publication July 24, 2018

Update on the Amarin-ITC Case and the Issues at Stake

‘Update on the Amarin-ITC Case and the Issues at Stake,’ by Rend Al-Mondhiry and Jennifer Adams, Regulatory Focus, Regulatory Affairs Professionals Society, July 2018.

This article discusses the history and implications of a lawsuit claiming that certain omega-3 fish oil products, synthetically-produced, were unlawfully labeled and marketed as “dietary supplements. The parties involved include a pharmaceutical company in Ireland, the US International Trade Commission, the US Food and Drug Administration and the US Congress. The outcome of the case could have implications beyond concentrated omega-3 products and the supplement industry as the regulatory classification of such ingredients will continue to receive attention from FDA, retailers and other industry stakeholders.

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