Exporting to the United States, FDA certification

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

La 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. The clearance issued by the FDA certifies that these products meet the safety and quality regulations established by the agency.

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

To obtain approval, manufacturers and distributors must demonstrate that their products meet specific FDA standards, which vary by product category and use. 

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

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

The role of the FDA 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 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 constant monitoring to maintain safety standards.

Being FDA-compliant is crucial for several reasons. First, without approval or registration, it is not possible to sell products in the United States. Compliance also ensures that products are safe for their intended use, giving fundamental protection to consumers. In addition, compliance avoids legal problems, such as fines or product seizures, that can arise if the rules are not followed.

How is FDA certification obtained?

In order 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 clearance is multifaceted and changes depending on the product category (food, medical devices, cosmetics, etc.). 

For each category, key steps include:

• Registration with the FDA: The first step is to register the manufacturer or importer with the FDA, a mandatory requirement for all companies wishing to sell regulated products in the U.S. market.
• Product evaluation: The FDA analyzes products to make sure they meet safety and quality standards. This requires the submission of detailed documentation, including scientific data, clinical trials and information on manufacturing processes.
• Inspection of facilities: The FDA may inspect manufacturing and distribution facilities to check that they actually comply with applicable regulations. During these inspections, production processes and quality control systems are evaluated.
• Final approval: Once the evaluations and inspections are completed, the FDA grants the necessary approval 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 path, although complex, is critical to ensuring that products meet the safety standards required for the U.S. market.

The Appointment of the FDA Agent

Another key step for companies that want to export to the United States, is the appointment of a FDA Agent, or a representative located in the United States who acts as an intermediary between the foreign company and the FDA. This figure 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 required 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 sector, enjoys a great reputation in the US. However, to export food and beverages to the country and ensure compliance with FDA regulations, it is critical to follow some key steps. Here is a detailed overview of the process:

1. Preliminary label review and ingredient verification

Before initiating registration with the FDA, it is important to ensure that product labels meet U.S. standards and that ingredients are allowed for import. This step avoids problems during the certification process and ensures that products can be sold smoothly.

2. FDA registration and obtaining the FDA number

All facilities that produce, process, package or store food for the U.S. 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 mentioned earlier, 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 of labels and preparation of nutrition table

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

5. Preparation of the Food Safety Plan (HARPC)

Since 2016, companies must prepare a food safety plan that complies with the Food Safety Modernization Act (FSMA). This plan is necessary to demonstrate that business practices meet food safety standards. U.S. 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 (ASLs). Before export, it is essential to check whether such permits are needed to avoid delays. In addition, products such as canned goods, canned tuna, and other long-life foods require registration with the Food Canning Establishment (FCE) from the FDA. Prior import clearance must also be obtained 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 the FDA. This advance notification must be submitted through the 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.

Importantly, Prior Notice is also required when sending samples or products for quality control. Exempt from this requirement, however, are foods for personal use, such as those carried in a suitcase, and gifts and products that do not fall under FDA jurisdiction, such as meat and eggs (regulated by the USDA).

Octagona, with its established experience in the business internationalization consulting, is at the side of companies wishing to export to the United States. We offer support at every step of the process to apply for and obtain FDA certification, whatever the area of interest. Contact us for any information.