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Omega-3 Drug Firm’s Trade Complaint Questions US Dietary Ingredient Standards

This article was originally published in The Rose Sheet

Executive Summary

Amarin targets purified EPA dietary supplements or formulations containing primarily EPA in ethyl ester or re-esterified form and raises general questions about using synthetic dietary ingredients in supplements and about the extent to which a substance’s previous identification as an IND candidate precludes its subsequent use as a dietary ingredient.

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Court Tosses Amarin Fair Trade Complaint Against Omega-3 Imports

Majority opinion by Federal Circuit upheld International Trade Commission's decision and denied as moot Amarin's petition for order to compel a judicial or government officer or agency to perform a duty. Dissenting opinion not only agrees ITC acted correctly denying the firm's complaint, but also says the commission's decision wasn't appealable. Ropes & Gray attorneys suggest ruling provides guidance for additional fair trade complaints about FDA-regulated products.

Court Tosses Amarin Fair Trade Complaint Against Omega-3 Imports

Majority opinion by Federal Circuit upheld International Trade Commission's decision and denied as moot Amarin's petition for order to compel a judicial or government officer or agency to perform a duty. Dissenting opinion not only agrees ITC acted correctly denying the firm's complaint, but also says the commission's decision wasn't appealable. Ropes & Gray attorneys suggest ruling provides guidance for additional fair trade complaints about FDA-regulated products.

DoJ Maintains Amarin 'Misplaced' Its Omega-3 Unfair Trade Argument

In an amicus opposing Amarin's petition in federal court for an order that the US ITC investigate its fair trade complaint targeting certain omega-3 oil ingredients, DoJ says the drug firm is attempting private enforcement of the FDC Act. The act "commits enforcement exclusively to the federal government to ensure that complex enforcement decisions are made with the benefit of FDA's scientific and regulatory expertise," DoJ argues.

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