CRN files amicus brief in support of the VMS status of fish oil

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CRN files amicus brief in support of the VMS status of fish oil

By Michael Johnsen - 03/23/2018
The Council for Responsible Nutrition and the Global Organization for EPA and DHA Omega-3s on Friday joined forces against an attempt by Amarin Pharma to classify concentrated EPA omega-3 fish oil supplements as pharmaceuticals.

“From the start, CRN recognized that Amarin’s intentions were iniquitous,” Steve Mister, president and CEO, CRN, said. “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."

Omega-3 fatty acid supplements are consumed by 16% of U.S. adults according to a recent survey by CRN.

CRN joined GOED in submitting an amicus brief Friday to the United States Court of Appeals for the Federal Circuit, addressing an appeal made by Amarin Pharma protesting the International Trade Commission’s decision not to review reclassifying the prescription status of 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."

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. 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, as Amarin claimed they were.