• 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
    Researchers Develop New Global Estimate of Medicinal Plant Species and Conservation Status

    All Eyes on Vision Health

    Health Benefits of Vitamin K: A Contemporary Cornerstone of Heart and Bone Health

    Vitamin D: A Fixture of Supplementation and Fortification

    Magnesium: An Essential Mineral with Many Forms and Functions
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Pycnogenol Supplementation Linked to Hair Density in Menopausal Women

    BAPP Paper Reviews Common Adulteration Practices Which Go Undetected

    CRN Announces Promotions and Welcomes New Staff Member

    Quercetin Ingredient Linked to Improved COVID-19 Recovery: Study

    Dr. Ranjini Murthy Joins Azelis Americas as SVP of Commercial and Digital Excellence
    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

    Pycnogenol Supplementation Linked to Hair Density in Menopausal Women

    BAPP Paper Reviews Common Adulteration Practices Which Go Undetected

    CBD Expectations: What Happens at FDA and Congress After Agency Seeks New Regulatory Pathway?

    Quercetin Ingredient Linked to Improved COVID-19 Recovery: Study

    Pomegranate Extract Tied to Gut and Skin Microbiome Benefits
    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

    Pycnogenol Supplementation Linked to Hair Density in Menopausal Women

    BAPP Paper Reviews Common Adulteration Practices Which Go Undetected

    CBD Expectations: What Happens at FDA and Congress After Agency Seeks New Regulatory Pathway?

    Quercetin Ingredient Linked to Improved COVID-19 Recovery: Study

    Pomegranate Extract Tied to Gut and Skin Microbiome Benefits
    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

    Pycnogenol Supplementation Linked to Hair Density in Menopausal Women

    Quercetin Ingredient Linked to Improved COVID-19 Recovery: Study

    Pomegranate Extract Tied to Gut and Skin Microbiome Benefits

    Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients

    Vitamin D Supplementation Reduces Risk of Dynapenia
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Verdure Sciences

    Bioenergy Life Science, Inc. (BLS)

    Bioactive Services

    JRS Pharma

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

    Bioenergy Life Science, Inc. (BLS)

    Bioactive Services

    JRS Pharma

    PhytoGaia 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
    Blog

    24 Years After DSHEA, Industry Still Lacks ODI Clarity

    An FDA-sanctioned database would alleviate uncertainty about the regulatory status of many dietary ingredients.

    24 Years After DSHEA, Industry Still Lacks ODI Clarity
    Related CONTENT
    • CBD Expectations: What Happens at FDA and Congress After Agency Seeks New Regulatory Pathway?
    • Regulatory Challenges Persist for Dietary Supplement Stakeholders
    • Manufacturing Gummies: Opportunities for Nutraceuticals and Pharmaceuticals
    • FDA Warning Letters Take Aim at Foods and Beverages Containing CBD
    • NDI Déjà vu: Another Ingredient Falls Victim to FDA’s Interpretation of Drug Preclusion Clause
    By Duffy MacKay, ND, Senior Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition04.02.18
    True or false: Companies ready to put a new product to market have clear direction on the status of ingredients.
     
    This seems simple enough. Old dietary ingredients (ODIs) are dietary ingredients marketed in the United States before Oct. 15, 1994, when the Dietary Supplement Health and Education Act (DSHEA) was enacted. Juxtaposed with new dietary ingredients (NDIs), which require manufacturers to submit a pre-market notification to FDA at least 75 days before a dietary supplement is marketed, ODIs are not subject to this pre-market review. Super easy and clear, right?
     
    Wrong. Under the current system, companies have limited resources and often no way of knowing if an ingredient is an ODI. A heavy burden on manufacturers, especially those new to the industry, the absence of an authoritative list of ingredients exempt from NDI notifications forces companies to dig up old evidence such as advertisements, marketing brochures, scientific literature, and internal documents in order to provide the necessary evidence required by FDA before a product hits store shelves.
     
