ITB HOLDINGS LLC

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FDA REGISTRATION NUMBER

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PRIOR NOTICE

REQUIRED with each shipment to the United States. Avoid the detention of your cargo by the U.S. Customs and Border Protection (CBP) on behalf of the FDA.

PRIOR NOTICE is a notification to the FDA that a product is being imported or offered for import into the United States, in advance of its arrival at a U.S. port or airport.

Prior Notice (PN) Confirmation Number is an Affirmation of Compliance when the CBP entry or admission is filed.

FDA will use the information provided with the Prior Notice to determine whether to inspect, sample the article of food when it arrives in the U.S. or deny entry.


PRIOR NOTICE DEADLINES

Except for food being sent by international mail (only covers foreign national mail services), Prior Notice must be submitted and the submission must be confirmed by FDA no less than:

2 hours before arrival, if the food is arriving by land by road

4 hours before arrival, if the food is arriving by land by rail

4 hours before arrival, if the food is arriving by air

8 hours before arrival, if the food is arriving by water.

ITB HOLDINGS LLC will submit a separate Prior Notice for each article of food that has a different complete FDA product code, different package size, or different manufacturer or grower, on your company's behalf.

$25.00 USD

When a customer or consignee has not been identified, the Third-party Logistics (3PL) where the merchandise will be delivered and stored is the ultimate consignee in Prior Notice submissions.

FDA believes that the facility where the goods are to be delivered should be considered the ultimate consignee in all circumstances.

FOOD TRADE SHOWS

Canadian and other foreign companies should contact us before traveling to New York or California.

Foreign Supplier Verification Program (FSVP)

Compliance is now enforced.

FDA Compliant Labels

Avoid CBP detention during U.S. Customs Clearance.



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■ 89,000 Domestic (U.S.) registered Food Facilities

■ 213,000 Foreign registered Food Facilities


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JUST YOU KNOW

When a substance is capable of having a food use and a non-food use, FDA will consider the substance to be “food” for the purpose of Prior Notice if it is reasonably likely to be directed to a food use.

If a product is for pharmaceutical testing purposes (use in a clinical trial involving a prescription or non-prescription drug), then prior notice is not required. However, if the product is being imported for use in the testing of dietary supplements or dietary ingredients, Prior Notice is required.

Prior Notice is not required for foods that are imported into the U.S. Territories (Guam, U.S. Virgin Islands, Northern Mariana Islands). Prior Notice is required for the Commonwealth of Puerto Rico.

Prior Notice rule does not exempt food imported for use by nonprofit food establishments.

The exception for “personal use” food applies only when the food is carried by or otherwise accompanies an individual when arriving in the U.S.


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■ Trade samples are imported or offered for import to generate sales, which is commercial. Therefore, Prior Notice is required.



FOOD FACILITIES

$99.00

SUPPLEMENTS FACILITIES

$99.00

U.S. AGENT SERVICE

$99.00

FOOD LABEL REVIEW

$99.00

PRIOR NOTICE

$25.00

FOOD CANNING

$350.00

MEDICAL DEVICES

$350.00

DRUGS

$350.00

COSMETICS (OTC)

$350.00

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In more than 100 countries

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PRIOR NOTICE ENFORCEMENT

What happens to food that is imported or offered for import without adequate Prior Notice?

■ Importer, owner, or ultimate consignee will have a very short opportunity to file or correct a Prior Notice

■ Cargo will be held for FDA inspection and disposition

■ Cargo will be returned, exported or destroyed.

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ITB HOLDINGS LLC

390 North Orange Avenue

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Orlando, FL 32801

United States

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