Amarin appeals from an International Trade Commission decision dismissing Amarin’s complaint and denying Amarin’s request to institute an investigation into the labeling and advertising of certain imported products. Amarin markets Vascepa®, the only purified ethyl ester E-EPA product sold in the United States as an FDA-approved drug. Amarin alleges that certain companies are falsely labeling or deceptively advertising their similar products as “dietary supplements” when the products are “drugs” that have not been approved for sale or use in the United States. The Commission refused to institute an investigation on view that Amarin’s allegations are precluded by the Food, Drug, and Cosmetics Act (“FDCA”), which is administered by the Food & Drug Administration.
Amarin argues that the Commission’s decision violates the Commission’s statutory obligations to investigate alleged violations of the Tariff Act and is contrary to controlling precedent of POM Wonderful in which the Supreme Court held that “Congress did not intend the FDCA to preclude Lanham Act suits.” The Commission contends that Amarin’s arguments require a determination of whether the accused products are in violation of the FDCA. The Commission also contends that Amarin’s reliance on POM Wonderful is misplaced because the complaint in that case was not premised on a violation of the FDCA.