• 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
    How Can the Nutraceuticals Industry Empower More Women?

    The Naturally Proud Network: Supporting Diversity, Equity, and Inclusion

    Radicle Science Aims to Set New Trajectory for Healthcare with Modern Clinical Trial Model

    Key Trends in Functional Foods for 2024

    New Cognitive Health Solutions Aim to Address Varied Consumer Needs
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Ahiflower Replaces Key Tissue DHA in Mice Comparably to Marine DHA

    Chromadex’s Niagen NR Tested in Phase 1 Parkinson's Study

    Alkemist Announces New Participants in its Transparency Program

    One Hemp Coalition Forms to Advocate for CBD Regulatory Standards

    Earthlight Whole Food Vitamin D Receives Food, Beverage Approval in Brazil
    Exclusives
    Top Companies
    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

    Ahiflower Replaces Key Tissue DHA in Mice Comparably to Marine DHA

    One Hemp Coalition Forms to Advocate for CBD Regulatory Standards

    Earthlight Whole Food Vitamin D Receives Food, Beverage Approval in Brazil

    FDA’s Safety Review of NAC to Go Under Peer Review

    Gnosis by Lesaffre Launches Private-Label Immune Support Supplement MenaQ7 Protect
    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

    Ahiflower Replaces Key Tissue DHA in Mice Comparably to Marine DHA

    Chromadex’s Niagen NR Tested in Phase 1 Parkinson's Study

    How Can the Nutraceuticals Industry Empower More Women?

    Alkemist Announces New Participants in its Transparency Program

    One Hemp Coalition Forms to Advocate for CBD Regulatory Standards
    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

    How Can the Nutraceuticals Industry Empower More Women?

    Pharmavite Acquires Women’s Health Brand Bonafide for $425 Million

    Kyowa Hakko Discussed Cognitive Health Supplements at Neuro Navigators Event

    Gnosis by Lesaffre Launches Private-Label Immune Support Supplement MenaQ7 Protect

    Beauty Brand Genaura to Launch Product Line Featuring Gencor’s Levagen+
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    JRS Pharma

    Sabinsa Corporation

    Aiya America, Inc. (Aiya Matcha)

    Bioenergy Life Science, Inc. (BLS)

    Kaneka Nutrients
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    JRS Pharma

    Sabinsa Corporation

    Aiya America, Inc. (Aiya Matcha)

    Bioenergy Life Science, Inc. (BLS)

    Kaneka Nutrients
    • 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
    • Top Companies
    • 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

    Ignore the Red Herrings: Myths & Facts about Mandatory Product Listing

    Industry should view both proposed legislation and arguments against it with a critical eye, but let’s address legitimate concerns while dismissing strawmen.

    Ignore the Red Herrings: Myths & Facts about Mandatory Product Listing
    By Steve Mister, President & CEO, Council for Responsible Nutrition04.26.22
    Editor’s Note: Views and opinions expressed in guest articles are intended to engage stakeholders and do not necessarily reflect those held by Nutraceuticals World or editorial staff.

    This week, Senator Richard Durbin (D-IL) introduced the Dietary Supplement Listing Act of 2022 (S. 4090), which would create a mandatory product listing requirement for dietary supplements. Basically, the legislation would require every marketer of finished product supplements to provide a copy of their labels to FDA as it brings the product to market. Under this legislation, FDA does not get to “approve” or “reject” the product—it must accept the label and post it in a publicly available website so that regulators, retailers, and consumers can see what supplements are in the U.S. marketplace at any given time. CRN has expressed strong support for this proposal.

    Unfortunately, some stakeholders have opposed mandatory listing without completely understanding what it does—and doesn’t do. It’s been misrepresented as "pre-market approval” in disguise, a gateway to FDA’s removal of ingredients, and an overly burdensome bureaucratic headache. It is none of these.

    I recently had the opportunity to assemble and refute many of these red herring arguments for the Senate Health, Education, Labor, and Pensions (HELP) Committee. In the interest of that same transparency promoted by mandatory listing itself, I want to share these myths and facts so industry members can make educated decisions about your own views toward mandatory listing.

    Myth #1: It’s already easy for FDA to find dietary supplements in the market.

    Facts: Yes, FDA currently has tools that were provided by the Dietary Supplement Health and Education Act (DSHEA) to regulate the industry, but the reality is that the agency can’t regulate what it can’t see. Food Safety Modernization Act (FSMA) facility registration identifies which facilities are engaged in supplement production, but it doesn’t tell FDA what’s being made in a facility. The much-touted ODS label database is not mandatory, comprehensive, or even current—it gets updated once or twice a year. And while FDA can get labels during an inspection, it currently only inspects about 5% of the industry each year. At that rate, it will take FDA 20 years to amass a complete collection of product labels. By comparison, a mandatory registry would immediately allow FDA to see what products and ingredients are available to U.S. consumers—something it can’t see now.

