• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Formulary
    • Exclusives
    • Top Companies
    • Raw Materials
    • End-User
    • Packaging
    • Directories
    • Events
    • Jobs
    • More
  • Magazine
  • News
  • Formulary
  • Exclusives
  • Top Companies
  • Raw Materials
  • End-User
  • Packaging
  • Directories
  • Events
  • Jobs
  • Current / Back Issues
    Features
    Columns
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    A Conversation with the Responsible Flushing Alliance

    Nice-Pak Meets Consumer Demands

    Wipes Manufacturers Meet Demand Surge

    Home Care Wipes: Sustainability in Sharper Focus as Cleaning Frenzy Simmers Following Pandemic

    The Cannabis Glow Up
    Online Exclusives
    Association News
    Breaking News
    Financial News
    Industry News
    International
    Marketing News
    New Products
    News Front
    Packaging News
    Patents
    Personnel
    Regulations
    Snapshots
    Top News
    Live From Shows
    Top News
    TFF Names 2021 Honorees for Lifetime Achievement Perfumer and Hall of Fame

    Ashland Donates $20,000 To Help Plant Trees

    Multi-Purpose Sustainable 'Just Add Water' Household Cleaner Expands Cleaning Products

    Kao Launches Oribe in Japan

    Love Beauty and Planet Shares Sustainability Initiatives With Refillable Hair Care at Target
    Blog
    Online Exclusives
    Infographics
    Podcasts
    Whitepapers
    Videos
    Expert's Opinion
    HappiTV
    eBook
    Surveys
    International Top 30 Report
    Top 50 Report
    Top Companies
    36. Helen of Troy

    21. Kosé

    8. Reckitt Benckiser

    10. Natura

    12. Bolton Group
    Actives
    Functional Ingredients
    Pigments
    Polymers
    Preservatives
    Surfactants

    The Estée Lauder Companies Is Beauty Inspired, Values Driven

    HCPA Mid-Year Meeting Adds Keynote

    CP Kelco's Progress Toward 2022 Sustainability Objectives

    Ball Care, a New Category in Men’s Grooming

    Jeen International Celebrates Its 25th Anniversary
    Air Care/Environmental Fragrance
    AP/Deo
    Color Cosmetics
    Disinfectants
    Fine Fragrance
    Hair Care
    Household Cleaning
    I&I Marketplace
    Laundry Care
    Oral Care
    OTC/Medicated
    Packaging
    Personal Cleansers
    Skin Care
    Sun Care
    Testing

    TFF Names 2021 Honorees for Lifetime Achievement Perfumer and Hall of Fame

    The Estée Lauder Companies Is Beauty Inspired, Values Driven

    Multi-Purpose Sustainable 'Just Add Water' Household Cleaner Expands Cleaning Products

    No H20: The Rising Tide of Waterless Beauty

    Kao Launches Oribe in Japan
    Lab Equipment
    Mixing
    Packaging
    Testing

    Pact Collective Is New Non-Profit Recycling Take-Back Program for Beauty

    New Beauty Brand sk*p Wants to Break Addiction to Plastic

    Arbonne's One Year Anniversary as a B Corp

    Admix Appoints COO to Advance Manufacturing, Supply Chain & Regulatory Compliance

    Tesco Eliminates Plastic Bags from Online Orders
    Contract Manufacturing / Private Label Directory
    Buyer's Guide
    Add New Company
    Corporate Profiles
    International Buyers Guide Companies
    Vantage Specialty Ingredients