    Info on ‘Identity’
    There are thousands of common vitamins, minerals, botanicals, and other ingredients that were indisputably on the market pre-DSHEA. However, a 1993 magazine ad marketing chamomile may not be enough to get the green light from regulators. FDA suggests it would need to receive information that describes the “identity” of the ingredient, such as the plant part, type of extract (water, alcohol, etc.), the ingredient source, or the manufacturing method.
     
    But how many of us have 24-year-old documents at our disposal? Do you have a way to open the files on that eight-inch floppy you found buried in a box somewhere? Do you have immediate access to a microfilm reader? To assume companies would have maintained these types of records is unreasonable, which is why a publicly available, FDA-sanctioned database of ODIs would alleviate the uncertainty and burden of gathering proof for companies, allowing them to have clarity about dietary ingredients. So, what’s the holdup?
     
    Back in 1994, after DSHEA passed, the leading industry trade associations and their members compiled lists of ingredients the new law had declared “grandfathered.” Unfortunately, in the 2011 NDI Draft Guidance, FDA stated that in the absence of supporting evidence, these lists were not enough to serve as an authoritative resource. This decision spurred a diverse set of opinions regarding the best path forward among stakeholders. Has too much time passed to be able to provide FDA with sufficient evidence to make a meaningful list? If a company does have access to the requested evidence, will they use it as an opportunity to make money instead of sharing it openly? Perhaps industry does not have an obligation to do anything and the burden of gathering documentation is instead FDA’s?
     
    Creating Clarity
    We’ve had a quarter of a century to think this over. Generally supportive of FDA’s willingness to develop a pre-DSHEA ingredient list, industry recognizes such a list would not only benefit supplement manufacturers, but FDA—and even consumers—as well, so long as it is appropriately crafted and tailored in collaboration with stakeholders.
     
    FDA’s current efforts toward developing an ODI list is an opportunity to create clarity as to the regulatory status of a wide variety of dietary ingredients, but CRN calls for something more: a list that includes the entire universe of ingredients that do not require NDI notification. This family of ingredients includes:

    • Pre-DSHEA ingredients
    • NDIs filed with no objection since Oct. 15, 1994
    • Unaltered ingredients in the food supply
    Of course, all finished dietary ingredients are required by the Food, Drug, and Cosmetic Act to be safe and free of adulteration. Even with products that include ingredients exempt from notification, manufacturers are bound by law to evaluate the safety of finished products. Still, a more complete list of ingredients from FDA would eliminate the laborious and redundant processes currently facing companies and would allow FDA to better focus its regulatory and enforcement priorities.
     
    Considering the stakeholder input it has received over the past two and a half decades, FDA is now tasked with conducting a close investigation of the resources available and evaluating the pros and cons of moving forward on this project. In the meantime, the current NDI draft guidance remains the agency’s most current thinking on the topic, and companies would be wise to follow those processes. If a company is unsure about whether an ingredient needs notification, CRN suggests consulting a trade association, a regulatory attorney, or FDA directly. If you ask, you may not like the answer, but at least there will be clarity.

