News

September 11, 2026

Dear Industry Leaders:

Recent and recurring multistate outbreaks of cyclosporiasis associated with fresh produce are a serious public health concern and a reminder of our shared responsibility to U.S. consumers. This letter is directed to every link in the supply chain: fresh produce growers, harvesters, packers, processors, distributors, importers, and retailers, both domestically and internationally. Our message is straightforward: while there are practices known to reduce Cyclospora risk, more work must be done. We are asking you to build on industry investments in prevention and mitigation efforts and to ensure these best practices are rigorously and consistently implemented throughout this supply chain.

FDA reminds the regulated industry that they must apply established, science-based agricultural water management practices, worker health and hygiene controls, and buildings and equipment sanitation practices, consistent with FSMA's Produce Safety Rule (21 CFR Part 112), and, as appropriate, requirements under FSMA’s Preventive Controls for Human Foods Rule (21 CFR Part 117) such as having a strong and effective supplier program. For importers, these requirements include rigorous foreign supplier verification consistent with 21 CFR Part 1, Subpart L (§§ 1.500–1.514.) Strong supplier verification is critical to ensuring that produce entering U.S. commerce meets U.S. food safety standards. We encourage you to review your programs now, assess whether they are functioning as intended, and strengthen them where gaps exist.

FDA also asks that every organization involved in the produce supply chain — from production through point of sale — review regulatory requirements and industry practices, and where practices are lacking, identify opportunities and develop new science-based practices that can minimize the risk of this pathogen. These efforts should take a One Health approach recognizing that Cyclospora risk is driven by the intersection of human health, sanitation practices, agricultural water quality, and environmental conditions across the global produce supply chain.

FDA is looking forward to engaging with a coalition of industry stakeholders on an ongoing basis to address gaps in knowledge and shortfalls in current practices, with the shared goal of ensuring stronger and more consistent Cyclospora prevention across every link in the supply chain. We are committed to collaborating with industry to protect the health of American consumers. Please visit our webpage for future updates and you can direct any questions or feedback to HFP-PSEBsupport@fda.hhs.gov.

Sincerely,

Donald A. Prater, DVM
Acting Deputy Commissioner for Food Human Foods Program

SEE: Letter to Industry Calling for Collaboration to Prevent Future Cyclospora Outbreaks | FDA

https://www.fda.gov/food/outbreaks-foodborne-illness/letter-industry-calling-collaboration-prevent-future-cyclospora-outbreaks