    Baralan USA

    Jeen International

    Ashland

    Praan Naturals
    Live From Shows
    Meetings
    Webinars
    Snapshots
    • Magazine
      • Current / Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Formulary
    • Directories
      • Buyer's Guide
      • Contract Manufacturing / Private Label Directory
      • Corporate Profiles
      • Add Your Company
    • Raw Materials
      • Actives
      • Functional Ingredients
      • Pigments
      • Polymers
      • Preservatives
      • Surfactants
    • End-User
      • Air Care/Environmental Fragrance
      • AP/Deo
      • Color Cosmetics
      • Disinfectants
      • Fine Fragrance
      • Hair Care
      • Household Cleaning
      • I&I Marketplace
      • Laundry Care
      • Oral Care
      • OTC/Medicated
      • Packaging
      • Personal Cleansers
      • Skin Care
      • Sun Care
      • Testing
    • Packaging
      • Lab Equipment
      • Mixing
      • Packaging
      • Testing
    • Top Companies
      • International Top 30 Report
      • Top 50 Report
    • Online Exclusives
    • Experts Opinion
    • Slideshows
    • HappiTV
    • Videos
    • Podcasts
    • eBook
    • Infographics
    • Blog
    • Whitepapers
    • Surveys
      • R & D Salary Survey
      • Sales & Marketing Salary Survey
    • Job Banks
    • Events
      • Industry Events
      • Live from show Events
      • Webinars
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Issues 15 CBD Warning Letters

    Companies are selling topical formulations and more.

    FDA Issues 15 CBD Warning Letters
    FDA continues to take a closer look at products with CBD.
    Related CONTENT
    • Foot Spray Fueled by CBD
    • The Skin-Caring Benefits of CBD
    • FDA Sends Warning Letter to Dollar Tree
    • A Horse of a Different Color
    • Rodial Adds CBD Booster Drops
    Happi staff11.26.19
    The US Food and Drug Administration yesterday issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Among the products listed were balms, lotions, eye cream and soap, to name just a few of the topical formulations.

    The agency also published a revised Consumer Update detailing safety concerns about CBD products more broadly, and also specifically addressed issues related to CBD in food.

    The agency this most recent step comes as it 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 rigorous public health standards. The 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. 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,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “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.”

    As outlined in the warning letters, the 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
    A list of previous warning letters sent 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 can be found here. 

    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.

    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.

    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.

    According to the agency, 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. Consumers may also put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.
    Additionally, some of the products outlined in the warning letters issued today raise other legal and public health concerns, including:
    • 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, noted FDA.
    Related Searches
    • soap
    • active
    • science
    • topical
    Related Knowledge Center
    • Personal Cleansers
    • Skin Care
    • OTC/Medicated
    Suggested For You
    Foot Spray Fueled by CBD Foot Spray Fueled by CBD
    The Skin-Caring Benefits of CBD The Skin-Caring Benefits of CBD
    FDA Sends Warning Letter to Dollar Tree FDA Sends Warning Letter to Dollar Tree
    A Horse of a Different Color A Horse of a Different Color
    Rodial Adds CBD Booster Drops Rodial Adds CBD Booster Drops
    FDA Sends Warning Letter to CBD Company FDA Sends Warning Letter to CBD Company
    A Call for Transparency About CBD in Beauty A Call for Transparency About CBD in Beauty
    Warning Letter Sent to SC Johnson Professional Warning Letter Sent to SC Johnson Professional
    The CBD Craze: Still Only the Beginning The CBD Craze: Still Only the Beginning
    Lessonia Launches Lessonia Launches 'Hemp' Range
    TriPollar Stop Prepares for Sales in US TriPollar Stop Prepares for Sales in US
    The Ongoing Challenges of Category I UV Filters and FDA The Ongoing Challenges of Category I UV Filters and FDA
    CBD Enhanced Lip Collection Launch CBD Enhanced Lip Collection Launch
    Salvona Technologies Introduces SalSphere CBD Salvona Technologies Introduces SalSphere CBD
    Chinese Wipes Maker Flagged by FDA Chinese Wipes Maker Flagged by FDA

    Related Breaking News

    • Color Cosmetics | Fine Fragrance | Packaging | Skin Care
      Pact Collective Is New Non-Profit Recycling Take-Back Program for Beauty

      Pact Collective Is New Non-Profit Recycling Take-Back Program for Beauty

      Credo, MOB Beauty and Hudson’s Bay are founding members.
      Christine Esposito, Managing Editor 04.22.21

