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FDA/CBP Post Documents on Prior Notice of Imported Food for: 1. Gift Packs 2. International Mail 3. Personal Shipments

The following Bioterrorism Act-related documents have been posted by the Food and Drug Administration (FDA) or U.S. Customs and Border Protection (CBP) to their respective Web sites:

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1. FDA Policy for Importing Gift Packs and Prior Notice

The FDA has posted to its Web site a document, dated November 2004, which discusses FDA policy for submitting prior notice for gift packs and provides examples of gift packs, defines single prior notice, discusses non-business purposes and what other criteria are important.

FDA's Gift Packs document available at http://www.cfsan.fda.gov/pn/pngift2.html.

2. FDA Guidance on Sending Food through International Mail

This document, dated October 2004, consists of selected excerpts from the FDA's Prior Notice interim final rule, guidance documents, and fact sheets.

This document provides information on the following topics: home-made foods, gifts of certain food, compliance policy guide and enforcement discretion, commercial shipments, non-commercial shipments, samples, additional selected excerpts, and abbreviated information on requirements.

FDA's International Mail document available at http://www.cfsan.fda.gov/pn/pnmail.html.

3. CBP Press Release on November 2004 Guide for Personal Shipments

U.S. Customs and Border Protection (CBP) has posted to its Web site a press release announcing the issuance of a revised Compliance Policy Guide (CPG) on FDA and CBP's strategy for enforcing the requirements of the interim final rule for submitting prior notice for imported food.

According to the press release, this revised CPG explains that FDA and CBP will exercise enforcement discretion on Bioterrorism Act issues until such time as the FDA publishes a final Bioterrorism Act rule for food imported or offered for import for non-commercial purposes. CBP's press release also defined "non-commercial purpose" and provides examples of foods imported or offered for import that may be covered in the non-commercial category.

CBP states that the revised CPG also clarifies that an individual is a sole human being, not a corporation and expands upon the difference under the Bioterrorism Act between a shipper (most likely an individual) and carrier (most likely a commercial entity).

(See ITT's Online Archives or 11/04/04 news, 04110410, for previous BP summary on the November 2004 CPG.)

CBP notice available at http://www.cbp.gov/xp/cgov/import/commercial_enforcement/bioterrorism/rev_comp_policy.xml,