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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
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
- 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 Importation
4.1. 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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