• 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
    PLT to Supply Traceable, Standardized Organic Elderberry Extract

    Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion

    BASF Venture Capital and Aqua-Spark invest in Sea6 Energy

    Lauren Aronson Joins Amin Talati Wasserman, LLP

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome
    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

    PLT to Supply Traceable, Standardized Organic Elderberry Extract

    Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion

    BASF Venture Capital and Aqua-Spark invest in Sea6 Energy

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    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

    PLT to Supply Traceable, Standardized Organic Elderberry Extract

    Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion

    BASF Venture Capital and Aqua-Spark invest in Sea6 Energy

    Lauren Aronson Joins Amin Talati Wasserman, LLP

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome
    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

    PLT to Supply Traceable, Standardized Organic Elderberry Extract

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise

    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Atlantia Clinical Trials

    JRS Pharma

    Verdure Sciences

    Botanic Healthcare LLC

    Bioenergy Life Science, Inc. (BLS)
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Atlantia Clinical Trials

    JRS Pharma

    Verdure Sciences

    Botanic Healthcare LLC

    Bioenergy Life Science, Inc. (BLS)
    • 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
    Breaking News

    CRN: FDA Misguides Consumers on CBD While Abdicating Regulatory Authority

    Agency should open the dietary supplement lane to CBD and enforce the laws and regulations for those products.

    CRN: FDA Misguides Consumers on CBD While Abdicating Regulatory Authority
    Related CONTENT
    • Sunflower Hemp Co
    • FDA Sends Latest Round of Warning Letters on CBD & Cites Safety Concerns
    • Industry Blasts Consumer Reports Coverage & Analysis of Supplements
    • Podcast: A Look at DSHEA 25 Years Later
    • DSHEA Milestone Marks Inflection Point for Industry
    11.27.19
    In response to the FDA’s recent warning letters and consumer advisory about safety concerns related to CBD, Steve Mister, president & CEO, Council for Responsible Nutrition (CRN), said the announcements were unnecessarily alarmist, noting the agency hasn’t offered a plan to address any perceived health risks.
     
    Mister went on to say that FDA has abdicated its regulatory oversight “for the subset of these products that do pose risks to consumers because they are poorly made, improperly labeled, or illegally deliver THC.”
     
    He further stated that FDA’s inaction for the past year has facilitated an unregulated marketplace, “which is bad for consumers and bad for business. It’s time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements.”
     
    FDA’s announcement raises serious and legitimate questions about the safety of CBD, but the agency’s actions to date have not advanced that cause, Mister added.
     
    For example, “FDA invokes potential adverse effects from CBD, but does not distinguish between the high doses delivered in the approved prescription drug, and supplement levels,” he said. “It is worth noting the CBD prescription drug Epidiolex uses daily doses that could be as high as 1,500 mg; many supplement products in the market provide suggested daily doses of 50 mg/day or less. As with most substances, the dose makes the poison, and publicly-available data, including a report from the World Health Organization indicates CBD is generally well tolerated and has a good safety profile.”
     
    FDA has acknowledged the presence of CBD-containing products that are in violation of general dietary supplement regulations—products that include appreciable levels of THC; ones whose CBD content does not come close to matching the labeled amounts; and others that contain unsafe levels of pesticides, heavy metals or other contaminants.
     
    “Third-party analyses by watchdog groups confirm these concerns,” said Mister. “FDA has the authority to mandate recalls, to begin seizures of potentially harmful products, and to issue injunctions, but instead, the agency is choosing to issue tepid warning letters about CBD while the market of poorly made products continues to explode.”
     
    FDA has the opportunity to receive meaningful safety data through new dietary ingredient notifications (NDIN) and generally recognized as safe (GRAS) submissions. “Yet while FDA broadly declares CBD to be an illegal ingredient—despite the express statutory discretion to change that status—the agency declines the opportunity to create incentives for that research or to give this data assurances of confidentiality that drug submissions are accorded,” Mister said. “FDA continues to call on industry to produce safety research for the public docket but to dismiss NDI notifications and GRAS declarations for CBD.”
     
    Mister suggested FDA “explicitly open the dietary supplement lane to CBD and be the ‘cop on the beat’ enforcing the whole range of dietary supplement laws and regulations against those products.”
     
    Otherwise, Congress should get involved to direct the agency toward these goals while offering ample enforcement tools.
     
    “Responsible companies marketing CBD in dietary supplements already comply with the law—which means that they hold data justifying their own evaluations that their products are safe, that they follow good manufacturing practices, that they register their facilities, and that they have a serious adverse event reporting system in place,” Mister said. “These responsible companies have been unfairly maligned by FDA’s overbroad warnings on safety, and ironically, are actually deterred from sharing the safety data they have with the agency.” 
    Related Searches
    • Research
    • Nutrition
    • crn
    • Dietary Supplement
    Related Knowledge Center
    • Herbs & Botanicals
    • Regulations
    • Quality & Safety
    Suggested For You
    Sunflower Hemp Co Sunflower Hemp Co
    FDA Sends Latest Round of Warning Letters on CBD & Cites Safety Concerns FDA Sends Latest Round of Warning Letters on CBD & Cites Safety Concerns
    Industry Blasts Consumer Reports Coverage & Analysis of Supplements  Industry Blasts Consumer Reports Coverage & Analysis of Supplements
    Podcast: A Look at DSHEA 25 Years Later Podcast: A Look at DSHEA 25 Years Later
    DSHEA Milestone Marks Inflection Point for Industry DSHEA Milestone Marks Inflection Point for Industry
    Federal Agencies Warn Company Marketing Unapproved CBD Products Federal Agencies Warn Company Marketing Unapproved CBD Products
    CRN Promotes Andrea Wong to Head of Scientific & Regulatory Affairs CRN Promotes Andrea Wong to Head of Scientific & Regulatory Affairs
    CBD in the Clinic: How Practitioners View Life After the Farm Bill CBD in the Clinic: How Practitioners View Life After the Farm Bill
    CRN: Clear Legal Plan & FDA Enforcement Can Ensure Safety & Benefits of CBD CRN: Clear Legal Plan & FDA Enforcement Can Ensure Safety & Benefits of CBD
    Council for Responsible Nutrition Increases Efforts to Connect with Retailers Council for Responsible Nutrition Increases Efforts to Connect with Retailers
    Clearing Up Chaos in the Modern Nutraceuticals Market Clearing Up Chaos in the Modern Nutraceuticals Market
    The CBD Craze: Still Only the Beginning The CBD Craze: Still Only the Beginning
    Cannovia: Clearing Up CBD Market Confusion Cannovia: Clearing Up CBD Market Confusion
    Area Code 420 Has Arrived Area Code 420 Has Arrived
    Charlotte’s Web Introduces Hemp Extract-Infused Gummies Charlotte’s Web Introduces Hemp Extract-Infused Gummies

