• 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
    Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges

    Blood Sugar Management: Personalized Testing Drives Home The Need for Early Intervention

    New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance

    Tapping Functional Beverages to Meet Modern Wellness Needs

    Adaptogens: Where Ancient Remedies Meet Modern Wellness Products
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    CRN Announces New Staff Appointments

    Food Supplements Europe: Most Consumers Use Dietary Supplements Safely

    True Westfjords Launches Dropi Cod Liver Oil Tonic

    Alkemist Labs Warns About Missing Components to Pesticide Testing

    Boswellia and Bengal Quince Fruit Extract Blend Linked to Respiratory Benefits
    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

    True Westfjords Launches Dropi Cod Liver Oil Tonic

    Alkemist Labs Warns About Missing Components to Pesticide Testing

    Boswellia and Bengal Quince Fruit Extract Blend Linked to Respiratory Benefits

    Largest Cannabinoids Trial to Date Yields Positive Findings on Pain Management

    Kensing Acquires Vitae Naturals
    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

    CRN Announces New Staff Appointments

    Food Supplements Europe: Most Consumers Use Dietary Supplements Safely

    True Westfjords Launches Dropi Cod Liver Oil Tonic

    ODSP Director Cara Welch Discusses Agency Priorities

    Alkemist Labs Warns About Missing Components to Pesticide Testing
    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

    Boswellia and Bengal Quince Fruit Extract Blend Linked to Respiratory Benefits

    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products

    Lynside® Forte B offers full range of B-vitamin benefits with nutritional yeast

    CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise

    Shiitake Mushroom Extract Appears Helpful in HPV Infections
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Gencor

    Bioactive Resources

    Verdure Sciences

    Atlantia Clinical Trials

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

    Bioactive Resources

    Verdure Sciences

    Atlantia Clinical Trials

    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
    Online Exclusives

    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.

    FDA Issues Draft Guidance on NDI Enforcement Discretion
    Related CONTENT
    • Prinova
    • Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development
    • EIRICH Machines
    • IFT Annual Meeting Event Info
    • ProTab Labs to Prioritize Infant Formula Production
    By Sean Moloughney, Editor05.20.22
    FDA has issued a draft guidance on late submissions of New Dietary Ingredient (NDI) Notifications, saying it intends to exercise enforcement discretion “for a limited time and in limited circumstances,” to encourage manufacturers and distributors to correct instances where a premarket NDI notification was required, but never submitted. FDA is accepting comments on its draft guidance by Jul. 19, 2022.

    In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetics Act (FD&CA) to require premarket notification to FDA of “new dietary ingredients” at least 75 days before introduction into interstate commerce.

    Since that time, FDA has received about 1,200 NDI notifications. However, the agency has estimated that more than 4,600 NDI notifications should have been submitted and were not. 

    “A number of firms have told us informally that they realize they should have previously submitted notifications and have the information ready to be submitted, but they are afraid of drawing attention to themselves with a late submission,” FDA’s draft guidance states.

    As such, FDA said it does not intend to take enforcement action against firms based on a failure to comply with the requirement to file an NDI notification in a timely fashion.

    Offering companies amnesty and allowing for late submissions would also help the agency gain additional safety information about the dietary supplement marketplace, according to FDA, which acknowledged its efforts to reform and modernize regulation.

    In the 7-page draft guidance, FDA stated: “Once we have more evidence about the identity and safety of NDI-containing dietary supplements in the marketplace, we will be able to better prioritize our enforcement efforts and protect consumers against products that do not satisfy the applicable safety standards.”

    “We remain committed to a flexible framework for dietary supplements that ensures the safety of these products for consumers,” Cara Welch, PhD, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said in a press release.

    Firms will be able to submit their NDI notifications within 180 days following the publication of a notice in the Federal Register announcing that the final version of the guidance document is available.

    NDI Guidance: History and Context
    What’s an NDI and when is a notification required? FDA has not established or accepted a master list of “old” dietary ingredients that were present in the food supply at the time of DSHEA’s passage.

    FDA released its initial draft guidance on NDI notifications in 2011, revised the draft in 2016, and has never issued a final guidance document on the process, leaving stakeholders to navigate uncertain terrain.

    For example, do companies invest the time and resources in filing an NDI, risk rejection, and potentially put themselves at a competitive disadvantage? Many have sidestepped NDI filing and opted for the Generally Recognized As Safe (GRAS) process for substances intended to be added to food.

    The self-determination GRAS procedure does not require FDA’s review or approval of scientific evidence gathered to demonstrate a substance is safe under the conditions of intended use. However, companies can voluntarily file a GRAS notice with FDA.

    “This guidance doesn’t deal with anything new. It doesn’t clarify anything. I don’t see why this has any real value to anyone, except for FDA,” said Daniel Fabricant, president and CEO of the Natural Products Association (NPA).

    When the NDI draft guidance was first published in 2011, Fabricant was the director of the Division of Dietary Supplement Programs (now an Office at NIH). Many of the same issues remain today because the FDA seems unwilling or unable to enforce existing regulations, he said.

