What are the consequences of failing to submit adequate Prior Notice information of an imported food shipment?
Food that is imported or offered for import with inadequate Prior Notice is subject to refusal and holding at the port or in secure storage. FDA will provide its staff with enforcement guidance containing the Agency’s policies on injunctions, prosecution, and debarment related to failure to provide timely and accurate Prior Notice, as well as the Agency’s policies regarding refusals under § 801(m)(1) and holds under § 801(l). FDA intends to include a transition period in this guidance, during which it will emphasize education to achieve compliance. While FDA will nonetheless be authorized to take various types of enforcement action for violations of the Prior Notice requirements, this planned transition period will allow FDA to focus its resources on the most appropriate circumstances. FDA also intends to provide guidance to its staff on enforcing the Prior Notice requirements after a transition period. FDA’s guidance documents will be available to the public, and FDA will publish a no
