FDA Country of Production

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Country of Origin or Country of Manufacture: CBP vs. FDA

Food in Natural State

For food that is in its natural state, the FDA Country of Production is generally the country where the food was grown or collected, including harvested and readied for shipment to the U.S. Articles of food grown, including harvested or collected and readied for shipment, in U.S. territories are considered to be grown in the U.S. However, for wild fish, including seafood, that is caught or harvested outside U.S. waters by a vessel that is not registered in the U.S., the FDA Country of Production is the country in which the vessel is registered.

The “country of origin” is defined in 19 CFR 134.1(b) as “the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the 'country of origin' within the meaning of this part.

A specialized rule governs seafood articles such that, unless the animal was caught or harvested within the territorial waters of a country, the country of origin follows the flag of the catching vessel. This rule of origin, the “Law of the Flag,” was affirmed by the Court of International Trade in Koru North America v. United States (CIT 1988). The court noted that “in international law, a ship on the high seas is considered foreign territory, functionally, 'a floating island of the country to which [it] belongs'.”

In-Depth Coverage: Country of Origin

Food not in Natural State

For food that is no longer in its natural state, the FDA Country of Production is generally the country where the food was made or processed. However, if the article is made from wild fish aboard a vessel, the FDA Country of Production is the country in which the vessel is registered. If the food that is no longer in its natural state was made in a U.S. Territory, the FDA Country of Production is the U.S.

The FDA Country of Production may be different from the CBP Country of Origin. For example, the CBP Country of Origin for beans that are grown and dried in the U.S. then rehydrated and canned in the Dominican Republic would be the U.S. The FDA Country of Production would be the Dominican Republic. Therefore, for purposes of the prior notice provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act, the “article of food” is canned beans, not dried beans. From a food safety standpoint, FDA is most interested in knowing where the article of food was processed and canned. To avoid confusion between FDA’s prior notice requirements and CBP requirements, the rule uses the term “FDA Country of Production” instead of the term “originating country” or “country from which the article originates.”

In-Depth Coverage: Marketing and Advertising Compliance

Examples

1. An imported product, such as shrimp, is peeled and deveined or otherwise preserved after importation, but is still identified and sold as “shrimp”. If labeled as a “product of the USA,” it would be misbranded because the labeling would be false and misleading within the meaning of section 403(a)(1) of the FFD&C Act.

U.S. Customs and Border Protection (CBP) has previously ruled that the processing of shrimp by peeling, de-veining, cooking, etc. does not effect a substantial transformation.

2. An imported product, such as shrimp, is peeled, deveined and incorporated into a shrimp dish, such as “Shrimp Quiche.” The product is no longer identifiable as shrimp but as “Quiche.” The quiche is a product of the USA. Therefore, labeling it as “Product of the USA” would not be a violation of the FFD&C Act. (Whether or not it violates CBP's requirements would need to be asked.)

3. An imported product, such as shrimp, is peeled and deveined. It is labeled as “Imported by” or “Distributed by” a firm in the USA. Such labeling would not violate the FFD&C Act, but it would not meet the CBP's requirement for country of origin labeling. The product would also have to be clearly identified as to country of origin.

FDA's policy regarding false or misleading country of origin labeling is to defer to CBP. Such labeling is also a violation of the Tariff Act of 1930, which is enforced by CBP, and CBP can generally deal with this problem more efficiently than FDA.

In-Depth Coverage: Food Import Requirements

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