FDA Registration: A Fundamental Requirement for Exporting to the USA

FDA Registration: A Fundamental Requirement for Exporting to the USA

For Italian companies wishing to export food, cosmetic, or medical products to the United States, registration with the Food and Drug Administration (FDA) is a mandatory step. This registration certifies the compliance of your products with the safety and quality standards required by the American market, thereby facilitating entry and distribution within the United States.

Who Needs to Register?

• All companies that export food, beverages, cosmetics, medical devices, or drugs to the USA must register their facility with the FDA.

• For some specific food products, it is also mandatory to register each product individually and obtain approval for labels that comply with US regulations.

Note for Cosmetic Products: Since July 19, 2024, a new regulation called MOCRA (Modernization of Cosmetics Regulation Act) has been in effect, introducing specific requirements for cosmetic compliance. For further details, please consult our Quick Guide to MoCRA Compliance.

What We Do for You

Link2America provides dedicated services to simplify and speed up your FDA registration, including:

• Company Registration (Bioterrorism Act / FSMA)

• US Agent service for FDA and biennial renewal

• Specific Product Registration (FDA – AF/LACF)

• Translation and Revision of Labels and Packaging

• Nutrition Facts Exemption Request

• MOCRA Regulatory Compliance (for Cosmetic Products) 

Free Valuation

Complete the questionnaire below to receive a free, personalized preliminary assessment of your US market registration and regulatory compliance needs.

Do not let bureaucracy slow down your business: rely on our expertise and successfully start your export journey to the United States.