• 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
    Consumers are Clamoring for Vintage Glam: Spate

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

    Self Care Trumps Home Care Post-Covid

    Sephora’s Virtual House of Beauty Returns with Exclusive Offerings

    JC Penney Appoints Chief Financial Officer
    Blog
    Online Exclusives
    Glossary
    Infographics
    Podcasts
    Whitepapers
    Videos
    Expert's Opinion
    HappiTV
    eBook
    Surveys
    International Top 30 Report
    Top 50 Report
    Top Companies
    Newell

    14. Sara Lee

    3. Estée Lauder

    Procter & Gamble

    15. Guthy-Renker
    Actives
    Functional Ingredients
    Pigments
    Polymers
    Preservatives
    Surfactants

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

    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

    The NAS Report Is a Victory for Sunscreen Industry
    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

    GBAC Offers Advice on Cleaning and Disinfecting for Monkeypox

    Healthiest Cities for Skin

    Consumers are Clamoring for Vintage Glam: Spate

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

    Self Care Trumps Home Care Post-Covid
    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
    Lubrizol Life Science

    Centerchem LLC

    BARALAN

    QRS (Quality Resourcing Services)

    LipoTrue Inc.
    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
    Features

    Navigating New Product Development in CBD

    Advice for personal care brands that want to market their own topical products.

    Navigating New Product Development in CBD
    Christine Esposito, Managing Editor04.01.21
    The CBD topicals marketplace continues to grow, and the prospects of added revenue from a new line of products that tap into this hot ingredient are appealing for any beauty company. But finding success in CBD isn’t as simple as ABC. For starters, there are myriad brands and products hitting the space and that means me-too products can very well get lost in this cluttered category, and making claims that take things a bit too far can bring unwanted attention from federal regulators.

    What’s A Brand To Do?

    “The first thing to think about is formulation, and how it fits with market expectations,” said Greg Dicum, co-founder and CEO of CWI Consulting Services, which provides functional product research and development to companies across several sectors from beverages to beauty products and more. The Fairfax, CA-based company specializes in cannabinoids.

    When Dicum’s company was creating its recently released CBD Topicals Report, it discovered a crowded space, but also a “big gulf between the best products and rest of the pack.”

    According to Dicum, the best CBD topicals tend to be natural products with simple ingredient lists and natural ingredients like essential oils that are understood and appreciated by consumers—think coconut oil and shea butter.

    Since CBD topicals tend to be more expensive than topicals in general—CBD is often the most expensive ingredient—consumers expect to see high quality natural products, said Dicum.

    “The typical price range is $20 to $50, so from the consumer’s perspective, these have to be high quality products in every dimension,” he said.

    Claim This, Not That

    In addition, Dicum said it is absolutely critical to focus on compliance throughout the entire product development process.

    FDA routinely reviews CBD product packaging, communications and marketing materials, and will not hesitate to send warning letters to companies it finds in violation of FDA rules.

    For example, in December 2020, Wellness BioSciences Rx, Houston, TX, received a warning letter from FDA after the agency reviewed its website (https://wbrxglobal.com) regarding CBD products.

    According to FDA, the claims on the website and social media pages establish BioSciences’ CBD products as unapproved new drugs. In April 2020, FDA also flagged The Dragontree Apothecary LLC.

    Among the products that caught the FDA’s attention was the Boulder, CO-based company’s CBD Muscle Melt Balm. FDA also reviewed the firm’s product labels collected during an August 2019 inspection. According to the FDA, the claims on the product labels and websites establish the product as a drug. Specifically, one claim for the CBD Muscle Melt Balm read: “[S]oothe uncomfortable muscles and joints more quickly and safely than oral pharmaceuticals.”

    Dicum suggested a more cautionary approach. “Perhaps the biggest compliance challenge for brands is steering clear of language that suggests CBD can cure or treat any diseases or conditions,” said Dicum. “Of course we know from both widespread anecdotal experience and a growing body of scientific studies that CBD is fantastic for helping people with many different wellness challenges, including chronic pain, sleep issues, anxiety and more—just don’t say that on your labels!”

    Unfortunately, according to Dicum, it has been rather common for CBD brands to make risky claims.

    “Fully a quarter of the products we looked at claimed to treat pain, exposing themselves to FDA action and also disqualifying themselves from the shelves of mainstream retailers,” he said.

    In general, it might be wise for brands to stick to vague wording like “relief” instead of “pain relief” and “de-stress” instead of “fights anxiety.” Additionally, Dicum said that companies should consult compliance experts who are up-to-date on the constantly changing CBD regulatory landscape.

    Be A Smart Shopper

    New brands that want to enter the CBD sector must nail down an ingredient supplier first.

    “The good news is that CBD wholesale prices have never been lower,” said Dicuum. “There is a big glut out there thanks to farmers planting as much as they could in the past few years on the expectation that federal CBD rules would be clarified and the market would burst into the mainstream. That has not happened yet, so prices are unbelievably low.”

