Clearances

FDA Filings

With the exception of most meat and poultry, all food, drugs, biologics, cosmetics, medical devices, and electronic products that emit radiation, as defined in the FD&C and related Acts, are subject to examination by the US Food & Drug Administration (FDA) when they are being imported or offered for import into the United States.

FDA Prior Notice
Nearly 20% of all imports into the U.S. are food and food products. In 2002 Congress passed the Bioterrorism Act as a part of its ongoing effort to combat terrorism - in this instance, by reducing the ability for international terrorists to carry out terrorist attacks in the U.S. by contaminating imported foods.

The Act requires that FDA receive prior notice before food is imported or offered for import into the United States. Advance notice of import shipments allows FDA, with the support of the US Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies.

FDA Prior Notice Facility Registration
On October 10, 2003, FDA and CBP issued interim final regulations establishing the requirements for registration and requiring that FDA receive prior notice of the importation of food beginning on December 12, 2003.
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.
If a foreign facility fails to register and also attempts to import food into the U.S., the Bioterrorism Act requires that the food be held at the port of entry unless FDA or U.S. Customs directs otherwise.
If the food must be moved, the private parties involved (i.e., the owner, purchaser, importer, or receiver of the food) must arrange for moving it and promptly notify FDA of its location. The private parties are responsible for any costs associated with moving or storage of the food.

Food as defined for Prior Notice
For the purposes of prior notice, "food" is defined as
1) articles of food or drink for man or other animals
2) chewing gum
3) articles used as components of any such article, except that it does not include food contact substances or pesticides.

Food Exempt from FDA Prior Notice
The requirements for Prior Notice do not apply to:
(1) Food for an individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States
(2) Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e. for non-business reasons) to an individual in the United States
(3) Food that is imported then exported without leaving the port of arrival until export
(4) Meat food products that at the time of importation are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act
(5) Poultry products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Poultry Products Inspection Act
(6) Egg products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Egg Products Inspection Act

About.

Freight N Cargo.com takes a proactive approach to cost savings utilizing innovative technologies more ...

Contact.

  • 1504 Old Country Rd,Westbury NY 11590 U.S.A
  • Phone: +1.516.414.7256
  • Website: FreightNCargo.com

Connect.

Connect with us