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Amarin's Omega-3 Fair Trade Complaint Questions US Dietary Ingredient Standards

Executive Summary

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.

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The drug maker says it's not asking ITC 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 on Oct. 27 will vote on whether to investigate the complaint targeting a large part of the omega-3 market.

Fair Trade Is Not FDA's Expertise, Amarin Says In Omega-3 Ingredients Filing

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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