Importing Gift Packs and Prior Notice

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What is the U.S. Food and Drug Administration policy for submission of prior notice for gift packs?

Although the Prior Notice Interim Final Rule (IFR) requires the submission of information about the identity of the food and identity of the manufacturer for each article of food. (for example, a gift pack consisting of 4 articles of food would require 4 prior notice submissions), FDA's Compliance Policy Guide, as revised November 2004, states:

FDA and Customs and Border Protection (CBP) staff should typically consider not taking regulatory action if there is a prior notice violation because a single prior notice is submitted for a gift pack and the identity of the facility that packed the gift pack is submitted in lieu of the identity of the manufacturer(s), provided that the gift pack is purchased or otherwise acquired by an individual and imported or offered for import for non-business purposes.

(See IFR §1.281(a)(5), §1.281(b)(4) and §1.281(c)(5) - "The identity of the article of food being imported or offered for import, as follows: (i) The complete FDA product code; (ii) The common or usual name or market name;" and §1.281(a)(6), §1.281(b)(5) and §1.281(c)(6) For an article of food that is no longer in its natural state, the name and address of the manufacturer and the registration number assigned to the facility that is associated with the article of food also must be provided.)

What are some examples of "gift packs"?

Examples of gift packs are:

• A gift basket containing fresh fruit and/or vegetables
• A gift box containing crackers and cheeses and canned condensed soups
• A gift basket of crackers, cheeses and fresh fruit
• A wicker basket with champagne, port, scotch whisky, smoked salmon, cheese, tea, coffee, chutney, pistachio nuts, biscuits, marmalade, honey, butter biscuits, crackers, cake, mustard, olive oil, and olives
• Tote bag with infant clothing, bib, booties, and coffee and candy for the parents;
• A toy dispenser with hard candy and powdered candy
• A gift bag with multiple pet food items such as rawhide chews and dog biscuits, with or without non-food items

What is a "single prior notice"?

A single prior notice means that the identity of the article of food as required by the Prior Notice IFR is described by submitting a single FDA product code and describing the article as a gift pack containing various items.

For example:

• FDA Product Code 37Y--01
• A gift box containing crackers and cheeses and canned condensed soups

• FDA Product Code 72E--99
• A gift bag for dogs with rawhide chews and dog biscuits, with toys

What are non-business purposes?

Food is considered to be for non-business purposes when it is not for sale, resale, barter, business use, or commercial use. For example, a gift pack purchased or otherwise acquired by an individual as a gift is covered by this policy. Gift packs imported or offered for import for business use are not covered by this policy, and therefore the identity of each article of food and the manufacturer of each article, if applicable, is required.

This policy applies irrespective of where the individual who purchased or otherwise acquired the gift pack lives and irrespective of the type of carrier. The policy also applies irrespective of whether it involves a commercial or non-commercial shipper.

For more information, see Compliance Policy Guide for Prior Notice of Imported Foods.

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