• 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
    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
    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

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort

    Cargill’s Stevia Sustainability Program Benchmarked by FSA

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

    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
    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

    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Beyond Raw Launches Concept X Pre-Workout Line

    Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort

    Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Applied Food Sciences, Inc.

    Aiya America, Inc. (Aiya Matcha)

    Gencor

    Atlantia Clinical Trials

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

    Aiya America, Inc. (Aiya Matcha)

    Gencor

    Atlantia Clinical Trials

    Verdure Sciences
    • 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

    FDA’s NDI Draft Guidance: What Insiders Need to Know

    The draft guidance is an intimidating document full of variables and shades of gray.

    FDA’s NDI Draft Guidance: What Insiders Need to Know
    Related CONTENT
    • FDA Issues Draft Guidance on NDI Enforcement Discretion
    • FDA Issues NAC Enforcement Discretion Guidance
    • Understanding Exclusion (Preclusion) and a Proposed Solution
    • Preliminary Research Suggests Osteoarthritis Benefits for Herbal Formula JointAlive
    • CHPA Encourages Members to Participate in Supplement OWL
    Kelly Waters, Marketing Manager, InstantGMP, Inc.11.21.16
    For many companies within the dietary supplements industry, complying with the Dietary Supplement Health and Education Act of 1994 (DSHEA) can be complicated and intimidating. The Food and Drug Administration (FDA) is trying to improve the overall rate of compliance to quality measures with the implementation of New Dietary Ingredient (NDI) regulation.
     
    To briefly summarize the draft guidance, the requirement to file an NDI hinges on whether a particular supplement was on the market before Oct. 15, 1994, specifically marketed as a dietary supplement in the U.S., and whether or not the key ingredient can be found in conventional food or drinks.
     
    Background
    From a 2012 report, the FDA estimated that the number of supplements on the market is about 55,600 with 5,500+ new supplements introduced to the market annually. This is a stark contrast to the estimate of 4,000 in 1994 when DSHEA was enacted.
     
    With so many new products on or coming onto the market, the FDA has struggled to keep up with compliance enforcement. In an effort to make dietary supplements safer and to ease their burden, the agency has exercised its authority to create clearer regulations in the form of pre-market approvals.
     
    Filing documentation for new drugs or investigative trials in pharma is standard, but for the dietary supplements industry, it will be a challenge—especially because the criteria, definitions, and requirements are difficult to interpret.
     
    2011 Draft Guidance Controversy
    DSHEA is the culmination of several decades of attempted regulations and in turn, was not seen as the last time the FDA would attempt to introduce more policies. In 2011, the FDA issued a draft guidance in an effort to introduce the concept of NDI notifications, among other topics, and was met with concern by stakeholders within the industry and outsiders. The author of DSHEA, Sen. Orrin Hatch (R-Utah) viewed the 2011 version as inconsistent with the original intent of the law.
     
    Within the supplements industry, the major independent organizations banded together to overhaul the proposed regulations. The American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA) banded together and urged the FDA to reconsider their original points regarding:
    • Definition of chemical alteration
    • Requirement for an NDI submission for every product from every manufacturer
    • Clarification of human-synthesized constituents of botanicals vs. plant synthesis
    • Shift the burden of proof that an ingredient does not need an NDI from the FDA to individual companies
    • Inability of companies to share data or cite another submission for an NDI notification
    • The final issue that these organizations wanted reconsidered related to the FDA’s disinterest in creating an authoritative list of grandfathered ingredients. Many lists had been compiled by these trade groups but were unofficial and would remain unrecognized by the FDA. The draft guidance was revised and now the current iteration has entered an extended commenting period.
     
    Defining New Dietary Ingredients
    A dietary ingredient is defined in the Food, Drug & Cosmetic Act (FD&C Act) 21 U.S.C. 201(ff)(1) as fitting into one of the following:

    A. Vitamin
    B. Mineral
    C. Herb or other Botanical
    D. Amino Acid
    E. Dietary Substance for use by humans to supplement the diet by increasing daily intake
    F. Concentrate, Metabolite, Constituent, or Extract
    G. Combination of A, B, C, D, or E

    However, lines are blurred when it comes to food additives or ingredients that are chemically altered pre-DSHEA. Thus, the FDA recommends contacting them for clarification.
     
    Essentially, a dietary ingredient must have an effect on the body. Ingredients used in a supplement that have no effect on the body must be approved for use. This can include additives or dyes. They must fall under the threshold of Generally Recognized as Safe (GRAS).
     
    Per 21 U.S.C. 32l(ff)(1)(a)(b)(d), vitamins; minerals; and amino acids can be synthetic. According to U.S.C. 32l(ff)(1)(c)(f), a synthetic copy of an herb or botanical is not an herb or botanical. For specific definitions and criteria, it is recommended that companies reference the 2011 FD&C Act guidance.
     
    The New Dietary Ingredient Notification Process Explained
    Any dietary supplement marketed in the U.S. after DSHEA must file an NDI notification with the FDA to demonstrate evidence of product safety to lawfully be marketed.
     
