Rules Of Origin
At A Glance
Rules of origin are the specific criteria, laws, and regulations that determine a product's country of origin. Every good entering the United States must be legibly marked with its country of origin in English, which is enforced by U.S. Customs and Border Protection (CBP). While most government agencies defer to CBP in determining origin, some agencies use different criteria for marking and labeling country of origin for products under their purview.
U.S. Customs Country Of Origin Determination
Trade Agreement
When a free trade agreement (FTA) or unilateral preference program exists, the rules of origin criteria are set by the text of the agreement.
Non-Trade Agreement
If there is not an FTA or unilateral preference program, CBP considers several factors to determine the rule of origin. To change a product’s country of origin, CBP must determine that it underwent a substantial transformation based on:
- Country of origin of any components
- Extent of processing within a country
- Whether processing gives it a new name, use, and character
- Resources expended on product design & development
- Extent of post-assembly inspection and testing procedures
- Skills required during the manufacturing process
Transshipment
Moving goods through a third country to disguise or obscure the true country of origin to avoid tariffs is unlawful. Under a 2025 Executive Order, CBP may assess a 40% tariff if it determines a good was transshipped in order to avoid tariffs.
In Order To Mark A Product “Made In USA”
In order to mark a product “Made in USA” without qualifications:
- All or virtually all ingredients or components of a product must be of U.S. origin
- All significant processing must occur in the U.S.
- Final assembly or processing occurs in the U.S.
The Federal Trade Commission enforces this standard.
FDA Definition For Medical Device Labeling
The Federal Drug Administration (FDA) generally defines origin based on the last country of manufacture. FDA requires any finished, packaged drug product to conspicuously identify the name and place of business of the manufacturer, packer, or distributor.
DISCLAIMER: These summaries are not all-encompassing. They are for informational purposes and do not replace the need for legal counsel.