1° The FDA Registration

The FDA registration is the first essential requirement to be authorized to export and import food & beverages products and dietary supplements into the US. The first step to registering your firm is to designate an independent consultant residing in the US, who interacts with the FDA on behalf of your firm as your US Agent. The US Agent is the U.S. contact person for the FDA communications to and from your firm if the FDA cannot reach out the foreign person in charge for the company.

2° The US Applicable Laws and Regulation

The producer needs to pin down the US laws and regulations relevant to his company and his food products. The producer before exposing his product at tradeshows or selling his products in the US, including the sales through web portals like Amazon, it is crucial to previously identify the specific US laws and regulations attaining to his products, to avoid running into any incompliance notifications by the FDA.

3° The FSMA regulation compliance

The firms that export to and/or import into the United States their food products must comply with the U.S. requirements set by the regulation Food Safety Modernization Act (FSMA), which is the FDA’s body of laws regulating the marketing of food products in the US. In particular, the foreign producers exporting their merchandise to the US are subjected to the PCHF regulation (Preventive Controls for Human Food), while the US importers are subjected to the FSVP regulation (Foreign Supplier Verification Program).

4° The label in compliance with the U.S. labeling regulation

In order to sell your products on the US local markets, or even expose commercial samples at American trade fairs or trade your merchandise through web portals like Amazon, the company needs to previously ascertain that the labeling standards of products meets the requirements of the relevant US regulations and the description of nutritional data, allergens, and additives, along with all other features of your labels, comply with such rules.

5° The FSVP Agent

In order to sell directly your food products on the US market, your firm, as a foreign producer, must pass the Foreign Supplier Verification Program (FSVP) regulation, which is an FDA check procedure aimed to ascertain that your products comply with the US laws and regulations. Your firm must officially designate a US resident, either a natural or legal person, professionally qualified to act in the role of FSVP Agent, who will be responsible for the compliance of the product with the relevant US import rules before the FDA, during the carrying out of all the import procedures.