    Related Buyers Guide Companies

    • Sunflower Hemp Co

      ...
      Colby Terip, Owner 09.15.21

    • Breaking News | Herbs & Botanicals | Industry & Market News | Quality & Safety | Regulations | Regulatory News
      FDA Sends Latest Round of Warning Letters on CBD & Cites Safety Concerns

      FDA Sends Latest Round of Warning Letters on CBD & Cites Safety Concerns

      Agency notes data gaps about CBD toxicity and concerns about potential harm.
      11.26.19

    • Dietary Supplements | Quality & Safety | Regulations | Testing
      Industry Blasts Consumer Reports Coverage & Analysis of Supplements

      Industry Blasts Consumer Reports Coverage & Analysis of Supplements

      Critics say testing used arbitrary standards and ignored federal regulations.
      By Sean Moloughney, Editor 11.01.19


    • Dietary Supplements | Regulations
      Podcast: A Look at DSHEA 25 Years Later

      Podcast: A Look at DSHEA 25 Years Later

      CRN’s Steve Mister discusses the legislation that shaped the dietary supplement industry and what to expect moving ahead.
      Sean Moloughney, Editor 10.29.19

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

      DSHEA Milestone Marks Inflection Point for Industry

      Where does the path forward lead?
      10.29.19

    Loading, Please Wait..
    Trending
    • Study Examines Vitamin K2 Content In Cheese
    • Chenland Nutritionals Self-Affirms GRAS For Cumin UP60 Ingredient
    • Omega-3 Fatty Acids Linked To Reduced Episodes Of Depression
    • 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
    • PLT to Supply Traceable, Standardized Organic Elderberry Extract
    • Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion
    • BASF Venture Capital and Aqua-Spark invest in Sea6 Energy
    • Lauren Aronson Joins Amin Talati Wasserman, LLP
    • Vitamin K2 May Ameliorate Polycystic Ovary Syndrome
    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

    PLT to Supply Traceable, Standardized Organic Elderberry Extract
    Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion
    BASF Venture Capital and Aqua-Spark invest in Sea6 Energy
    Coatings World

    Latest Breaking News From Coatings World

    Axalta: Red Continues as Most Preferred Car Color of Consumers in Mexico
    Ashland Completes Sale of Land in Ajax, Canada
    Chemours Begins Commissioning New Sand Mine in Clay County, FL
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Study: RhinAer Treatment Improves Chronic Rhinitis Symptoms
    CE Mark Granted for IVF Decision Support Tool
    FDA Approves Full-Body MRI Compatibility With Inspire Therapy
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Rentschler Biopharma Appoints Mark Caswell as VP, Site Head
    Cellipont Unveils Plans for Cell Therapy Facility in Houston
    GenScript Launches Expedited mRNA Service
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Estée Lauder Companies Delivers Strong Results in Fiscal 2022
    Fastest-Growing Consumer Product Companies in the U.S.
    Winky Lux is Among the Top 20 Fastest-Growing Beauty Companies
    Happi

    Latest Breaking News From Happi

    Symrise's Global President of Fragrance Division Eder Ramos Named President of Union for Ethical BioTrade
    Hume Vegan Probiotic Deodorants Enters First Personal Care Collaboration with Vuori
    Full Year Net Sales Increase 9% for The Estée Lauder Companies
    Ink World

    Latest Breaking News From Ink World

    DuPont Selects 2022 Lavoisier and Pedersen Award Medalists
    Chemours Begins Commissioning Newest Sand Mine in Clay County, FL
    Marabu to Present Safe Inks for Indirect Contact with Food at K 2022
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Colordyne brings single-pass hybrid printing to Labelexpo Americas
    Schreiner MediPharm's vial labeling system in use for Octapharma
    Labelexpo Americas to highlight digital press launches
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    INDA Appoints Director of Membership and Industry Relations
    Nexwear Acquires Incontinence Products Brand Lily Bird
    Because Market Expands into Retail Stores
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FDA Clears Accelus' Toro-L Interbody Fusion System
    FDA OKs VySpine's VyPlate Anterior Cervical Plates
    Moximed Raises $40M for Knee OA Shock Absorber Implant
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    DuPont Names 2022 Lavoisier and Pedersen Award Medalists
    Photonic Glasses Give Solar Panels Pleasing Colors
    SEMI Appoints John Cooney to Lead Global Advocacy and Public Policy

    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