• 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
    GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe

    Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board

    Expert Consensus Statement: Diet is Best Primary Intervention to Achieve Diabetes Remission

    Choline Alone May Improve Maternal DHA Status During Pregnancy

    Cranberry Consumption Linked to Memory and Neurological Function Improvements
    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

    GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe

    Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board

    Choline Alone May Improve Maternal DHA Status During Pregnancy

    Cranberry Consumption Linked to Memory and Neurological Function Improvements

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

    FDA Issues Draft Guidance on NDI Enforcement Discretion

    GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe

    Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board

    Expert Consensus Statement: Diet is Best Primary Intervention to Achieve Diabetes Remission

    Choline Alone May Improve Maternal DHA Status During Pregnancy
    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

    Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board

    Expert Consensus Statement: Diet is Best Primary Intervention to Achieve Diabetes Remission

    Choline Alone May Improve Maternal DHA Status During Pregnancy

    Cranberry Consumption Linked to Memory and Neurological Function Improvements

    Bilberon Bilberry Extract Receives U.S. Patent For Eye Strain, Neck/Shoulder Pain
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    KLK OLEO

    PhytoGaia Inc

    Sabinsa Corporation

    ESHA Research

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

    PhytoGaia Inc

    Sabinsa Corporation

    ESHA Research

    Aiya America, Inc. (Aiya Matcha)
    • 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

    UNPA to Host NDI Guidance Workshop Sep. 8

    Economic cost to industry could be billions of dollars, according to Loren Israelsen.

    Related CONTENT
    • FDA Issues Draft Guidance on NDI Enforcement Discretion
    • FDA Rejects Two New Dietary Ingredient Notifications for CBD
    • UNPA Offering New GMP Training Course June 27-28
    • Dietary Supplement Associations to Host May 10 Seminar
    • AHPA: FDA Acknowledged About 25% of Recent NDI Notifications With No Objection
    08.23.16
    In response to the Aug. 11 publication of a revised new dietary ingredient (NDI) guidance by the Food and Drug Administration (FDA), the United Natural Products Alliance (UNPA) will conduct a one-day, immersive workshop in Salt Lake City, UT, on Thursday, Sep. 8, to analyze the 102-page document that fundamentally changes the regulatory status of thousands of dietary ingredients and dietary supplements.

    The workshop, “NDI GUIDANCE II & Substances Generally Recognized as Safe,” will include a presentation from and participation in extended Q&A sessions from Cara Welch, PhD, senior advisor for the Office of Dietary Supplement Programs. The conference, which will include case studies, audience polling and a comprehensive workbook, will address issues and concerns around a large number of the expected and not-expected provisions in the draft guidance, including:
    • Official FDA ODI List
    • NDI triggers
    • 'Master Files'
    • Synthetic botanicals
    • Impact on probiotics
    • 'Manufacturing Changes'
    • Budgeting for safety studies
    • 'Chemical Alteration'

    “Based on our initial analysis, FDA has structured this guidance to create a vastly larger universe of NDIs by virtue of limiting chemical alteration of food and food ingredients in the human diet and by treating most manufacturing changes as a trigger for NDI status,” said UNPA President Loren Israelsen, who will present a detailed overview of the guidance document. “The economic cost to industry could be billions of dollars. Understanding and responding to this FDA policy is an urgent priority.”
    • Workshop topics include:
    • The revised NDI guidance explained, plus FDA’s real-time responses
    • ODI/NDI determinations and associated costs
    • The intersection of NDIs and GRAS
    • Guidance vs. regulation: FDA’s enforcement game plan
    • Does Congress have a role in this process?
    • Cost implications and impacts

    “With the current comment period set to close Oct. 11, there is a great urgency to examine, understand and prepare comments as well as enhance individual company readiness to deal with NDIs—the No. 1 issue for the dietary supplement industry,” Mr. Israelsen added.

    For more information, the agenda, lodging information and to register, view/download the workshop program, or visit the UNPA website.
    Related Searches
    • Regulations
    • Dietary Supplements
    Related Knowledge Center
    • Regulations
    • Dietary Supplements
    Suggested For You
    FDA Issues Draft Guidance on NDI Enforcement Discretion FDA Issues Draft Guidance on NDI Enforcement Discretion
    FDA Rejects Two New Dietary Ingredient Notifications for CBD FDA Rejects Two New Dietary Ingredient Notifications for CBD
    UNPA Offering New GMP Training Course June 27-28 UNPA Offering New GMP Training Course June 27-28
    Dietary Supplement Associations to Host May 10 Seminar Dietary Supplement Associations to Host May 10 Seminar
    AHPA: FDA Acknowledged About 25% of Recent NDI Notifications With No Objection AHPA: FDA Acknowledged About 25% of Recent NDI Notifications With No Objection
    OmniActive to Acquire Indfrag OmniActive to Acquire Indfrag
    NPA to Host 2017 Natural Products Day on March 22 NPA to Host 2017 Natural Products Day on March 22
    In the Post-Election Lull, Cultivate Clinical Allies In the Post-Election Lull, Cultivate Clinical Allies
    State of the Industry Update & Outlook for 2017 State of the Industry Update & Outlook for 2017
    FDA’s NDI Draft Guidance: What Insiders Need to Know FDA’s NDI Draft Guidance: What Insiders Need to Know
    They’re Back … They’re Back …
    BASF to Highlight Novel Delivery Formats for Healthy Aging BASF to Highlight Novel Delivery Formats for Healthy Aging
    Industry Leaders to Address NDIs, Supply Chain Management at AHPA Botanical Congress Industry Leaders to Address NDIs, Supply Chain Management at AHPA Botanical Congress
    UNPA Welcomes Wasatch Scientific Services as New Member UNPA Welcomes Wasatch Scientific Services as New Member
    UNPA Signs MOU Partnership with Natural Algae Astaxanthin Association UNPA Signs MOU Partnership with Natural Algae Astaxanthin Association

