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

Executive Summary

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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Trade Panel Bolsters FDA's View In Amarin Omega-3 Complaint

International Trade Commission won't investigate Amarin's complaint that some dietary supplements containing omega-3 formulations similar to icosapent ethyl in its Vascepa are actually drugs and should be blocked from import into US, likely discouraging others from this novel approach.

Trade Panel Bolsters FDA's View In Amarin Omega-3 Complaint

International Trade Commission won't investigate Amarin's complaint that some dietary supplements containing omega-3 formulations similar to icosapent ethyl in its Vascepa are actually drugs and should be blocked from import into US, likely discouraging others from this novel approach.

FDA Objects To Amarin Trade Complaint Against Omega-3 Ingredients

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.

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