FDA USA Certification and Registration: What It Is and How It Works

FDA registration is the first step to obtaining FDA certification to import food products and dietary supplements into the United States.

As of March 26, 2024, there were a total of 220,111 food facilities registered with the United States Food and Drug Administration (FDA). This total includes 91,225 domestic facilities within the United States and 128,886 foreign facilities located in various countries around the world. Of the 128,886 foreign food facilities registered with the FDA, 11,329 were Italian food facilities, accounting for 8.8% of the registered foreign food facilities.

The FDA has jurisdiction over food products, cosmetic products, dietary supplements, and medical devices. Below are the basic steps for registering and certifying food products with the American Food and Drug Administration.

These are the steps for FDA certification [of which registration is an integral part]:

• Review product labels
• Eligibility analysis of ingredients
• Compliance with FSMA [FDA regulations on food product preparation]
• Compliance with FSVP [Foreign Supplier Verification Program, related to American importers of food products]
• Appointment of FSVP Agent [this is the figure who certifies that the food products to be imported comply with FSMA regulations]
• Appointment of FDA Agent [serves as the contact for all communications with the FDA]
• Payment of the annual registration fee [only for importing medical devices]
• FDA Registration to obtain the FDA number [registration is mandatory for importing food products, medical devices, and dietary supplements. Sometimes registration is also required for importing cosmetic products]

FDA registration is the prerequisite for FDA certification of products to be imported into America. Both are essential for exporting food products to the United States, but it is also necessary for the export of beverages, cosmetics, and dietary supplements destined for the US market, as well as for warehouses: warehouses must also register with the FDA if they store food products intended for sale in the USA.

Essential for the certification process is obtaining the FDA registration number, which must be indicated on the import customs documents for America and is required by law. Essentially, the Food and Drug Administration, the government agency responsible for issuing regulations in this regard, ensures that food products intended for the US market are safe, healthy, hygienic, and properly labeled.

FDA registration must be renewed every 2 years, and during renewal, any changes in the information provided at the time of initial registration must be communicated. There are only a few exceptions for farms, restaurants, non-profits, and establishments under the jurisdiction of the U.S. Department of Agriculture (USDA) that handle egg, poultry, and meat products.

 

What Happens If You Ship Goods Without an FDA Registration Number?

The FDA can also take civil or criminal actions, but it will certainly block the goods at customs, then destroy them or send them back to Italy [at the sender's expense, of course]

Contact us if the FDA has blocked your products at customs

 

What Are the Steps for FDA Certification and Shipping Food Products to America?

• Registration of the Italian company with the FDA to obtain the so-called "FDA number"
  Appointment of the "FDA Agent" (must necessarily have an address in America)
• Review of product labels and packaging
  Preparation of the nutritional facts table in compliance with FDA regulations.

ExportUSA offers the service of reviewing food product labels to be exported to America.

The Main Information Required for FDA Registration Includes:

• Address of the facility or warehouse,
• Type of warehouse [ambient temperature, controlled, etc.]
• List of other food products stored in the warehouse,
• Company name of the producer,
• Name of the owner or contact person,
• Exported brands,
• Products handled,
• Name, address, phone number, and email of the FDA Agent in the USA, and
• Emergency contacts.
   

FDA Registration and FDA Number

The registration number is assigned to each individual manufacturing facility, foreign or American, each of which must be represented in the USA by an FDA agent (with a residence or domicile in the United States) who becomes the point of contact for any communications.

A unique registration number is assigned to each registered foreign food manufacturing facility and is the first step toward approval of the facility or product [if the type of product requires the approval procedure and/or certification of the facility] by the U.S. FDA. This registration number must be indicated on invoices and in any company communications with the FDA.

ExportUSA can provide FDA registration within 48 hours

 

FDA-Compliant Labels for Exporting to the USA

To comply with the FDA, food products must meet certain requirements, with the label being the foremost, which must adhere to the FDA's regulations. The labels of food products intended for export to America must include specific and clear information such as:

• Nutritional values
• Ingredients
• Any preservatives, colorings, and allergens
• English name
• Net weight in pounds/ounces or in fluid ounces [liquids, gels, creams]

Certain elements must also be located in specific parts of the label itself. It should be noted that the advertising message on the label, the company website, and the company's social media pages are also subject to FDA review to ensure they do not contain unclear, misleading, or unapproved messages - promises - statements. Finally, it is worth noting that the FDA also specifies the sizes and spacing of characters to be used in preparing nutritional tables.