According to Section 801 (21 USC 381) of the Federal Food Drug and Cosmetic Act (FFDCA), a product can be refused admission into the U.S. under certain conditions:

In sum, if it “appears from examination” that the product is:

• Produced under insanitary conditions
• Adulterated or misbranded
• The importer is not in compliance with Foreign Supplier Verification Program (FSVP)
• The recordkeeping requirements (including the traceability rule) have not been compiled

Certainly, a standard of “appears from examination” is a higher regulatory bar for foreign fresh produce than the domestic standard of “prohibited…from introduction or delivery for introduction into interstate commerce of any food … that is adulterated or misbranded.”  (Section 301(a) (21 U.S.C. §331(a) FFDCA).

However, there is a strong argument that the lack of Food Safety Modernization Act (FSMA) enforcement actions by the U.S. Food and Drug Administration (FDA) provides an advantage to foreign fresh fruit and vegetable producers and thus a net economic boost to those producers by the avoidance of associated regulatory costs and managing associated risks that domestic producers must bear.

Take, for an example, a scan of the 38 FSVP FDA Warning Letters issued in 2024; 19 of those letters were issued to importers of fresh produce or roughly 40 percent.

Going a bit further, the FDA’s Division of Southwest Imports alone wrote 10 of the 19 letters, showing more than half were for the southwest border crossings. This means these importers did not have the obligatory records necessary to support that the fresh produce that was actively being imported was compliant with the requirements of FSMA.

There are important examples of fresh produce importers that have received multiple FSVP inspections with significant non-compliant findings followed by a Warning Letter in the FDA’s database. These warning letters clearly state the importer was found to be non-compliant with Section 805 of the FFDCA, or the requirements of FSVP. The letters also demonstrate that the time period between the first FDA FSVP inspection and the issuing of the Warning Letter can span multiple years.

So, let’s think about that for a minute. An importer has more than once, by FDA inspection, failed to meet the requirements of Section 801 (21 USC 381) of the FFDCA because of noncompliance with FSVP. Yet, this importer apparently continued to import fresh produce without any significant regulatory consequence.

These Warning Letters argue that the FDA is not willing to use its full authorities at the border to protect public health by allowing non-compliant importers to bring potentially unsafe fresh produce into the U.S. (If the required records were not available, how does the agency know the imported fresh produce was safe?)

Secondly, it can also be argued that the foreign producers that supply to known non-compliant importers have an economic advantage because these producers would not necessarily, depending on the distribution channel for the items, need to provide any food safety records for the supply chain once they are in the U.S.  By contrast, virtually all domestic producers–except for potentially the very small producers–that place fresh fruits and vegetables with handlers, shippers or retailers and others in the supply chain, are required to provide food safety records. This results in higher food safety compliance requirements and costs for domestic producers when compared to foreign producers whose product enters U.S. supply chain through non-compliant importers.

If a member of the domestic supply chain for fresh fruits and vegetables were to receive an equivalent regulatory action, the following are likely additional regulatory actions that could result:

1) Site re-inspection with potential for fee collection, product pathogen sampling at field, harvest equipment, packing shed or processing facility. There would be costs to the producer related to sampling events as well as costs associated with remedying the record-keeping findings.

2) Potential supply chain actions related to Global Food Safety Initiative (GFSI) re-certification and lost business, at a minimum, until the findings of the Warning Letter are resolved.

This is not to say that the FDA regulatory non-compliant findings and associated costs are not appropriate and warranted. But aren’t the costs to remedy these findings also appropriate and warranted for foreign fresh produce growers, handlers/shippers and their importers? FDA Warning Letters to those in the domestic food supply chain have serious business consequences. The same does not seem to be true for FSVP non-compliant importers and their respective foreign supply chain. Maybe it should be.

Domestic production of fresh fruits and vegetables is on the decline in the U.S. because of many cost-driven factors with rising regulatory compliance costs being just one. If we all agree that supporting our current production in the U.S. is critical for the Nation’s nutritional security and helping to assure safe fresh produce, then we need to address the economic advantages of non-compliant foreign producers, including the lack of FSVP enforcement at our border.