    Duffy MacKay, ND, is the senior vice president, scientific & regulatory affairs, Council for Responsible Nutrition (CRN), a leading trade association for the dietary supplement and functional food industry.
    Related Searches
    • crn
    • DSHEA
    • fda
    • vitamins
    Related Knowledge Center
    • Dietary Supplements
    • Regulations
    Suggested For You
    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?
    Regulatory Challenges Persist for Dietary Supplement Stakeholders Regulatory Challenges Persist for Dietary Supplement Stakeholders
    Manufacturing Gummies: Opportunities for Nutraceuticals and Pharmaceuticals Manufacturing Gummies: Opportunities for Nutraceuticals and Pharmaceuticals
    FDA Warning Letters Take Aim at Foods and Beverages Containing CBD FDA Warning Letters Take Aim at Foods and Beverages Containing CBD
    NDI Déjà vu: Another Ingredient Falls Victim to FDA’s Interpretation of Drug Preclusion Clause NDI Déjà vu: Another Ingredient Falls Victim to FDA’s Interpretation of Drug Preclusion Clause
    Council for Responsible Nutrition (CRN) Council for Responsible Nutrition (CRN)
    Adulterants Prevention Program Releases Best Practices on Adulterated Ingredients Adulterants Prevention Program Releases Best Practices on Adulterated Ingredients
    Immune Health Uninterrupted: Year-Round Attention Highlights Prevention’s Value Immune Health Uninterrupted: Year-Round Attention Highlights Prevention’s Value
    Did White Mulberry Leaf Kill Loretta McClintock? There’s Good Reason to Be Skeptical Did White Mulberry Leaf Kill Loretta McClintock? There’s Good Reason to Be Skeptical
    ‘Prohibited Acts’ Provision Could Be Used to Target Law-Abiding Companies & Legit Dietary Ingredients ‘Prohibited Acts’ Provision Could Be Used to Target Law-Abiding Companies & Legit Dietary Ingredients
    A Deep Well for Hydration, Complex Flavors, and Health Ingredients A Deep Well for Hydration, Complex Flavors, and Health Ingredients
    Beneath the Surface: Delivering Beauty Benefits with Proven Functional Ingredients Beneath the Surface: Delivering Beauty Benefits with Proven Functional Ingredients
    ADM delivers clean label dietary supplements for today’s health-conscious consumers. ADM delivers clean label dietary supplements for today’s health-conscious consumers.
    Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    A Growing Herbal Products Market Still Faces Formidable Threats, Challenges A Growing Herbal Products Market Still Faces Formidable Threats, Challenges

    Related Online Exclusives

    • Dietary Supplements | Herbs & Botanicals | Regulations
      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?

      Stakeholders disappointed by agency inaction but welcome chance to influence legislation.
      By Sean Moloughney, Editor 01.31.23

    • Dietary Supplements | Regulations
      Regulatory Challenges Persist for Dietary Supplement Stakeholders

      Regulatory Challenges Persist for Dietary Supplement Stakeholders

      Experts discussed structure-function claims, drug preclusion issues, and more at AHPA’s Regulatory Congress.
      By Mike Montemarano, Associate Editor 12.20.22

    • Consumer Trends | Contract Manufacturing | Delivery & Dosage Technologies | Dietary Supplements
      Manufacturing Gummies: Opportunities for Nutraceuticals and Pharmaceuticals

      Manufacturing Gummies: Opportunities for Nutraceuticals and Pharmaceuticals

      Fueled by consumer preference, process innovations are opening up new possibilities in dose delivery.
      By Michael Stott, Partner, Mathys & Squire LLP 12.12.22


    • Dietary Supplements | Herbs & Botanicals | Regulations
      FDA Warning Letters Take Aim at Foods and Beverages Containing CBD

      FDA Warning Letters Take Aim at Foods and Beverages Containing CBD

      Recent batches of warning letters signal the agency’s focused on more than disease claims.
      By Mike Montemarano, Associate Editor 11.28.22

    • Dietary Supplements | Regulations
      NDI Déjà vu: Another Ingredient Falls Victim to FDA’s Interpretation of Drug Preclusion Clause

      NDI Déjà vu: Another Ingredient Falls Victim to FDA’s Interpretation of Drug Preclusion Clause

      Agency rejected an NDI notification from Kingdomway saying beta nicotinamide-mononucleotide was first investigated as a new drug.
      By Mike Montemarano, Associate Editor 11.15.22

