• 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
    Florida Food Products Acquires Javo

    Roquette Launches Nutralys Rice Protein

    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy

    CTRL Launches Meal On-The-Go Bars

    GNC and RealEats Meal Delivery Partnership Expands Nationally
    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

    Roquette Launches Nutralys Rice Protein

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

    Study Reveals Low Intake of Tocotrienols in Polish Population

    Combination of Collagen and Boswellia Serrata Shown to Reduce Joint Discomfort

    Nutralliance Adds Eggshell-Derived Ingredients for Beauty and Joint Health to Portfolio
    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

    Florida Food Products Acquires Javo

    Roquette Launches Nutralys Rice Protein

    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy

    CTRL Launches Meal On-The-Go Bars

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development
    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

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

    Botanical Gum for Kids Aims to Curb Sugar Cravings

    Combination of Collagen and Boswellia Serrata Shown to Reduce Joint Discomfort

    Childhood Fitness and Obesity Impact Cognition Later in Life, Study Finds

    Nutralliance Adds Eggshell-Derived Ingredients for Beauty and Joint Health to Portfolio
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    JRS Pharma

    Bioactive Resources

    Gencor

    Nutrition21, LLC

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

    Bioactive Resources

    Gencor

    Nutrition21, LLC

    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
    Breaking News

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

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

    FDA Sends Latest Round of Warning Letters on CBD & Cites Safety Concerns
    Related CONTENT
    • Sunflower Hemp Co
    • Developing Scientific Support for Product Claims
    • Partnership with Federal Agencies Targets Food Waste Reduction
    • Federal Agencies Warn Company Marketing Unapproved CBD Products
    • CBD in the Clinic: How Practitioners View Life After the Farm Bill
    11.26.19
    The U.S. Food and Drug Administration (FDA) issued warning letters to 15 companies for selling products containing cannabidiol (CBD) in ways the agency said violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). At the same time, FDA published a revised Consumer Update detailing safety concerns about CBD products more broadly.
     
    Based on the lack of scientific information supporting the safety of CBD in food, the FDA also indicating that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.
     
    The actions come as FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s public health standards. FDA said it plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.
     
    “As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD.
     
    “In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” she continued. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety—including reports of products containing contaminants, such as pesticides and heavy metals—and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
     
    Many unanswered questions and data gaps about CBD toxicity exist, FDA noted, and some of the available data raise concerns about potential harm from CBD. The revised Consumer Update outlines specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.
     
    CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams. As outlined in the warning letters, these particular companies are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.
     
    The companies receiving warning letters are:
     
    Koi CBD LLC, of Norwalk, California
    Pink Collections Inc., of Beverly Hills, California
    Noli Oil, of Southlake, Texas
    Natural Native LLC, of Norman, Oklahoma
    Whole Leaf Organics LLC, of Sherman Oaks, California
    Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colorado
    Apex Hemp Oil LLC, of Redmond, Oregon
    Bella Rose Labs, of Brooklyn, New York
    Sunflora Inc., of Tampa, Florida/Your CBD Store, of Bradenton, Florida
    Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, California
    Private I Salon LLC, of Charlotte, North Carolina
    Organix Industries Inc., doing business as Plant Organix, of San Bernardino, California
    Red Pill Medical Inc., of Phoenix, Arizona
    Sabai Ventures Ltd., of Los Angeles, California
    Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky
     
    The FDA has previously sent warning letters to other companies illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act. Some of these products were in further violation because CBD was added to food, and some of the products were also marketed as dietary supplements despite products which contain CBD not meeting the definition of a dietary supplement.
     
    Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.
     
    Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of unapproved CBD drug products has not been subject to FDA review as part of the human or animal drug approval processes.
     
    Some of the products outlined in the warning letters today raised other legal and public health concerns, according to FDA.
     
    For example, some of the products are marketed for infants and children—a vulnerable population that may be at greater risk for adverse reactions due to differences in the ability to absorb, metabolize, distribute, or excrete a substance such as CBD.
     
    Some of the products are foods to which CBD has been added. Under the FD&C Act, it is illegal to introduce into interstate commerce any human or animal food to which certain drug ingredients, such as CBD, have been added. In addition, the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food. There also is no food additive regulation which authorizes the use of CBD as an ingredient in human food or animal food, and the agency is not aware of any other exemption from the food additive definition that would apply to CBD. CBD is therefore an unapproved food additive, and its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient.
     
    Some of the products are marketed as dietary supplements. However, CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.
     
    One product outlined in a warning letter to Apex Hemp Oil LLC is intended for food-producing animals. The agency remains concerned about the safety of human food products (e.g., meat, milk, and eggs) from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels.
     
    The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.
     
