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How to Comment
The comment period opens June 16, 2016.
Submit written comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2011-N-0179.
Contains Nonbinding Recommendations
On November 7, 2008, the Food and Drug Administration (FDA or we) published a final rule (Prior Notice rule) in the Federal Register requiring submission to FDA of prior notice of food, including food for animals, that is imported or offered for import into the United States (73 FR 66294). The Prior Notice rule implements section 801(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188), and requires that FDA receive prior notice of food imported into the United States. Section 304 of the FDA Food Safety Modernization Act (FSMA) (Public Law 111-353) amended section 801(m) of the FD&C Act.
On May 5, 2011, FDA published an interim final rule “Information Required in Prior Notice of Imported Food” (76 FR 25542). The interim final rule amended the Agency’s regulations on prior notice of imported food. As required by section 304 of FSMA, FDA issued the interim final rule to require an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. Section 304 of FSMA also required the interim final rule be published no later than 120 days following the date of enactment of the legislation and that the amendment made by section 304 take effect 180 days after the date of enactment. The effective date of the interim final rule was July 3, 2011.
On May 30, 2013, FDA published a final rule (78 FR 32359) that adopted, without change, the interim final rule.
This is the third edition of this document. The first and second editions were issued on December 16, 2003, and May 3, 2004, respectively. A draft version of this document was published on March 31, 2014. Revisions and additions since publication of the draft document are noted by date. This guidance document provides a list of questions that frequently have been asked about the requirements of the prior notice regulation, and the answers to those questions. It is being issued to help the food industry and others comply with the legal requirements established by the Prior Notice rule.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.
This guidance has been prepared by the Division of Food Defense Targeting in cooperation with the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine of the U.S. Food and Drug Administration.