U.S. food manufacturers have many options when it comes to sourcing raw ingredients and other products necessary to do business.

The underlying question, of course, is who to buy from. Many factors go into choosing a supplier, from year-round availability, price, quality, and country of origin. Sometimes the best option is to source from another country. While that adds another layer of responsibilities for food safety compliance and related issues for U.S. companies, the Food and Drug Administration offers resources to help importers comply with Food Safety Modernization Act (FSMA) regulations.

This blog from ImEPIK will shed light on steps importers must take to import food and how to safeguard against doing business with suppliers who have exhibited problems in the past.

Foreign Supplier Verification Program

The FSMA’s imported food regulations are addressed through Foreign Supplier Verification Programs (FSVP) for importers.

The FSVP rule was finalized in early 2016 and is designed to ensure that products imported into the U.S. are just as safe as items produced by domestic companies. The FSVP rule requires importers to perform risk-based activities to verify that:

  • The food is made in a manner that provides the same level of public health protection as those foods subject to hazard analysis and risk-based preventive controls or follow standards for producing and harvesting fruits and vegetables that are raw agricultural commodities;
  • The food is not adulterated; and
  • The food is not misbranded/mislabeled concerning food allergens.

To comply, importers should consider the following advice.

Buyer Beware: Investigate Potential Trading Partners


Woman working on computer to verify supplier recordsAs is the case with forging a business partnership with any supplier, it is incumbent upon importers to ensure they’re doing business with a reputable company. A good starting point is with the FDA, which compiles databases of bad actors – and those who have had minor missteps that are a part of doing business. Import alerts are certainly cause for concern, although you should research the root cause of the alerts. Sometimes the exporting company has had no issues, but the product being imported has had a history of recalls. In some cases, the FDA works with the appropriate authorities in the exporting country to clear exporters on a case-by-case basis.

The FDA offers supplier evaluation resources that will flag a foreign supplier’s past dealings with the regulatory agency, including recalls and problems that arise during inspections and how the company responded to those issues.

Evaluate risks and react accordingly

Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subject to adequate verification activities before being imported.

After that step, importers must develop, maintain and follow an FSVP for each food brought into the U.S. and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers. If importers receive many different foods from a single supplier, a separate FSVP is needed for each food.

 FSVP Compliance

Importers that are also manufacturers/processors are deemed in compliance with most FSVP requirements if:

  • They comply with supply-chain program requirements under the preventive controls rules;
  • They implement preventive controls for the hazards in the food in accordance with the requirements in the preventive controls rules; or
  • They are not required to implement preventive controls in certain circumstances, such as when the food has to undergo a heating process before consumption.

Mandated supplier verification activities

In most cases, importers only have to establish that they import from approved foreign suppliers, and the proper supplier verifications are followed. The importers can tailor those verification activities to unique food risks and supplier characteristics, including:

  • Annual on-site audits of the supplier’s facility when there is a reasonable probability that exposure to a hazard controlled by the foreign supplier will result in serious adverse health consequences.
  • As an alternative, importers can choose another means of verification if it ensures the food is made according to U.S. safety standards through sampling and testing or a review of food safety records.

ImEPIK helps guide food safety decisions

Whether sourcing ingredients from domestic or foreign suppliers, ImEPIK offers a solid resource to ensure compliance of food safety regulations outlined in the FSMA.

Contact ImEPIK to inquire about our 100% online food safety courses that allow participants to proceed at their own pace as they pursue Preventive Controls Qualified Individual status as specified by FSMA.