The U.S. Food and Drug Administration (FDA) today announced a draft guidance entitled "Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)." The draft guidance (to be published on Monday) addresses questions received since the publication of the second edition of the guidance in May 2004 and includes information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.
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 The draft guidance is intended to help the food industry and others comply with prior notice requirements.
The comment period on this draft guidance opens March 31, 2014. Comments on guidance are accepted at any time, but to ensure that the Agency considers comments on this draft guidance before it begins work on the final version, interested parties should submit either electronic or written comments (using Docket No. FDA-2011-N-0179) within 60 days starting March 31.
Electronic comments on the draft guidance may be submitted via Regulations.gov; written comments should be sent to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
For additional information, see:
- Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
- Federal Register notice announcing the availability of the draft guidance
- Prior Notice of Imported Foods