In August 2017, the release notes, Amarin Pharma filed a complaint with the ITC against 18 manufacturers of EPA omega-3 fish oil supplements and companies that market the supplements. CRN filed two legal briefs with the ITC urging them to reject the investigation, as it would usurp FDA’s authority to determine what is a supplement under federal law; a month later, FDA issued a letter of opposition stating that Amarin “crossed a legal boundary” by trying to bypass FDA. The ITC decided not to pursue the investigation in October 2017.
In December 2017, Amarinappealed the decisionto the U.S. Court of Appeals for the Federal Circuit. In March 2018, CRN and GOEDsubmitted an amicus briefto the Court of Appeals emphasizing the importance of FDA’s jurisdiction. In May 2019, the Court of Appealsaffirmed the ITC’s decision—and in July 2019, Amarin asked the Supreme Court to review the decision. As of December 6, the Supreme Court has denied Amarin’s petition.
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Megan Olsen, Assistant General Counsel at CRN, said in the release: “CRN applauds the Supreme Court’s action to deny Amarin Pharma Inc.’s petition for a write of certiorari, upholding the Federal Circuit’s previous decision of the case. This decision maintains FDA’s proper jurisdiction to interpret and enforce the provisions of the Food, Drug and Cosmetic Act (FDCA), including the complex question of whether or not a substance is a dietary supplement…“CRN has been fighting this case from the beginning to maintain FDA’s exclusive jurisdiction over the FDCA, protect legitimate manufacturers selling fish oil supplements, and ensure consumers have access to concentrated omega-3 fish oil supplements without a prescription. This case has been a win for the dietary supplement industry at every stage, and the win has been upheld with the Supreme Court’s most recent action denying cert. CRN is please to see that the Federal Circuit’s decision will be upheld.”
