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 comm