    Myth #2: ODS already has a label database; we don’t need another one.

    Facts: The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) does maintain a dietary supplement label database, but it is not a complete listing of dietary supplements currently in the market. The ODS database is voluntary, and a contractor is responsible for locating and entering many labels in the database (sometimes without the manufacturers’ knowledge). Without a formal, enforceable requirement to participate, there is no legal incentive to put labels in the ODS system.

    Nor is there any accountability for the accuracy of those entries, or verification from the marketers that the “on market” designation is accurate or current. It’s no knock on ODS to admit that database was created as a research tool (and serves that purpose well), but it is not intended to be a real-time snapshot of the market. Even Amazon or Google searches and CRN’s Supplement OWL (Online Wellness Library) are not complete pictures. Only a mandatory listing will give an accurate and complete view of the marketplace.

    Myth #3: A mandatory product listing will turn into pre-market approval for supplements.

    Facts: This false claim seems to be getting a lot of traction these days, perhaps because “pre-market approval” is such a dog whistle to stop any proposal in its tracks. Mandatory listing can be implemented with safeguards to prevent potential abuses of this authority by FDA. CRN’s mantra for mandatory listing is that any proposal it supports must be “a birth certificate—not a driver’s license.” FDA cannot be authorized to reject a label or refuse to enter it into the registry.

    A requirement to provide FDA with a copy of product labeling on the way to market does not give FDA the ability to refuse to accept it. This construct can be, and should be, enshrined in the legislation. If FDA has no ability to reject a product listing, then this requirement can’t serve to prevent introduction of new products or inhibit innovation. The listing serves as a record of products marketed under the moniker of “dietary supplement”—good or bad.

    Myth #4: FDA can use the mandatory listing to keep products it doesn’t like off the market.

    Facts: As described above, if FDA is required to accept all labels for the listing, FDA gets transparency, but not the ability to slow down market entry. Product innovation and speed to market are hallmarks of this industry—mandatory listing would not change that. The registry will give FDA visibility to find such products, but it would still have to pursue existing legal processes to remove a product from the market.

    Myth #5: It’s too burdensome for companies. Small businesses can’t comply.

    Facts: Over four years ago, CRN embarked on creating The Supplement OWL, a voluntary version of a mandatory listing of supplement labels and publicly available product information.  The Supplement OWL can now serve as a template for mandatory listing because it works—without creating unreasonable burdens on participants.

    Companies of all sizes participate in the Supplement OWL. Automating much of the data entry has permitted companies with six labels or 600 labels to upload their data efficiently. Because the registry is limited to only that information that is on the label, companies can scan the label and then extract the relevant data right into the database. Compared to adverse event reporting and GMP compliance—two initiatives the industry has long supported to raise confidence in our products—this requirement is a piece of cake.

    Myth #6: Bad actors won’t enter their labels; it’s just one more administrative burden for the “good” companies to observe and “bad” companies to ignore.

    Facts: Mandatory listing gives FDA an administrative violation that is easy to enforce. Failure to list would make the product misbranded under 21 USC 343 and marketing a product without listing it would be a prohibited act. Listing violations do not require lab testing, independent analysis, chain of custody and other obstacles to quick prosecution that burdens prosecutions for adulterated ingredients. They are easy to enforce and a few high-profile actions by FDA would send a clear message to companies to provide their labels. 

    Myth #7: A mandatory listing won’t solve all the industry’s problems, so let’s not do it.

    Facts: Not so much a myth as a misguided excuse. We agree that FDA has not enforced existing regulations as aggressively as it should, but mandatory listing is the essential first step to creating a truly transparent industry. Consumers assume FDA already knows what is in the market; they are surprised to learn that FDA doesn’t even know how many products and ingredients are out there. Mandatory listing won’t immediately address willful bad actors, but it will bring many firms that operate in the grey areas into the sunshine for FDA’s evaluation. 

    Myth #8: If FDA isn’t using the enforcement tools it has, we shouldn’t give the agency any more.

    Facts: FDA has repeatedly asked for mandatory listing in its budget requests. This tool will help the agency be more responsive to illegal behavior. CRN would be first in line to criticize FDA for not being aggressive enough with illegal ingredients brought to its attention, for being timid with warning letters, and slow to address adulterated supplements, counterfeit products and non-compliant manufacturers. But that is not a reason to deny the agency of a tool that will make its enforcement more efficient.

