• 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
    Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains

    Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality

    Nutrition and Flavor: Formulating for Modern Product Preferences

    What Do Consumers Know About the Gut Microbiome?

    How Will the European Green Deal Impact Dietary Supplements?
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market

    Tazo Transitions to Regenerative Organic Agriculture

    Protein Ingredient Formulated for Chronic Kidney Disease Patients

    IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations
    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

    Fact or Myth: Antioxidants Negatively Impact Iron Absorption

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market

    Tazo Transitions to Regenerative Organic Agriculture

    Protein Ingredient Formulated for Chronic Kidney Disease Patients
    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

    Fact or Myth: Antioxidants Negatively Impact Iron Absorption

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market

    Tazo Transitions to Regenerative Organic Agriculture

    Protein Ingredient Formulated for Chronic Kidney Disease Patients
    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

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits

    Monk Fruit Sweetener May Have Prebiotic Activity, Study Finds

    People with Low-Fiber Diets Benefit the Most from Fiber Supplements, Study Finds

    Gut Microbiome May Be Part of Link Between Red Meat and Heart Disease Risk
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Gencor

    Nutrition21, LLC

    KLK OLEO

    Xsto Solutions

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

    Nutrition21, LLC

    KLK OLEO

    Xsto Solutions

    ESHA Research
    • 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

    Dietary Supplement Leaders Lament Pitfalls of FDA’s Approach to NDIs

    Novel dietary ingredients often eschew a required approval process, and execs say this breeds adulteration, low-quality knockoffs, and possible health risks.

    Dietary Supplement Leaders Lament Pitfalls of FDA’s Approach to NDIs
    Industry experts say that selective enforcement against ingredients that don't get approved hurts both the industry and consumers.
    Related CONTENT
    • Food Processing for Health and Wellness
    • Formulating for Nutrient Bioavailability
    • JAMA: FDA Warning Letters Fail to Result In Removal of Illegal Supplement Ingredients
    • NJ Labs Warns Industry of FDA Warning Letters on Water Testing
    • Substantiating Environmental, Social, and Governance Claims
    By Mike Montemarano, Associate Editor12.07.20
    During one of several discussions held at The Big Natural, an event hosted by the Natural Products Association (NPA), dietary supplement executives discussed some of the pitfalls that come with the way the U.S. Food and Drug Administration currently enforces the New Dietary Ingredient (NDI) policy.
     
    Since the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, a company introducing a novel dietary ingredient that wasn’t commonly used for human consumption prior to 1994 is required to file suitable documentation with the FDA which thoroughly covers safety information. Few new dietary ingredients have actually made it through this process, which DSHEA requires; and FDA, by and large, does not take enforcement actions against manufacturers and sellers who eschew the process.
     
    “We want the agency to tell us, ‘here’s the law, here’s the punishment, and here’s how to avoid such a result.’ While people know the rules, they’re not acting on them,” said Vaughn DuBow, North American marketing manager, Lonza.
     
    “A lot of [companies] have just decided that this process is time consuming, and they’re going ahead and releasing a product to market in the off chance that no one will ever care,” said Mark LeDoux, CEO of Natural Alternatives International and chairman of the board at NPA. “50,000 new products have entered the marketplace since the passage of DSHEA. This entails safety data, toxicology data, and more—it’s a very thorough submission which allows the agency to do a deep dive into the processes and the science.”
     
    Especially in the botanicals category, eschewing the NDI process exacerbates the presence of bad actors who attempt to sell fraudulent ingredients or finished products which don’t contain the active compounds or nutrients they promise.

    Adulteration
    Travis Borchardt, vice president of regulatory affairs and QC/QA at Nature’s Way, described just how concerning this “regulatory gap,” as the FDA describes it, has been for elderberry, a botanical tied to immune support which has seen unprecedented spikes in demand since the onset of the COVID-19 pandemic.
     
    Without the publication of an NDI notification to back claims that an elderberry product contains not only elderberry, but an efficacious amount of bioactive components, for example, the burden lies on ingredient buyers and those within the supply chain to test products to confirm they are in fact sourced from the materials they claim to be.
     