    • Color Cosmetics | Fine Fragrance | Hair Care | Skin Care
      It

      It's Official! L'Oréal Gets New CEO on May 1

      As reported, Nicolas Hieronimus succeeds Jean-Paul Agon.
      Tom Branna, Editorial Director 04.21.21

    • Hair Care | Packaging | Personal Cleansers | Skin Care
      New Beauty Brand sk*p Wants to Break Addiction to Plastic

      New Beauty Brand sk*p Wants to Break Addiction to Plastic

      Uses proprietary paper-based container that can hold up in the shower and its own bio-fermented honey extract.
      Christine Esposito, Managing Editor 04.21.21


    • Skin Care
      Clinique’s #ZitHappens TikTok Challenge Celebrates ‘Skin Positivity’

      Clinique’s #ZitHappens TikTok Challenge Celebrates ‘Skin Positivity’

      Campaign rolls out today.
      Christine Esposito, Managing Editor 04.21.21

    • Actives | Functional Ingredients | Hair Care | Personal Cleansers | Skin Care
      CP Kelco

      CP Kelco's Progress Toward 2022 Sustainability Objectives

      Accomplishments include 12% reduction in water intensity and world class safety performance.
      Tom Branna, Editorial Director 04.21.21

    • Skin Care
      Kiehl’s Launches Sustainable Pouch Refillables for Hair Care, Skin Care

      Kiehl’s Launches Sustainable Pouch Refillables for Hair Care, Skin Care

      Save on average 80% more plastic than a typical Kiehl’s single-use product.
      Melissa Meisel, Associate Editor 04.20.21


    • Color Cosmetics | Skin Care
      Amazon Adds SCS’ Carbon Neutral Certification to Its Climate Pledge Friendly Program

      Amazon Adds SCS’ Carbon Neutral Certification to Its Climate Pledge Friendly Program

      Certifies products to multiple internationally recognized carbon neutral standards.
      Melissa Meisel, Associate Editor 04.20.21

    • Skin Care
      Cosphatec Introduces Cosphaderm Dicapo Natural

      Cosphatec Introduces Cosphaderm Dicapo Natural

      A blend with natural caprylyl glycol.
      Charles Sternberg, Assistant Editor 04.20.21

    • Color Cosmetics | Skin Care
      P&G Reports Solid Cash Results in Q3 of Fiscal 2021

      P&G Reports Solid Cash Results in Q3 of Fiscal 2021

      Net sales were $18.1 billion, a five percent increase versus the prior year.
      Charles Sternberg, Assistant Editor 04.20.21


    • Skin Care
      Jergens Launches Mother’s Day Campaign

      Jergens Launches Mother’s Day Campaign

      Shines a light on nontraditional and under-recognized moms.
      Charles Sternberg, Assistant Editor 04.19.21

    • Actives | Functional Ingredients | Hair Care | Personal Cleansers | Polymers | Preservatives | Skin Care | Sun Care | Surfactants
      Jeen International Celebrates Its 25th Anniversary

      Jeen International Celebrates Its 25th Anniversary

      Its entrepreneurial approach to beauty has attracted more than 3,000 customers around the world.
      Tom Branna, Editorial Director 04.19.21

    • Functional Ingredients | Hair Care | Skin Care | Surfactants
      What You

      What You're Reading on Happi.com

      The most-viewed news on our site for the week ended April 17, 2021.
      Tom Branna, Editorial Director 04.18.21


    • Color Cosmetics | Pigments | Skin Care
      Top Beauty Influencers

      Top Beauty Influencers

      Cosmetify ranks Huda Kattan, James Charles and others based on payments per post.
      Tom Branna, Editorial Director 04.17.21

    • Color Cosmetics | Personal Cleansers | Skin Care
      Former L’Oréal Exec Joins Glossier