    Mandatory listing will help FDA create enforcement priorities based on what’s actually in the marketplace. The agency can find noncompliant products quicker, address safety concerns faster, and utilize resources more efficiently. The notion that because industry doesn’t think FDA is aggressive enough, that’s an argument against helping it become more targeted and efficient just doesn’t make sense.

    Myth #9: Instead of mandatory listing, the industry needs a massive reform of DSHEA—do it all or do nothing.

    Facts: This argument is the flipside of #8. Some stakeholders urge that unless we can get a full package of changes to DSHEA, the industry should not agree to any incremental changes. That’s unrealistic and naïve in this complicated, uber-partisan Congressional environment. Responsible companies should want mandatory listing; it demonstrates accountability to our regulators and transparency to our consumers. It is a “win” for responsible players as much as it is for FDA. When did mandatory listing morph from being a benefit to industry to a “give” that requires a “get” in return? Mandatory listing is something we can all agree on, and it can pass on a bipartisan basis in this Congress. It's achievable when many other proposed reforms are not.

    It’s easy to criticize efforts to construct policies that move industry forward. It’s harder to build consensus, forge compromises with detractors and develop pragmatic solutions that can be enacted. Industry would be wise to view both the mandatory listing legislation and the arguments against it with a critical eye. Be skeptical, but also recognize a red herring when you see it. Let’s try to address legitimate concerns while dismissing the strawmen. If we work together, we can devise a mandatory listing system that elevates this industry for the future.


    Steve Mister has been President & CEO of CRN since 2005. Founded in 1973 and based in Washington, D.C., CRN’s mission is “to sustain and enhance a climate for our members to responsibly develop, manufacture and market dietary supplements, functional foods and nutritional ingredients.”
    Related Searches
    • Quality & Safety
    • Dietary Supplements
    • Regulations
    Related Knowledge Center
    • Quality & Safety
    • Regulations
    • Dietary Supplements
    Suggested For You
    How Can the Nutraceuticals Industry Empower More Women? How Can the Nutraceuticals Industry Empower More Women?
    FDA’s Safety Review of NAC to Go Under Peer Review FDA’s Safety Review of NAC to Go Under Peer Review
    Can Ayana Bio’s Plant Cell Cultivation Technology Overcome the Limits of Conventional Agriculture? Can Ayana Bio’s Plant Cell Cultivation Technology Overcome the Limits of Conventional Agriculture?
    Proactive Formulations for Innovative Healthy Aging Proactive Formulations for Innovative Healthy Aging
    Designs for Health Launches Two New Collagen Formulas Designs for Health Launches Two New Collagen Formulas
    2024 Projected Supplement Trends: The Industry’s Most Popular Ingredients & Categories 2024 Projected Supplement Trends: The Industry’s Most Popular Ingredients & Categories
    Federal Judge Orders Balance of Nature to Stop Production and Sale of Products Federal Judge Orders Balance of Nature to Stop Production and Sale of Products
    Regulatory Roadmap: Authorization and communication of ingredients in Europe and the U.S. Regulatory Roadmap: Authorization and communication of ingredients in Europe and the U.S.
    cbdMD Executive Ronan Kennedy on the Company’s Expanding Product Portfolio cbdMD Executive Ronan Kennedy on the Company’s Expanding Product Portfolio
    Premium Labels & Packaging Solutions Appoints Two Industry Veterans To Senior Management Roles Premium Labels & Packaging Solutions Appoints Two Industry Veterans To Senior Management Roles
    New Nutrition Business Highlights Emerging Interest In Blood Sugar Management New Nutrition Business Highlights Emerging Interest In Blood Sugar Management
    No Substantive FDA Response to CRN Petition on ‘Drug Preclusion’ No Substantive FDA Response to CRN Petition on ‘Drug Preclusion’
    Low-Dose Valerian Extract May Benefit Mood and Sleep Low-Dose Valerian Extract May Benefit Mood and Sleep
    Key Trends in Functional Foods for 2024 Key Trends in Functional Foods for 2024
    Success Factors in Sports Nutrition Success Factors in Sports Nutrition

    Related Features

    • Dietary Supplements | Women's Health | World Markets
      How Can the Nutraceuticals Industry Empower More Women?

      How Can the Nutraceuticals Industry Empower More Women?

