FDA Exercises New Authority Over Foreign Food Importers

According to an article published in the Economic Times, part of the India Times, foreign food importers who don’t register with the Food and Drug Administration face the possibility of being banned from importing food into the country thanks to the United States being overly cautious about possible terrorism.

Whether or not fears of terrorism play into the new registration guidelines, the Food Safety Modernization Act (FSMA) (P.L. 111-353), which was signed into law on January 4, 2011, enables the FDA to strengthen the security and integrity of food in the United States through a variety of measures including more stringent rules and registration standards for foreign food importers. According to the FDA, their new areas of concentration and enforcement include:

  • Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment)
  • Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for FDA to recognize accreditation bodies is due 2 years after enactment)
  • Certification for high risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S.
  • Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)
  • Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.

Biennial registration for food facilities began on October 22, 2012. Whether or not foreign importers will be banned after the new year remains to be seen, but as the FSMA implementation continues, it is something to watch. In 2011 alone, India imported almost 3 billion dollars worth of food and dietary supplements into the US, so the economic impact of a ban could have far reaching implications.