      Former L’Oréal Exec Joins Glossier

      Kleo Mack appointed VP of brand.
      Tom Branna, Editorial Director 04.17.21

    • Hair Care | Household Cleaning | Laundry Care | Oral Care | Skin Care
      P&G Emphasizes Small Actions at Home To Be More Sustainable

      P&G Emphasizes Small Actions at Home To Be More Sustainable

      New campaign looks to close the gap between consumer intention and action.
      Christine Esposito, Managing Editor 04.16.21

    Trending
    • Sunscreen On The Spot
    • It's Official! L'Oréal Gets New CEO On May 1
    • Clinique’s #ZitHappens TikTok Challenge Celebrates ‘Skin Positivity’
    • BASF Increases Price Of Kaolin
    • K18 Biomimetic Hairscience Debuts In Salons
    Breaking News
    • TFF Names 2021 Honorees for Lifetime Achievement Perfumer and Hall of Fame
    • Ashland Donates $20,000 To Help Plant Trees
    • Multi-Purpose Sustainable 'Just Add Water' Household Cleaner Expands Cleaning Products
    • Kao Launches Oribe in Japan
    • Love Beauty and Planet Shares Sustainability Initiatives With Refillable Hair Care at Target
    View Breaking News >
    CURRENT ISSUE

    CBD Inside & Out

    • The Cannabis Glow Up
    • Mary Jane's Botanicals
    • A Closer Look at cbdMD
    • Is Cannabidiol Coming to Your City or Hamlet?
    • USDA's Final Rule on Hemp
    • A CBD Packaging Evolution
    • CBD Food & Supplement Market Is in Limbo
    • CBD New Product Development
    • 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

    Ashland Supports the Nature Conservancy Forest Restoration Effort to Help Plant a Billion Trees
    Martin Bauer Announces Installation of Agile Filling System at Bethlehem, PA Facility
    PepsiCo and Ingredion Begin Pilot Partnership with Soil and Water Outcomes Fund
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Shareholders Approve Final Dividend at Annual General Meeting
    PPG Maintains EcoVadis Gold Rating
    Sustainable Plastics Will Make Up More Than 15% of Production by 2030
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Getinge Receives FDA Clearance for Multiple Products
    Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry
    TEAM Technologies Acquires ViruDefense
    Contract Pharma

    Latest Breaking News From Contract Pharma

    RDIF, Minapharm to Make Over 40M Doses of the Sputnik V Vaccine in Egypt
    Bora Pharmaceuticals Completes Health Canada Inspection
    Nanoform, Aprecia Partner to Advance 3DP Nanomedicines
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Johnson & Johnson Reports Sales Increase in First Quarter of 2021
    THG Launches Recycling Program in UK
    Knoll Printing & Packaging Commits to a Healthy Ocean and Planet
    Happi

    Latest Breaking News From Happi

    L’Oréal Successfully Defends Itself In Patent Infringement Lawsuit
    TFF Names 2021 Honorees for Lifetime Achievement Perfumer and Hall of Fame
    Ashland Donates $20,000 To Help Plant Trees
    Ink World

    Latest Breaking News From Ink World

    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    Acrylic Resins Market Worth $21.9 Billion by 2025: MarketsandMarkets
    SE-DA Invests in Kornit Presto S
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Ashland commits to forest restoration
    Epson upgrades SurePress demo facility
    Xeikon helps converters navigate toner and inkjet
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Savaré Strengthens Technical Support for the Americas
    FiberVisions, Avgol Partner with Polymateria
    High-Tech Conversions Launches Wipes Dispenser
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FDA Clears Orthofix's 3D-Printed FORZA Titanium TLIF Spacer System
    Patients Conclude Clinical Visits in Knee Osteoarthritis Treatment Study
    SeaSpine Begins Limited Rollout of WaveForm TO 3D-Printed Interbodies
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv, Ameta International Announce US, Canadian Distribution Partnership
    Adesis Achieves ISO 9001:2015 Certification
    Louis Widmer SA Complies with EU Anti-Counterfeiting Directive with Zebra Technologies’ Solution

    Copyright © 2021 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