Foreign Co - FDA U.S. Agent

Foreign Suppliers

Registration with the FDA

United States imports increased to an all-time high of $321.7 billion in February 2023. Here is a partial list.

Foods, feeds, and beverages total imports were $16.93 billion.

Other foods: $2.19B
Fruits, frozen juices: $2.20B
Feedstuff and foodgrains: $761M
Fish and shellfish: $2.15B
Cane and beet sugar: $181M
Green coffee: $454M
Dairy products and eggs: $283M
Cocoa beans: $106M

Meat products: $1.39B
Tea, spices: $224M
Alcoholic beverages, excluding wine: $1.07B
Bakery products $1.62B
Vegetables: $1.6B
Nonagricultural foods: $122M
Nuts: $240M
Wine, beer, and related products: $1.1B
Food oils, oilseeds: $1.09B.

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Therefore, exporting to the United States represents a good opportunity for companies around the world, including Food Startups, Small Import-Export Businesses, Chocolate Master Shops, Coffee Roasteries, Online Shops, Bakeries and Fulfillment by Amazon (FBA) stores.

However, foreign suppliers must first register with the United States Food and Drug Administration. (FDA). Also, there is a listing requirement for medical devices and drug products.

FDA REGISTRAION REQUIREMENT

FDA Registration is required before shipping any regulated product to the United States, to avoid the detention of your shipment by the U.S. Food and Drug Administration and the U.S. Customs.

FDA regulated products include:

▪ Food.

▪ Dietary Supplements.

▪ Medical Devices.

▪ Prescription Drugs.

▪ Over-the-counter (OTC) Drugs.

▪ Cosmetics.

Also, no FDA Registration can be completed without a DUNS Number and U.S. Agent, as described below.

U.S. AGENT

Foreign suppliers (facilities or establishments) must designate a U.S. Agent such as ITB HOLDINGS LLC, for purposes of communication between the companies and the U.S. Food and Drug Administration (U.S. FDA). The U.S. Agent is authorized to register any facility or establishment.

The Food and Drug Administration will not confirm a registration, provide a registration number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.

The agency will conduct this verification step by sending an email to ITB HOLDINGS LLC. If the FDA does not receive a response to its verification request within 30 calendar days, the registration, registration renewal, update, or cancellation submission will be removed from its database and a new submission will be required.

DUNS NUMBER

Since July 24, 2022, the use of the entity identification code “UNK” is no longer an option when filing an entry with U.S. Customs and Border Protection (CBP). Furthermore, FDA Registrations cannot be completed without a DUNS Number (Data Universal Numbering System, abbreviated as DUNS or D-U-N-S).

So, obtain a DUNS number by contacting Dun & Bradstreet, Inc (D&B) directly by phone at 1-866-705-5711, or here www.dnb.com.

Getting a DUNS Number takes 30 days, and is free in the U.S. However, for expedited service, payment of a fee is required.

Below are specific countries DUNS Number links:

FDA REGISTRATION SERVICE FEES & USER FEES

While Service Fees are paid to ITB HOLDINGS LLC, some registrations, mainly for medical device and drug establishments, are preceded by the payment of User Fees to the U.S. Treasury.

FDA REGISTRATION SERVICE FEES

ITB HOLDINGS LLC provides the following services to foreign suppliers, at the lowest fees in the United States:

Food Facility Registration.

Supplement Facility Registration.

Food Canning Establishment.

Foreign Supplier Verification Program.

U.S. Agent Service.

Prior Notice.

Label Review.

Label Design.

Medical Device Establishment Registration.

Drug Establishment Registration.