Increased consumption of fresh fruits and vegetables requires a compensatory focus on food safety to avoid an overall increase in foodborne illness. Currently, the U.S. imports approximately 50 percent to 60 percent of its fresh fruits and about 40 percent of its fresh vegetables, reflecting a steady, decades-long decline in domestic production. This requires our public health authorities to enact clear proactive, prevention-based strategies for both domestic and imported fresh produce to assure safety.
For the domestic fresh produce supply chain, the Food and Drug Administration (FDA) directly oversees and enforces compliance with rules and regulations for safe production. Domestic farms, harvesting, packing and storage operations are subject to inspection. Under FDA inspection, these operations may be sampled for pathogens, noncompliance with regulations noted and inspection observations posted publicly. For those operations with significant noncompliance observations during an inspection, or repeated noncompliance observations, the agency may issue a Warning Letter.
For imported fresh produce, the FDA regulatory system has basically two goals:
- Address potential food safety issues before the food reaches the U.S.
- Ensure that imported food is produced in accordance with the same safety standards as domestic production.
To accomplish these goals, the agency relies heavily on importers through the Foreign Supplier Verification Program (FSVP), third-party audits, and international regulatory agreements and collaborations to ensure foreign produce companies are complying with U.S. regulations. FDA also can inspect foreign farms, however, for various reasons, the agency has inspected very few foreign farms (no specific numbers were verifiable).
The FDA has no inventory of farms in foreign countries that export fruits and vegetables to the U.S., and there is no requirement for registration or other notification for a foreign farm prior to import. The FDA has also failed to meet its mandated inspection schedule, both domestically and internationally. The January 2025 U.S. Government Accountability Office report on food safety noted that the FDA conducts far fewer foreign inspections versus domestic inspections.
In 2023, the agency completed approximately 11,000 domestic inspections compared with 1,500 foreign inspections. Domestic farms must be prepared for FDA inspection and respond to observations often with economic investment. Because of resourcing, government agreements and other reasons, foreign farms do not have the same expectation of direct FDA oversight, regardless of the risk of the commodity or growing region.
The FDA also uses sampling of fresh produce as part of its efforts to keep contaminated products from reaching consumers and to facilitate a greater understanding of hazards. The FDA’s surveillance sampling assignments generally target commodities in domestic regions and include collecting samples from farms, packing facilities, coolers, warehouses or retail.
For domestic fresh produce operations, surveillance sampling assignments can be costly and disruptive to business, especially when conducted in the field or pre-shipment. For sampling of imported produce, samples are generally collected at ports of entry, warehouses and distribution centers; however, samples are rarely collected from farms or pre-shipment.
As previously stated, the FDA relies heavily on importers as the party responsible for ensuring their foreign suppliers are following the appropriate food safety regulations. However, there is strong evidence that FSVP, as an import control, is not working to protect consumers as intended. A review of the 361 food-related Warning Letters written by the agency between 2020 to 2025, 81 (22 percent) were to importers of fresh produce for non-compliance with FSVP. This data would indicate that there is a systemic compliance issue with importers of fresh produce that should be actively addressed by the agency given the importance and risk level of the food category.
FDA has the authority to do more. The agency, for example, could place non-compliant importers on Import Alert, seek to bar repeat offenders from being allowed to import food into the U.S., or impose re-inspection fees on importers whose products fail inspection at the border. The absence of meaningful consequences for importers with significant FSVP failures can be providing foreign farms with an economic advantage over domestic growers. Foreign farms would not always need to make the same monetary investments as domestic farms to demonstrate compliance with food safety regulations, if demonstrating compliance is not consistently enforced at the border.
FSMA also authorizes the FDA to require third party certifications, or other assurances as deemed appropriate, for specific types of imported food based on public health considerations. The FDA recently used this authority for the first time for shrimp and spices from certain regions of Indonesia. These certifications or assurances can be provided in the form of shipment-specific certificates, a listing of certified entities, or in another form specified by FDA. The agency could leverage the use of these certificates to provide greater oversight over imported fresh produce, especially following a food safety event or when other public health considerations are met, such as a growing region of concern. The use of this authority would also help subject foreign farms to the similar compliance rigor as applied to domestic farms.
There are known fresh produce items and fresh produce growing regions that have been associated with repeated food safety concerns, both foreign and domestic. In response, domestically, the FDA has provided public prevention strategies, such as the Leafy Greens STEC Action Plan or published in-depth outbreak investigation reports. However, for imported produce, the publicly available information regarding prevention strategies following a food safety event is limited, infrequent or silent. For example, the public may be made aware of an updated Import Alert, as in the case of cantaloupes from Mexico, but there was little other accompanying information to explain the investigation outcome or steps taken to improve safety of the cantaloupes being imported.
For domestic growers, these public investigation reports and prevention strategies set expectations with the supply chain, regulators and consumer advocates for programmatic improvements in food safety. The public should be provided with the same transparency and accountability for foreign farms and their supply chain following a foodborne illness outbreak as is provided for domestically sourced produce.
The FDA has various regulatory tools that it can employ to improve its oversight of imported fresh fruits and vegetables. Deployment of a strategic regulatory compliance program for imports that is risk-based (commodity, region, company), tracked for public transparency and enforced equitably, is necessary to ensure safety for U.S. consumers.
Domestic producers must not be placed at an economic disadvantage to their foreign competitors because of regulatory compliance costs that are not faced by their foreign competitors. Nutritional security for the U.S. is a public health priority. How food safety regulations are enforced should not undermine that priority.