Trade Compliance

GHY discusses changes to international trade regulations and explores cutting-edge compliance strategies.

FDA Releases Updated Draft Guidance on Prior Notice of Imported Foods

Posted April 02, 2014

Earlier this week, the Food and Drug Administration (FDA) made available draft guidance entitled Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3).

The draft guidance addresses questions received since the publication of the second edition of the guidance in May 2004 and includes information related to the FDA Food Safety Modernization Act (FSMA), which requires that additional information be provided in a prior notice of imported food submitted to FDA.
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In addition to other information already required, a prior notice must indicate whether the article of food has been refused entry by any country. The draft guidance is intended to help the food industry and others comply with prior notice requirements.

Comments on guidance are accepted at any time, but to ensure that the Agency considers comments on this draft guidance before it begins work on the final version, interested parties are asked to submit either electronic or written comments within 60 days starting March 31, 2014.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.