In 2013, the US Food and Drug Administration issued proposed regulations implementing the foreign supplier verification programmes designed to strengthen the oversight of imported foods and protect US consumers. About 15 per cent of the US food supply is imported; the FDA wants to see the same standards applied to both domestic and foreign firms.

The proposed rules place primary responsibility on the importers for food imported into the US. The FDA has admitted that the task of ensuring the safety of all imports is too big for the agency to handle on its own; these rules shift some of that responsibility to importers.

The proposed regulations vary based on the type of food product, the category of importer, the nature of the hazard in the food and who is to control the hazard. All importers (unless exempt) would be required to develop, maintain and follow a foreign supplier verification programme for each imported food.

Importers would have to conduct a range of verification activities, including the following:

Compliance status review

Periodically review compliance status of food and potential foreign supplier before importing.

Hazard analysis

Analyse and identify hazards reasonably likely to occur for each type of food imported.

Verification activities

Provide adequate control of hazards identified above (e.g. through supplier audits and other risk-based procedures).

Corrective actions

Review complaints received about imported food, investigate when necessary and take appropriate corrective actions.

Periodic reassessment

Reassess their verification programme every three years – or sooner if they become aware of new information about potential hazards.

Importer identification

Provide their name and DUNS identification number for each food product offered for importation.


Keep records for these reviews, analyses and activities.

One of the main consequences of this is the shifting of responsibility for safe-food imports from government to industry. Although importers will still have to worry about FDA compliance, the primary method of enforcement of a verification programme will probably come through private litigation. Some of the language contained in the proposed regulations might make such litigation enticing to potential claimants. The combination of mandatory verification standards and language requiring ‘prudent’, ‘responsible’ and ‘careful’ importers could lead to class actions in response to adverse events.

Under the proposed regulations, certain products and importers might be subject to modified requirements or exempt from the verification programme altogether.

Public comments were due by January 27, 2014.