• 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
    Nutraceuticals for Men: Muscle Health and Performance Nutrition

    Aging in Place: Healthy Lifestyles Supplement Science-Based Solutions

    Getting an Edge in Esports: Meeting the Health Needs of Competitive Gamers

    Beyond CBD: Cannabis Compounds Warrant Recognition and More Research

    Leveling Out the Energy Segment for Mainstream, and Rethinking Caffeine
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Bilberon Bilberry Extract Receives U.S. Patent For Eye Strain, Neck/Shoulder Pain

    Jordan Process Receives Nutrasource ICAP Certification for CBD

    FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Supplements

    Nootropics and Adaptogens Respond to Demand for Mind and Mood Support

    Sabinsa Honors 70th Anniversary of Diplomacy Between India and Japan
    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

    Bilberon Bilberry Extract Receives U.S. Patent For Eye Strain, Neck/Shoulder Pain

    Jordan Process Receives Nutrasource ICAP Certification for CBD

    Nootropics and Adaptogens Respond to Demand for Mind and Mood Support

    Sabinsa Honors 70th Anniversary of Diplomacy Between India and Japan

    Solvay Invests in Suanfarma’s Vanillin Production
    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

    Bilberon Bilberry Extract Receives U.S. Patent For Eye Strain, Neck/Shoulder Pain

    Jordan Process Receives Nutrasource ICAP Certification for CBD

    Senate Bill to Reauthorize FDA User Fees Includes Dietary Supplement Listing Provision

    FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Supplements

    Nootropics and Adaptogens Respond to Demand for Mind and Mood Support
    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

    Bilberon Bilberry Extract Receives U.S. Patent For Eye Strain, Neck/Shoulder Pain

    FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Supplements

    Nootropics and Adaptogens Respond to Demand for Mind and Mood Support

    Experts Debate Role of Supplements in Improving Public Health in EU

    GNC Adds Products from The Honest Company, Hers, and Womaness
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    PhytoGaia Inc

    Botanic Healthcare LLC

    KLK OLEO

    ESHA Research

    Ecuadorian Rainforest
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    PhytoGaia Inc

    Botanic Healthcare LLC

    KLK OLEO

    ESHA Research

    Ecuadorian Rainforest
    • 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

    Federal Court Dismisses Lawsuit Aimed at Self-Affirmed GRAS Process

    The dismissal favored the current procedure in which certain parties may notify the FDA about the self-affirmed safety of dietary ingredients.

    Federal Court Dismisses Lawsuit Aimed at Self-Affirmed GRAS Process
    Related CONTENT
    • Nootropics and Adaptogens Respond to Demand for Mind and Mood Support
    • Solvay Invests in Suanfarma’s Vanillin Production
    • Leaven Essential to Launch Branded Botanical Extracts to Global Markets
    • Third-Party Certifications Support Consumer Demand for Quality and Transparency
    • Podcast: Michael McGuffin Discusses Dietary Supplement Regulation and Mandatory Product Listing Bill
    10.07.21
    The GRAS (Generally Recognized As Safe) process, by which companies establish the safety of an ingredient under the conditions of intended use and may notify the U.S. Food and Drug Administration about this self-affirmation, was recently targeted in a lawsuit that reached the U.S. District Court for the Southern District of New York.
     
    However, the case was dismissed in favor of the GRAS determination process, which has become an industry standard since a final rule declaration which occurred in 2016 to establish the voluntary process by which companies can notify the FDA.
     
    According to the trade association AHPA (American Herbal Products Association), the suit was originally filed by five advocacy associations, but three of these organizations were removed when FDA challenged their standing to bring the suit. The two remaining plaintiffs were the Center for Food Safety and the Environmental Defense Fund.
     
    “This is an important decision that protects a regulatory option that many responsible suppliers use to bring safe ingredients to the U.S. market,” Michael McGuffin, AHPA president, said.
     
    The main arguments that the two plaintiff organizations made were that the GRAS process unlawfully subdelegates FDA’s statutory authority to private parties (namely those who self-affirm the GRAS status of their ingredients), that the GRAS process contradicts the regulatory intentions of the Food, Drug, and Cosmetic Acct and exceeds FDA’s statutory authority, and that the rule is “arbitrary and capricious in violation of the FDCA and the Administrative Procedures Act.”
     
    In U.S. District Judge Vernon S. Broderick’s statement, and accompanying judgment, issued on September 30, he rejected each of the allegations made by the plaintiff organizations.
     