    Loading, Please Wait..
    Trending
    • Vitamin D Supplementation Reduces Risk Of Dynapenia
    • NOW Switches To Bottles Made From 100% Post-Consumer Recycled Resin
    • Shiitake Mushroom Extract Appears Helpful In HPV Infections
    • CBD Expectations: What Happens At FDA And Congress After Agency Seeks New Framework?
    Breaking News
    • Pycnogenol Supplementation Linked to Hair Density in Menopausal Women
    • BAPP Paper Reviews Common Adulteration Practices Which Go Undetected
    • CRN Announces Promotions and Welcomes New Staff Member
    • Quercetin Ingredient Linked to Improved COVID-19 Recovery: Study
    • Dr. Ranjini Murthy Joins Azelis Americas as SVP of Commercial and Digital Excellence
    View Breaking News >
    CURRENT ISSUE

    Jan/Feb 2023

    • Healthy, Clean Label Snacks and Nutrition Bars Help Fill Nutrient Gap Cleaved By Modern Lifestyles
    • Magnesium: An Essential Mineral with Many Forms and Functions
    • Vitamin D: A Fixture of Supplementation and Fortification
    • Health Benefits of Vitamin K: A Contemporary Cornerstone of Heart and Bone Health
    • All Eyes on Vision Health
    • Researchers Develop New Global Estimate of Medicinal Plant Species and Conservation Status
    • 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

    Pycnogenol Supplementation Linked to Hair Density in Menopausal Women
    BAPP Paper Reviews Common Adulteration Practices Which Go Undetected
    CRN Announces Promotions and Welcomes New Staff Member
    Coatings World

    Latest Breaking News From Coatings World

    ROSS Offers Heavy-Duty Three Roll Mills for High Viscosity Dispersions
    PPG Achieves ISO 14001 Certification of Environmental Management System
    AmCoat’s Rhino Shield and Floor Shield Break Records in 2022
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA Clears H2o Therapeutics' Parkinson's Disease Monitoring App
    MICRO's Costa Rica Facility Achieves ISO 13485:2016 Certification
    FDA Clears SafeSource Direct's Nitrile Exam Gloves
    Contract Pharma

    Latest Breaking News From Contract Pharma

    HPNE Launches New Approach to Single-Use Assembly Production
    Andelyn Biosciences, Odylia Therapeutics Partner to Manufacture Gene Therapy for Vision Loss
    Lonza Breaks Ground on Commercial Drug Product Facility in Stein
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L’Oréal Group Recognized by Bloomberg Gender-Equality Index 2023
    Unilever Ventures Invests in Aussie Scalp Care Brand Straand
    La Roche-Posay Named the Fastest Growing Skincare Brand of 2022 by NielsenIQ
    Happi

    Latest Breaking News From Happi

    Ross Introduces Heavy-Duty Three Roll Mills for High-Viscosity Dispersions
    Perfect Corp Partners with Beekman 1802 for New My Skin Biome Tool
    OPI’s Nature Strong Introduces Botanical Base Coat and New Colors
    Ink World

    Latest Breaking News From Ink World

    C3Nano Offers New SuperGrid Flexible Low-Temperature Ink
    ROSS Develops Heavy-Duty Three Roll Mills for High Viscosity Dispersions
    Alexander's Adds Two New HP Indigo 100K Digital Presses to Fleet
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Baker Labels invests in Digicon 3000 for flexible packaging division
    PIM promotes Kristin Pilling-Davis to executive director
    Stratus Packaging embraces automation with Bobst
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    WPT Nonwovens to Add Thermobonding Line in Kentucky
    Superior Felt & Filtration Adds Domestic Injection Molding to its Medical Filtration Capabilities
    Ahlstrom Launches New Generation FluoroFree Technology
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Solid Growth Ahead for Orthopedic Power Tools Market
    Mobi-C Cervical Disc Replacement Procedures Top 200,000
    OPUM, Corflex Global Partner on Knee Assessment Technology
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Alexander Everke Hands Over ams OSRAM CEO Position to Aldo Kamper
    Angèle Reinders Named New Director of Solliance
    C3Nano Launches New SuperGrid Flexible Low-Temperature Ink

    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