• Feature ArticlesFeature Articles

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

    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 a...
  • Regulatory NewsRegulatory News

    NDI Guidance: The Waiting Game

    This article discusses FDA's publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) and the implications regarding the lack of finalization in the year following its publication. The authors make suggestions regarding what companies may begin doing prior to and in anticipation of eventual finalization. Introduction Regarding how dietary supplements should be regulate...