FDA Import Violations: FSVP Enforcement, Import Alerts, and Detention

FDA issues warning letters to importers found to have no FSVP or an inadequate FSVP during inspection. Common findings: no hazard analysis for imported foods, no supplier evaluation and approval, no verification activities conducted, and no corrective action procedures. FDA inspected FSVP compliance at an accelerating rate through 2023–2025, with particular focus on high-risk categories including spices, seafood, fresh produce, and mushrooms. Warning letters explicitly state that continued failure will result in refusal of admission and placement on import alert.

Import alerts authorize FDA field offices to detain food shipments without physical examination (DWPE) when there is evidence that the product may be adulterated or misbranded. Import Alert 99-41 covers FSVP violations specifically. Once an importer is placed on an alert, every shipment matching the alert criteria is automatically detained at the border. The importer bears the burden of demonstrating that their products comply with U.S. requirements before FDA will release the shipment. Import alerts effectively block market access — products sit at the port at the importer's expense until released or destroyed.

Under Section 801 of the FD&C Act (21 USC 381), FDA can refuse admission to any food that appears to be adulterated, misbranded, or in violation of FSMA requirements. Refused products must be exported within 90 days or destroyed under FDA supervision. The importer bears all costs — storage, re-export freight, destruction fees, and any associated penalties. Repeated refusals strengthen FDA's case for broader enforcement including import alerts covering additional products from the same supplier or country of origin. Refusal of admission data is publicly available on FDA's Import Refusal Reports.

Importers who knowingly introduce adulterated or misbranded food into U.S. commerce face criminal prosecution under 21 USC 333. Intent to defraud or mislead elevates the charge to a felony. If food is smuggled into the U.S. to avoid FDA inspection (through misrepresentation of contents, use of unauthorized ports, or falsification of entry documents), additional federal smuggling charges under 18 USC 545 apply with penalties up to $250,000 and 10 years imprisonment. A veterinary drug distributor was ordered to pay more than $23 million in criminal fines and forfeitures in May 2024 after pleading guilty to distributing misbranded prescription products — the third settlement in a string of cases totaling over $86 million.

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What is detention without physical examination (DWPE)?

DWPE means FDA field offices can detain imported food shipments at the port of entry without physically inspecting or sampling them, based solely on the import alert listing. The shipment is held until the importer provides evidence that the product complies with U.S. requirements — documentation of supplier verification, third-party lab results, or proof that the violation has been corrected. DWPE shifts the burden of proof from FDA (normally required to demonstrate a violation) to the importer (required to demonstrate compliance). Products detained under DWPE sit at the port at the importer's expense. If the importer cannot provide adequate evidence of compliance, the product is refused admission and must be exported or destroyed within 90 days.

How do I get removed from an FDA import alert?

Removal from an import alert requires the importer to demonstrate that the conditions that led to the alert have been corrected. For FSVP-related alerts (Import Alert 99-41), this typically means: (1) developing and implementing a compliant FSVP program, (2) providing documentation of hazard analysis, supplier evaluation, and verification activities, (3) submitting evidence of corrective actions for all cited deficiencies, and (4) requesting that FDA conduct a follow-up inspection to verify compliance. FDA reviews the submission and may conduct a re-inspection before removing the firm from the alert. There is no guaranteed timeline — removal depends on the adequacy of the importer's documentation and FDA's inspection schedule. Some firms remain on import alerts for years.

Does every food importer need an FSVP?

Almost every food importer needs an FSVP. The rule applies to importers of food for humans and animals, with limited exemptions: (1) food imported for research or personal consumption; (2) food transshipped through the U.S. (not entering U.S. commerce); (3) juice, seafood, and low-acid canned food subject to specific HACCP regulations (though importers still need some verification); (4) food imported from a supplier in a country whose food safety system FDA has officially recognized as comparable. Very small importers (below $1M in sales of human food, below $2.5M in animal food) have modified FSVP requirements but are not fully exempt. If you import food into the U.S. for sale, you almost certainly need an FSVP.