1. What is FDA? FDA is the abbreviation for the phrase “US Food and Drug Administration”, understood as the United States Food and Drug Administration.

2. Why must FDA registration be required?

According to FDA regulations, businesses exporting goods to the US market are required to register with the FDA. Includes businesses that produce, process, package, and hold beverages, foods, and food ingredients for human and animal consumption in the United States.

3. Does the FDA issue a certificate upon registration?

When completing FDA registration procedures, businesses will receive a series of codes (including 7 digits) to declare and fill out export documents to the US. FDA DOES NOT issue any clearance for this registration.

4. Does the FDA come to inspect factories and production facilities?

Every year, the FDA will send inspection teams to factories (registered with the FDA) around the world to check the production quality, food safety and hygiene of businesses exporting to the US.

FDA will notify businesses at least 3 to 6 months to prepare for the inspection.

In case, the Enterprise refuses to carry out the inspection, it will be banned from exporting goods to the US.

5. Items that the FDA considers to be foods include:

Live animals are used for food

Milk and products made from milk

Unprocessed eggs


Sea food

Canned food

Cakes and candies of all kinds


Food for animals

Diet products

6. Items exempted by FDA include:

Food created by individuals at home and sent as gifts.

Food samples not intended for consumption are valued at less than 200 USD. These are sample products for food manufacturers or laboratories.

Meat food products, poultry products, and eggs are under the exclusive jurisdiction of the United States Department of Agriculture.

7. Some difficulties when businesses register with the FDA

Normally, Vietnamese businesses must register with the FDA themselves or ask a partner in the US to register. However, registration faces many difficulties such as understanding FDA standards, language, information declaration, registration process, etc., which takes time and affects the business’s export plans.

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