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Cannabidiol (CBD) Market will Rise at a Potential Growth Rate of 27.8% by 2029, Market is analyzed by Growth Insights, Upcoming Trends, Size, Share, Opportunity and Demand Analysis

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Cannabidiol (CBD) Market will Rise at a Potential Growth Rate of 27.8% by 2029, Market is analyzed by Growth Insights, Upcoming Trends, Size, Share, Opportunity and Demand Analysis

Cannabidiol (CBD) Market will Rise at a Potential Growth Rate of 27.8% by 2029, Market is analyzed by Growth Insights, Upcoming Trends, Size, Share, Opportunity and Demand Analysis

PR Newswire

MANCHESTER , England, Aug. 18, 2022

MANCHESTER , England, Aug. 18, 2022 /PRNewswire/ — The comprehensive industry research on “Global Cannabidiol (CBD) Market” published by Data Bridge Market research which includes growth analysis, regional marketing, challenges, opportunities, and drivers analyzed in the report. To have best level of market insights and knowhow of the most excellent market opportunities into the specific markets, Cannabidiol (CBD) market research report is an ideal key. This Cannabidiol (CBD) market report encompasses a market data that provides a detailed analysis of the Cannabidiol (CBD) industry and its impact based on applications and different geographical regions. Additionally, this market report also gives a detailed overview about product specification, technology, and product type and production analysis by taking into consideration other major factors such as revenue, cost, and gross margin. The Cannabidiol (CBD) report is presented with full commitment by assuring the best possible service depending upon business requirements.

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The global cannabidiol (CBD) market is expected to gain market growth in the forecast period of 2022 to 2029. Data Bridge Market Research analyses that the market is growing with a CAGR of 27.8% in the forecast period of 2022 to 2029. Technological advancements in cannabidiol (CBD) drug treatments and the rise in the healthcare sector are other factors driving the growth of the global cannabidiol (CBD) market in the forecast period.

Download Exclusive Sample Report PDF (with All Related Graphs & Charts) @ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-cannabidiol-market&PNW/18Aug2022

Cannabidiol (CBD) Market Analysis and Insights

Cannabidiol (CBD) is a chemical compound that is found in the cannabis sativa plant, and is extracted from hemp or cannabis, generally from hemp due to its naturally high cannabidiol (CBD) content. It has several benefits in treating anxiety and seizures and reducing pain. Due to its healing properties, the demand for CBD for health and wellness purposes is high, which is the major factor driving the market

The data and information about the cannabidiol (CBD) market are taken from reliable sources such as websites, annual reports of the companies, and journals, and then validated by the market experts. It covers major manufacturers, suppliers, distributors, traders, customers, investors, and major types, and major applications. The principal players of the cannabidiol (CBD) market are making moves like product launches, joint ventures, developments, mergers, and acquisitions which is affecting the market and this Industry as a whole and also affecting the sales, import, export, revenue, and CAGR values. The dependable cannabidiol (CBD) market analysis report brings into light key market dynamics of the sector.

However, side effects associated with CBD oil and counterfeit and synthetic products available in the market will restrain the market growth. Adoption of strategic alliances like partnerships and acquisitions by key market players act as an opportunity for the growth of the global cannabidiol (CBD) market.

Global CBD Market Dynamics:

Drivers

  • Increasing demand for CBD in health & fitness

Rising awareness among consumers regarding health and fitness will help the CBD market to witness rapid growth. Increasing consumer disposable income along with the legalization of medicinal cannabis is anticipated to have a positive impact on the demand for cannabidiol in this sector.

Moreover, CBD products are used to relieve various problems such as anxiety/ stress, sleep/insomnia, chronic pain, migraine, skin care, seizures, joint pain & inflammation, neurological conditions, and many others. Chronic pain treatment has gained much popularity due to the additional benefits offered by CBD when used. There have been increasing demand for cannabidiol (CBD) products over recent years owing to its widespread medical applications and pain relief treatment. CBD helps in reducing chronic pain by acting on a variety of biological processes in the body. In addition, CBD possesses antioxidant, anti-inflammatory, and analgesic properties. Therefore, CBD products reduce the anxiety that is experienced by people suffering from chronic pain. Thus, the increasing demand for CBD in the treatment of chronic pain is augmenting the market to growth. This also helps people to maintain their health and fitness routines while staying away from the pain that may occur during fitness activities.

