Trade Panel Bolsters FDA's View In Amarin Omega-3 Complaint
This article was originally published in The Pink Sheet
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.
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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.
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.
Court blesses combination of statements and disclosures that must accompany Vascepa promotions in a ruling that rejects FDA's narrow interpretation of 2012 Caronia case.