US FDA Releases Third Edition of the Draft Guidance on Prior Notice of Import Foods

FAIRFIELD, N.J. - May 15, 2014 - PRLog -- On 28 March 2014 the United States Food and Drug Administration (US FDA) made available their third edition of the draft guidance on Prior Notice on Imported Foods. This edition lists the questions and answers asked about Prior Notice of Import Foods that the US FDA received and answered since the second edition was published in May of 2004. Comment period ends 30 May 2014.

Draft Guidance for Industry: Prior Notice of Imported Foods Questions and Answers

As legally required, the US FDA must receive prior notification (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm078911.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery) of an article of food for humans or animals that is being imported or offered for import in advance of the article of food arriving at the US border.

As required by Food Safety Modernization Act (FSMA) the prior notice regulation (https://www.federalregister.gov/articles/2013/05/30/2013-12833/information-required-in-prior-notice-of-imported-food) was revised and then finalized 30 May 2013 (2).  Subsequently the US FDA revised the guidance to this section of the regulation. This guidance provides background, definitions, applicable scope, requirements and consequences for not following the requirements.

Examples of when a food sample submitted to an US laboratory for testing would require or not require prior notice: if the food is a form whereby it could be consumed, e.g. a head of lettuce or a canned product, then the samples require prior notice but if the sample is in a form of slurry or in a sterile sample bag identified clearly as a sample, then the sample does not require prior notice.

Another example: meat, poultry and egg products under the jurisdiction of the United States Department Agriculture does not require prior notice to the US FDA but requires complying with the USDA Food Safety Inspection Service requirements but if the same product is intended for feed for animals, including pets, then this product will require US FDA prior notification.

For more information on FSMA and how to comment on the proposed regulations visit the United States Food and Drug Administration’s website (http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm ).

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