consumer Reports' director of food policy and a former deputy under secretary for food safety at the U.S. Department of Agriculture.

Ronholm said FMI, the trade group representing the consumer food supply chain, lobbied Congress for the delay. "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," he said.

Craig Hedberg, a University of Minnesota professor who studies outbreak investigations, put the unfinished business plainly: "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."

For produce buyers and menu planners, the practical stakes are record-keeping requirements that now arrive in 2028 rather than 2026 — and, until then, traceability gaps that can extend outbreaks and broaden collateral losses across the fresh-cut supply chain.