    “In a final attempt to strike down the GRAS rule, Plaintiffs argue that the GRAS rule is unlawful because its criteria for determining GRAS status contradicts the FDCA. In particular, Plaintiffs aver that the criteria within the GRAS Rule differs from the FDCA’s requirement that a substance is eligible for GRAS status only if that substance is ‘generally recognized, among experts qualified by scientific training and experience… as having been adequately shown through scientific procedures… to be safe under the conditions of its intended use.’
     
    “Plaintiffs cite to five reasons: the GRAS Rule fails to include sufficient criteria to ensure that the data, information, and methods upon which manufacturers base their GRAS determinations are ‘generally recognized’; the GRAS Rule does not include criteria to ensure that manufacturers’ GRAS determinations are free from conflicts of interest; the GRAS Rule does not contain any criteria to ensure manufacturers do not self-certify substances as GRAS after FDA raises safety concerns about them; FDA finalized the GRAS Rule without including any criteria to prevent manufacturers from secretly self-certifying newly synthesized or novel substances as GRAS; and the GRAS Rule fails to include criteria clarifying that the carcinogenic substances can never be deemed safe for use in food.”
     
    Broderick said that the third and fourth reasons have been flagged in other challenges. He added that he disagreed with the plaintiffs’ argument that information in GRAS determination cannot be “generally recognized,” that he disagreed with the argument that there are no safeguards against potential financial conflicts of interest in the GRAS process due to the fact that certifying the notice requires a signed statement ensuring that a submission is balanced with known unfavorable information, and, lastly, that he disagreed with the fifth reason due to the fact that GRAS Rule criteria requires “reasonable certainty that the substance is not harmful under the conditions of its intended use.”
     
    The plaintiff organizations will have the option of filing an appeal of the decision.
     
    Related Searches
    • Regulations
    • Testing
    • Dietary Supplements
    • Functional Foods & Beverages
    Related Knowledge Center
    • Testing
    • Quality & Safety
    • Regulations
    Suggested For You
    Nootropics and Adaptogens Respond to Demand for Mind and Mood Support Nootropics and Adaptogens Respond to Demand for Mind and Mood Support
    Solvay Invests in Suanfarma’s Vanillin Production Solvay Invests in Suanfarma’s Vanillin Production
    Leaven Essential to Launch Branded Botanical Extracts to Global Markets Leaven Essential to Launch Branded Botanical Extracts to Global Markets
    Third-Party Certifications Support Consumer Demand for Quality and Transparency Third-Party Certifications Support Consumer Demand for Quality and Transparency
    Podcast: Michael McGuffin Discusses Dietary Supplement Regulation and Mandatory Product Listing Bill Podcast: Michael McGuffin Discusses Dietary Supplement Regulation and Mandatory Product Listing Bill
    AB-Biotics to Bring Latest Probiotic Solutions at Vitafoods Europe AB-Biotics to Bring Latest Probiotic Solutions at Vitafoods Europe
    Gelita to Debut Three Ingredients at Vitafoods Europe 2022 Gelita to Debut Three Ingredients at Vitafoods Europe 2022
    What to Expect Next Week at Vitafoods Europe 2022 What to Expect Next Week at Vitafoods Europe 2022
    Guayusa for Gametime: Opportunities in Esports and Beyond Guayusa for Gametime: Opportunities in Esports and Beyond
    Fullscript Drives Consolidation While Eyeing Inroads to Conventional Care Fullscript Drives Consolidation While Eyeing Inroads to Conventional Care
    Aging in Place: Healthy Lifestyles Supplement Science-Based Solutions Aging in Place: Healthy Lifestyles Supplement Science-Based Solutions
    Nutraceuticals for Men: Muscle Health and Performance Nutrition Nutraceuticals for Men: Muscle Health and Performance Nutrition
    Dietary Supplement Delivery Formats Offer Strong Appeal and Unique Challenges Dietary Supplement Delivery Formats Offer Strong Appeal and Unique Challenges
    Beneo Announces New Pulse Processing Plant Beneo Announces New Pulse Processing Plant
    Ignore the Red Herrings: Myths & Facts about Mandatory Product Listing Ignore the Red Herrings: Myths & Facts about Mandatory Product Listing

    Related Content

    • Breaking News | Cognitive Function | Consumer Trends | Dietary Supplements | Functional Foods & Beverages | Herbs & Botanicals | Industry & Market News | Mood Health & Sleep
      Nootropics and Adaptogens Respond to Demand for Mind and Mood Support

      Nootropics and Adaptogens Respond to Demand for Mind and Mood Support

      Product success is challenging, and rare, according to Julian Mellentin, who has authored a new strategy briefing.
      05.17.22

    • Breaking News | Flavors & Colors | Herbs & Botanicals | Supplier News
      Solvay Invests in Suanfarma’s Vanillin Production