    Related Content

    • Dietary Supplements | Regulations
      FDA Issues Draft Guidance on NDI Enforcement Discretion

      FDA Issues Draft Guidance on NDI Enforcement Discretion

      Amnesty for late NDI notifications is intended to encourage manufacturers and distributors to correct past failures while collecting safety data, FDA said.
      By Sean Moloughney, Editor 05.20.22

    • Herbs & Botanicals | Quality & Safety | Regulations | Regulatory News
      FDA Rejects Two New Dietary Ingredient Notifications for CBD

      FDA Rejects Two New Dietary Ingredient Notifications for CBD

      The decision likely means the agency will not approve future NDIs for CBD barring a directive from Congress.
      By Mike Montemarano, Associate Editor 08.13.21

    • Breaking News | Industry & Market News | Quality & Safety | Regulations

      UNPA Offering New GMP Training Course June 27-28

      Two-day course to be taught by former FDA investigator, UNPA’s Larisa Pavlick.
      04.25.17


    • Breaking News | Industry & Market News | Quality & Safety | Regulations

      Dietary Supplement Associations to Host May 10 Seminar

      FDA, industry experts will discuss key issues facing the market.
      04.17.17

    • Breaking News | Dietary Supplements | Industry & Market News | Quality & Safety | Regulations | Regulatory News

      AHPA: FDA Acknowledged About 25% of Recent NDI Notifications With No Objection

      Eighteen of 59 notifications were considered incomplete.
      03.27.17

      Trending
      • Vitamin D3, Omega-3s, Exercise May Cumulatively Reduce Cancer Risk In Older Adults | Nutraceuticals World
      • Leaven Essential To Launch Branded Botanical Extracts To Global Markets | Nutraceuticals World
      • Vitamin D3, Omega-3s, Exercise May Cumulatively Reduce Cancer Risk in Older Adults
      • Oregon Files Lawsuit Against GNC | Nutraceuticals World
      • Vitamin K2 Status May Impact Blood Pressure And Pulse Wave Velocity | Nutraceuticals World
      Breaking News
      • GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe
      • Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board
      • Expert Consensus Statement: Diet is Best Primary Intervention to Achieve Diabetes Remission
      • Choline Alone May Improve Maternal DHA Status During Pregnancy
      • Cranberry Consumption Linked to Memory and Neurological Function Improvements
      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

      GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe
      Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board
      Expert Consensus Statement: Diet is Best Primary Intervention to Achieve Diabetes Remission
      Coatings World

      Latest Breaking News From Coatings World

      What Are You Reading?
      Teknos Receives EcoVadis Gold Medal for Sustainability Performance
      AkzoNobel and Partners Team Up to Hack Carbon Reduction Challenges
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      MPO's Most-Read Stories This Week—May 21
      Iterative Scopes Expands its Senior Leadership Team
      Viz.ai Raises $100 Million in Series D Funding
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Piramal Pharma Solutions New API Plant in Canada Now Online
      MG America Appoints Claudio Radossi as President
      Catalent Invests $175M to Expand Mfg. Capabilities at Winchester, KY
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Authentic Beauty Concept Launches Second-Generation ‘Refill Bar’
      HASK Beauty Enters Exclusive Partnership with Amazon
      Garance Doré Launches Made in France Skincare Line
      Happi

      Latest Breaking News From Happi

      P&G Closes HQ Due To Security Threat, Launches New Hair Care Line
      SPF Setting Spray, Lip Contour and Knotless Braids Are Hot Trends: Spate
      Nutrafol Launches Collagen Infusion
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Zeller+Gmelin, Sun Chemical and Kornit Top This Week’s News
      Nazdar Celebrates 100 Years with a New Look
      hubergroup Chemicals Exhibits at Paint India for First Time
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Brook + Whittle's new acquisition, SunDance goes to HP and more
      Specialty announces move to new facility
      Mark Andy hosts dealer's open house in Warsaw
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Weekly Recap: Kimberly-Clark to Expand Diaper, Wipes Production in Brazil; The Honest Company to Sell Diapers, Wipes at Walmart & More
      3M to Expand in Nebraska
      Nicely Offers Nonwoven Slitters, Winders
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      ODT's Most Read Stories This Week—May 21
      FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System
      Paragon 28 Rolls Out TenoTac 2.0 Hammertoe and Soft Tissue Repair
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: Graphene Flagship, Japan Display and LG Display Top This Week’s Stories
      Evonik Launches New Processing Aids for PV Wafer Cutting
      NREL Creates Highest Efficiency 1-Sun Solar Cell

      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