Fair Trade Is Not FDA's Expertise, Amarin Says In Omega-3 Ingredients Filing
This article was originally published in The Pink Sheet
Maker of Rx Vascepa says it's not asking trade panel to interpret the FD&C Act, but to investigate whether some omega-3 ingredient suppliers and marketers are failing to fulfill "certain marketplace expectations about the nature" of their products. ITC is about to decide whether to investigate complaint, which could impact a number of dietary supplement firms.
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FDA Chief Counsel Rebecca Wood says Amarin's request for an ITC investigation necessarily turns on questions of drug and supplements policy, where it is the expert and authorized agency. If successful, Amarin's move could encourage others to similarly seek alternative forums for action.
CRN recommends the International Trade Commission not investigate Amarin's complaint against dietary supplements containing primarily ethyl ester or re-esterified EPA. The firm markets Vascepa, a synthetically produced ethyl ester drug approved to reduce triglyceride levels in adults with severe hypertriglyceridemia.
Amarin's recent fair trade complaint targetting purified EPA dietary supplements and formulations also raises broader questions about using synthetic dietary ingredients in consumer supplements and the extent to which a substance’s identification in an IND precludes subsequent use as a dietary ingredient.