CPG Sec. 560.200 Country of Origin Labeling 
 
BACKGROUND: 
A statement of the country of origin on the labeling of imported foods is not required by the 
Federal Food, Drug, & Cosmetic Act. This is a requirement of the U.S. Customs *and Border 
Protection (CBP)* as authorized by the Tariff Act of 1930 and CPB regulations (19 USC 1304(a) 
and 19 CFR Part 134). 
Repackers are required by *CBP* to mark containers of repackaged imports with the English 
name of the country of origin. In the event that further reprocessing or material added to the 
article in another country results in a "substantial transformation" of the product, the other 
country becomes the country of origin within the meaning of *CBP's* labeling requirements, 19 
CFR 134.1(b) and 134.11. As a result of *CBP's* seizure actions and other regulatory follow-up 
involving imported shrimp that was peeled, deveined, and repacked in the United States and 
labeled as a product of the U.S. FDA received congressional, industry, and field inquiries 
regarding FDA's jurisdiction and policy on country of origin labeling for this product. *CBP* 
considers that peeling, deveining, and repacking is not a "substantial transformation" of the 
product, sufficient to permit the shrimp to be declared as a product of the U.S., within the 
meaning of *CBP's* laws and regulations. 
POLICY: 
Food labeling statements regarding geographical origin must not be false or misleading in any 
particular. FDA's policy prohibiting false or misleading labeling of food applies equally to 
imported and domestic products (*section 403(a)(1)* and 21 CFR 101.18). 
It is possible that a violation of *CBP's* requirement concerning country of origin labeling, 
whether by omission or deviation, could also result in false or misleading labeling that violates 
the FFD&C Act and FDA regulations. 
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. 
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. 
REGULATORY ACTION GUIDANCE: 
Information acquired by FDA personnel regarding false or misleading country of origin labeling 
should be transmitted by the Program Field Office to the local *CBP* office for their 
consideration, together with offers of FDA cooperation in the matter and a request that the field 
office be advised of any regulatory follow-up by *CBP*. 
*Material between asterisks is new or revised* 
Issued: 10/1/80 
Revised: 6/30/89, 5/2005 
Updated: 11/29/0