• 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
    Bold Hues & The Skinification of Makeup Lead Fall 2022 Color Cosmetic Trends

    Fine Fragrance Packaging: It’s What’s On the Outside That Counts

    The Top 50

    ACI Prepares for a Busy Second Half of 2022

    Honeywell Technology Boosts Efficiency And Reduces Carbon Footprints
    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
    Dr. Bronner’s Releases 2022 All-One! Report, ‘Leading with Heart’

    Indeed Labs Skin Care Launches at Target

    In-Cosmetics Asia Returns to Bangkok to Deliver Look at Market Trends and Ingredient Innovations

    Perfect Corp. AI Skin Analysis Beauty SaaS Brand Console Is HIPAA-Compliant

    Black-Owned Dinobi Detergent Uses Plant-Based Green Ingredients
    Blog
    Online Exclusives
    Glossary
    Infographics
    Podcasts
    Whitepapers
    Videos
    Expert's Opinion
    HappiTV
    eBook
    Surveys
    International Top 30 Report
    Top 50 Report
    Top Companies
    9. Lion

    2. Colgate-Palmolive

    Orveon

    29. Scentsy

    27. PZ Cussons
    Actives
    Functional Ingredients
    Pigments
    Polymers
    Preservatives
    Surfactants

    Kayali’s Lovefest Fragrance, Newell’s New Candle and HydraFacial’s Record Financial Results

    Kering Said To Be Mulling Acquisitions in the Luxury Beauty Space

    J&J To Stop Global Sales of Talc-Based Products by 2023

    Covid-Related Lockdowns in China, Impact Shiseido's First Half Results

    Brenntag Specialties Expands Collaboration with Preservatives Producer ISCA in Europe
    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

    Dr. Bronner’s Releases 2022 All-One! Report, ‘Leading with Heart’

    In-Cosmetics Asia Returns to Bangkok to Deliver Look at Market Trends and Ingredient Innovations

    Perfect Corp. AI Skin Analysis Beauty SaaS Brand Console Is HIPAA-Compliant

    GBAC Offers Advice on Cleaning and Disinfecting for Monkeypox

    Healthiest Cities for Skin
    Lab Equipment
    Mixing
    Packaging
    Testing

    Fine Fragrance Packaging: It’s What’s On the Outside That Counts

    Genderless Skincare Brand, S'able Labs, Debuts Next Week

    Deadline Nears for NJ Recycled Content Law

    L’Oréal Paris Has a New Answer For Men with Gray Hair

    Labskin's Microbiome-Friendly+ Seal of Approval Available in the US
    Contract Manufacturing / Private Label Directory
    Buyer's Guide
    Add New CMPL Directory Company
    Add New Buyers Guide Company
    Corporate Profiles
    International Buyers Guide Companies
    Acme-Hardesty

    BARALAN

    Lubrizol Life Science

    LipoTrue Inc.

    BotanicalsPlus
    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
    • Glossary
    • Experts Opinion
    • Slideshows
    • HappiTV
    • Podcasts
    • Videos
    • Infographics
    • eBook
    • 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
    Live From Shows

    FDA Sends Warning Letter to CBD Company

    Florida company selling roll-on oral care and other products.

    Related CONTENT
    • More than CBD
    • Eco Lips Introduces CBD Line
    • Nordic Cosmetics Launches CBD on Tmall
    • CBD-Infused Cosmetics: A Comprehensive Legal Overview
    • Fekkai Debuts CBD Collection
    Happi staff10.24.19
    A warning letter has been sent by FDA to Ryan P. Collett and Cade Copeland of Rooted Apothecary LLC, a Naples, FL-based company that is selling cannabidiol (CBD) products, including topical roll-ons. In its letter, dated Oct. 10, FDA said it had reviewed the company’s website (www.rootedapoth.com) in July as well as the company’s social media, regarding the following products: “Teeth/TMJ – Essential Oil + CBD Infusion” and “Ears – Essential Oil + CBD Infusion, roll-on products for topical application in adults and children, as well as “Hemp Infused Body Butter,” and hemp capsules and oil.
     
    In doing so, FDA said it has determined that the firm’s “Teeth/TMJ – Essential Oil + CBD Infusion,” “Ears – Essential Oil + CBD Infusion,” “Hemp Capsules, 750 mg,” “Hemp Infused Body Butter,” and “Hemp Oil” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). FDA also said that these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA also noted that introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. 
     
    As FDA stated in an announcement regarding a warning letter on July 23, 2019, “while we recognize the potential opportunities and significant interest in drug products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority,”  the Agency continues to be concerned about the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses without having been reviewed for safety and effectiveness by the FDA as is required by law and to protect the public health. 
     
    FDA noted: “There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD. Without this information, we are unable to ensure that these products will not cause harm to people who use them. With the exception of Dronabinol, Epidiolex, Marinol and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population.”
     
