• 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
    JRS Pharma

    Verdure Sciences

    Gencor

    Atlantia Clinical Trials

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

    Verdure Sciences

    Gencor

    Atlantia Clinical Trials

    Sabinsa Corporation
    • 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 Requests Mandatory Product Listing in 2023 Budget Proposal

    Trade associations are weighing in on efforts to modernize the Dietary Supplement Health and Education Act.

    FDA Requests Mandatory Product Listing in 2023 Budget Proposal
    Related CONTENT
    • CRN Announces New Staff Appointments
    • Food Supplements Europe: Most Consumers Use Dietary Supplements Safely
    • ODSP Director Cara Welch Discusses Agency Priorities
    • Largest Cannabinoids Trial to Date Yields Positive Findings on Pain Management
    • Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company
    By Mike Montemarano, Associate Editor 03.31.22
    Within its FY2023 budget request, the U.S. Food and Drug Administration (FDA) requested that Congress pass legislation to amend the Dietary Supplement Health and Education Act (DSHEA) to establish a mandatory product listing program and clarify its authority to facilitate enforcement. The idea of a mandatory product listing has been floated before, and opinions among trade associations have been mixed.

    In this year’s budget request, recently-appointed FDA Commissioner Robert Califf, MD, requested a budget of $8.4 billion, representing a 34% ($2.1 billion) increase from last year’s budget. While FDA identified many spending priorities relevant to the dietary supplements world, industry leadership weighed in mostly on the mandatory product listing portion of the request, which included both appropriations and legislative change.

    In the request, “Justification of Estimates for Appropriations Committees,” the agency said that it seeks “a package of legislative proposals designed to bolster the FDA’s authorities.” Among other legislative items, the agency seeks to “modernize dietary supplement regulation, seeking to require annual listing with the FDA of individual dietary supplement products, including basic information about each unique product. It is estimated that the current supplement market is between 50,000 and 80,000 products. Additionally, the agency seeks to clarify its authorities over marketed dietary supplement products to better facilitate enforcement against unlawfully marketed products, allowing the FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers.”

    The mandatory product listing is included in a $13.5 million component of the budget request, called the “Healthy and Safe Food for All” initiative, to complement the requested regulatory change.

    “There has been a ten-fold increase in the dietary supplement market since the passage of DSHEA, from $4 billion to $40 billion. This trend has only increased during the COVID-19 pandemic. Yet most dietary supplements can be lawfully introduced to the market without ever notifying FDA. The resources requested will support the legislative proposal to amend [DSHEA] by establishing a product listing requirement,” FDA stated.

    The agency also requested the passage of legislation which would clarify its authority to take enforcement action against products that may be marketed as dietary supplements but do not, in fact, meet those legal definitions, such as those which contain drug ingredients.

    Pros and Cons
    In a statement, the Council for Responsible Nutrition shared its support for the agency’s request. “CRN is pleased to see FDA continuing the call for legislation to create a mandatory product listing. We share FDA’s interest in creating a more transparent industry for regulators and consumers alike. We also appreciate FDA’s continued efforts to clarify its jurisdiction over products that are marketed as dietary supplements but fail to actually contain a legal dietary ingredient. While we differ from FDA’s current reservations on enforcement—CRN believes FDA’s Office of Dietary Supplement Programs does indeed have authority over products that call themselves out as supplements regardless of their contents—we are on record supporting legislation to provide clarity on this matter. We are glad to see FDA advancing this issue.”

    As a condition of membership, CRN member companies are required to submit their product information to its Supplement OWL (Online Wellness Library), which serves as a self-regulatory initiative. CRN also expressed support for the agency’s request for increased funding toward enhanced inspection capacity and alternative methods for product testing. However, the association lamented FDA’s apparent lack of interest in additional funds for cannabinoid safety research, or funds designated to create a legal market for supplements containing cannabinoids.

    Scott Melville, president and CEO of the Consumer Healthcare Products Association, supported the key aspects of FDA’s budget request involving dietary supplements, including the significant increase in funding itself.

