Enforcement Policy to Delay Requirements to Submit International Mail Tracking Number and Mail Service Name Until May 1, 2027: Guidance for Industry: Guidance for Industry

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Enforcement Policy to Delay
Requirements to Submit Mail Service
Name and International Mail
Tracking Number Until May 1, 2027:
Guidance for Industry
You may submit electronic or written comments regarding this guidance at any time. Submit
electronic comments to http://www.regulations.gov. Submit written comments on the guidance
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 title of the guidance document and Docket No. FDA-2011-N-0179.
For questions or information regarding this guidance, contact the Office of Inspections and
Investigations (OII), Office of Inspectional Performance Optimization, Division of Inspectorate
Policy (DIP), Food and Drug Administration at OIIPolicyStaffs@fda.hhs.gov. For questions
regarding Prior Notice, contact the FDA's Division of Targeting and Analysis (DTA) at (866)
521-2297 or prior.notice@fda.hhs.gov. For ACE inquiries, contact FDA ACE Support at
ACE_Support@fda.hhs.gov
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Inspections and Investigations
October 2026

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Contains Nonbinding Recommendations
Table of Contents
I. 	Introduction
II. 	Background
III. 	Discussion

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Contains Nonbinding Recommendations
Enforcement Policy to Delay Prior
Notice Requirements to Submit Mail
Service Name and International Mail
Tracking Number Until May 1, 2027:
Guidance for Industry
This guidance represents the current thinking of the Food and Drug Administration (FDA, we, or
the Agency) 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.
I. 	Introduction
The U.S. Food and Drug Administration (FDA, the Agency, or we) is issuing this guidance1 to
announce our intent not to enforce until May 1, 2027 the prior notice requirements to submit the
name of the mail service and the mail tracking number for articles of food arriving by international
mail. This policy provides additional time to ensure that the information technology system
functionality is updated so that it can accept the mail service name and mail tracking number for
food arriving by international mail as part of prior notice.
FDA's 	guidance 	documents, 	including 	this 	guidance, 	do 	not 	establish 	legally 	enforceable
responsibilities. Instead, guidances describe the Agency's 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 Agency guidances means that something is suggested or recommended,
but not required.
1 This guidance has been prepared by the Division of Inspectorate Policy in the Office of Inspections and Investigations at the
U.S. Food and Drug Administration.

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Contains Nonbinding Recommendations
II. 	Background
Section 801(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m))
directs the FDA to issue regulations requiring prior notice to FDA of food that is imported or
offered for import into the United States. The prior notice regulations specify the information
about food offered for import into the United States that must be submitted to FDA. The
information in prior notice enables FDA to target import inspections more effectively, thereby
helping to protect our nation's food supply against bio-terrorist acts and other public health
emergencies.
On September 25, 2025, FDA published a final rule titled, “Prior Notice: Adding Requirement to
Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe
for Post-Refusal and Post-Hold Submissions,” (90 FR 46045), to amend its prior notice
regulations. Among other amendments, the rule required that, beginning October 1, 2026, prior
notice submissions for food arriving by international mail must include:
• 	The name of the mail service; and
• 	The mail tracking number (21 CFR 1.281(b)(10)).
The final rule stated that receiving the name of the mail service and mail tracking number for
articles of food arriving by international mail would enable the FDA to better coordinate with the
U.S. Postal Service (USPS), U.S. Customs and Border Protection (CBP), and other agencies to
effectively track and inspect articles that have been identified as a possible bioterrorism risk.
The final rule also allows prior notice for food arriving by international mail to be submitted
through the CBP’s Automated Broker Interface/Automated Commercial
Environment/International Trade Data System (ABI/ACE/ITDS) or the FDA’s Prior Notice
Systems Interface (PNSI) (21 CFR 1.280(a)(2)).
During the public comment period for the rule, FDA received a comment (Comment 4) asking
FDA not to implement requirements to submit the mail service name and mail tracking number
until the relevant information technology systems were updated and able to accept the newly
required information2. In response to the comment, and to provide adequate time for PNSI and
ACE to be updated to accommodate the newly required information, in the final rule, FDA added
that the requirements to submit the mail service name and mail tracking number for articles of
food arriving by international mail would begin on October 1, 2026. In the final rule preamble,
FDA stated that, if we receive information to indicate that PNSI and/or ACE will not be ready to
receive the name of the mail service and mail tracking number by October 1, 2026, we will
consider the appropriate means to address this, including whether the temporary exercise of
enforcement discretion for the requirements to submit the name of the mail service and tracking
number would be appropriate until the time that PNSI and ACE can receive such information.
2 90 F.R. 46045, 46051 (September 25, 2025).

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Contains Nonbinding Recommendations
III. 	Discussion
Since publication of the final rule, FDA has become aware that the relevant information
technology systems will not be ready to receive the name of the mail service for food arriving by
international mail by October 1, 2026. Therefore, FDA intends not to enforce the prior notice
requirements at 21 CFR 1.281(b)(10) to submit the name of the mail service and mail tracking
number for food arriving by international mail until May 1, 2027.
FDA will continue to assess the status of the relevant information technology systems readiness as
May 1, 2027 approaches, and update this policy, if needed.