- Available in PDF (71KB)
- Docket No. FDA-2011-N-0179 for commenting starting June 16, 2016
- Federal Register Notice
- Importing Food Products into the United States
- More Imports & Exports Guidance Documents & Regulatory Information
Contains Nonbinding Recommendations
Additional copies are available from:
Office of Food and Feed Operations
Division of Food Defense Targeting HFC-180
Office of Regulatory Affairs
Food and Drug Administration
12420 Parklawn Drive
Rockville, MD 20740
You may submit electronic or written comments regarding this guidance at any time. Submit electronic comments 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. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
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.
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 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.