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The United States
has a new law, the Bioterrorism Act, to protect
the food supply from being contaminated by
terrorist acts. The U.S. Food and Drug
Administration (FDA) is the United States
Government agency with the responsibility to
implement the Bioterrorism Act. The FDA will
require:
The term
"food" is defined by the FDA as any and all food
or beverage items consumed by people or animals
including dietary supplements, bottled water,
candy, etc.
The Bioterrorism
Act requires any and all foreign companies that
manufacture, process, pack, or hold food for
human or animal consumption in the United States
to register with the FDA no later than March
12, 2004. Non-United States companies with
multiple operations must register each facility
separately. In addition, all companies located
in the United States which manufacture, process,
pack, transport, distribute, receive, hold, or
import food and beverages intended for human or
animal consumption in the United States also
must register with the FDA by that date.
LALANDIA,
has for more than 15 years
assisted U.S. and foreign carrier entities in
front of the Federal Maritime Commission (FMC)
and the U.S. Customs with tariff- and AMS
filings respectively. We
may be properly designated as a
United States agent for foreign companies, so we
can assist foreign as well as U.S. companies in
properly registering with the FDA, properly
completing the Prior Notice Submission form,
communicating with both the FDA and Customs if
any difficulty arises.
The effective
date of the regulations is December 12, 2003. As
of that date, all companies involved in the
manufacture, processing, holding, and storage of
food and beverage items into and within the
United States must be registered with the FDA
and must timely submit properly completed
prior notice
submission form information to the FDA.
LALANDIA
offers FDA Registration and FDA U.S. Agent
services for a fee of U.S.$250.00 for the first
year and U.S.$150.00 for the following years.
Prior Notice filings are offered at U.S.$15.00
per issued Prior Notice Confirmation Number, as
issued by the FDA.
To
sign-up for Lalandia's FDA Registration & U.S.
Agent assignment, please click on the below link
and fill-in the required
facility/owner/emergency names and addresses
plus information about the foodstuff exported to
the U.S.
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Upon receipt of the
duly filled-in form and the corresponding payment of the
yearly
U.S. Agent retainer of $250.00 for the first years
(thereafter $150.00 per year ONLY) payable by a
valid Credit Card.
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LALANDIA
now duly authorized by the foreign company,
will register the foreign entity with the
FDA and the foreign entity will receive the
FDA Registration No., which to be used for
any correspondence with the FDA. |
LALANDIA
also offer
filing of Prior Notice to the FDA via our
Internet site, just like we
file AMS on behalf of Carriers into the U.S.
Customs Automated Manifest System as a Value-Added service.
The filing
fee is $15.00
per each Prior Notice
Confirmation No., as issued by the FDA. No
set-up fees or monthly minimums, just a flat fee
every time you ship foodstuff to the United
States of America in an easy, economically and
time efficient way.
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