FDA issues third edition of guidance regarding prior notice for imported food.

  • Under Section 801(m) of the Federal Food, Drug, and Cosmetic Act, FDA requires the submission of “prior notice” in advance of an article of food arriving at the U.S. border.  “Food” is defined broadly to include finished foods, ingredients, and raw materials.  The prior notice requirements have been in effect since 2003.
  • On June 16, 2016, FDA issued its third edition of a guidance document addressing prior notice of imported food.  The guidance provides a list of questions that frequently have been asked about the prior notice requirements, and the answers to those questions.
  • Interested parties may find the updated guidance helpful, particularly as it addresses a relatively recent amendment to the prior notice regulations as required by the FDA Food Safety Modernization Act (FSMA).  Specifically, under FSMA, a person submitting prior notice of imported food now must report the name of any country to which the article has been refused entry.