Licencia FDA

FDA is responsible for:

  • Protect public health by ensuring that food (except for livestock, poultry and some egg products that are regulated by the U.S. Department of Agriculture) is safe, wholesome, sanitary and properly labeled; ensure that human and veterinary drugs, vaccines and other biological products and medical devices intended for human use are safe and effective.
  • Protect the public from radiation from electronic products.
  • Ensure that cosmetics and dietary supplements are safe and properly labeled.
  • Regulate tobacco products.
  • Promote public health by helping to accelerate product innovations.

FDA’s responsibilities extend to all 50 U.S. states, the District of Columbia, Puerto Rico, Guama, the Virgin Islands, American Samoa and other U.S. territories and possessions.

What is an FDA number?

Registration of food producers or establishments with the Food and Drug Administration (FDA) is required for establishments that manufacture, process, pack or hold food products, including alcoholic beverages such as wine.

This means that if your company is a winery that produces, makes, bottles and/or stores wine, you will have to register with the FDA for food establishment registration, even overseas.

How can I get an FDA number?

A winery can register at FDA, but will have to notify a designated “U.S. agent” as a referrer for the U.S. market (this could be your importer, sales agent, etc.).

This agent based in the United States must validate the registration.

After creating your FDA number, the registration must be renewed with FDA at the end of each even-numbered year (2020, 2022, etc.). If a registration is not renewed by December 31 of the even-numbered year, the registration will terminate or expire in the FDA system. In that case, a new registration must be submitted.

A new additional verification step: Unique Facility Identifier (UFI) and Data Universal Numbering System (DUNS).

After October 1, 2020, each establishment will be recognized by a unique identifier number (UFI) to avoid duplicate registrations.

FDA recognizes the D-U-N-S universal data numbering system as an acceptable UFI number.