    “FDA’s recent request for a 34% budget increase in FY2023 shows that new FDA Commissioner Robert Califf recognizes the critical importance of self-care in public health,” Melville said. “FDA’s budget aligns with CHPA’s priorities to empower self-care by ensuring Americans continue to have access to safe, reliable, and affordable personal healthcare products including over-the-counter medicines, consumer medical devices, and dietary supplements. Specifically, we’re pleased to see FDA’s proposed budget also prioritizes modernization of dietary supplement regulation by supporting mandatory product listing, increasing inspection capacity, and clarifying its authority to better facilitate enforcement against unlawfully marketed products. The budget proposal makes it clear that Dr. Califf views stronger oversight of dietary supplements as a key part of FDA’s mission to advance the health and wellbeing of every American.”

    Michael McGuffin, president of the American Herbal Products Association (AHPA), expressed reservations about a mandatory product list citing several “unaddressed concerns, including that such a requirement could prove not only harmful, unnecessary, redundant and inaccurate, but would restrict consumer choice and access to dietary supplements. MPL also threatens to distract FDA from more essential regulatory enforcement of the dietary supplements category.”

    In a statement, McGuffin said AHPA has interest in potential regulatory modernization, “provided that it actually benefits consumers. To this end, there remain many unaddressed concerns about MPL proposals—including that any MPL requirement could destabilize the balance that the Dietary Supplement Health and Education Act struck between informed consumer access and appropriate FDA authority. With the goal of modernizing regulation while retaining this balance, AHPA advocates for the removal of obstacles to the dissemination of truthful and not misleading information to consumers. AHPA similarly advocates for amendments to the prior drug exclusion provision to establish a more-reasonable pathway to market for all natural products, even if that means that certain ingredients would eventually exist in both the pharmaceutical and dietary supplement markets.

    The Natural Products Association called mandatory product listing “a non-starter,” arguing it amounts to pre-market approval that jeopardizes safe and substantiated ingredients like NAC, CBD, and whatever else FDA itself may deem unlawful.

    Daniel Fabricant, president and CEO of NPA, said: “Year after year, FDA receives more funding, including a $2 million increase in FY22. Yet, despite these increases, FDA consistently does less with more. Mandatory product listing is pre-market approval disguised as transparency and would only add to the bureaucratic nightmare the industry is experiencing with NAC and CBD. Instead of framing the dietary supplement industry as a regulatory crisis, FDA should recognize the importance of dietary supplements to the health and wellness of American consumers, as evident by the nearly 80% who use our products.”
    Related Searches
    • Dietary Supplements
    • Quality & Safety
    • Regulations
    Related Knowledge Center
    • Regulations
    • Quality & Safety
    • Dietary Supplements
    Suggested For You
    CRN Announces New Staff Appointments CRN Announces New Staff Appointments
    Food Supplements Europe: Most Consumers Use Dietary Supplements Safely Food Supplements Europe: Most Consumers Use Dietary Supplements Safely
    ODSP Director Cara Welch Discusses Agency Priorities ODSP Director Cara Welch Discusses Agency Priorities
    Largest Cannabinoids Trial to Date Yields Positive Findings on Pain Management Largest Cannabinoids Trial to Date Yields Positive Findings on Pain Management
    Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company
    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products
    NOW Identifies Misleading Certificate of Analysis for Supplements Sold on Amazon NOW Identifies Misleading Certificate of Analysis for Supplements Sold on Amazon
    Kensing Acquires Vitae Naturals Kensing Acquires Vitae Naturals
    Shiitake Mushroom Extract Appears Helpful in HPV Infections Shiitake Mushroom Extract Appears Helpful in HPV Infections
    Florida Food Products Acquires Javo Florida Food Products Acquires Javo
    Xsto Solutions Xsto Solutions
    GNC and RealEats Meal Delivery Partnership Expands Nationally GNC and RealEats Meal Delivery Partnership Expands Nationally
    CHPA Hires Two Key Personnel CHPA Hires Two Key Personnel
    Jamieson Wellness to Acquire Nutrawise Health & Wellness Beauty Corporation Jamieson Wellness to Acquire Nutrawise Health & Wellness Beauty Corporation
    Senate HELP Committee Advances Bill with Supplement Provisions That Industry Trade Groups Oppose Senate HELP Committee Advances Bill with Supplement Provisions That Industry Trade Groups Oppose

    Related Breaking News

    • Breaking News | Industry & Market News | Quality & Safety | Regulations
      CRN Announces New Staff Appointments

