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% 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% of U.S. adults, according to a recent survey by CRN.