Previously, we discussed the essential elements of the Food Safety Modernization Act (FSMA), and touched briefly upon the new role for importers of food from foreign suppliers. This posting is intended to further develop issues specific to U.S.-based importers of food products into the United States under the FSMA, and the implications the FSMA might have for foreign food suppliers.

We recently discussed the importance of the FSMA on importers of food products. One of the key elements of this law is the responsibility it places on importers to monitor themselves and the foreign manufacturer to insure the safety of foods (with the repercussion of FDA sanctions if they fail to do so). Specifically, the following provisions will affect importers:

  • Supplier verification: importers will be required to perform risk-based verifications of foreign suppliers to insure that such suppliers are adhering to food safety standards similar to those imposed on domestic suppliers; this includes the requirement that importers document their verification efforts, and maintain records of their efforts to verify that food safety standards are followed;
  • Voluntary qualified importer program: importers may opt to voluntarily seek status under the qualified importer program, whereby importers who are approved by the FDA may obtain expedited importation of certain foods;
  • Authority to refuse admission of food products: the FDA may detain food that it has “reason to believe” is adulterated or misbranded; this would be particularly problematic for highly perishable foods that might not withstand a lengthy delay in delivery to U.S. markets;
  • Authority to require import certifications: the FDA may require that certain foods, based on risk associated either with the food, its place of origin, or both, be accompanied by certifications that the food is produced in compliance with U.S. food safety laws and regulations; and
  • Accreditation of third-party auditors: to accomplish the goals of foreign manufacturer inspections and certifications, the FDA may create a program of accreditation of third-party auditors, including foreign government agencies.

A March 16, 2011 Law360 article by Lisa M. Noller and Carmen N. Couden, “Growing Risk: FCPA Exposure For Foreign Food Cos.” (account required), noted that the proposed certification process has implications for compliance with the Foreign Corrupt Practices Act, discussed in Brian Manning’s GatewayFDA posting on March 15. Specifically, foreign companies, unaware of the FCPA, “may be tempted to seek leniency from the foreign inspectors in exchange for gifts or other payments” in order to meet FDA’s certification requirements. False certifications carry the risk of criminal charges, but even truthful certifications can be tainted by violations of the FCPA.

Congress left many of the details (PDF) of this law to be determined through guidance and rulemaking by the FDA. At this point, with the exception of FDA’s authority to require import certifications which was effective on enactment, the above mandates have not yet gone into effect. Under the FSMA, FDA must issue interim final rules related to its authority to refuse admission of food products six months from the date of enactment, or roughly early July 2011. Otherwise, Congress mandated guidance, regulations, or both to be issued by FDA from one to two years after the date of enactment.