Export to the United States, FDA certification

For companies that intend to export to the United States, it is essential to understand the requirements of FDA authorization, which is necessary to ensure that imported products are safe and effective for their intended use. Without this authorization, products may not be allowed for sale or may be restricted in the U.S. market.

There FDA (Food and Drug Administration) is the U.S. federal agency that has jurisdiction over a wide range of products, including foods, cosmetics, dietary supplements, and medical devices. Authorization issued by the FDA certifies that such products comply with the safety and quality standards established by the agency.

It is important to note that warehouses where products intended for export to the USA are stored must also be registered with the FDA.

To obtain authorization, manufacturers and distributors must demonstrate that their products meet specific FDA standards, which vary depending on the product category and its use. 

The authorization process involves several specific steps and requirements, which we will explain below.

FDA Certification for export to the United States: what is essential to know

The FDA’s role is to protect public health in the United States by ensuring that products such as medical devices and foods are safe and effective. However, it should be noted that the FDA does not issue formal “certifications.” 

It approves or registers the products in fact, without providing an official certificate of conformity.

It is also important to remember that compliance with FDA regulations is not final: after initial approval, products must continue to comply with regulations and are subject to ongoing monitoring to maintain safety standards.

Being FDA compliant is crucial for several reasons. First, without approval or registration, you cannot sell products in the United States. Compliance also ensures that products are safe for their intended use, providing essential protection to consumers. In addition, complying with the regulations helps avoid legal problems, such as fines or product seizures, that can arise if the rules are not followed.

How do you get FDA certification?

In order to be able to export to the United States Therefore, manufacturers and distributors must demonstrate that their products meet the safety and quality standards set by the FDA. These requirements vary depending on the type of product and its use. For example, drugs must pass rigorous clinical trials, while food products must comply with food safety regulations.

The process for obtaining FDA authorization is complex and varies depending on the product category (food, medical devices, cosmetics, etc.). 

For each category, the key steps include:

• FDA RegistrationThe first step is to register the manufacturer or importer with the FDA, a mandatory requirement for all companies wishing to sell regulated products on the US market.
• Product Ratings: The FDA reviews products to ensure they meet safety and quality standards. This requires the submission of detailed documentation, including scientific data, clinical trials, and information about manufacturing processes.
• Inspection of structures: The FDA may inspect manufacturing and distribution facilities to ensure that they are actually complying with applicable regulations. During these inspections, manufacturing processes and quality control systems are evaluated.
• Final approval: Once the evaluations and inspections are completed, the FDA grants the necessary authorization to market the product in the United States. Approval can occur through various procedures, such as the “New Drug Application (NDA) for drugs or the “Food Contact Notification” (FCN) for food products.

This process, although complex, is essential to ensure that products meet the safety standards required for the US market.

Appointment of FDA Agent

A further fundamental step for companies that want export to the United States, is the appointment of a FDA Agent, which is a representative located in the United States who acts as an intermediary between the foreign company and the FDA. This role is mandatory for companies outside the United States and plays a crucial role in managing communications with the agency. 

The FDA Agent is responsible for several key tasks: managing official communications between the company and the FDA, assisting in the preparation of necessary documentation, and coordinating inspections and audits conducted by the agency. This representative ensures that all required paperwork is followed correctly and helps facilitate the certification process.

FDA Certification: The Case of Food Products

The Made in Italy, especially in the food industry, enjoys a great reputation in the USA. However, to export food and beverages to the country and ensure compliance with FDA regulations, it is essential to follow some key steps. Here is a detailed overview of the process:

1. Preliminary label review and ingredient check

Before starting the registration with the FDA, it is important to ensure that the product labels comply with US standards and that the ingredients are allowed for importation. This step avoids problems during the certification process and ensures that the products can be sold without a hitch.

2. FDA Registration and Obtaining FDA Number

All facilities that produce, process, package, or store food intended for the American market must be registered with the FDA. This also includes warehouses that store products. Registration is therefore also required for distributors who store products from export to the United States.

3. Appointment of FDA Agent

As previously mentioned, foreign companies are required to appoint an FDA Agent, which is a representative located in the United States who acts as an intermediary between the company and the FDA. 

4. Review labels and prepare nutritional table

Labels must comply with FDA's precise regulations regarding both content and form. It is essential that labels comply with US standards and include information such as ingredients, nutritional values, preservatives, colorants and allergens. The nutritional table must be adapted to FDA standards, which differ from European standards.

5. Preparation of the Food Safety Plan (HARPC)

Since 2016, companies have been required to prepare a food safety plan in accordance with the Food Safety Modernization Act (FSMA). This plan is necessary to demonstrate that company practices meet food safety standards. American importers, through the Foreign Supplier Verification Program (FSVP), are responsible for verifying the compliance of foreign suppliers.

6. Import permits and health certificates

Some food products require specific import permits and health certificates issued by local authorities (ASL). Before exporting, it is essential to check whether these permits are necessary to avoid delays. In addition, products such as preserves, canned tuna and other long-life foods require registration with the Food Canning Establishment (FCE) FDA. It is also necessary to obtain a pre-import authorization through the SID procedure, which evaluates the sterilization process of the product.

The Prior Notice

For export to the United States, it is mandatory to send a Prior Notice to FDA. This advance notification must be submitted through FDA's electronic system and must contain detailed information such as the exporting company's details, FDA registration number, a description of the products, package details, and transportation information.

It is important to note that Prior Notice is also required for sending samples or products intended for quality control. However, foods intended for personal use, such as those carried in suitcases, and gifts and products that do not fall under FDA jurisdiction, such as meat and eggs (regulated by the USDA), are exempt from this requirement.

Octagona, with its consolidated experience in consultancy for the internationalization of companies, is at the side of companies that wish export to the United States. We offer support at every stage of the process to apply for and obtain FDA certification, whatever the sector of interest. Contact us for any information.