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Amarin asks Supreme Court to hear dispute involving omega-3 supplements

Amarin Pharma Inc. wants the nation’s highest court to hear a long-running dispute with several dietary supplement companies that the U.S. International Trade Commission (ITC) declined to investigate in 2017.

Amarin, the maker of the pharmaceutical drug Vascepa, filed a July 30 petition for a writ of certiorari with the U.S. Supreme Court after an appeals court affirmed ITC’s decision.

It’s Amarin’s last chance in the judiciary to compel ITC to investigate its complaint over the legality of certain “synthetically produced omega-3 products” promoted as dietary supplements, a category of products principally regulated by FDA.

A ruling by the Supreme Court could provide clarity over ITC’s authority to hear complaints involving unsettled issues within FDA’s expertise. A quasi-judicial federal agency, ITC has broad powers over matters of trade, including enforcement of the Tariff Act of 1930.

Representatives for FDA and ITC declined to comment on the petition.

“This case offers the Court an opportunity to restore the private rights of action that Congress granted parties under the Tariff Act of 1930 in order to protect domestic industry from unfair trade practices,” Amarin wrote in its 38-page petition through its outside counsel, Ashley C. Parrish of King & Spalding LLP.

Amarin’s grievances are with several prominent dietary supplement firms, including Nordic Naturals Inc., Nordic Pharma Inc., Pharmavite LLC, DSM Nutritional Products LLC and related DSM entities.

“We are disappointed that Amarin continues to pursue this issue, and we are confident that the U.S. Supreme Court will rule consistent with the ITC and the Federal Circuit Court rulings on this matter,” said Hugh Welsh, president of DSM North America, in an email.

Nordic Naturals, Nordic Pharma and Pharmavite did not immediately respond to requests for comment.

In its 2017 complaint, Amarin alleged the companies’ products above are unapproved new drugs under the Federal Food, Drug & Cosmetic Act (FDCA). Therefore, the false labeling of the products, Amarin argued, constituted an unfair act or method of competition under Section 337 of the Tariff Act of 1930 because the acts violate the Lanham Act and standards the FDCA established.

FDA asked ITC to refrain from an investigation because the agency hadn’t determined whether the products subject to the complaint were drugs or dietary supplements. And in June 2018, a U.S. Department of Justice (DOJ) attorney noted a guidance from FDA on the regulatory classification of these articles would not be forthcoming.

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Omega-3s market outlook

04_08 Market for Omega-3

Omega-3 fatty acids are essential for overall health. Mary Ann Siciliano, national sales manager, Aristra Industries Inc., said omega-3s have been found to be particularly good for heart health, joint and inflammation support, eye health, cognitive function, pregnancy and healthy child development and immune function, among other benefits.

The omega-3s include the essential fatty acid alpha-linolenic acid (ALA), and the longer-chain eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Plant-based sources of ALA omega-3 include flaxseed, chia seeds, canola, walnut and soybean oils and leafy and green vegetables. The short-chain omega-3 ALA can be converted in the body to the longer-chain omega-3s. However, the body’s ability to convert ALA into EPA and/or DHA is inefficient, making ingestion of pre-formed EPA and DHA beneficial.

The biggest challenge for both consumers and industry affecting consumption of omega-3 food supplements is taste. Marine sources of long-chain fatty acids often yield a “fishy” taste that is unappealing to consumers.

Proprietary research from the Global Organization of EPA and DHA Omega-3s (GOED) showed highest supplement use is occurring in the United States, China and Australia. Statistica 2018 estimated the supplement market for omega-3 supplements in 2025 will reach US$57 billion, compared to $33 billion in 2016. This is indeed a steep growth for an individual supplement segment.

Consumption of omega-3-rich food is reasonably high in the high-population markets of China and India, but that is largely fresh-food based. As these economies evolve and nutrition management in the nouveau riche comes to vogue, the demand for supplements will rise.

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