Amarin's Omega-3 Fair Trade Complaint Reaches Regulatory Dead End
This article was originally published in The Rose 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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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.
FDA warns three US firms marketing products labeled as dietary supplements but containing selective androgen receptor modulators, SARMs, anabolic steroid-like ingredients that have the potential to increase the risk of heart attack and stroke and for which long-term effects are unknown.
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.