    FDA said that it is “particularly concerned” that Rooted Apothecary is marketing unapproved new drugs for uses in infants and children. 
    Related Searches
    • oil
    • marketing
    • essential oil
    • media
    Related Knowledge Center
    • OTC/Medicated
    • Oral Care
    Suggested For You
    More than CBD More than CBD
    Eco Lips Introduces CBD Line Eco Lips Introduces CBD Line
    Nordic Cosmetics Launches CBD on Tmall Nordic Cosmetics Launches CBD on Tmall
    CBD-Infused Cosmetics:  A Comprehensive Legal Overview CBD-Infused Cosmetics: A Comprehensive Legal Overview
    Fekkai Debuts CBD Collection Fekkai Debuts CBD Collection
    Hemp/CBD Legislation Introduced in House Hemp/CBD Legislation Introduced in House
    Hemp Council Weighs in on CBD Cosmetics Hemp Council Weighs in on CBD Cosmetics
    Zotos Adds Wellphoria CBD Hair Care Zotos Adds Wellphoria CBD Hair Care
    Mibelle Launches Lipobelle Pino C Mibelle Launches Lipobelle Pino C
    Mibelle Launches Lipobelle Pino C Mibelle Launches Lipobelle Pino C
    Natural Ingredients Gain Popularity Natural Ingredients Gain Popularity
    Virginia to Pass Law Regulating CBD As Food Virginia to Pass Law Regulating CBD As Food
    New CBD Products from R+Co New CBD Products from R+Co
    Madrigal Creatives Rolls Out CBD-Infused Lip Serum Madrigal Creatives Rolls Out CBD-Infused Lip Serum
    I+I Botanicals Promotes Self Care I+I Botanicals Promotes Self Care

    Related Live From Shows

    • Actives | Skin Care

      More than CBD

      Mibelle launches Lipobelle Pino C.
      Happi Staff 10.02.20

    • Skin Care
      Eco Lips Introduces CBD Line

      Eco Lips Introduces CBD Line

      Includes three lip balm flavors: lavender orange, lavender mint and natural.
      Happi Staff 09.30.20

    • Functional Ingredients | Skin Care
      Nordic Cosmetics Launches CBD on Tmall

      Nordic Cosmetics Launches CBD on Tmall

      It's China's first consumer CBD store.
      Happi Staff 09.28.20


    • CBD-Infused Cosmetics: A Comprehensive Legal Overview

      ...
      09.18.20

    • Hair Care
      Fekkai Debuts CBD Collection

      Fekkai Debuts CBD Collection

      Launches contest to find a ‘Chief Shower Officer.’
      Happi Staff 09.10.20

    Loading, Please Wait..
    Trending
    • Tree Hut Launches Pumpkin Spice Latte, Velvet Coffee-Flavored Shea Sugar Scrubs
    • Top Beauty, Wellness & Lifestyle Influencers On Social Media For 2022
    • Healthiest Cities for Skin
    • The NAS Report Is A Victory For Sunscreen Industry
    • Sephora’s Virtual House Of Beauty Returns With Exclusive Offerings
    Breaking News
    • Dr. Bronner’s Releases 2022 All-One! Report, ‘Leading with Heart’
    • In-Cosmetics Asia Returns to Bangkok to Deliver Look at Market Trends and Ingredient Innovations
    • Perfect Corp. AI Skin Analysis Beauty SaaS Brand Console Is HIPAA-Compliant
    • Black-Owned Dinobi Detergent Uses Plant-Based Green Ingredients
    • Consumers Clamor for Vintage Glam: Spate
    View Breaking News >
    CURRENT ISSUE

    August 2022

    • Bold Hues & The Skinification of Makeup Lead Fall 2022 Color Cosmetic Trends
    • Fine Fragrance Packaging: It’s What’s On the Outside That Counts
    • 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

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Tazo Transitions to Regenerative Organic Agriculture
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures Posts Record 2Q 2022 Results
    Advanced Polymer Coatings Strikes Series of New Tanker Deals
    Barentz Named Distributor for Pilot Chemical Segments in US and Canada
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Spartech Promotes Three Staff Members
    Elisabeth Lackner Named Chief Scientific Officer at Element Materials Technology
    Natech Plastics Purchases Three New Injection Molding Machines
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Novavax Submits EUA for Protein-based COVID-19 Vax Booster
    BeiGene, Ontada Enter Strategic Oncology Alliance
    AskBio Appoints Clinical Ops Executives
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Mary Kay Supports International Women's Forum's Latest Research
    Vegamour Launches in the UK
    Maelys Rolls Out to Ulta Beauty
    Happi

    Latest Breaking News From Happi

    Dr. Bronner’s Releases 2022 All-One! Report, ‘Leading with Heart’
    In-Cosmetics Asia Returns to Bangkok to Deliver Look at Market Trends and Ingredient Innovations
    Perfect Corp. AI Skin Analysis Beauty SaaS Brand Console Is HIPAA-Compliant
    Ink World

    Latest Breaking News From Ink World

    BASF Breaks Ground on Riverfront Park in East Newark
    Roland DG Corporation to Relocate HQ to Miyakoda, Japan
    Gallus Launches Gallus One, Its First Fully Digital Inkjet Label Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Schreiner ProTech develops nameplate-integrated PCS solution
    Pro Label Inc. installs first Mark Andy DSiQ hybrid press
    Gallus launches Gallus One inkjet label press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Daio Paper Acquires Pet Care Products Manufacturer
    Honest Reports Increased Revenue
    Weekly Recap: Essity Switches to Recyclable Packs for Feminine Pads, FTC Sues PPE Maker on False Origin Claims & More
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FundamentalVR Raises $20 Million in Series B Funding
    Bioventus Achieves Strong Growth in Q2 2022
    Bone Void Fillers Market Growing at 6%
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    onsemi Celebrates Expansion of Silicon Carbide Production Facility in New Hampshire
    Applied Materials CTO Dr. Om Nalamasu Receives IEEE Frederik Philips Award
    Weekly Recap: ALTANA, Universal Display and Emerson Top This Week’s Stories

    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