What foods are exempt from FSVP?

FSVP does not apply to juice products (including raw materials or other ingredients) that are imported from a foreign supplier that is required to comply with, and is in compliance with, 21 CFR 120. As the importer and/or manufacturer, you must also be in compliance with 21 CFR 120 with respect to the products that you import, or manufacture from the raw materials or other ingredients that you import.

FSVP does not apply to fish and fishery products (including raw materials or other ingredients) that are imported from a foreign supplier that is required to comply with, and is in compliance with, 21 CFR 123. As the importer and/or manufacturer, you must also be in compliance with 21 CFR 123 with respect to the products that you import, or manufacture from the raw materials or other ingredients that you import.

FSVP does not apply to food imported for research or evaluation use provided that such food:

1. Is not intended for retail sale and is not sold or distributed to the public
2. Is labeled with the statement “Food for research or evaluation use”
3. Is imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose, the food is used only for this purpose, and any unused quantity is properly disposed of
4. Is accompanied, when filing entry with U.S. Customs and Border Protection, by an electronic declaration that the food will be used for research or evaluation purposes and will not be sold or distributed to the public.

FSVP does not apply to food imported for personal consumption, provided that such food is not intended for retail sale and is not sold or distributed to the public. Food is imported for personal consumption only if it is purchased or otherwise acquired by a person in a small quantity that is consistent with a non-commercial purpose and is not sold or distributed to the public.

FSVP does not apply to alcoholic beverages that are imported from a foreign supplier that is a facility that meets the following two conditions:

1. Under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type that, if it were a domestic facility, would require obtaining a permit from, registering with, or obtaining approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States; and
2. Under section 415 of the Federal Food, Drug, and Cosmetic Act, the facility is required to register as a facility because it is engaged in manufacturing/processing one or more alcoholic beverages.

Additionally, FSVP does not apply to food that is not an alcoholic beverage but is imported from a foreign supplier as described above, provided such food:

1. Is in prepackaged form that prevents any direct human contact with such food; and
2. Constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.

Additionally, FSVP does not apply to raw materials and other ingredients that are imported for use in alcoholic beverages provided that:

1. The imported raw materials and other ingredients are used in the manufacturing/processing, packing, or holding of alcoholic beverages;
2. Such manufacturing/processing, packing, or holding is performed by the importer;
3. The importer is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act; and
4. The importer is exempt from the regulations in 21 CFR 117 in accordance with 21 CFR 117.5(i).

FSVP does not apply to food:

1. That is transshipped through the United States to another country and is not sold or distributed to the public in the United States; or
2. That is imported for processing and future export and that is not sold or distributed to the public in the United States; or
3. That is manufactured/processed, raised, or grown in the United States, exported, and returned to the United States without further manufacturing/processing in a foreign country.

FSVP does not apply to:

1. Meat food products that at the time of importation are subject to the requirements of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
2. Poultry products that at the time of importation are subject to the requirements of the USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.); and
3. Egg products that at the time of importation are subject to the requirements of the USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

On March 21, 2018, the FDA released guidance indicating that they would exercise enforcement discretion regarding importation of certain live animals. FDA does not intend to enforce the FSVP requirements for importation of:

1. Live animals for slaughter being processed at USDA facilities (or state-inspected establishments with equivalent requirements), including designated feeder animals; and
2. Breeder and Show animals as they are not reasonably likely intended as food.