Amarin Pharma, maker of the omega-3 drug Vascepa, has failed in its attempt to get an investigation launched against certain omega-3 dietary supplement products. On May 1, the United States Court of Appeals for the Federal Circuit upheld a 2017 decision of the International Trade Commission (ITC) not to investigate Amarin’s complaints against companies like omega-3 oils supplier DSM Nutritional Products and omega-3 supplement brands such as Pharmavite LLC and Nordic Naturals Inc. The decision is considered a big win for the omega-3 dietary supplement industry.
In September 2017, Amarin filed a lawsuit with the ITC, requesting that the ITC investigate certain omega-3 dietary supplement companies, alleging that the supplement companies’ omega-3 eicosapentaenoic acid (EPA) fatty acid concentrates, in either ethyl ester or re-esterified form, are synthetic and therefore not considered dietary ingredients and not allowed in dietary supplements according to the Federal Food Drug and Cosmetic Act (FD&C Act). (Amarin’s Vascepa drug comprises 1 g of EPA in ethyl ester form, synthetically produced from fish oil, and is marketed to adults with severe hypertriglyceridemia. It is the only purified ethyl ester EPA sold as an FDA-approved drug.)
Amarin urged the ITC to stop the “unlawful importation or sale in the United States of synthetically produced omega-3 products.” This move was largely seen in the dietary supplement industry as an attempt by the drug company to eliminate competition from the supplement companies. It was not the only time Amarin had gone after omega-3 dietary supplement companies, either. Last year, Amarin filed suit against two omega-3 supplement makers, alleging that the companies used positive results from Amarin’s own REDUCE-IT clinical drug trial to advertise their own supplement products.
Following Amarin’s September 2017 ITC complaint, dietary supplement advocates, such as dietary supplement industry association the Council for Responsible Nutrition (Washington, DC), urged the ITC not to proceed with an investigation.
In October 2017, the U.S. FDA itself also urged ITC not to investigate the case. Namely, the agency said, only FDA can determine whether or not these products are not dietary ingredients and are unapproved new drugs under the FD&C Act, and that private parties are prohibited from bringing such enforcement actions. The agency said it had not reached any conclusion as to whether or not the omega-3 concentrate ingredients in question are dietary ingredients and that any decisions reached by ITC, were ITC to investigate, could contradict an eventual FDA decision.
In October 2017, the ITC ultimately decided not to investigate Amarin’s complaint, citing grounds that FD&C Act determinations are the purview of FDA and also that Amarin’s complaint of false advertising did not hold up under the Lanham Act of 1946, which prohibits trademark infringement and false advertising.
Following ITC’s dismissal of the case, in December 2017, Amarin filed an appeals case with the United States Court of Appeals. Its arguments were heard in June 2018. Ultimately, the news came this May that the company lost this appeal. (One judge dissented.) The court majority wrote that it agreed with ITC’s decision that Amarin had “failed to allege a cognizable claim based on an unfair method of competition or unfair act under 19 U.S.C. § 1337(a)(1)(A).”
Dietary supplement industry leaders celebrated the news. In a statement, CRN’s president and CEO, Steve Mister, said: “CRN welcomes the decision of the U.S. Court of Appeals for the Federal Circuit in Amarin Pharma, Inc. v. ITC, affirming the International Trade Commission’s decision not to investigate Amarin’s complaint that alleged certain types of concentrated omega-3 fish oil products were not dietary ingredients and therefore could not be imported as dietary supplements. This decision is significant and beneficial for the dietary supplement industry as it confirmed FDA’s exclusive jurisdiction to interpret and enforce the provisions of the Food, Drug and Cosmetic Act.”
He continued: “CRN recognized that Amarin was seeking to impose restrictions that could have created a market monopoly for pharmaceutical companies over a subset of omega-3 products, hindered responsible manufacturers from selling beneficial fish oil supplements, and removed consumers’ abilities to buy affordable products that benefit their health and well-being. We continue to be committed to fight for our member companies in this space and for proper jurisdiction of FDA.”
The Amarin case yields discussion of how drug and supplement companies sometimes suffer an adversarial relationship but other times do not. Nutritional Outlook covered the topic in the feature story of our recent April 2019 issue. Read that story here.