Key players in the global CBD market are:

  • CV Sciences, Inc.
  • VIVO Cannabis Inc.
  • Gaia Herbs Hemp
  • Phoena Holdings Inc.
  • Medical Marijuana, Inc.
  • The Cronos Group
  • CHARLOTTE’S WEB
  • HEXO Corp.
  • Aurora Cannabis
  • Canopy Growth Corporation
  • Jazz Pharmaceuticals, Inc.
  • Tilray
  • Curaleaf
  • KAZMIRA
  • Freedom Leaf, Inc.
  • Koi CBD
  • Groff North America Hemplex
  • Joy Organics
  • Elixinol Wellness Limited
  • Isodiol International Inc.
  • Healthy Food Ingredients, LLC
  • NuLeaf Naturals, LLC
  • Diamond CBD
  • Medterra CBD
  • ENDOCA
  • Green Roads

Access Full 350 Pages PDF Report @ https://www.databridgemarketresearch.com/checkout/buy/enterprise/global-cannabidiol-market?PNW/18Aug2022

Challenge

  • Side effects associated with CBD oil

Cannabidiol is well-known for its ability to cure a variety of illnesses, including anxiety, seizures, neurological problems, cancer-related nausea, chronic pain, and more. However, being useful for a variety of medical illnesses, various studies and research conducted by numerous organizations have shown that CBD-based medicines can have negative effects as well.

Some of the side effects that are commonly experienced by consumers include dry mouth, drowsiness, low blood pressure, and lightheadedness. CBD is also known to raise the level of Coumadin (a blood thinner) in the body, which can interact with other drugs and cause negative side effects. These factors might impede the future adoption of CBD for therapeutic purposes.

Market Segmentation Analysis:

The global cannabidiol (CBD) market is segmented on the basic source, grade, application, product type, and nature. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the Difference in your target markets.

BY SOURCE

  • HEMP
  • MARIJUANA

 BY PRODUCT TYPE

  • CBD OIL
  • CBD ISOLATES
  • CBD CONCENTRATES
  • OTHERS

BY NATURE

  • ORGANIC
  • INORGANIC

BY GRADE

  • FOOD GRADE
  • THERAPEUTIC GRADE

BY APPLICATION

  • Tincture
  •  Food
  •  Beverages
  • Pharmaceutical
  • Topicals
  • Dietary supplements
  • Others

To Gain More Insights about this Research, Visit @ https://www.databridgemarketresearch.com/reports/global-cannabidiol-market?PNW/18Aug2022

Country Level Analysis

The cannabidiol (CBD) market is analyzed and market size information is provided by source, grade, application, product type, nature.

The countries covered in the cannabidiol (CBD) market report are U.S., Canada, Mexico, Germany, U.K., Italy, Netherlands, Switzerland, France, Russia, Spain, Turkey, Belgium, Rest of Europe, China, Japan, India, South Korea, Thailand, Malaysia, Australia, New Zealand and rest of Asia-Pacific, U.A.E, Israel, South Africa and rest of the Middle East and Africa, Brazil, Argentina and the rest of South America.

In 2022, North America is dominating due to the presence of key market players along the largest consumer market with high GDP. U.S is expected to grow due to rise in technological advancement in drug treatments.

Trends:

The market is projected to grow at a fast pace during the forecast period, due to various latest trends such as rising online sales of cannabidiol (CBD), use of blockchain technology, rising demand for natural products, expanding research areas, rising demand for ingestible products, etc. Due to the convenience and heavy discounts provided by the online platforms people are shifting towards e-commerce. Online platforms also widen the reach of the manufacturers and enable them to sell CBD products even to those customers who were not aware of the CBD-based products.

What to Expect from the Report, a 7-Pointer Guide

  • The cannabidiol (CBD) report dives into the holistic Strategy and Innovation for this market ecosystem
  • The cannabidiol (CBD) report keenly isolates and upholds notable prominent market drivers and barriers
  • The cannabidiol (CBD) report sets clarity in identifying technological standardization as well as the regulatory
  • framework, besides significantly assessing various implementation models besides evaluation of numerous use cases
  • The cannabidiol (CBD) report is also a rich repository of crucial information across the industry, highlighting details on novel investments as well as stakeholders and relevant contributors and market participants.
  • A through market analytical survey and forecast references through the forecast tenure, encapsulating details on historical developments, concurrent events as well as future growth probability

Inquire or Share Your Questions If Any before Purchasing This Report @ https://www.databridgemarketresearch.com/inquire-before-buying/?dbmr=global-cannabidiol-market&PNW/18Aug2022

TABLE OF CONTENTS

Part 01: Executive Summary

Part 02: Scope Of The Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers And Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

To View this Premium Report TOC, Click here @ https://www.databridgemarketresearch.com/toc/?dbmr=global-cannabidiol-market&PNW/18Aug2022

Region-wise Related Reports:-

Europe Cannabidiol (CBD) Market – Industry Trends and Forecast to 2029:  Europe cannabidiol (CBD) market is expected to gain market growth in the forecast period of 2022 to 2029. Data Bridge Market Research analyses that the market is growing with a CAGR of 26.7% in the forecast period of 2022 to 2029. Technological advancements in cannabidiol (CBD) drug treatments and the rise in the healthcare sector are other factors driving the growth of the Europe cannabidiol (CBD) market in the forecast period.

