The food industry in the United States is highly dependent on import, and is conditional on compliance with regulations and technical and health requirements. The Food and Drug Administration (FDA) regulates and dictates these requirements.
The FDA regulates the entry of pharmaceuticals, vaccines, medical devices, cosmetics, biologicals, drugs, and animal feed. The office in Europe is in Brussels, however all procedures take place in the USA.
Depending on the product, we may also have to take into account another body, such as the Department of Agriculture (USDA), which regulates part of the food related to poultry, meat or foods that contain more than 2% meat.
All imported food must meet the same requirements as products made in the United States.
In recent decades, the American consumer habits have changed, for instance, now they demand nutritious and healthy food. Well-being is a primary factor in choosing food, American consumers prefer natural and fat-free foods.
In addition, there is also an increase of the awareness of the environment, and new requirements such as the non-use of chemicals or with the least possible amount of added substances.
To comply with the regulations we must consider the following basic requirements. However, these may vary according to the nature of the product:
- Free from microbial, chemical, dirt, and other contamination.
- Produced under good agricultural practices.
- Comply with the required administrative rules and procedures.
- Properly labeled.
Regulations on labeling
Exporters must ensure that their products comply with the necessary label required. Above all, they must include specifications, for the front and back label, and the exceptions derived from the different sizes and requirements. Ingredients and colors must appear with their usual approved name.
Among the general requirements, the label must be in English (it can be bilingual if all the information is in both languages), the measurements must follow the US metric system, and the nutritional information must follow the “nutrition facts” format.
The mandatory information that all products must carry on their labels is the following:
- Food identity.
- List of ingredients.
- Name and address of the company or business.
- Nutritional information.
- Net content.
- Allergen information.
- Relevant information.
Allowed colorants and additives
The FDA approves the ingredients, additives and colorants contained in the products. If an ingredient or additive of the product is not on the list, you can ask for the inclusion, but the process takes time since it is necessary to carry out analyzes, laboratory tests, among others.
According to the requirements and regulations to import, among the prohibited colorants we have the following:
- Calcium carbonate.
- Carbon black.
- Orchilla Ink
- Ferric chloride.
- Ferrous sulfate.
Import process into the EE.UU.
First, the importer submits a notification of entry of the products to US Customs, which in turn notifies the FDA.
The FDA determines whether the shipment approves and whether it needs examination. If the FDA does not carry out the inspection, the corresponding duties are paid and the product can now be marketed in the US. At this point we have two situations:
- If FDA decides to inspect the consignment, samples are taken for testing and the responsible party should hold the shipment in a warehouse and keep it unaltered until contacted by FDA. After review, if everything is in order, the shipment is released for distribution once the duties are paid.
- If the products do not meet the established requirements, the FDA issues a notice of detention and hearing , and the importer can request reconditioning of the product. If the FDA denies the entry of the products, the importer must re-export or destroy them.
Law against Bioterrorism
This law arises from the need to avoid being the target of terrorist attacks through imported food. According to this law, the following requirements are mandatory:
- Food Facility Registration: Facilities where food is processed, packaged, or distributed must be registered with the FDA. In addition, you must notify in advance about the shipment of the food that you want to export to the US, otherwise it will not go to the FDA electronic system. This registration is free, it can be done through the FDA page and you need to indicate an agent in the USA. It must be updated every two years and only a new one is created, the facility changes ownership or moves.
- Establishment and maintenance of records: These records are necessary to identify the source of origin and destination of the food and are mandatory for manufacturers or processors, packers or those who carry out storage operations. It is important to note that this requirement applies to each and every facility, not to companies as a whole.
- Administrative Detention: FDA has the power to immediately detain any food that it deems suspicious or constitutes a threat.
If you want more information on import requirements and regulations to the United States, you can expand it at this link of US Customs and Border Protection.
Finally, you can find more posts related to International Business on our blog!
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Written by: Gloria Andia del Carpio.
Optimized by: Adrián Pérez.