    But as there are different types of CBD inputs, Dicum said it is important for formulators to know what they want and be savvy buyers in the CBD space. CWI advises clients to use a broad-spectrum oil which will have THC removed, but still contains other natural constituents of the hemp plant such as terpenes.

    “The reason we like broad spectrum is that on the one hand, it contains the entourage of hemp compounds, while on the other hand, does not contain any THC. THC in low levels won’t hurt anyone—and in fact it helps CBD do its job—but there is residual paranoia in the marketplace about ‘getting high’ or failing drug tests, so broad spectrum presents a smoother path to market. For that reason, fully 49% of the top 10 CBD topicals use broad spectrum hemp oil,” said Dicum.

    But, he warned that sourcing CBD isn’t like sourcing ordinary ingredients.

    “Your ingredient house probably doesn’t have it, so you’re going to be working with new suppliers. It’s commonplace in the sector to request a sample and run your own lab tests prior to a purchase. In these tests, you want to see CBD levels confirming the seller’s claims, non-detectable THC, and no solvents, heavy metals or pesticides. If any of these are present, they should be well below regulatory standards.”

    Looking Down the Line

    Because they are not ingested and are therefore more lightly regulated, topicals have been leading the way in the entrance of CBD to the mainstream marketplace. They will continue to do so in 2021, opening shelf space for CBD in national key accounts and becoming an enduring category, insisted Dicum.

    The big change for CBD products will come when the federal government finally clarifies the rules regarding cannibidiol.

    “When that happens, we will have a uniform national CBD marketplace, free from residual restrictions and legal gray areas. That in turn will trigger the starting gun for the biggest brands in the world to launch their CBD products. They all have them—I know because some of them are our clients—but they’re waiting for legal clarity before launching,” he said.

    While there’s no set timeline for any ruling, experts contend the Biden Administration is likely to move toward that end.

    In the meantime, small brands will have the playing field to themselves, said Dicum.

    “CBD topicals are a very crowded space, yet no brands dominate and most of them will fail. Rather than being scared away by this dynamic situation, brands that have a clear vision of why they want to include CBD in their products, who they are making them for, and are up to the challenges of quality and regulatory excellence, can find a place in the sector,” he insisted. “It’s early enough that anyone focused on doing it right can help define the next stage in the evolution of CBD topicals.”  

    CBD: Just Another Crop?
    Wholesale prices for CBD inputs such as isolate and extracts have been tumbling since they first became readily available.

    According to Greg Dicum, prices have been falling because hemp and CBD are evolving into normal agricultural products. Prior to this evolution, markets for hemp-based cannabinoids were restricted and unevenly and capriciously regulated; the risks were high and the supply was low.

    “As things change toward more openness—hemp remains subject to higher regulatory burdens for farmers than other crops, but it’s nothing like it used to be—hemp is becoming just another crop. When CBD follows suit a little later to become just another supplement, both hemp and CBD will be pure commodities, like corn and corn-based vitamin C,” predicted Dicum.

    In any agricultural commodity, it is not the farmers or the primary processors in the value chain who make the money; it is the brands that bring the finished product to consumers.

    “Starbucks captures the value chain, not Juan Valdez,” quipped Dicum. “The same thing is happening with hemp and CBD. Brands are becoming the primary center of gravity in the industry, not producers.” 

    FDA Officials: More Research Is Needed on CBD
    The knowledge gap remains. In January 2020, then-FDA Commissioner Stephen M. Hahn, MD and Principal Deputy Commissioner Amy Abernethy, MD, PhD, released a statement about the need for more research related to CBD due to the “limited understanding of the safety profile of CBD and many other cannabis-derived compounds,” including potential safety risks for people and animals. 

    “At the U.S. Food and Drug Administration, we see these knowledge gaps as an opportunity to develop new ways of building the science to inform public health decisions,” they said in a joint statement.

    FDA said it thinks that real-world data (RWD) on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current gaps in its understanding.

    Sampling and testing of marketed CBD products is another way the FDA said it has gathered more information about the safety profile of CBD products. According to FDA, this is an important component of its work because little is known about the amounts of CBD and various related cannabinoids, as well as the occurrence of toxic elements, pesticides, other possible chemical contaminants, and adulterants, that may be present in CBD products marketed to consumers.

    In the letter, FDA noted it is testing CBD product samples in the following ways:
    • The FDA, at times, tests products as part of its compliance and enforcement activities. For example, in connection with several warning letters sent to firms for marketing unapproved new drugs that allegedly contain CBD, the agency tested the cannabinoid content of certain products and many were found to not contain the levels of CBD they claimed to contain.
    • The FDA has also designed surveys of the market and currently is conducting a two-phase marketplace sampling and testing study. The first phase involved a small sampling and analysis study (approximately 200 samples) conducted by the agency. While the data collected so far are from a limited sample size and are insufficient to draw definitive conclusions regarding the prevalence of results in marketed products, FDA said general observations indicate fewer than half of the tested products which presented label claims contained CBD at concentrations within 20% of their claimed amount and some products contained the psychoactive, intoxicating cannabinoid THC.
    • FDA said it is currently working with a third party on conducting the second phase of the sampling plan that will involve a much larger sample set (1,000-3,000) that includes collection of CBD-containing products of various types.
    In the letter, FDA officials said they are “encouraged” by the many groups that are interested in helping to develop better data on the use and safety of CBD products, but also noted that existing efforts generally are not adequate to fill the outstanding knowledge gaps.