Middle East and Africa Cannabidiol (CBD) Market – Industry Trends and Forecast to 2029: The Middle East & Africa cannabidiol (CBD) market is expected to gain market growth in the forecast period of 2022 to 2029. Data Bridge Market Research analyses that the market is growing with a CAGR of 22.7% in the forecast period of 2022 to 2029. Technological advancements in cannabidiol (CBD) drug treatments and a rise in the healthcare sector are other factors driving the growth of the Middle East & Africa cannabidiol (CBD) market in the forecast period.

North America Cannabidiol (CBD) Market – Industry Trends and Forecast to 2029: North America cannabidiol (CBD) market is expected to gain market growth in the forecast period of 2022 to 2029. Data Bridge Market Research analyses that the market is growing with a CAGR of 28.7% in the forecast period of 2022 to 2029. Technological advancements in cannabidiol (CBD) drug treatments and the rise in the healthcare sector are other factors driving the growth of the North America cannabidiol (CBD) market in the forecast period.

Asia-Pacific Cannabidiol (CBD) Market – Industry Trends and Forecast to 2029: Asia-Pacific cannabidiol (CBD) market is expected to gain market growth in the forecast period of 2022 to 2029. Data Bridge Market Research analyses that the market is growing with a CAGR of 24.1% in the forecast period of 2022 to 2029. Technological advancements in cannabidiol (CBD) drug treatments and the rise in the healthcare sector are other factors driving the growth of the Asia-Pacific cannabidiol (CBD) market in the forecast period.

Hemp-Derived Cannabidiol Market – Industry Trends and Forecast to 2028: Hemp-derived cannabidiol market is expected to gain market growth in the forecast period of 2021-2028. Data Bridge Market Research analyses the market to account to grow at a CAGR of 27.20% in the above-mentioned forecast period.

About Data Bridge Market Research:

Data Bridge Market Research is a multinational management consulting firm with offices in India and Canada. As an innovative and neoteric market analysis and advisory company with unmatched durability levels and advanced approaches. We are committed to uncovering the best consumer prospects and fostering useful knowledge for your company to succeed in the market.

Data Bridge Market Research is a result of sheer wisdom and practice that was conceived and built-in Pune in the year 2015. The company came into existence from the healthcare department with far fewer employees intending to cover the whole market while providing the best class analysis. Later, the company widened its departments, as well as expanded its reach by opening a new office in the Gurugram location in the year 2018, where a team of highly qualified personnel joins hands for the growth of the company. “Even in the tough times of COVID-19 where the Virus slowed down everything around the world, the dedicated team of Data Bridge Market Research worked round the clock to provide quality and support to our client base, which also tells about the excellence in our sleeve.”

We provide a variety of services such as market verified industry reports, technology trend analysis, Formative market research, strategic consulting, vendor analysis, production and demand analysis, and consumer impact studies among many others.

Contact Us 
Data Bridge Market Research
US: +1 888 387 2818
UK: +44 208 089 1725
Hong Kong: +852 8192 7475
Email – corporatesales@databridgemarketresearch.com

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SOURCE Data Bridge Market Research



Global Cannabidiol (CBD) Market Report 2022: Rising Demand for Natural & Ingestible Products and Expanding Research Areas Present Avenues for Growth

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Global Cannabidiol (CBD) Market Report 2022: Rising Demand for Natural & Ingestible Products and Expanding Research Areas Present Avenues for Growth

Global Cannabidiol (CBD) Market Report 2022: Rising Demand for Natural & Ingestible Products and Expanding Research Areas Present Avenues for Growth

PR Newswire

DUBLIN, July 29, 2022

DUBLIN, July 29, 2022 /PRNewswire/ — The “Global Cannabidiol (CBD) Market: Analysis By Product, By Source, By End User, By Distribution Channel, By Region Size and Trends with Impact of COVID-19 and Forecast up to 2026” report has been added to ResearchAndMarkets.com’s offering.

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In 2021, the global CBD market was valued at US$4.20 billion. The market is projected to reach US$12.64 billion by 2026. The growing regulatory approvals is a major driver of the market. The CBD market is expected to grow at a CAGR of 25.53% during the forecast period of 2022-2026.

