As a follow up to Loren’s Oct. 20 Member Memo on this subject, below is a note from GOED issued today, discussing the International Trade Commission’s decision to not institute an investigation into Amarin’s complaint re: its claim that a number of dietary supplement companies had been engaged in “unfair competition.” —Frank
ITC Dismisses Amarin Complaint
October 30: The United States International Trade Commission (ITC) has decided to not institute an investigation based on Amarin’s August 30 complaint “concerning certain synthetically produced, predominantly EPA omega-3 products in ethyl ester or re-esterified triglyceride form” and has dismissed the complaint.
According to the ITC, “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 notes that the Lanham Act allegations in this case are precluded by the Food, Drug and Cosmetic Act (FDCA). The Commission also notes that the Food and Drug Administration is charged with the administration of the FDCA.”
Most ITC complaints are instituted, but this was an unusual circumstance that involved asking the ITC to interpret the Food Drug and Cosmetic Act and the Commission clearly agreed that this is not within its purview. We do not expect this matter to completely disappear, but there 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. It is important to note that the ITC, in its letter, stated that the sale of these concentrates as supplements does not create unfair competition and that the use in dietary supplements is clearly within FDA's jurisdiction.
GOED will continue to monitor the situation and provide more information as we receive it.