    The FDA encourages human and animal healthcare professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
     
     
    Related Searches
    • Healthcare
    • Natural
    • Children
    • Cancer
    Related Knowledge Center
    • Herbs & Botanicals
    • Regulations
    • Quality & Safety
    Suggested For You
    Sunflower Hemp Co Sunflower Hemp Co
    Developing Scientific Support for Product Claims Developing Scientific Support for Product Claims
    Partnership with Federal Agencies Targets Food Waste Reduction Partnership with Federal Agencies Targets Food Waste Reduction
    Federal Agencies Warn Company Marketing Unapproved CBD Products Federal Agencies Warn Company Marketing Unapproved CBD Products
    CBD in the Clinic: How Practitioners View Life After the Farm Bill CBD in the Clinic: How Practitioners View Life After the Farm Bill
    Clearing Up Chaos in the Modern Nutraceuticals Market Clearing Up Chaos in the Modern Nutraceuticals Market
    CBD Regulatory Status Update: The Chaos Continues CBD Regulatory Status Update: The Chaos Continues
    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
    FDA Approves Impossible Foods Petition, Allows Soy Leghemoglobin as Color Additive FDA Approves Impossible Foods Petition, Allows Soy Leghemoglobin as Color Additive
    Industry Calls for Label Literacy of New Supplement Facts Label Industry Calls for Label Literacy of New Supplement Facts Label
    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
    FDA Allows Claims for EPA/DHA Omega-3 and Risk of Hypertension & Coronary Heart Disease FDA Allows Claims for EPA/DHA Omega-3 and Risk of Hypertension & Coronary Heart Disease
    Levagen PEA: A Legal Answer to CBD’s Issues Levagen PEA: A Legal Answer to CBD’s Issues

    Related Buyers Guide Companies

    • Sunflower Hemp Co

      ...
      Colby Terip, Owner 09.15.21

    • Dietary Supplements | Healthcare Trends | Medical Nutrition | Quality & Safety | Regulations | Testing
      Developing Scientific Support for Product Claims

      Developing Scientific Support for Product Claims

      Generally accepted scientific principles should be used to determine the quality of studies used as evidence to substantiate a claim.
      By Greg Stephens, Windrose Partners & Sanford W. Bigelow, PhD, DABT, Vanguard Global Associates LLC 11.05.19

    • Breaking News | Consumer Trends | Industry & Market News | Regulations
      Partnership with Federal Agencies Targets Food Waste Reduction

      Partnership with Federal Agencies Targets Food Waste Reduction

      More than one-third of all available food goes uneaten through loss or waste in the U.S.
      11.01.19


    • Breaking News | Herbs & Botanicals | Industry & Market News | Regulations | Regulatory News
      Federal Agencies Warn Company Marketing Unapproved CBD Products

      Federal Agencies Warn Company Marketing Unapproved CBD Products

      ‘These actions should send a message to the broader market about complying with FDA requirements,’ says Acting FDA Commissioner.
      10.22.19

    • Dietary Supplements | Healthcare Trends | Herbs & Botanicals | Medical Nutrition | Quality & Safety | Regulations
      CBD in the Clinic: How Practitioners View Life After the Farm Bill

      CBD in the Clinic: How Practitioners View Life After the Farm Bill

      Holistic, functional medicine practitioners see therapeutic value of CBD and have confidence in its efficacy for a range of common health concerns.
      By Erik Goldman, Holistic Primary Care 10.07.19

    Trending
    • Three Grams Of Omega-3s May Be Optimal Dose For Reducing Blood Pressure
    • 3 grams of Omega-3s May be Optimal Dose for Reducing Blood Pressu
    • Olive/Pomegranate Extract May Improve Dyslipidemia
    Breaking News
    • Florida Food Products Acquires Javo
    • Roquette Launches Nutralys Rice Protein
    • New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    • CTRL Launches Meal On-The-Go Bars
    • GNC and RealEats Meal Delivery Partnership Expands Nationally
    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

    Florida Food Products Acquires Javo
    Roquette Launches Nutralys Rice Protein
    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    Coatings World

    Latest Breaking News From Coatings World

    The Southern Society for Coatings Technology's 84th Annual Technical Conference A Success
    PPG to Showcase Specialty Automotive, Aerospace Adhesives, Sealants at Adhesives & Bonding Expo
    PPG’s New Paint for a New Start Initiative to Transform 25-plus Schools Worldwide
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most Read Stories This Week—June 25
    Magnetic Insight Announces $17 Million in Series B Funding
    BreatheSuite Adds Brad Fluegel to its Board
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pierre Fabre and Lonza Enter Manufacturing Agreement
    MasterControl and Elemental Machines Form Biomanufacturing Partnership
    Qosina Strengthens Aseptic Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Benefit Exec Joins Madison Reed's Board
    Peroni & Ellis Brooklyn Launch Fragrance Collection Inspired by Italian Spritz Cocktails
    Rhode Is Trending for June, Trendalytics Says
    Happi

    Latest Breaking News From Happi

    Wonder Curl Wins GlossWire's GlossPitch Competition
    Anti-aging Skincare Brand Vitabrid C12 Launches Bestsellers on Amazon
    Botanical Embedded Candles Can Be Fire Hazard, Says National Candle Association
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    British Coatings Federation Posts Online History
    Orion Announces Price Increases, Reduced Payment Terms
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PCMC teams with IGT, Fujifilm makes big announcement and more
    Loftware recognized as 'AIDC Company of the Year'
    Schreiner MediPharm highlights sustainability of Needle-Trap technology
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Tranzonic Names VP of Supply Chain
    Ontex Climate Action Targets Approved by Science-Based Targets Initiative
    Suominen Test Center Assesses Biodegradability of Nonwovens
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 25
    3Spine Inc. Receives IDE Approval for U.S. Pivotal Clinical Trial
    Volume-Based Procurement to Reduce Chinese Orthopedic Market Value
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories
    NREL Names Jennifer Logan to Leadership Team as CFO
    National Grid Renewables Orders 2 GW of First Solar Modules

    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