El Nogal, wellness nuts since 1980

FDA requirements for Spanish food importers

The United States is the main importer of Spanish products outside the EU and trade relations between Spain and the United States are generally favorable. Of Spain’s main exports, fruits and nuts occupy seventh place. They represent three percent of the country’s total export earnings and generate around $8.7 billion a year.

In order to consume Spanish products in the US, importers have to know a series of requirements.

FDA Requirements:


The first requirement for exporting agri-food products to the U.S. is that foreign facilities that manufacture, process, pack, or store food, food ingredients, or other products for use in the U.S. must be registered with the FDA.

In addition, it is imperative that foreign facilities designate a U.S. agent, this requirement is also necessary for the completion of the FDA registration of the exporting company. Such registration must be completed prior to the export of the products.

Prior Notice, the purpose of which is to allow the FDA to have prior knowledge of intended shipments to the US.

Registration number (foreign facility registration number), must immediately notify the FDA of any incident that they believe could affect the safety of the food.

In the U.S., food product labeling is under FDA control.

Products must bear two mandatory labels: general and nutritional.

a) General labelling:

The label shall include:

– Product name

– Net Contents

– Name and address of manufacturer, packer or distributor.

– Country of origin shall be indicated in English

– Declaration of ingredients

– Declaration of the presence of allergens 


b) Nutrition labelling:

It has very strict rules both in terms of format and dietary content of the product. It is regulated in 21CFR101.9.

The nutrition label must include information on:

– Number of calories per serving of the food product.

– Amount of total fat, saturated fat and trans fat,

– Cholesterol, sodium, potassium, carbohydrates, protein, vitamins, minerals.

The format requirements are contained in 21 CFR 101.2(a) and 21CFR 101.9.



For more information on mandatory food product labeling, see the official source of FDA Labeling & Nutrition Guidance Documents & Regulatory Information, as well as the guidance developed by the FDA Food Labeling Guide. See also the FDA Industry Resources on the Changes to the Nutrition Facts Label.


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