- The USA’s “Public Health Security and Bio-terrorism Preparedness and Response Act of 2002,” (also known as the bio-terrorism Act or BTA) includes provisions designed to protect the United States against bio-terrorist threats to its food supply including food from foreign sources.The U.S. Food and Drug Administration (FDA) released regulations in response to the Bioterrorism Act of 2002 (BTA) outlining specific requirements on the importation of food and food products.As a result, US Customs can return or abandon all shipments that do not comply with all required provisions. The US government will enforce all fines/penalties described for non-compliance.This law has two major provisions impacting FOCUSGAZE Express Customers:
- Registration of Facilities: The FDA will require that domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States register with the FDA. US based farms, retail facilities, restaurants and non-profit food facilities in which food is prepared for or served directly to the consumer are exempt from these requirements.
- Prior Notice of Importation of Food: The FDA requires that US purchasers or US importers or their agents submit to the FDA prior notice on the importation of food.
Registration and Prior Notice has a significant impact on the trading community. This document aims to provide an overview of the relevant provisions that may impact on you as customers of FOCUSGAZE Express.
Importing Food to the US
FDA Regulations for Shipping Food to the US
Ensure speedy customs clearance and earliest delivery when shipping food to the US. Focusgaze helps you understand the latest FDA and US customs regulations.
Regulations
Registration
Prior Notice of Importation
Regulations
Registration
- All facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the FDA.
DXHPOINT Express USA Inc can file Prior Notice for individual shipments (see Section 4 below), but does not offer registration services. Customers can register direct with the FDA at the FDA Website
Prior Notice of Importation
FDA requires prior notice for all Food products presented to import into the United States. Prior notice must be submitted no less than four hours before flight arrival but may not be submitted more than five days prior to shipment arrival.
Prior Notice applies to food for humans and/or animals that is imported or offered for import into the U.S. Food is defined as articles used for food or drink for man or animals, such as chewing gum, and articles used for components of any such articles.
Examples of commodities the FDA consider to be food include:
- Dietary supplements and dietary ingredients
- Beverages including alcoholic beverages and bottled water
- Fruits and vegetables
- Fish and seafood
- Dairy products and shell eggs
- Raw agricultural commodities for use as food or components of food
- Canned and frozen foods
- Live food animals
- Bakery goods, snack foods, candy and chewing gum
- Animal feed and pet food
The following are exempt from Prior Notice requirements:
- Meat food products, poultry products and egg products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) and comply with the USDA rules and regulations
- All Personal food shipments: food items sent person to person for non-commercial purposes.
- Food in household goods, including military, civilian, governmental agency, and diplomatic transfers;
- Food purchased by a traveler and mailed or shipped to the traveler’s U.S. address by the traveler;
- Gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment;
- Food contained in diplomatic pouches.
Note: This does not include shipments sent from a retailer or distributor to an individual. Such shipments do require Prior Notice.
The FDA has the sole authority to determine the scope of the covered commodities. Further details are available on the FDA Website.
FOCUSGAZE will require submission of a Prior Notice confirmation number or the required data elements to submit a Prior Notice application on the shipping documentation at the time of pick up.
The FDA also allows food importers to submit the Prior Notice application directly. Prior notice must be submitted electronically at the FDA Website
In addition to standard invoice requirements, the following elements must be included on the shipping invoice and be available at the time of pick up:
- Identification of each article of food, including the common or usual name or market name, the quantity described at the smallest package size, and the lot or code numbers or other identifier.
- In order to be able to submit a proper Prior Notice FOCUSGAZE requires English language description of each food item shipped. (The FDA product code, if known (available from the FDA Website, will speed up the process.)
- Complete name and address of the manufacturer or grower and their FDA registration number (if available)
- Country of production
- Complete name and address of shipper and their FDA registration number (if available)
- Complete name and address of the importer, purchaser or ultimate consignee and their FDA registration numbers (if available)
The “Required Information for FDA Prior Notice Submission” must be included with the shipping documents for FOCUSGAZE to file PN on the customer’s behalf.
Note that a separate prior notice is required for each article of food when any of the above items varies or changes. This also includes changes in the size or kind of packaging or container.
FOCUSGAZE will require a copy of the prior notice confirmation to accompany the shipment. The confirmation number must also be clearly identified on the Commercial/Proforma invoice. The DXHPOINT waybill should include complete and accurate goods description.
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.
Further guidance on the relevant requirements and the assistance that FOCUSGAZE can provide is available through your local FOCUSGAZE office. More information is also available on the FDA Website.
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