    “Some of the raw materials offered to us had zero elderberry within them, simply a mimic,” Borchardt said. “The costs per kilo of elderberry, however, show that you get what you pay for, with a range of anywhere from $12 to $550 per kilo.”
     
    “This is not just elderberry,” Borchardt continued. “It happens over the years with all sorts of botanicals that become very popular and observe a spike. Revenue opportunity means opportunities for cheating, and incentives to play around with the supply chain when there are shortages spurred by incredible demand […] it’s a very confusing space for the consumer in terms of determining the value of what they’re buying.”
     
    With the new updates to FDA compliance guidance in the works, however, Borchardt said he remains optimistic regarding statements being made about the agency’s inspection priorities, and the agency’s acknowledgement of the challenges involved in identity and strength testing as part of its routine inspections.

    The Knock-Offs
    Beyond adulteration creating confusion for consumers, a lack of differentiation on nuanced products types such as extracts that comes with an absence of NDI enforcement seriously muddles categories such as collagen, DuBow, said.
     
    “It entails spending millions of dollars developing a product, just so someone else can steal the idea,” he said. “It’s not fair, it’s not right, and the ‘regulatory gap’ is here to stay.” FDA has indicated that “it will persist no matter how many resources are made available,” he said.
     
    With Lonza’s UC-II undenatured type II collagen ingredient, the company saw firsthand what happens when a competitor neglects to meet NDI requirements.
      
    “We performed tons of studies on the efficacy and mechanism of action of UC-II, investing about $4 million on research and development alone,” DuBow said. “Very little money is being spent by the companies that don’t do this.”
     
    Soon enough, a competing product was launched at a significantly lower cost, which led Lonza to suspect the competing product couldn’t be adhering to the same standards for the price. Internal testing of the competing product revealed that the competitor’s testing method of their collagen product actually denatured it, which is known to create bioavailability issues upfront.
     
    Further, comparisons in solubility showed stark differences between the two competing products’ abilities to disperse in water, DuBow said. Lastly, standard testing methods revealed that while Lonza’s product exceeded label claims, the competitor’s product contained less than one-fourth of the claimed undenatured type II collagen.
     
    Because the competing company did not go through the NDI process, which entails a deep analysis of the chemical composition surrounding its collagen, any issue the agency would take with purity, strength, or efficacy was put on the back-end, rather than dealt with upfront.
     
    “Our competitor claimed that their ingredient was exempt from an NDI, without having proven that their collagen product was present in the food supply, and without having proven that it was not chemically altered, despite our tests which show that it was hydrolyzed,” DuBow said. “The definition of an NDI, according to DSHEA, is a vitamin, mineral, herb, botanical, amino acid, or other dietary substance for use by man to supplement the total dietary intake; and it’s been that way since 1994 for anything that wasn’t marketed in the U.S. as a supplement prior. It might sound like everything under the sun, and that the law is black and white, but it’s not.”

    Untested Synthetics, Too?  
    Marc Ullman, an attorney with Rivkin Radler specializing in FDA regulatory issues, described perhaps the most pressing of all issues pertaining to the NDI issue: adverse events among consumers.
     
    He chronicled the advent of a supplement called BioPQQ, an organically-made version of an antioxidant called PQQ, found abundantly in a wide variety of foods, which went through 25 clinical trials prior to the company filing an NDI notification with FDA, with extensive safety and toxicology data to boot.
     
    Shortly after BioPQQ hit the market, a number of synthetically-produced PQQ ingredients were launched—all of which are untested and potentially dangerous given adverse events recorded during in vitro clinical trials. Ullman said that test animals used in preclinical trials on synthetic PQQ were developing tumors, for example.
     
    Due to several problems, competitors had their NDIs rejected—not only because of safety and toxicology concerns, but also because, as a synthetic ingredient, PQQ which is not manufactured organically is not a dietary ingredient, Ullman said.
     
