Washington, D.C., May 2, 2019–In response to the U.S. Court of Appeals for the Federal Circuit’s decision in Amarin Pharma, Inc. v. ITC, issued on May 1st, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:
Statement by Steve Mister, president & CEO, CRN:
“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.
CRN has been involved in challenging Amarin’s actions since 2017 by urging the ITC not to initiate an investigation that would have placed the ITC in the position of interpreting the federal Food, Drug & Cosmetic Act and then bootstrapping that interpretation onto the Lanham Act to prevent the sale of these omega-3 products as dietary supplements in the U.S. CRN alerted members of Congress and FDA to the detrimental effects Amarin’s action could have on FDA’s exclusive authority over these products in addition to filing two of its own amicus briefs before the ITC. The ITC agreed, and in October 2017, it declined to pursue an investigation. CRN subsequently filed an amicus brief in Amarin’s appeal to the Federal Circuit.
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 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, Facebook, and LinkedIn.