• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    A Kingdom of Their Own: Fungi Shine While Mushrooms Emerge as Market Stars

    The Pet Health Boom: Supplement Growth Set to Build on Rapid Expansion

    (Re)Open for Business: China’s Strong Demand for Natural Products Spells Opportunity for U.S. Brands

    Review Finds No Causative Connection Between Dietary Supplements and Eating Disorders

    KA! Empathogenics: Creating Calm and Connectedness with Inspiration from Nature
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing

    BGG Receives Patent for Saw Palmetto ID Method

    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification

    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion

    Verdure Sciences’ Boswellia Ingredient Receives USP Verification
    Exclusives
    Blogs & Guest Articles
    Health E-Insights
    Area Code 420
    eBook
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    A Kingdom of Their Own: Fungi Shine While Mushrooms Emerge as Market Stars

    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing

    BGG Receives Patent for Saw Palmetto ID Method

    ‘Uniquely Unbound’: Releasing the Potential, and Genius, of Walnuts

    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    A Kingdom of Their Own: Fungi Shine While Mushrooms Emerge as Market Stars

    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing

    BGG Receives Patent for Saw Palmetto ID Method

    The Pet Health Boom: Supplement Growth Set to Build on Rapid Expansion

    ‘Uniquely Unbound’: Releasing the Potential, and Genius, of Walnuts
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    A Kingdom of Their Own: Fungi Shine While Mushrooms Emerge as Market Stars

    ‘Uniquely Unbound’: Releasing the Potential, and Genius, of Walnuts

    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion

    Gaming and Esports Health Concerns

    Bioiberica’s DAOgest Authorized as Novel Food ingredient in EU
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Aiya America, Inc. (Aiya Matcha)

    Gencor

    Botanic Healthcare LLC

    Xsto Solutions

    Applied Food Sciences, Inc.
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Aiya America, Inc. (Aiya Matcha)

    Gencor

    Botanic Healthcare LLC

    Xsto Solutions

    Applied Food Sciences, Inc.
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • eBook
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    CRN & GOED File Joint Amicus Brief Calling for Dismissal of Amarin Pharma Complaint

    Last year Amarin asked the ITC to declare concentrated EPA to be a drug and prohibit its importation for use in supplements.

    03.23.18
    The Council for Responsible Nutrition (CRN) and the Global Organization for EPA and DHA Omega-3s (GOED), have submitted an amicus brief to the United States Court of Appeals for the Federal Circuit addressing the appeal made by Amarin Pharma Inc. and Amarin Pharmaceuticals Ireland Ltd. regarding the International Trade Commission’s (ITC’s) decision to decline an investigation into concentrated EPA omega-3 fish oil supplements.
     
    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.
    Related Searches
    • survey
    • labeling
    • fda
    • Omega-3
    Suggested For You
    Review Finds No Causative Connection Between Dietary Supplements and Eating Disorders Review Finds No Causative Connection Between Dietary Supplements and Eating Disorders
    CRN Petitions FDA to Change Course on CRN Petitions FDA to Change Course on 'Drug Preclusion'
    11th Legal, Regulatory & Compliance Forum on Dietary Supplements 11th Legal, Regulatory & Compliance Forum on Dietary Supplements
    Building on Steps to Improve Children’s Health Around the World Building on Steps to Improve Children’s Health Around the World
    Podcast: Steve Mister on Regulatory Concerns, the Drug Exclusion Clause in DSHEA, and FTC Warnings on Health Claims Podcast: Steve Mister on Regulatory Concerns, the Drug Exclusion Clause in DSHEA, and FTC Warnings on Health Claims
    Ingredient Overages Widespread in Melatonin Gummies, Study Claims Ingredient Overages Widespread in Melatonin Gummies, Study Claims
    Most Americans Want FSAs and HSAs to Cover Supplements Most Americans Want FSAs and HSAs to Cover Supplements
    Study: Prenatal Supplements Not Meeting Target Dosages Study: Prenatal Supplements Not Meeting Target Dosages
    CBD MarketWatch 2023: FDA Claims New Regulatory Pathway Needed for CBD CBD MarketWatch 2023: FDA Claims New Regulatory Pathway Needed for CBD
    CRN Hires New of Communications Team Leader CRN Hires New of Communications Team Leader
    Senate Resolution Recognizes Dietary Supplement Industry’s Role in Health and Economy Senate Resolution Recognizes Dietary Supplement Industry’s Role in Health and Economy
    CBD Expectations: What Happens at FDA and Congress After Agency Seeks New Regulatory Pathway? CBD Expectations: What Happens at FDA and Congress After Agency Seeks New Regulatory Pathway?
    CRN Announces Promotions and Welcomes New Staff Member CRN Announces Promotions and Welcomes New Staff Member
    FDA Denies CBD Petitions, Cites Safety Concerns, Looks to Congress for New Regulatory Pathway FDA Denies CBD Petitions, Cites Safety Concerns, Looks to Congress for New Regulatory Pathway
    CRN Highlights CRN Highlights 'Supplement to Savings' Report for National Heart Month