    “A synthetic copy of a dietary substance is not a dietary substance,” he said. “It’s also not reasonably safe for human consumption because there’s no explanation about why test animals are developing kidney tumors. After several NDIs were rejected, this competing company decided to submit a GRAS (Generally Recognized As Safe) notification to FDA. The FDA, operating in silos with people who weren’t informed that this ingredient had a history of rejected NDI notifications, took no action. This case is a poster child of the left hand not talking to the right hand, with neither hand even speaking to the brain,” Ullman continued.
     
    “What does it take for FDA to act? Is everything short of liver failure and death okay? […] This is an apocryphal story and it’s the kind of thing that should concern everybody in the supplement trade. Knockoff, low-quality ingredients with impurities are hurting consumers.”

    At least to start with, NPA has long supported the idea that FDA should issue import alerts on any new dietary ingredient that enters the U.S. without first receiving NDI approval. However, its advocacy efforts have been to no avail. Despite all this, until NDI enforcement does occur, the trade association anticipates the market will still see unapproved NDIs, leaving the burden of differentiating approved products upon companies, third-party testing facilities, and others. 
     
    Related Searches
    • Testing
    • Contract Manufacturing
    • Quality & Safety
    • Delivery & Dosage Technologies
    Related Knowledge Center
    • Testing
    • Quality & Safety
    • World Markets
    Suggested For You
    Food Processing for Health and Wellness Food Processing for Health and Wellness
    Formulating for Nutrient Bioavailability Formulating for Nutrient Bioavailability
    JAMA: FDA Warning Letters Fail to Result In Removal of Illegal Supplement Ingredients JAMA: FDA Warning Letters Fail to Result In Removal of Illegal Supplement Ingredients
    NJ Labs Warns Industry of FDA Warning Letters on Water Testing NJ Labs Warns Industry of FDA Warning Letters on Water Testing
    Substantiating Environmental, Social, and Governance Claims Substantiating Environmental, Social, and Governance Claims
    Senator Richard Burr Introduces Alternative Legislation Without MPL Provisions Senator Richard Burr Introduces Alternative Legislation Without MPL Provisions
    How Will the European Green Deal Impact Dietary Supplements? How Will the European Green Deal Impact Dietary Supplements?
    A Growing Herbal Products Market Still Faces Formidable Threats, Challenges A Growing Herbal Products Market Still Faces Formidable Threats, Challenges
    Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    What Do Consumers Know About the Gut Microbiome? What Do Consumers Know About the Gut Microbiome?
     HP Ingredients Receives NSF/ANSI 455-2 Dietary Supplement GMP Certification HP Ingredients Receives NSF/ANSI 455-2 Dietary Supplement GMP Certification
    ODSP Director Cara Welch Discusses Agency Priorities ODSP Director Cara Welch Discusses Agency Priorities
    Shiitake Mushroom Extract Appears Helpful in HPV Infections Shiitake Mushroom Extract Appears Helpful in HPV Infections
    Three Grams of Omega-3s May be Optimal Dose for Reducing Blood Pressure Three Grams of Omega-3s May be Optimal Dose for Reducing Blood Pressure
    Poison Control Center Reports of Kids Ingesting Melatonin Rise by 530% Since 2012 Poison Control Center Reports of Kids Ingesting Melatonin Rise by 530% Since 2012

    Related Online Exclusives

    • Delivery & Dosage Technologies | Enzymes | Functional Foods & Beverages | Natural/Organic | Proteins, Peptides, Amino Acids | Research
      Food Processing for Health and Wellness

      Food Processing for Health and Wellness

      At IFT FIRST, a panel of researchers covered the benefits of upcycled materials and sustainable measures to produce health and wellness products.
      By Mike Montemarano, Associate Editor 08.09.22

    • Antioxidants | Delivery & Dosage Technologies | Fiber & Carbohydrates | Functional Foods & Beverages | Research
      Formulating for Nutrient Bioavailability

      Formulating for Nutrient Bioavailability

      At IFT FIRST, food scientists discussed innovation and insights into how we digest, absorb, and utilize nutrients.
      By Mike Montemarano, Associate Editor 08.09.22

