Amarin Not Giving Up On Omega-3 Trade Battle
This article was originally published in The Pink Sheet
Amarin asks Federal Circuit Court to direct US ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs. Company questions FDA's request for policy deference given resource constraints and says Supreme Court rulings show compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information renders a product an unapproved drug or represents false advertising.
You may also be interested in...
National Advertising Division, in rare review of an Rx drug firm’s challenge of supplement ad claims, reported Innovix Pharma pulled health claims for OmegaVia brand supplements challenged by Amarin. Innovix prevailed in defending its labeling as accurate and its name as not false advertising.
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 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.