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.
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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.
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.