      We consulted experts about efforts to support women in business, and to develop better health solutions.
      By Sean Moloughney, Editor 12.01.23

    • Antioxidants | Breaking News | Dietary Supplements | Regulations | Regulatory News
      FDA’s Safety Review of NAC to Go Under Peer Review

      FDA’s Safety Review of NAC to Go Under Peer Review

      After a years-long dispute over whether N-acetyl-cysteine meets dietary ingredient criteria, the agency began exercising enforcement discretion.
      11.29.23

    • Antioxidants | Contract Manufacturing | Delivery & Dosage Technologies | Healthy Aging | Herbs & Botanicals
      Can Ayana Bio’s Plant Cell Cultivation Technology Overcome the Limits of Conventional Agriculture?

      Can Ayana Bio’s Plant Cell Cultivation Technology Overcome the Limits of Conventional Agriculture?

      CEO Frank Jaksch discusses how the company can produce affordable, nutrient-dense ingredients optimized for high bioactive content.
      By Sheldon Baker 11.27.23


    • Proactive Formulations for Innovative Healthy Aging

      Proactive Formulations for Innovative Healthy Aging

      Consumers are focused on wellness throughout their lives, aiming to proactively address concerns related to joint health/mobility, blood sugar, and more.
      11.25.23

    • Breaking News | Dietary Supplements | Products | Proteins, Peptides, Amino Acids
      Designs for Health Launches Two New Collagen Formulas

      Designs for Health Launches Two New Collagen Formulas

      The powder formulations, which combine collagen with complementary ingredients, are designed for beauty and metabolic support.
      11.21.23

    Loading, Please Wait..
    Breaking News
    • Ahiflower Replaces Key Tissue DHA in Mice Comparably to Marine DHA
    • Chromadex’s Niagen NR Tested in Phase 1 Parkinson's Study
    • Alkemist Announces New Participants in its Transparency Program
    • One Hemp Coalition Forms to Advocate for CBD Regulatory Standards
    • Earthlight Whole Food Vitamin D Receives Food, Beverage Approval in Brazil
    View Breaking News >
    CURRENT ISSUE

    November 2023

    • Success Factors in Sports Nutrition
    • Key Trends in Functional Foods for 2024
    • New Cognitive Health Solutions Aim to Address Varied Consumer Needs
    • Why Women are Fleeing STEM Jobs, and How the Nutraceutical Industry Can WIN Them Back
    • Liposomal Delivery: The Future for Dietary Supplement Innovation
    • 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

    Ahiflower Replaces Key Tissue DHA in Mice Comparably to Marine DHA
    Chromadex’s Niagen NR Tested in Phase 1 Parkinson's Study
    Alkemist Announces New Participants in its Transparency Program
    Coatings World

    Latest Breaking News From Coatings World

    PPG Earns Equality 100 Award in 2023 Corporate Equality Index
    Beckers Aiming for New Industry Standard for Sustainability
    Birla Carbon Celebrates 65th Anniversary of Cubatão Plant in Brazil
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    What You’re Reading in November
    Millstone Medical Outsourcing Moves Testing Services into Expanded Facility
    Nordson Medical Expands Easton, PA Operations
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Intas Pharmaceuticals Receives Another Warning Letter from FDA
    Ono Expands Investment in Ono Venture Fund to $200M
    Sirnaomics Names Francois Lebel Chief Medical Officer
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Mary Kay Expands Operations into Hungary
    Anti-Aging Products Market to Hit $60 Billion by 2030
    Wella Company Marks 3 Years of Success—& Aims to Expand
    Happi

    Latest Breaking News From Happi

    Beverly Hills MD Sells Over 7.5 Million Units of Its Dermal Repair Complex
    Mary Kay Expands to Hungary
    Itching: Is a Common Skin Bacterium Behind It?
    Ink World

    Latest Breaking News From Ink World

    Pacer Print Produces High Quality Labels with Epson SurePress L-6534VW UV
    BASF Expands Certification of Recyclability of Multi-layer Films Containing Polyamide
    Mark Andy Selects Duane Pekar as CEO
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Top stories from November
    Davis-Standard's headquarters attains ISO 14001 certification
    Abbott Label named AFFLINK preferred supplier
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Optima Packaging Group Awarded for its Digitalization Strategy
    What You’re Reading on Nonwovens-Industry.com
    ISSA Clean Advocacy Summit and Fly-In Set for April
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT’s Most Read Articles in November
    Anika's Integrity Implant System Makes its O.R. Debut
    Study Shows How a Multimodal Feedback System Can Improve Laser Surgery
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Emerson Appoints Michael Tang as Chief Legal Officer
    Canatu Presents Film Heaters at DVN LiDAR
    Jabil Updates Fiscal 2024 Outlook

    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