    Conducting safety studies for an NDI dossier can be expensive—upward of $1 million for an ingredient without a history of traditional use. Copycat and knockoff products based on legitimate NDI filings continue to be a major problem, according to Fabricant.

    “If you spend the money, FDA doesn’t protect your investment. As soon as you get a ‘good day letter’ someone knocks you off for pennies on the dollar because FDA doesn’t enforce … If you say ‘mine’s the same’ but you don’t have to prove it, that’s insane.”

    Recently, the agency has issued a string of warning letters to companies selling ingredients that it believes are subject to the premarket NDI notification requirement, including CBD.

    During Fabricant’s tenure at FDA the agency sent a series of warning letters to companies selling DMAA. “When they didn’t comply we went right to the next level. We didn’t wait," he said. "If you’re going to send a warning letter you better follow it up with some real action. If you’re not then it doesn’t mean anything. The agency doesn’t seem to get that.”

    Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), encouraged companies with products in the market that are clearly using new dietary ingredients to take advantage of this opportunity and submit data to FDA demonstrating safety of their products.

    “Unfortunately, the concerns the agency expressed are partially of its own making by failing to provide a clear direction for when an NDI notification is required and failing to enforce the existing requirements,” Mister said. “FDA has refused to develop an authoritative list of grandfathered ingredients—or to accept as authoritative—the well-documented lists developed by the industry. Eleven years after FDA first proposed a draft guidance to clarify when an ingredient qualifies as ‘new,’ consumers and industry alike are still waiting for the agency to finalize that guidance.”

    He added, “FDA cannot expect firms to submit their safety dossiers and manufacturing processes for possible objection when it provides neither meaningful consequences for the failure to file nor a clear roadmap for when an NDI notification is necessary.” 

    What to File?
    If a company submits a late notification consistent with FDA’s enforcement discretion policy, it must include the information required under section 413(a)(2) of the FD&C Act and 21 CFR 190.6, including information to support a conclusion that a dietary supplement containing the NDI will reasonably be expected to be safe.

    FDA also recommended that firms provide a copy of the current label for the dietary supplement and documentation that the NDI-containing dietary supplement described in the notification was marketed in the U.S. as of May 20, 2022.

    With respect to what information you should provide to support a conclusion that your product is reasonably expected to be safe, FDA noted that companies are not limited in what evidence to rely on. “In general, we suggest including a history of safe use, safety studies, or both,” the guidance stated.

    “We suggest that you also include any evidence related to the history of your product’s use since it has been on the market, including any customer complaints and adverse events (whether serious or non-serious) associated with the product. If you conclude that the product’s history of use does not raise safety concerns, you should explain how you reached that conclusion.”

    Process and Expectations
    FDA said it intends to prioritize review of these submissions. “However, although we expect to confirm receipt of your submission within 75 days after we receive it, we do not anticipate being able to complete our scientific evaluation and provide a response within 75 days after receipt,” the agency said.

    “We encourage early communication and discussion so that you can obtain initial feedback on the kind of information to provide and how to provide it. Furthermore, if you are uncertain as to the regulatory status of your product, you may contact us within the first 90 days of the enforcement discretion period with questions about whether your product is subject to the requirement for premarket notification or other questions you may have regarding your product’s status.”

    Fabricant noted that FDA has 75 days to respond to a company that files an NDI. “If they don’t respond on day 75 that’s effectively an acknowledgement letter. So people need to understand that as well,” he said. 
    Related Searches
    • Regulations
    • Dietary Supplements
    Related Knowledge Center
    • Dietary Supplements
    • Regulations
    Suggested For You
    Prinova Prinova
    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development
    EIRICH Machines EIRICH Machines
    IFT Annual Meeting Event Info IFT Annual Meeting Event Info
    ProTab Labs to Prioritize Infant Formula Production ProTab Labs to Prioritize Infant Formula Production
    Ensuring Quality Elderberry: INS Farms Discusses Authentication and Combatting Adulteration Ensuring Quality Elderberry: INS Farms Discusses Authentication and Combatting Adulteration
    Sempera Organics Launches, Introducing Standardized, Organic-Certified Mushroom Ingredients Sempera Organics Launches, Introducing Standardized, Organic-Certified Mushroom Ingredients
    Sen. Markey Introduces Bill Calling for Stricter GRAS Framework Sen. Markey Introduces Bill Calling for Stricter GRAS Framework
    FDA Debuts Dietary Supplement Education Initiative FDA Debuts Dietary Supplement Education Initiative
    Dietary Supplements Are Regulated, and Chronic Stress Has Been Normalized Dietary Supplements Are Regulated, and Chronic Stress Has Been Normalized
    New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance
    Chris Hillman Discusses Trends and Challenges in Today’s Competitive Job Market Chris Hillman Discusses Trends and Challenges in Today’s Competitive Job Market
    Tapping Functional Beverages to Meet Modern Wellness Needs Tapping Functional Beverages to Meet Modern Wellness Needs
    Adaptogens: Where Ancient Remedies Meet Modern Wellness Products Adaptogens: Where Ancient Remedies Meet Modern Wellness Products
    Senate HELP Committee Introduces FDA Safety and Landmark Advancements Act Senate HELP Committee Introduces FDA Safety and Landmark Advancements Act

    Related Live From Shows

    • Prinova

      Prinova

      Visit us at the IFT Annual Meeting, Booth #: S2010!
      07.01.22

    • Antioxidants | Energy | Functional Foods & Beverages | Herbs & Botanicals
      Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

      Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

      Ryan Wories, Director of Marketing at FutureCeuticals discusses the ingredient’s formulation potential and appeal to eco-conscious consumers.

