Washington, D.C., March 23, 2018—The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, and GOED, the Global Organization for EPA and DHA Omega-3s, has submitted an amicus brief to the United States Court of Appeals for the Federal Circuit addressing the appeal made by Amarin Pharma Inc. and Amarin Pharmaceuticals Ireland Ltd. regarding the International Trade Commission’s (ITC’s) decision to decline an investigation into concentrated EPA omega-3 fish oil supplements. Amarin last year asked the ITC to declare concentrated EPA to be a drug and to prohibit its importation for use in supplements, a move which CRN previously warned would “dramatically affect consumers’ access by making it more difficult and expensive, if not impossible, to obtain the health benefits associated with these products."
“From the start, CRN recognized that Amarin’s intentions were iniquitous,” said Steve Mister, president & CEO, CRN. “They sought to create a market monopoly over a subset of omega-3 products, which would directly hinder legitimate manufacturers from selling fish oil supplements. CRN is committed to fight for its member companies in this space and ensure responsible industry can continue to do business without the burdensome restrictions Amarin seeks to impose. Further, inhibiting consumers’ ability to obtain concentrated omega-3 supplements without a prescription deprives consumers of the health benefits those supplements can provide."
GOED Interim Executive Director Ellen Schutt agreed, citing the public health concern with more than 95 percent of Americans not getting enough EPA and DHA to be cardioprotective. “GOED’s mission is to continue to increase consumption of EPA and DHA omega-3s to adequate levels around the world, and maintaining consumer access to concentrated EPA dietary supplements is a key way to achieve that goal,” Ms. Schutt said.
In the brief, CRN and GOED defended ITC’s decision to dismiss Amarin’s complaint, as Amarin’s requested relief would require ITC to inject itself into the statutory and regulatory framework explicitly authorized to the Food and Drug Administration (FDA). Because Amarin “did not, and could not, allege that the concentrated fish-oil products accused were not, in fact, dietary supplements under any objective standard or ruling,” CRN noted that the complaint failed to satisfy the requirements of the statute and ITC’s rules governing complaints. “Market participants have significant reason to believe that the current practice of labeling concentrated omega-3 products as ‘dietary supplements’ is proper,” wrote CRN, maintaining that companies marketing these products are in no way violating the Food, Drug & Cosmetic Act (FDCA), as Amarin claims they are.
Battling the Amarin complaint on the front lines since it was filed last year, CRN actively participated in the case on behalf of its members, filing two legal briefs with ITC and strongly urging FDA to weigh in on the usurpation of its authority to determine what is a drug under federal law by the pharmaceutical company seeking a drug monopoly on the popular fish oil products. CRN praised FDA for issuing a stern letter of opposition which reinforced CRN’s argument that Amarin “crossed a legal boundary” by seeking to bypass the agency’s rightful authority to interpret federal food and drug laws to determine what is a drug and what is a dietary ingredient.
Omega-3 fatty acid supplements are consumed by 16 percent of U.S. adults according to a recent survey by CRN.
Note to Editor:
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements and LinkedIn.
The Global Organization for EPA and DHA Omega-3s (GOED) is The Global Organization for EPA and DHA Omega-3s (GOED) is a trade association representing approximately 200 companies worldwide active in the EPA and DHA omega-3 industry. GOED’s membership includes all segments of the omega-3 supply chain from fishing and seafood companies, to refiners, supplement manufacturers, food and beverage marketers and pharmaceutical companies. GOED's members agree to adhere to product quality and ethical standards that are as strict, or more strict, than any set of regulations in the world. GOED focuses specifically on addressing the insufficient consumption of EPA and DHA in the human diet by promoting global consumption of EPA and DHA and protecting the consumer by making sure members produce quality products. Visit www.goedomega3.com.