    • Dietary Supplements | Quality & Safety | Regulations | Testing
      JAMA: FDA Warning Letters Fail to Result In Removal of Illegal Supplement Ingredients

      JAMA: FDA Warning Letters Fail to Result In Removal of Illegal Supplement Ingredients

      According to product recall reports, just a portion of products containing illegal ingredients were recalled following the issuance of warning letters.
      By Mike Montemarano, Associate Editor 08.02.22


    • Contract Manufacturing | Industry & Market News | Quality & Safety
      NJ Labs Warns Industry of FDA Warning Letters on Water Testing

      NJ Labs Warns Industry of FDA Warning Letters on Water Testing

      Warning letters have been calling out companies that don’t validate their water systems through total organic carbon analysis.
      08.02.22

    • Consumer Trends | Healthcare Trends | Natural/Organic | Regulations
      Substantiating Environmental, Social, and Governance Claims

      Substantiating Environmental, Social, and Governance Claims

      At the federal and state level, experts project that ESG claims will be more heavily policed.
      By Mike Montemarano, Associate Editor 07.18.22

    Loading, Please Wait..
    Trending
    • First Day Life Shuts Down Children's Behavioral, Cognitive Health Claims Following Challenge
    • Study Examines Vitamin K2 Content In Cheese
    • Chenland Nutritionals Self-Affirms GRAS For Cumin UP60 Ingredient
    • Pycnogenol Evidenced To Have Skin Benefits In Dermatology Study
    • ADM And Benson Hill Partner To Scale High Protein Soy For U.S. Market
    Breaking News
    • Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    • ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    • Tazo Transitions to Regenerative Organic Agriculture
    • Protein Ingredient Formulated for Chronic Kidney Disease Patients
    • IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • A Growing Herbal Products Market Still Faces Formidable Threats, Challenges
    • Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    • Nutrition and Flavor: Formulating for Modern Product Preferences
    • Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains
    • How Will the European Green Deal Impact Dietary Supplements?
    • What Do Consumers Know About the Gut Microbiome?
    • 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

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Tazo Transitions to Regenerative Organic Agriculture
    Coatings World

    Latest Breaking News From Coatings World

    SONGWON Industrial Group Reports Strong Q2 Financial Results
    PPG Completes COLORFUL COMMUNITIES Project for Boys & Girls Clubs of Greater Houston
    Paul N. Gardner Now Offers Bacharach Sling Psychrometer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    Abbott Invests €440 in New Irish Facility
    FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AskBio Appoints Clinical Ops Executives
    SpectrumX Partners With UK Contract Manufacturer
    GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Arkay Chairman Emeritus Howard Kaneff Has Died
    Nutricosmetics Market to Hit $13.7 Billion by 2030
    Estée Lauder Pledges 100% Electric Fleet of Vehicles by 2030
    Happi

    Latest Breaking News From Happi

    J&J To Stop Global Sales of Talc-Based Products by 2023
    Net Sales Increase 2% for Naples Soap Company in Second Quarter
    Net Revenue Down 12% for Grove Collaborative in Second Quarter
    Ink World

    Latest Breaking News From Ink World

    Heidelberg Enjoys Successful Start to 2022-23 Fiscal Year
    Mimaki Announces New LATAM Website
    Paul N. Gardner Offers Bacharach Sling Psychrometer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Esko, Constantia Flexibles announce acquisitions and more
    Hybrid Software joins The Flexo Xperience Center
    Flexo Wash LLC and Mike Potter celebrate 20 years
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Focke & Co. to Host Destination: Your Hygiene Hub on August 31
    Exports Dominate Chinese Trade of Tissues, Hygiene Products and Wipes
    Freudenberg to Present Friction Inserts for Wind Energy
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Dental 3D Printing Market is Expanding 20% Annually
    Study Results Released for Abbott's Concussion Blood Test
    Bone Growth Stimulators Market to Top $3B by 2030
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    eMagin Corporation Announces 2Q 2022 Results
    Zebra Technologies’ Emission Reduction Targets Validated by SBTi
    Identiv Delivers Impressive 41% Year-over-Year Growth in RFID Business

    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