    The process is straightforward—yet cumbersome for manufacturers and distributors not familiar with current Good Manufacturing Practices (cGMP)—as much of the information required for the NDI notification should not be intimidating for companies already following GMPs.
     
    A manufacturer or distributor must submit the following in their NDI notification:
    • Specify an ingredient category
    • Information supporting that conclusion
    • Description of physical properties, chemical or molecular composition or structure of an ingredient
    • List of vendors and suppliers
    Specifications for raw materials and ingredients with critical identity attributes (this includes information about purity and strength, as well as the level and identities of impurities or contaminants)
    • Toxicity studies pertaining to the safety profile data including identities of No-Observed-Adverse-Effect-Level (NOAEL) and No-Observable-Effect-Level (NOEL)
    • Maximum Acceptable Daily Intake (ADI)
    • Information regarding the calculation of ADI
    • Animal studies/trials, if applicable
    • Manufacturing process (emphasis on detailing manufacturing steps where an ingredient might undergo a change in identity or purity and introduction of possible contaminants as well as in-process controls)

    NDI notifications can be electronically submitted. Once the notification has been filed, the FDA has 75 days to respond. Adding more information or making an update to the notification (such as changing the manufacturing process), the 75-day period restarts. Until the FDA has responded, the dietary supplement in question cannot be distributed or sold. In some cases, a new NDI notification is necessary.
     
    The FDA will respond with one of the following:
    • Letter of acknowledgement without objection
    • Letter of deficiencies to address under 21 CFR Part 190.6
    • Objection letter with information in safety gaps
    • Letter raising regulatory issues under 21 U.S.C. 32l(ff)(1) or 21 U.S.C. 32l(ff)(2)

    NDI notifications will be made public after a 90-day period. Companies wishing to keep their NDI notification private must inform the FDA during their submission. For example, if Company X wishes to keep Ingredient Y private, they may do so. However, a record of their filing and ingredient notification are accessible. Companies may reference other NDI notifications, but are still required to submit their data and evidence.
     
    Other Considerations Within the Draft Guidance
    Within the draft guidance, the FDA notes that changes in a serving level, source, manufacturing process, or chemical alterations require a new NDI notification submission. To the FDA, divergence from the original notification requires the creation of a new “safety profile.” Due to the variability in processing, what constitutes chemical alteration or “identity change” is unclear and highly situation-dependent.
     
    If an ingredient was initially authorized for investigation as a new drug or biologic, the FDA will not approve an ingredient for use as a dietary supplement even if that substance has undergone substantial studies, trials or investigations.
     
    The FDA is working on a list of pre-DSHEA dietary supplements and ingredients. The agency noted that it will not be a fully exhaustive list, as numerous exemptions and exceptions apply to those trying to be grandfathered in. Approval of an NDI notification does not absolve manufacturers and distributors from possible warnings and/or corrective action (Warning letters, audits, etc.).
     
    Summary
    Industry insiders are happy that the FDA is taking its dietary supplement compliance enforcement to a new level to increase safety, but worry that the requirements in the draft guidance will bottleneck the agency and create other enforcement problems. With the sheer amount of manufacturers and distributors, the onus is on them to proactively comply.
     
    The draft guidance is an intimidating document full of variables and shades of gray needing further clarification. However, companies that have implemented cGMP compliant workflows and controls will already have a majority of the information needed in an NDI notification already on-hand. Thus, it makes sense to become GMP compliant ahead of the finalized guidance.


    InstantGMP, Inc. is the creator of InstantGMP MES, an affordable, cloud-based compliance software designed for manufacturers of dietary supplements. For more information: www.instantgmp.com.
     
    Related Searches
    • Regulations
    • Dietary Supplements
    • Quality & Safety
    Related Knowledge Center
    • Quality & Safety
    • Regulations
    • Dietary Supplements
    Suggested For You
    FDA Issues Draft Guidance on NDI Enforcement Discretion FDA Issues Draft Guidance on NDI Enforcement Discretion
    FDA Issues NAC Enforcement Discretion Guidance FDA Issues NAC Enforcement Discretion Guidance
    Understanding Exclusion (Preclusion) and a Proposed Solution Understanding Exclusion (Preclusion) and a Proposed Solution
    Preliminary Research Suggests Osteoarthritis Benefits for Herbal Formula JointAlive Preliminary Research Suggests Osteoarthritis Benefits for Herbal Formula JointAlive
    CHPA Encourages Members to Participate in Supplement OWL CHPA Encourages Members to Participate in Supplement OWL
    GRMA Invites Participation in Developing GMP Standard for Dietary Supplements GRMA Invites Participation in Developing GMP Standard for Dietary Supplements
    AHPA: FDA Acknowledged About 25% of Recent NDI Notifications With No Objection AHPA: FDA Acknowledged About 25% of Recent NDI Notifications With No Objection
    2017 Trends to Watch 2017 Trends to Watch
    Herbalife: A Nutrition Leader in Transition Herbalife: A Nutrition Leader in Transition
    NPA to Host 2017 Natural Products Day on March 22 NPA to Host 2017 Natural Products Day on March 22
    State of the Industry Update & Outlook for 2017 State of the Industry Update & Outlook for 2017
    In the Post-Election Lull, Cultivate Clinical Allies In the Post-Election Lull, Cultivate Clinical Allies
    AlgaeHealth Files NDI for New Astaxanthin Dosage AlgaeHealth Files NDI for New Astaxanthin Dosage
    CRN Submits Comments on the Status of Vinpocetine CRN Submits Comments on the Status of Vinpocetine
    NPA Supports Lawful Marketing of Vinpocetine NPA Supports Lawful Marketing of Vinpocetine