    • EIRICH Machines

      EIRICH Machines

      ...
      06.22.22


    • IFT Annual Meeting Event Info

      IFT Annual Meeting Event Info

      ...
      06.21.22

    • Breaking News | Contract Manufacturing | Infant & Children's Health | Supplier News | World Markets
      ProTab Labs to Prioritize Infant Formula Production

      ProTab Labs to Prioritize Infant Formula Production

      The company is capable of customization, fast turnaround time, and in-house analytical lab services for quality control.
      06.16.22

    Loading, Please Wait..
    Trending
    • Three Grams Of Omega-3s May Be Optimal Dose For Reducing Blood Pressure
    • High Blood DHA Levels Linked To 49% Reduced Risk Of Alzheimer’s
    • CoQ10 And Royal Jelly Supplementation May Improve High Intensity Exercise
    • First Day Life Shuts Down Children's Behavioral, Cognitive Health Claims Following Challenge
    • Olive/Pomegranate Extract May Improve Dyslipidemia
    Breaking News
    • CRN Announces New Staff Appointments
    • Food Supplements Europe: Most Consumers Use Dietary Supplements Safely
    • True Westfjords Launches Dropi Cod Liver Oil Tonic
    • Alkemist Labs Warns About Missing Components to Pesticide Testing
    • Boswellia and Bengal Quince Fruit Extract Blend Linked to Respiratory Benefits
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • Tapping Functional Beverages to Meet Modern Wellness Needs
    • Adaptogens: Where Ancient Remedies Meet Modern Wellness Products
    • New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance
    • Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges
    • Blood Sugar Management: Personalized Testing Drives Home The Need for Early Intervention
    • 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

    CRN Announces New Staff Appointments
    Food Supplements Europe: Most Consumers Use Dietary Supplements Safely
    True Westfjords Launches Dropi Cod Liver Oil Tonic
    Coatings World

    Latest Breaking News From Coatings World

    Waterborne Symposium Issues 2023 Call for Papers
    JNS-SmithChem Acquires Gulf Coast Chemical in Tampa, Florida
    Teknos Makes its Coatings with Help of Solar Power in Rajamäki, Finland
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    3M to Shed Neoplast, Neobun Brands
    FDA OKs Ra Medical Systems' DABRA 2.0 Catheter
    Hyperfine Leader Dave Scott to Step Down
    Contract Pharma

    Latest Breaking News From Contract Pharma

    TCG Lifesciences Inaugurates New R&D Facility in Pune
    Fujifilm Investing $1.6B to Expand Cell Culture Manufacturing Services
    Sharp Expands Clinical Services Operations at Heerenveen Facility
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Kevyn Aucoin Beauty To Launch Contour Eyeshadow Palettes
    Junoco Promotes #ToBeHuman Campaign
    Old Spice and Arby’s Launch Limited-Edition Meat Sweat Defense Kit
    Happi

    Latest Breaking News From Happi

    Sustainability Expert Aris Vrettos Joins Croda
    PCA Skin Introduces New Pigment Gel Pro Dark Spot Treatment
    Deadline Nears for NJ Recycled Content Law
    Ink World

    Latest Breaking News From Ink World

    BASF Venture Capital Invests in Climentum Capital’s First Fund
    JNS-SmithChem Acquires Tampa-Based Gulf Coast Chemical
    Quad Added to Membership of US Small-Cap Russell 2000 Index
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Optimum Group acquires Labelco
    Provident announces appointment of Jake Garner
    APR announces VP promotions
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Heartland Polymers Begins Polypropylene Production in Alberta
    Malowaniec Receives Lifetime Achievement Award from EDANA
    Weekly Recap: Lifetime Technical Achievement Award Presented to Richard Knowlson, Alkegen Completes Luyang Acquisition & More
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    SpineX Begins SCONE Clinical Trial
    First Patient Enrolled in BioRestorative Therapies' Chronic Lumbar Disc Disease Trial
    Zimmer Biomet Creates Independent Philanthropic Non-Profit Coalition
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    NREL Scientists Explore How to Make PV Even Greener
    ams OSRAM Announces Closing of Sale of AMLS Business to Plastic Omnium
    Confidex’s Carrier Dual Delivers Shared RAIN RFID and NFC Memory

    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