CRN challenges Amarin Pharma complaint against 18 omega-3 manufacturers

WASHINGTON — The Council for Responsible Nutrition on Thursday strongly urged the United States International Trade Commission to reject a complaint filed by Amarin Pharma against 18 manufacturers of concentrated EPA omega-3 fish oil.



In two separate filings with the ITC, CRN argued the complaint is “financially motivated” to expand Amarin’s near monopoly over a subset of omega-3 products and would “dramatically affect consumers’ access by making it more difficult and expensive, if not impossible, to obtain the health benefits associated with these products.”



Additionally, the Amarin complaint suffers from significant legal deficiencies that should “preclude institution of an investigation under Section 337 and the Commission Rules.”



“This appears to be a case of a company seeking a market monopoly that would deprive both legitimate manufacturers of selling legal fish oil supplements and consumers of having access to products that benefit their health and well-being,” stated Steve Mister, president and CEO CRN.



In asking the ITC to make a legal determination whether the products in question “are ‘dietary supplements’ within the meaning of [Food, Drug & Cosmetic Act (FDCA)] Section 321,” CRN says Amarin has crossed a legal boundary. “Amarin is inappropriately seeking to bypass the U.S. Food and Drug Administration’s rightful authority to make this determination by filing its complaint with the ITC,” said Rend Al-Mondhiry, associate general counsel, CRN. “Contrary to Amarin’s assertions, FDA has exclusive authority to make this determination.”



CRN submitted two separate filings in the case: the first arguing that Amarin’s requested prohibition on the importation or sale of concentrated omega-3 supplements runs counter to public interest, and the second urging the ITC to reject the complaint because it essentially asks the ITC to second-guess how the FDA would answer the question of these products’ legal status under the FDCA.



The first filing focuses on public interest implications and argues that Amarin’s request would limit millions of Americans’ ability to obtain concentrated omega-3 supplements without a prescription for the preventive benefits those supplements provide. Additionally, the request would further convert a highly competitive market to an Amarin monopoly.

In the second filing, which focuses on legal standing, CRN refutes Amarin’s claims that concentrated omega-3 supplements have not been recognized as dietary supplements by the FDA. Amarin cannot ask the ITC to find a violation of the FDCA without pointing to specific cases or documents where FDA has expressly adjudicated the status of these supplements; therefore, CRN states the Commission has ample ground to reject Amarin’s complaint and determine not to institute an investigation.



CRN is working in consultation with the law firm Adduci, Mastriani & Schaumberg, specialists in international trade law.