    Related Features

    • Dietary Supplements | Healthcare Trends | Research | Sports Nutrition | Weight Management/Weight Loss
      Review Finds No Causative Connection Between Dietary Supplements and Eating Disorders

      Review Finds No Causative Connection Between Dietary Supplements and Eating Disorders

      Studies attempting to link supplements to ED are inadequately designed, and often conflate drugs and dietary supplements.
      By Mike Montemarano, Associate Editor 05.23.23

    • Breaking News | Dietary Supplements | Industry & Market News | Regulations | Regulatory News
      CRN Petitions FDA to Change Course on

      CRN Petitions FDA to Change Course on 'Drug Preclusion'

      CRN asked for clearer and more consistent application of the statute which prohibits ingredients from dietary supplements due to past drug research.
      By Mike Montemarano, Associate Editor 05.10.23

    • Industry & Market News

      11th Legal, Regulatory & Compliance Forum on Dietary Supplements

      ...
      05.02.23


    • Dietary Supplements | Healthcare Trends | Infant & Children's Health | Minerals | Regulations | Vitamins | World Markets
      Building on Steps to Improve Children’s Health Around the World

      Building on Steps to Improve Children’s Health Around the World

      What role can dietary supplements play in supporting the health of vulnerable populations?
      By Sean Moloughney, Editor 05.01.23

    • Dietary Supplements | Healthcare Trends | Herbs & Botanicals | Minerals | Proteins, Peptides, Amino Acids | Quality & Safety | Regulations | Testing | Vitamins
      Podcast: Steve Mister on Regulatory Concerns, the Drug Exclusion Clause in DSHEA, and FTC Warnings on Health Claims

      Podcast: Steve Mister on Regulatory Concerns, the Drug Exclusion Clause in DSHEA, and FTC Warnings on Health Claims

      The Council for Responsible Nutrition's president and CEO also reflected on the association's 50th anniversary, its values, and priorities.
      Sean Moloughney, Editor 04.28.23

    Loading, Please Wait..
    Trending
    • Soviets Took Probiotics To The Next Level
    Breaking News
    • Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    • BGG Receives Patent for Saw Palmetto ID Method
    • Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    • Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion
    • Verdure Sciences’ Boswellia Ingredient Receives USP Verification
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Cellular Aging and Longevity: Ingredients for a New Age of Health
    • Addressing the Plastic-Packaging Problem: Getting to Zero-Waste with Zero Compromise
    • Moms Raise the Bar for Kids Supplements
    • Building on Steps to Improve Children’s Health Around the World
    • FDA Remains Focused on Modernizing DSHEA
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    Coatings World

    Latest Breaking News From Coatings World

    Sherwin-Williams Launches Ultra-High-Solids Epoxy
    IMCD Strengthens North America Technical Capabilities with New Lab
    Sherwin-Williams Leads Global Paints Brands in Value: Brand Finance
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Japanese Regulators Approve EDAP's ExactVu Micro-Ultrasound
    Celanese Forges Agreement With Glaukos for Sustained Release Glaucoma Treatment
    Cardio Diagnostic Holdings, Lifespan.io Collaborate on Heart Disease Research
    Contract Pharma

    Latest Breaking News From Contract Pharma

    FDA Approves Pfizer’s ABRYSVO Vax for RSV Prevention
    Novartis Buys Avrobio Gene Therapy for $88 Million
    Meiji Seika Pharma, Adcock Ingram Pharma Complete Construction of New Manufacturing Facility
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Sky Organics Earns B Corp Certification
    Beauty Pie Taps Kevin Cornils as CEO
    Selva Ventures Closes $34M Second Fund Backed by Unilever
    Happi

    Latest Breaking News From Happi

    Azelis Reinforces Personal Care Presence in Asia Pacific Through New Distribution Agreement with Groupe Berkem
    BioFormula Select’s Stop Guessing Expands into Canada
    MAC Cosmetics Launches Day of Giving To Benefit Viva Glam Campaign
    Ink World

    Latest Breaking News From Ink World

    Graphco and Printing & Finishing Solutions Participate at IPMA
    IMCD Strengthens North America Technical Capabilities
    Arkema Partners with Habitat for Humanity Philadelphia
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    ACTEGA teams with Makro Labelling to advance Signite technology
    Constantia Flexibles and SB Packagings commence joint venture
    Inland donates new VersaStudio printer to local high school
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Biodiapers Signs Agreement with Sicam
    Sinaatec Uses Two A.Celli End-Of-Line Solutions
    Mann+Hummel Names President Air Filtration Americas
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Artelon Closes $20M Series B Funding
    Orthofix Unveils Seven-Year Outcome Data for M6-C Artificial Cervical Disc
    Enrollment Completed in Anika Therapeutics' Hyalofast Study
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Arkema Collaborates with Habitat for Humanity Philadelphia
    Vitesco Technologies, onsemi Sign SiC Long-Term Supply Agreement
    Ambiq Receives 2023 Bronze Stevie Award

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login