Before your products arrive in the United States, you must have a Foreign Supplier Verification Program (FSVP) Plan in place. If you don’t have a physical presence in the USA, then you need to then appoint an FSVP Agent to communicate with the FDA. However, there are a few things you need to know before you start drafting up an FSVP Plan and finding an FSVP Agent.

What is the FSVP?

FSVP is a requirement under the Food Safety Modernization Act (FSMA) created as a preventive measure to prevent foodborne illnesses in the USA. FSVP rule is a way to ensure foreign food suppliers are following the same food safety standards as those required in the USA.

Who must comply with FSVP?

All importers who import food into the US must comply with the FSVP. If you are a US importer and your food is coming from a foreign supplier, you must have an FSVP Plan in place before importing your products. If you do not have a representative in the US then you will need to appoint an FSVP Agent. The FSVP Ag...

Running a business can be overwhelming if you don’t have all your ducks in a row. You think you’ve checked all the boxes and are ready to ship to the United States, only to find out the facility that manufactures your products is not registered with the FDA. If this is you, US Imports is here to help.

If your brand is manufactured by someone else, you must get permission to register their facility with the FDA. The FDA requires that all U.S. and foreign facilities that manufacture, process, pack or store food, beverages, or dietary supplements exported to the United States must register. If your facility is not registered with the FDA, your business may face serious consequences.

Why Do You Have to Get Permission to Register a Food Facility?

Only the owner of a facility can register with the FDA. However, the owner can give someone written permission to register their facility. If you fail to obtain permission from the owner the registration may be rejected by the FDA and your prod...

In 2011, the FDA Food Safety Modernization Act (FSMA) amended U.S. food safety laws, requiring all foreign and domestic food businesses to register their facilities that manufacture, process, package or food intended for human or animal consumption. Dietary supplements are included in this requirement. This allows FDA to have access to all food and dietary supplement facilities so that they may be inspected if necessary, in order to prevent serious adverse health reactions. Under FSMA, all dietary supplement facilities must renew their registrations with FDA every even-numbered year. 

Domestic dietary supplement companies can submit a registration form for facilities online. However, foreign dietary supplement companies must designate a U.S. Agent for their facilities before they are able to register. This Agent must physically reside in the United States and be  available 24-hours a day to handle all communications with FDA regarding questions about shipments and scheduling facility ...