Country of Origin for Omega-3 Capsules Is Norway for Government Procurement, CBP says
The country of origin for omega-3-acid ethyl ester capsules is Norway for the purposes of government procurement, as they don't undergo a substantial transformation when the Norwegian active pharmaceutical ingredient is combined with inactive ingredients in China, CBP said. The product's name, character or use doesn't change as a result of the processing in China, CBP said.
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The final determination, which was issued March 28 and CBP notified on April 2, came in response to a ruling request filed by New York-based company Epic Pharma, which said that the omega-3-acid ethyl esters are the sole active pharmaceutical ingredient in the final product and is produced in Norway. In China, the inactive ingredients are combined to create an "encapsulating gel," which is then used to capture the active pharmaceutical ingredient and then "imprinting ink" is applied for "any trademark or content information," the company said.
CBP has previously ruled that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation, even when the active pharmaceutical ingredient is combined with other inactive ingredients, the agency said. Epic Pharma's production scenario is similar, and the processing of inactive ingredients into measured doses does not result in a substantial transformation, CBP said.
Epic Pharma didn't respond to our request for comment.