      Solvay Invests in Suanfarma’s Vanillin Production

      The group aims to develop capabilities for natural food ingredients, flavors, and fragrance markets.
      05.16.22

    • Breaking News | Herbs & Botanicals | Supplier News | World Markets
      Leaven Essential to Launch Branded Botanical Extracts to Global Markets

      Leaven Essential to Launch Branded Botanical Extracts to Global Markets

      The company believes in Ayurveda and is focused on formulating efficacious, science-backed ingredients through research and clinical validation.
      05.16.22


    • Consumer Trends | Dietary Supplements | Quality & Safety | Regulations | Testing
      Third-Party Certifications Support Consumer Demand for Quality and Transparency

      Third-Party Certifications Support Consumer Demand for Quality and Transparency

      Validation of standards can help build trust and ensure products are safe, efficacious, and contain what they claim.
      By Lisa Thomas, Senior Director, North America Product Marketing and Innovation, Herbalife Nutrition 05.10.22

    • Dietary Supplements | Regulations
      Podcast: Michael McGuffin Discusses Dietary Supplement Regulation and Mandatory Product Listing Bill

      Podcast: Michael McGuffin Discusses Dietary Supplement Regulation and Mandatory Product Listing Bill

      AHPA President offers his analysis of the Dietary Supplement Listing Act of 2022, and where industry goes from here.
      Sean Moloughney, Editor 05.05.22

      Breaking News
      • Bilberon Bilberry Extract Receives U.S. Patent For Eye Strain, Neck/Shoulder Pain
      • Jordan Process Receives Nutrasource ICAP Certification for CBD
      • FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Supplements
      • Nootropics and Adaptogens Respond to Demand for Mind and Mood Support
      • Sabinsa Honors 70th Anniversary of Diplomacy Between India and Japan
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Aging in Place: Lifestyle Supplements Science-Based Solutions
      • Getting an Edge in Esports: Meeting Health & Nutrition Needs
      • Nutraceuticals for Men: Muscle Health and Performance Nutrition

      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

      Bilberon Bilberry Extract Receives U.S. Patent For Eye Strain, Neck/Shoulder Pain
      Jordan Process Receives Nutrasource ICAP Certification for CBD
      FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Supplements
      Coatings World

      Latest Breaking News From Coatings World

      AGM Secures Exclusive Distribution Agreement with Indian Partner Imkemex
      Microban Announced as Lead Sponsor of BCF Annual Conference and Dinner 2022
      DIC’s Indian Subsidiary Begins Construction of Coating Resins Production Facility
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Robocath Presents Results from R-Evolution Clinical Study
      Medtronic's Resolute Onyx Drug-Eluting Stent Shows Success for Left Main PCI
      Medtronic Shares 3-Year Renal Denervation Blood Pressure Trial Data
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Emergent CDMO Case Studies: Project Design & Implementation of Fill/Finish Technologies
      Aptar Pharma Launches HeroTracker Sense
      MasterControl Features Quality Management and Manufacturing Execution Systems
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Mielle Organics Welcomes Steve Pamon to Advisory Board
      Makeup Revolution Expands into Walgreens
      Nu Skin Joins EcoBeautyScore Consortium
      Happi

      Latest Breaking News From Happi

      Revolution Beauty Expands Makeup Revolution Into Walgreens
      Barentz Develops Electronic Personal Care Product Guide
      P&G Temporarily Closes Downtown Cincinnati Office Due to Potential Security Concerns
      Ink World

      Latest Breaking News From Ink World

      Nazdar Ink Technologies to Showcase Latest Ink Innovations at FESPA Global Print Expo 2022
      Epson Introduces First Direct-to-Fabric Printer for North America
      ProAmpac Facilities Secure Safety Awards 2022
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      In-Mold Decorating Association announces 2022 IMDA Awards Competition
      Essentra Packaging invests in Landa Nanographic press
      Nazdar to manufacture VFP electronic ink for US Market
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      'Right' Hygiene Conference to be Held in June
      Freudenberg to Present Battery Pack and Liquid Absorbers at Battery Show
      H&V Appoints Vice President and General Counsel
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Envista To Acquire Osteogenics
      Exactech Earns Breakthrough Status for JointMedica's Polymotion Hip Resurfacing
      Orthotic Brace Suppliers Convicted in $6.5M Fraud Scheme
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Emerson Earns Third Consecutive 2022 ENERGY STAR Partner of the Year Award
      First Solar to Sell Japan Project Development, O&M Platforms to PAG Real Assets
      Jabil Strengthens Additive Manufacturing Offerings

      Copyright © 2022 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