    “Filling these gaps will not be a trivial exercise but will require high-quality data analyzed using robust methods. We believe there is an opportunity to develop better sources of RWD to provide incremental improvements in our scientific understanding of the safety profile of CBD in the general population and, potentially, in specific populations,” Hahn and Abernathy wrote.

    According to FDA, in the coming months, the agency intends to develop and refine plans for research projects that use the following strategies, among others, to address the gaps in current CBD data research capabilities:
    • Work with existing and emerging data systems; e.g., poison control databases, electronic health records, opt-in consumer/patient registries, to enable precise identification of CBD products that may be associated with reported adverse events through appropriate coding, data curation, and other means.
    • Evaluate approaches to link adverse event data with CBD product sampling and testing data.
    • Collaborate on the development and evaluation of systems and methods, such as an open, opt-in registry for users of CBD, to gain a better understanding of safety outcomes of interest and incorporate data from other sources.
    • Evaluate the use of market-research data and other data sources that provide insights on the use of specific CBD products in different populations.
    • Evaluate use of data linkage approaches to provide insights about safety risks that may appear across time while protecting the privacy of patients and consumers.
    • Evaluate the value of combining multiple research and data approaches to synthesize an aggregate view of CBD safety and quality across the market and across time.
    • Evaluate which strategies are best for safety and quality monitoring for different types of CBD products.
    According to FDA, the use of novel data sources to complement other scientific data (e.g., toxicology studies) will be key to providing the foundational science needed to more fully understand the safety profile of products containing CBD.

    The Hahn and Abernathy statement concluded with the following: “we see significant promise in small, targeted projects that improve data methods in the near-term and point to future opportunities for collecting and analyzing data on CBD products and, potentially, other types of products in the future.”


    For More Insight Visit
    www.Happi.com and www.NutraceuticalsWorld.com
    Related Searches
    • Functional Ingredients
    • OTC/Medicated
    • Skin Care
    Related Knowledge Center
    • Skin Care
    • OTC/Medicated
    • Functional Ingredients
    Loading, Please Wait..
    Trending
    • The NAS Report Is A Victory For Sunscreen Industry
    • Sephora’s Virtual House Of Beauty Returns With Exclusive Offerings
    • Gillette Venus Launches #SayPubic Campaign With Rapper Princess Nokia
    • Pantone Reveals Fashion Color Trend Report For Autumn/Winter 2022/2023
    • Kayali’s Lovefest Fragrance, Newell’s New Candle And HydraFacial’s Record Financial Results
    Breaking News
    • Consumers are Clamoring for Vintage Glam: Spate
    • Kayali’s Lovefest Fragrance, Newell’s New Candle and HydraFacial’s Record Financial Results
    • Self Care Trumps Home Care Post-Covid
    • JC Penney Appoints Chief Financial Officer
    • Sephora’s Virtual House of Beauty Returns with Exclusive Offerings
    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

    What are you Reading this Week?
    SONGWON Industrial Group Reports Strong Q2 Financial Results
    PPG Completes COLORFUL COMMUNITIES Project for Boys & Girls Clubs of Greater Houston
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—Aug. 13
    'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    Abbott Invests €440 in New Irish Facility
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AskBio Appoints Clinical Ops Executives
    SpectrumX Partners With UK Contract Manufacturer
    GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Arkay Chairman Emeritus Howard Kaneff Has Died
    Nutricosmetics Market to Hit $13.7 Billion by 2030
    Estée Lauder Pledges 100% Electric Fleet of Vehicles by 2030
    Happi

    Latest Breaking News From Happi

    Consumers are Clamoring for Vintage Glam: Spate
    Kayali’s Lovefest Fragrance, Newell’s New Candle and HydraFacial’s Record Financial Results
    Self Care Trumps Home Care Post-Covid
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Printing Ink Primer, Zeller+Gmelin Lead This Week’s News Stories
    Heidelberg Enjoys Successful Start to 2022-23 Fiscal Year
    Mimaki Announces New LATAM Website
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Esko, Constantia Flexibles announce acquisitions and more
    Hybrid Software joins The Flexo Xperience Center
    Flexo Wash LLC and Mike Potter celebrate 20 years
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Essity Switches to Recyclable Packs for Feminine Pads, FTC Sues PPE Maker on False Origin Claims & More
    Focke & Co. to Host Destination: Your Hygiene Hub on August 31
    Exports Dominate Chinese Trade of Tissues, Hygiene Products and Wipes
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—Aug. 13
    Dental 3D Printing Market is Expanding 20% Annually
    Study Results Released for Abbott's Concussion Blood Test
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: ALTANA, Universal Display and Emerson Top This Week’s Stories
    eMagin Corporation Announces 2Q 2022 Results
    Zebra Technologies’ Emission Reduction Targets Validated by SBTi

    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