What are FDA import requirements?

All imported FDA-regulated products must:

• Be manufactured, processed, packed, and held under sanitary conditions.
• Not be forbidden or restricted for sale in the country the product is produced or exported from.
• Not be adulterated (e.g. contaminated with a harmful or filthy substance or other substance prohibited by US law).
• Not be misbranded (e.g. must meet all federal labeling requirements.)
• Not otherwise be a product prohibited by federal law for distribution in US commerce e.g. unapproved drugs.
• Meet any registration, listing, and other filing requirements.

Why does the FDA have import requirements?

FDA’s import requirements help ensure that foods, drugs, cosmetics, medical devices, and other FDA regulated products are safe for use and that the products’ labeling is truthful and not misleading and correctly bears all required information such as an appropriate statement of identity, any required warning/caution statements, nutrition labeling and allergen declarations for foods, etc. FDA’s import requirements help ensure that that products are not contaminated with any harmful or illegal substances or actionable levels of filth e.g. insect fragments, mold, debris, etc. and were not manufactured, processed, prepared, packed, held, or transported under conditions that can lead to such contamination.

Who fills out the FDA import requirements?

The importer who files the entry with US Customs (the “filer”) declares the shipments to Customs, FDA, and all other pertinent federal agencies and files the required import documents with the respective agencies. Usually, this is handled by a US Customs-licensed broker. However, all parties involved in the distribution of the goods into US commerce are responsible for ensuring the goods meet all FDA and other legal requirements.

What happens if you don’t meet FDA’s import requirements?

If FDA finds any violations in imported products, the Agency may detain the shipments and require the importer to overcome the violations during a hearing period (the “detention period”) before FDA releases the products. For example, products that are not labeled in accordance to FDA’s labeling regulations may be relabeled to overcome the detention. If the goods cannot be brought into compliance with FDA law during the detention period, FDA may refuse admission of the goods and require that they be re-exported or destroyed under FDA or Customs supervision.

Companies that do not comply with FDA’s regulations may be placed on an import alert under which FDA may automatically detain their future shipments without requiring physical exam. FDA or Customs may also seize the products. Persons that violate FDA law may be subject to enforcement actions such as warning letters, injunction, debarment, monetary penalties, and criminal prosecution.

Which imports have FDA import requirements?

FDA regulates foods for human or animal use (except for meats, poultry, catfish, and certain egg products regulated by the U.S. Department of Agriculture), drugs, cosmetics, medical devices, biologics, certain electronic devices that emit radiation, and tobacco products. FDA’s regulatory requirements for imported products are the same as for domestically produced products. For example, if a color additive in a product is not allowed in a domestically produced food product, it is not allowed in an imported product even if the color additive is permitted in the country in which the product is produced.

FDA Requirements for Domestic and Imported Foods

This section details FDA’s requirements for food products. FDA’s regulatory requirements and food safety standards for domestically produced foods e.g. label requirements, permissibility of food and color additives, pesticide tolerances, filth defect action levels etc. apply to imported foods. For example, if a certain color additive is not approved for use in products manufactured in the US, it is not permitted in imported foods even if that color is permitted for use in the country of production.

Some additional legal provisions apply specifically to imported foods and food importers. For example, if the product is forbidden or restricted for sale in the country in which the product is manufactured or in the country from which it is exported, it may be refused admission into the US. As another example, FDA requires food importers to have a foreign supplier verification program (unless exempt by law) for each food they import to verify that their foreign manufactures/suppliers are meeting FDA’s food safety standards for preventing foodborne illness.
Learn more about FDA Requirements for Domestic and Imported Foods

FDA Requirements for Domestic and Imported Cosmetics

This section details FDA’s requirements for cosmetic products. FDA’s regulatory requirements for domestically produced cosmetics e.g. label requirements, permissibility of ingredients, etc. apply to imported cosmetics. For example, if a certain color additive is not approved for use in cosmetic products manufactured in the US, it is not permitted in imported cosmetics even if that color is permitted for use in the country of production.

Some additional legal provisions apply specifically to imported cosmetics. For example, if the product is forbidden or restricted for sale in the country in which the product is manufactured or in the country from which it is exported, it may be refused admission into the US.
Learn more about FDA Requirements for Domestic and Imported Cosmetics

FDA Requirements for Domestic and Imported Drugs

This section details FDA’s requirements for pharmaceutical drug products. FDA’s regulatory requirements for domestically produced drugs apply to imported drugs e.g. requirements for labeling, ingredients/formulation, doses, etc. For example, active ingredient requirements for over-the-counter drugs made in the US are the same as for imported over-the-counter drugs. Also, FDA’s drug good manufacturing practices (GMPs) apply to drug manufacturers whether they are domestic or foreign establishments.

Some additional legal provisions apply specifically to imported drugs. For example, if the product is forbidden or restricted for sale in the country in which the product is manufactured or in the country from which it is exported, it may be refused admission into the US.
Learn more about FDA Requirements for Domestic and Imported Drugs

FDA Requirements for Domestic and Imported Medical Devices

This section details FDA’s requirements for medical devices. FDA’s regulatory requirements for domestically manufactured medical devices e.g. requirements for labeling, clinical and nonclinical testing, good manufacturing practices (GMPs), etc. apply as well to imported medical devices. For example, performance testing is required for premarket approval of certain medical devices whether they are manufactured in the US or in a foreign country.

Some additional legal provisions apply specifically to imported medical devices. For example, if the product is forbidden or restricted for sale in the country in which the product is manufactured or in the country from which it is exported, it may be refused admission into the US.
Learn more about FDA Requirements for Domestic and Imported Medical Devices