Omega-3 Ingredients Fair Trade Complaint? Not FDA's Bailiwick, Amarin Says
This article was originally published in The Rose Sheet
The drug maker says it's not asking ITC 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 on Oct. 27 will vote on whether to investigate the complaint targeting a large part of the omega-3 market.
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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.
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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.