According to a report in The GOED Current—the newsletter of the Global Organization for EPA and DHA Omega-3s (GOED)—The United States International Trade Commission (ITC) has chosen not to initiate an investigation in response to a complaint by Amarin Pharma “concerning certain synthetically produced, predominantly EPA omega-3 products in ethyl ester or re-esterified triglyceride form,” as the original Amarin complaint states. In fact, the ITC has dismissed said complaint.
As Nutritional Outlook reported earlier, Amarin Pharma, maker of a synthetic EPA omega-3 drug in ethyl ester (EE) form that it markets as Vascepa, filed its complaint with the ITC on August 30, alleging that synthetically produced omega-3 dietary supplements predominantly comprising EPA in either the EE or re-esterified (rTG) form are synthetic and therefore not considered “dietary ingredients” under Section 201(ff)(1) of the Federal Food Drug and Cosmetic Act (FDCA).
Because the allegation implies that such supplements aren’t dietary supplements at all, but, rather, unapproved new drugs, Amarin’s complaint asks the ITC to investigate the “unlawful importation or sale in the United States of synthetically produced omega-3 products” that it believes are “falsely labeled, and/or promoted for use as, or in ‘dietary supplements.’”
Citing the Lanham Act of 1946—the primary federal statute prohibiting trademark infringement, trademark dilution and false advertising—the ITC states in its response that “Amarin’s complaint does not allege an unfair method of competition or an unfair act cognizable under 19 U.S.C. § 1337(a)(1)(A), as required by the statute and the Commission’s rules.” The commission further notes that the complaint’s allegations are precluded by the FDCA, and that administration of the FDCA falls under FDA purview.
The GOED Current notes that the ITC institutes most of the complaints it receives, but that Amarin’s request for an ITC interpretation of the FDCA made the circumstances of its complaint unusual. However, the newsletter continues, “We do not expect this matter to completely disappear.” Until and unless it does, it states, “[T]here is a very long history of omega-3 concentrates being sold as dietary supplements in the United States, and we think that any reasonable authority will conclude that these are dietary ingredients authorized for sale in the US.”
In a statement released by the Council for Responsible Nutrition (CRN; Washington, DC), Steve Mister, president, CEO, CRN, applauded the decision:“CRN extends its appreciation to ITC for its decision to reject a complaint filed by Amarin Pharma Inc. and Amarin Pharmaceuticals Ireland Ltd. against omega-3 companies. In doing so, ITC recognizes that, under the Food, Drug & Cosmetic Act, FDA has exclusive authority to make the determination requested by Amarin—and, for that, we are grateful. This decision is a victory not only for legitimate manufacturers that sell legal fish oil supplements, but for consumers depending on accessible, affordable products that benefit their health and well-being.
He continued: "We graciously acknowledge those who worked parallel to CRN in advising ITC toward this crucial decision. Individual companies, industry trade associations, and bipartisan voices from Capitol Hill maintained a strong, united presence on the front lines of opposition efforts, and we are pleased to see the proper jurisdiction of FDA respected and maintained.”