U.S. Customs and Border Protection has issued a final determination concerning the country of origin of omega-3-acid ethyl ester capsules that may be offered to the U.S. government.
According to CBP, the capsules at issue are used to help treat adults with severe hypertriglyceridemia. The esters are the sole active pharmaceutical ingredient in the capsules and are produced in Norway. They are encapsulated into dosage form in China and the capsules are there imprinted with any trademark or content information.
In ruling HQ H331488, CBP concludes that the esters are not substantially transformed in China when combined with certain inactive ingredients and encapsulated into dosage form. CBP explains that the processing in China results in no change in name, character, or use of the esters and notes that it has consistently held that the processing of drug products from bulk form into measured doses does not result in a substantial transformation of the product.
Any party-at-interest may seek judicial review of this determination by May 3.
CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. government. For more information on BAA requirements or restrictions, please contact Mark Segrist, Mark Tallo, or Josh Rodman.
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