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US FDA Regulations for  Importation of Food Articles

 

As a part of the Bio-terrorism Act 2002, the US Food & Drug Administration (FDA) has announced new implementations for food shipments imported into the US with effective from December 12th, 2003. 

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 by December 12, 2003. 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. Additionally, facility registration is not required for shipments from one private person to another private person (e.g. Christmas gifts).Without proper registration, food shipments are subject to refusal to enter the US.

The FDA will require that U.S. purchasers or U.S. importers or their agents or foreign shippers submit to the FDA Prior Notice on the importation of food. 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.Self submission of Prior Notice can be done electronically at www.access.fda.gov. Important Information

  • Food items sent from one private person to another private person do not require Registration of Facilities, but are subject to Prior Notice requirement. Please indicate clearly on the Airwaybill and invoice that the items are "Personal gift for non business reason".When shipping food items, sender must:
    1. 1.             State clearly on the Airwaybill: "Food or Food Product"2.             If shipper is a food manufacturer, indicate FDA Registration Number on the shipping invoice3.             Attach Prior Notice Confirmation document to shipments or fill up Prior Notice Submission Data Form for every food item
      • If your shipments are not allowed to enter the US because of failure to comply with the FDA regulations, DHL will not return the shipments and will not reimburse the transportation fee.

More details are available on the FDA Web site at www.fda.gov/oc/bioterrorism/bioact.html. 

 

GUIDELINES FOR SHIPPING FOOD TO THE UNITED STATES

  1. What types of commodities are covered?

Examples of commodities the FDA consider to be food include:

  • ?        Dietary supplements and dietary ingredients?        Infant formula (baby food)?        Beverages including alcoholic beverages and bottled water?        Fruits and vegetables?        Fish and seafood?        Dairy products and 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 FDA has the sole authority to determine the scope of the covered commodities. Further details are available on the FDA website at www.fda.gov.2.       What types of commodities are exempted?The following are exempt from Prior Notice requirements

  • ?        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.
  • ?        Meat food products, poultry products and processed 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.

The FDA has the sole authority to determine the scope of the covered commodities. Further details are available on the FDA website at www.fda.gov.Note: Shipments containing purchased food items from one private person to another private person (e.g. Christmas gifts) are not exempted from Prior Notice requirements.

3.       Registration of Facilities 3.1.    Who needs to register and by when? All facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the FDA by December 12, 2003.

3.2.    What information is required? Each registration must include:

  • ?        the name, address and phone number for the facility and its parent company (if applicable);?        the name, address and phone number of the owner operator or agent in charge;?        all trade names the facility uses;?        applicable food product categories; and
  • ?        a statement certifying that the information submitted is true and accurate and that the person is authorized to submit the registration.

All non-US facilities must also designate a U.S. Agent who must live or maintain a place of business in the U.S. and be physically present in the U.S. for purposes of registration.

3.3.    When should any changes to a previous facility application be submitted? When any required element of a facility’s registration changes, an update must be submitted within 60 days of the change.3.4.    How can customers register their company facilities details with the FDA? Customers can self registration. This can be done directly by each customer through the FDA website at www.fda.gov.4.       Prior Notice of Importation4.1.    How can customers ensure that the FDA receives timely prior notice? At the time of pick up shipping companies & couriers  will require submission of a Prior Notice confirmation number or the required data elements on the shipping documentation to submit a Prior Notice application.Prior Notice requirements apply regardless of:

  • ?        the quantity imported (samples, full orders, etc.)?        the purpose of importation (testing, consumption, etc.)
  • ?        the type of transaction (commercial or gift).

The FDA and Customs & Border Protection (CBP) have announced that they intend to allow food importers to provide the required information on imports to both agencies using an integrated process.Self submission of prior notice can be done electronically at www.access.fda.gov.4.2.    Are there any other information requirements?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, DHL requires the English language description of each food item shipped. (The FDA product code, if known (available from www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM), will speed up the process.)?                    Complete name and address of the manufacturer or grower and their FDA registration number?                    Country of production?                    Complete name and address of shipper and their FDA registration number (if different from the manufacturer)
  • ?                    Complete name and address of the importer, purchaser or ultimate consignee and their FDA registration numbers

Note that a separate prior notice is required for each article of food within a single shipment when any of the above items varies or changes. This also includes changes in the size or kind of packaging or container.4.3.    What information does shipping companies require if customers choose to submit prior notification directly to the FDA?will require a copy of the prior notice confirmation to accompany the shipment. The confirmation number must also be clearly identified on the shipping invoice. The DHL airway bill should state Food or Food Product.

4.4.    What will occur if customers do not follow the above requirements? 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, seizure, destruction, fines, and penalties related to failure to provide timely and accurate Prior Notice.

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