On October 31, 2008, the FDA and Customs and Border Protection announced revisions to a 2003 interim rule requiring food importers to provide “prior notice” to the FDA when importing into the United States. The FDA and Customs simultaneously published a draft “Compliance Policy Guide” to help importers interpret these updates.
The Kelley Drye Food and Drug Law
and International Trade
Practice Groups prepared this Client Advisory describing changes to the rule, including revised definitions, the new submission requirement, and its implementation.