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Focus: US food sheriff gets greater reach

26 September 2011

In brief: Sweeping food safety reforms, including strict new requirements for importers, were passed into law by the United States Congress earlier this year. Partner Annette Hughes and Law Graduate Ali Ridley report on these new obligations.

How does it affect you?

  • Importers now have a responsibility to ensure that their foreign suppliers and manufacturers have adequate risk-based preventative controls in place.
  • Products may be refused entry into the US if the US Food and Drug Administration (the FDA) is denied access to a facility where the product is produced.
  • Importers must notify the FDA if any country has refused entry of their products.


The Food Safety Modernization Act (the Act)  seeks to prevent food-borne illness and ensure foreign manufacturers meet the same rigorous standards as domestic producers. The FDA describes this Act as the most comprehensive reform of US food safety law undertaken in 70 years, covering almost all food imported into the US and, unsurprisingly, is expected to have a significant impact on organisations that do this.

While the Act's effects are wide ranging, this article will focus on its impact on food importers. Any organisation that supplies food products to the US market should ensure that it has considered the impact of the Act when determining the nature of its obligations.

Nature of the reforms

The FDA has stated that the current reliance on port-of-entry inspection is unable to keep up with the growing demand for imported food products in the US. Consequently, the Act has initiated a number of measures that require importers to play a greater role in the accreditation of the food products they import. Among other obligations, importers must now ensure that the products they import have been appropriately produced and handled by foreign manufacturers and suppliers.

Controls on foreign suppliers and producers

The Act places a significant emphasis on preventative, rather than reactive, measures. By the end of 2011, the FDA will require importers to verify that their foreign suppliers and producers have implemented risk-based preventive controls (such as ensuring produce is stored at appropriate temperatures) to ensure that their food products meet the same standards as those required of domestic suppliers. Furthermore, an importer's products can now be refused entry into the US if the FDA is denied access to the manufacturing facility in which the products were made. This is significant, as the Act also mandates that the FDA must significantly increase its inspections of foreign facilities. Finally, the Act also imposes a requirement on all importers to notify the FDA of any refusal by another nation to accept their products.

Third-party audits

As a practical measure, to assist with expeditious processing under the new reforms, the FDA intends to establish a system, by June 2012, in which third-party auditors will be able to accredit high-risk imported foods to the standards of the FDA. Consequently, all high-risk1 imported foods will need to be accompanied by this certification, or some other form of compliance, before being allowed entry into the US. It is important to note that organisations that already have a rigorous verification process may not be required to engage a third-party auditor, provided the FDA finds that the verification process is of a sufficient standard.

Also by June 2012, a voluntary program for importers will be initiated for products that are not high-risk, allowing for the expedited review and entry of food products from participating importers, through the use of third-party auditors. Once again, under this program all imported products must be accompanied by a safety certification, reducing delays in processing.

To assist with the above reforms, the FDA has indicated that it intends to establish a number of offices in foreign nations. This is expected to provide importers with easier access to support and advice from the FDA, in order to assist with compliance with importers' importation requirements.

Costs of compliance

While the Act imposes considerable obligations on importers, the FDA doesn't expect the cost of compliance to be too high, as many importers already have adequate food safety verification procedures incorporated into their supply chain management systems. As a result of these measures, many importers already meet the required standards and the new reforms will make little difference to their current operations. For importers that do not meet the required standards, compliance may be more difficult, necessitating significant investment in manufacturing processes , cooperation with other smaller importers or withdrawal from the US market.

The Act is being phased in over the next few years, in order to provide members of food supply chains with the opportunity to make the changes it requires. The full impact of the changes is not expected to be known until all elements of the Act are in force.


Those involved in producing food products for, or importing food products to, the US should ensure they can meet the standards the Act imposes. They must be vigilant regarding the additional measures and requirements being rolled out, and audit and manage their processes accordingly, or risk refusal of entry of their products to the US.

We will shortly report on the reforms' impact in more detail and discuss the major changes for organisations that supply food products within the United States.

  1. The FDA will determine what is classified as high-risk food products by considering such factors as the known risks of a food based on food-borne illness data, the likelihood that a particular food has a high potential risk for contamination, and the likely severity of an illness attributed to a particular food.reference

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