    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

    • Dietary Supplements | Proteins, Peptides, Amino Acids | Regulations
      FDA Issues NAC Enforcement Discretion Guidance

      FDA Issues NAC Enforcement Discretion Guidance

      The agency maintains NAC was first approved as a new drug before it was marketed as a dietary supplement, but may issue a rule following NPA request.
      By Mike Montemarano, Associate Editor 04.21.22

    • Delivery & Dosage Technologies | Dietary Supplements | Herbs & Botanicals | Quality & Safety | Regulations
      Understanding Exclusion (Preclusion) and a Proposed Solution

      Understanding Exclusion (Preclusion) and a Proposed Solution

      Confusion regarding interpretation of language in the Food, Drug, and Cosmetic Act requires some clarification.
      By Todd Harrison, Venable 11.11.21


    • Bone & Joint Health | Breaking News | Dietary Supplements | Healthcare Trends | Herbs & Botanicals | Inflammation | Medical Nutrition | Natural/Organic | Research | Supplier News | World Markets
      Preliminary Research Suggests Osteoarthritis Benefits for Herbal Formula JointAlive

      Preliminary Research Suggests Osteoarthritis Benefits for Herbal Formula JointAlive

      Chenland Nutritionals’ formula saw significant results in an animal study, with a human clinical trial slated for completion in 2022.
      Mike Montemarano, Associate Editor 02.11.21

    • Breaking News | Dietary Supplements | Industry & Market News | Regulations

      CHPA Encourages Members to Participate in Supplement OWL

      Announcement follows discussions between CHPA and its Dietary Supplements Committee.
      04.17.17

      Trending
      • Leaven Essential To Launch Branded Botanical Extracts To Global Markets | Nutraceuticals World
      • Oregon Files Lawsuit Against GNC | Nutraceuticals World
      • Vitamin D3, Omega-3s, Exercise May Cumulatively Reduce Cancer Risk In Older Adults | Nutraceuticals World
      • Coca-Cola To Phase Out Honest Tea Brand By Year’s End, Citing Supply Chain Challenges | Nutraceuticals World
      Breaking News
      • Thorne Relaunches Gut Health Test with Microbiome Wipe
      • Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      • GC Rieber Foundations Expand Philanthropic Efforts
      • Danone Celebrates 10th anniversary of Grant Program for Probiotics Research
      • Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
      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

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      Pylon Coatings Uses Polygiene Biomaster & Verimaster for Antimicrobial Surface Protection
      Sto Corp. Recognized with Multiple Honors at the EIFS Hero Awards
      Powder Coatings Institute 2022 Scholarship Recipients Announced
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      In Vitro Diagnostic Medical Devices Regulation Takes Effect
      Brian Case Appointed Chief Technology Officer at KORU Medical
      Solid Growth Expected for India's Medical Device Sector
      Contract Pharma

      Latest Breaking News From Contract Pharma

      DFE Pharma Opens India CoE for Fast-Track Formulation Services
      Helsinn Establishes New R&D Hub in the U.S.
      CureVac, myNEO Partner on Antigen Targets for mRNA-Cancer Vax Development
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Carlyle To Acquire HCP Packaging
      Estée Lauder Companies Faces Class Action Lawsuit
      La Roche-Posay Launches Matte Moisturizer for Oily Skin
      Happi

      Latest Breaking News From Happi

      AspenClean Plastic-Free Detergents Now Available in the US
      Rhode Island Senate Looks to Pass Legislation to Move Wellness Supplements Behind the Counter
      Insect Repellent Market Expected to Surge Through 2031
      Ink World

      Latest Breaking News From Ink World

      NAPIM’s Virtual Digital & Emerging Technologies Conference is Back, June 14–15, 2022
      CEMATEX Introduces Online Business Platform to Connect Global Textile Community
      PICO Chemical Celebrates 46 Years
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Zeller+Gmelin named Berry Global’s 2021 Ink Supplier of the Year
      Videojet and Loftware partner to accelerate labeling automation
      Scratch Off Systems acquires HP Indigo 7K digital press
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Emovi, Geneva Foundation Providing Knee Treatment Tech to U.S. Army
      Study Confirms Knee Shapes are Highly Individualized
      Stryker Launches EasyFuse Dynamic Compression for Foot & Ankle
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      ams OSRAM Introduces New Horticulture LEDs
      Avery Dennison Launches AD Twist U7XM Inlays
      ARPA-E Funding Drives Innovation, Industry Partnerships at NREL

      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