Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref. : EIC 111/2/19

2 November 2023

Dear Sirs,

Commercial Information Circular No. 802/2023

US : Proposed Revisions to Prior Notice Regulations for Articles of Food

The US Food and Drug Administration (FDA) published in the Federal Register (FR) of 1 November 2023 a proposed rule amending its prior notice regulations to add requirement to submit mail tracking number for articles of food arriving by international mail and timeframe for post-refusal and post-hold submissions. Interested parties may submit comments on this proposed rule to FDA by 30 January 2024.

2.FDA uses prior notice information to, among other things, determine what products should be inspected upon arrival into the US. The proposed rule, if finalised, would: (1) add a requirement for people submitting prior notice for articles of food arriving by international mail to provide the name of the mail service and the mail tracking number; (2) add a requirement that prior notice be submitted within 10 calendar days from the date a notice of refusal or hold was issued and that food facility registration be submitted within 30 calendar days from the date a notice of refusal or hold was issued; and (3) make certain technical amendments including the removal of the requirement that only the FDA Prior Notice Systems Interface (PNSI) be used for the submission of prior notice for articles of food arriving by international mail.

3.For details, please refer to the FR notice at https://www.govinfo.gov/content/pkg/FR-2023-11-01/pdf/2023-24086.pdf.

ENQUIRIES

4.For enquiries concerning the content of this circular, please contact Miss K Y HO at telephone number 2398 5405.

Yours faithfully,

(Miss Kwany KOU)
for Director-General of Trade and Industry

Note: While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.