The Foreign Supplier Verification Program (FSVP) rule requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations and that the food is not adulterated or misbranded with respect to allergen labeling.

You are the FSVP importer if you are the U.S. owner or consignee of an article of food that is being offered for import into the United States (21 CFR 1.500). If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulation.

A U.S. agent or representative of a foreign supplier of a food is a person in the United States who is designated by the foreign owner or consignee of a food as the owner or consignee’s agent or representative for purposes of meeting the requirements of the FSVP regulation, as confirmed in a signed statement of consent to serve as the FSVP importer (21 CFR 1.500). If there is no U.S. owner or consignee of an article of food at the time of entry, the foreign owner or consignee of the food must designate a U.S. agent or representative to serve as the importer of the food for FSVP purposes (21 CFR 1.509(b)). The U.S. agent or representative will be identified as the importer and will be responsible for meeting the FSVP requirements.

Yes. Rancho Consulting may serve as your FSVP agent or representative depending on the type of product(s) and associated level of risk.

“U.S. owner or consignee” means the person in the United States who, at the time of entry of an article of food into the United States, either owns the food, has purchased the food, or has agreed in writing to purchase the food (21 CFR 1.500).

The FSVP importer must be physically located in the United States (21 CFR 1.500). It is not sufficient to merely have a mailbox or answering service.

When there are multiple entities that meet the “importer” definition, these entities will need to determine who will be responsible for meeting the FSVP requirements and be identified as the importer of the food at entry.

You must establish an FSVP for each food you import from each of your foreign suppliers. However, you do not need to establish a separate FSVP for different versions of the same food from a single foreign supplier when the differences in the foods do not result in different hazards requiring a control.

Yes. Rancho Consulting’s qualified individuals can help write and implement FSVP on behalf of your importing company.

A qualified individual as defined in 21 CFR 1.500 must develop your FSVP and perform each of the activities required under the FSVP regulation (21 CFR 1.503(a)).

A qualified individual is a person who has the education, training, or experience (or a combination of these) necessary to perform an activity required under the FSVP regulation, and can read and understand the language of any records that the person must review in performing this activity.

All foreign food, beverage, dietary supplement, medical device or drug companies who import or offer to import products into the United States must have their company registered with the FDA and must designate a U.S. Agent.

The responsibilities of the U.S. Agent are as follows:

  • Assisting the FDA will all communications between FDA and the foreign business;
  • Responding to questions from the FDA regarding the products that are imported or offered for import into the United States;
  • Assisting FDA in scheduling inspections of the foreign business; and
  • If FDA is unable to contact the foreign business, FDA may provide the information and/or documents to the U.S. Agent, which serves as the equivalent to providing the same information and/or documents to the foreign business.

All foreign businesses who import or offer to import foods must register with the FDA before the products enter the United States. If you do not register your foreign business, your products will not be allowed into the United States. Penalties may also apply.

Previously registered facilities are required to renew their registration, including U.S. Agent information, biennially (every other year) between October 1 and December 31 of each even-numbered year. (i.e. 2020, 2022, 2024, etc.)

If you do not register your foreign business, your products will not be allowed into the United States. In addition you will be responsible for paying all related expenses such as storage and transportation. Additional penalties may apply.

The FDA will issue an FDA registration number which must be given on every prior notice of every shipment of your products into the United States. In addition, Rancho Consulting will issue a certificate of registration for your records.

No. The FDA does not issue a registration certificate. However, Rancho Consulting issues a certificate for the records of the foreign business.

Rancho Consulting’s fee for serving as U.S. Agent and registering the foreign business with the FDA is $299.00.