Supreme Court Cosmetic, Food Decisions Shape Amarin's Appeal For Omega-3 Trade Inquiry
This article was originally published in The Rose Sheet
Executive Summary
Amarin's petition to the Federal Circuit Court to direct ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs leans on Supreme Court decisions that compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information rendered a product an unapproved drug or represented false advertising.
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NDI Guidance Could Drive Amarin's Gambit To Block Some Omega-3 Imports
Amarin's argument would swing on a finding by FDA that synthetics of omega-3s are not dietary ingredients. With such an FDA determination, a fair trade complaint to International Trade Commission about imports of omega-3 ingredients similar to the active ingredient in Amarin's Rx Vascepa theoretically would not be asking ITC to interpret FDA regulations by investigating imports of substances which FDA has not identified as noncompliant with its regulations.
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.