Country of Origin Labeling for FDA-Regulated Products: What Foreign Manufacturers Must Mark on Every Package

Country of origin marking is one of the simplest regulatory requirements in concept — mark the package with the country where the product was made — and one of the most frequently violated in practice. Under 19 CFR Part 134, every article of foreign origin imported into the United States must be marked in a conspicuous place with the English name of the country of origin, in a manner that is legible, indelible, and permanent as nearly as the nature of the article permits. This requirement is enforced by US Customs and Border Protection (CBP), not by the FDA, but it applies to all FDA-regulated products — food, drugs, cosmetics, and medical devices — and violations result in marking duties, penalties, and potential product detention.

Basic marking requirements

The country of origin must appear in English on the article itself (not just on the shipping container), in a location where an ultimate purchaser in the United States can see it at the time of purchase. The marking must be legible — large enough to read under normal conditions — and must be permanent or at least as durable as the product itself. For most consumer products, this means printing 'Product of [Country]' or 'Made in [Country]' on the retail packaging in a location that is visible to the consumer before purchase. The country name must be the full English name — abbreviations, country codes (ISO codes like 'CN' or 'DE'), and non-English country names are not acceptable. 'Made in China,' not 'Made in CN.' 'Product of Germany,' not 'Hergestellt in Deutschland.'

Substantial transformation and country of origin determination

When a product incorporates materials or components from multiple countries, the country of origin is the country where the last substantial transformation occurred — the processing step that transformed the article into a new and different article of commerce with a name, character, or use distinct from its components. For food products, this means the country where the food was manufactured, processed, or packed into its final form for retail sale — not the country where raw materials were grown. For drugs, the country of origin is typically the country where the finished dosage form was manufactured. For cosmetics, it is the country where the product was formulated and filled. Simply packaging, repackaging, labeling, or minor processing (such as slicing, grinding, or mixing without transformation) does not constitute substantial transformation.

FDA-specific country of origin requirements

In addition to the CBP marking requirements under 19 CFR Part 134, FDA regulations impose their own country of origin requirements for certain product categories. For food products, the FDA food labeling regulations require the country of origin to appear on the label of all imported foods. For drugs, 21 CFR 201.1 and related regulations require identification of the manufacturer's location. For cosmetics, 21 CFR 701.12 requires the name and place of business of the manufacturer, packer, or distributor — and if the product is manufactured outside the US, the country of origin must be identified. These FDA requirements supplement the CBP marking requirements — compliance with one does not automatically satisfy the other, and the specific placement, format, and wording requirements may differ.

Common marking violations

The most frequent country of origin marking violations among FDA-regulated imports include omission of the country marking entirely (particularly common on inner packaging when the outer shipping carton is marked but the retail unit is not), marking in a non-conspicuous location (such as on the bottom of the package in small print that is difficult to read), using the wrong country name (listing the country of the exporter or trading company rather than the country where the product was manufactured), marking in a non-English language, and using removable labels that fall off during handling or display. CBP treats marking violations seriously — the standard remedy is a 10 percent ad valorem marking duty on the improperly marked articles, and repeated violations can result in penalties, redelivery orders, and increased scrutiny of future shipments.

Products of multiple countries

Products that incorporate substantial processing in multiple countries present particular challenges. A seafood product caught in international waters, processed in one country, and packed in another must be marked with the country where the last substantial transformation occurred. A cosmetic formulated in France using Italian raw materials and filled in Poland must identify the country of origin based on where the substantial transformation (typically the formulation and filling step) took place. When products are assembled or blended from components of multiple origins, the determination of which country performed the last substantial transformation requires analysis of the specific processing steps and their significance in creating the finished product.

How FDABridge helps with labeling compliance

FDABridge provides label compliance review services for foreign manufacturers exporting food, cosmetics, and drugs to the United States. Our review includes evaluation of country of origin marking against both CBP and FDA requirements, ensuring your product packaging satisfies both agencies' standards before the product reaches a US port. Visit fdabridge.com to see our services or fdabridge.com/contact to request a label review.