      CRN Announces New Staff Appointments

      The new hires of Mike Meirovitz, Erin Storer, and Anthony Esteban round out CRN's team to 20 total staff positions.
      07.05.22

    • Breaking News | Consumer Trends | Dietary Supplements | Industry & Market News | World Markets
      Food Supplements Europe: Most Consumers Use Dietary Supplements Safely

      Food Supplements Europe: Most Consumers Use Dietary Supplements Safely

      Thousands of supplement users from 14 countries reported high rates of interaction with and understanding of product labels.
      07.05.22

    • Breaking News | Dietary Supplements | Industry & Market News | Quality & Safety | Regulations
      ODSP Director Cara Welch Discusses Agency Priorities

      ODSP Director Cara Welch Discusses Agency Priorities

      Facility inspections, NDIs, enforcement, and education are all top-of-mind.
      Mike Montemarano, Associate Editor 07.05.22


    • Breaking News | Herbs & Botanicals | Medical Nutrition | Research | Research News
      Largest Cannabinoids Trial to Date Yields Positive Findings on Pain Management

      Largest Cannabinoids Trial to Date Yields Positive Findings on Pain Management

      Over 1,600 people with pain were randomized to take one of six cannabinoid formulations containing CBD and some combination of rare cannabinoids from OBX.
      07.05.22

    • Breaking News | Dietary Supplements | Industry & Market News | Mergers & Acquisitions | World Markets
      Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company

      Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company

      Deal includes the GO Healthy supplement brand, a manufacturing facility in Auckland, and Manuka honey brand Egmont.
      06.30.22

    Loading, Please Wait..
    Trending
    • High Blood DHA Levels Linked To 49% Reduced Risk Of Alzheimer’s
    • Three Grams Of Omega-3s May Be Optimal Dose For Reducing Blood Pressure
    • CoQ10 And Royal Jelly Supplementation May Improve High Intensity Exercise
    • Oregon Files Lawsuit Against GNC
    • First Day Life Shuts Down Children's Behavioral, Cognitive Health Claims Following Challenge
    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

    Advanced Polymer Coatings Inks Ten Tanker deal with Turkey’s Chemfleet
    Heubach Launches Expanded Colanyl 500 range for Vibrant Orange Colors
    The ChemQuest Group Launches New Website
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Getinge Completes Purchase of Fluoptics SAS
    InBody Expands Blood Pressure Line
    Royal Philips Teams Up with Biodesix
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Evotec, Boehringer Ingelheim and BioMérieux Form Joint Venture
    Qualigen, Hande Sciences Partner to Scale-Up Mfg. for IND-Enabling Studies
    KBI Biopharma, Selexis Open State-of-the-Art Facility in Geneva
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Summer Camp Launches Line of Safe & Effective Sun Care Products
    Ameripen’s Dan Felton Voices Concerns About California Senate Bill 54
    Arkay Receives Platinum Rating in EcoVadis CSR Assessment
    Happi

    Latest Breaking News From Happi

    Azelis Signs Distribution Agreement with Seqens Advanced Cosmetics
    Talc-Free Eyeshadow Debuts from Kevyn Aucoin Beauty
    Jojoba Desert Achieves EcoVadis Gold Medal
    Ink World

    Latest Breaking News From Ink World

    Two ProAmpac Facilities Receive Key ISO Certifications
    BASF Venture Capital Invests in Climentum Capital’s First Fund
    JNS-SmithChem Acquires Tampa-Based Gulf Coast Chemical
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Paper Resources rebrands as Pri+
    Rotocon debuts new logo
    Mark Andy to showcase digital transformation at Labelexpo ​​​​​​
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Paper Excellence Group to Buy Resolute Forest Products
    Rose Baby Diaper Brand to Be Available in U.S.
    SWM, Neenah Complete Merger of Equals
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Enovis Buys Insight Medical Systems, a Surgical Guidance Firm
    No Revisions, Few Complications for Exactech's Total Ankle System
    SpineX Begins SCONE Clinical Trial
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Veridos Acquires Valid’s US Identity Solutions Business
    First Solar Completes Sale of Japan Project Development Platform to PAG Real Assets
    NREL Scientists Explore How to Make PV Even Greener

    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