Market Segmentation Analysis:

  • By Product: The report identifies eleven segments on the basis of product: Oil, Tinctures, Capsules, Cream and roll on, Isolates, Transdermal Patches, Suppository, CBD Inhalers, Vape oil, Tablet and Others.
  • By Source: The report includes bifurcation of the market into two segments on the basis of source: marijuana and hemp.
  • By End User: On the basis of end user, the market is divded into two segments: medical and other end users. 
  • By Distribution Channel: The report includes bifurcation of the market into two segments on the basis of distribution channel: online and offline
  • By Region

Global CBD Market Dynamics:

Growth Drivers

  • Increasing millennial Population
  • Rising Government Approvals of CBD Products
  • Growing Application of CBD in Skincare Industry
  • Increasing Prevalence of Chronic Pain

Challenges

  • Availability of Duplicate & Synthetic Products
  • Lack of Awareness Among Consumers

Market Trends

  • Rising Online sales of Cannabidiol (CBD)
  • Use of Blockchain Technology
  • Rising Demand for Natural Products
  • Expanding Research Areas
  • Rising Demand for Ingestible Products

Key players of the global CBD market are:

  • Canopy Growth Corporation
  • Elixinol Wellness Limited
  • Jazz Pharmaceuticals PLC
  • High Tide Inc. (NuLeaf Natural LLC)
  • CV Sciences Inc.
  • Tilray Brand Inc.
  • Medical Marijuana, Inc.
  • Aurora Pharmaceutical, Inc.
  • Medterra
  • Endoca
  • Isodiol International Inc.
  • CBD American Shaman

Key Topics Covered:

1. Executive Summary

2. Introduction

3. Global Market Analysis

4. Regional Market Analysis

5. Impact of COVID-19

6. Market Dynamics

7. Competitive Landscape

For more information about this report visit https://www.researchandmarkets.com/r/ibx5lt

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

 

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SOURCE Research and Markets



CannaLean Biotechs Announces a Phase 2a Clinical Trial of Cannabidiol-Based Formulation for Lowering Blood Cholesterol Levels

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CannaLean Biotechs Announces a Phase 2a Clinical Trial of Cannabidiol-Based Formulation for Lowering Blood Cholesterol Levels

CannaLean Biotechs Announces a Phase 2a Clinical Trial of Cannabidiol-Based Formulation for Lowering Blood Cholesterol Levels

PR Newswire

TEL AVIV, Israel, June 21, 2022

TEL AVIV, Israel, June 21, 2022 /PRNewswire/ — CannaLean Biotechs is happy to announce “first patient in,” under its phase 2a, randomized, double-blind, placebo-controlled, multicenter clinical trial, for lowering blood cholesterol levels in patients with hyperlipidemia (increased levels of lipids in the blood).

CannaLean Biotechs headquartered in Israel, is a clinical stage company committed to the research and development of a novel proprietary and evidence-based formulation of Cannabidiol (CBD) and Chitosan for both the pharmaceutical and wellness markets that will potentially benefit millions of patients suffering from hyperlipidemia.

The purpose of the study will be to evaluate the tolerability, safety, and efficacy of the formulation as lipid lowering treatment in patients suffering from elevated cholesterol blood levels (hypercholesterolemia), who failed to respond to statins or are reluctant to continue with statins. Up to 60 participants with elevated cholesterol will be included in the study with a 2:1 CBD: placebo treatment ratio.

CannaLean, addresses a huge market, and will potentially benefit millions of patients suffering from hyperlipidemia, a condition in which one or more of the blood lipids such as total cholesterol, LDL cholesterol (“the bad”) and/or triglycerides, are elevated. It is believed that about 50% of the adult population worldwide suffer from some kind of hyperlipidemia.

The current first line medical treatment for high cholesterol levels (Hypercholesterolemia), when lifestyle changes are insufficient, are statins.

While highly effective, statins often cause many side effects, including muscle pain and cramps, digestive problems, mental fuzziness, and liver damage. Often, patients discontinue statins and physicians avoid prescribing these agents to patients with borderline levels.  

The study’s principal investigator is Dr. Daniel Tsalichin, a specialist family physician, an expert in metabolic diseases, and Director, Ben-Yair Clinic of the CLALIT HMO services. Other investigators are expert physicians in several community clinics in Israel. 

About CannaLean Biotechs, Ltd.

CannaLean develops cannabidiol-based anti-lipid treatments. Its formulation have been successfully tested in several experimental mod     els. These pre-clinical experiments, demonstrated encouraging safety profile together with impressive efficacy. The clinical experience gained so far with cannabis derived components in other diseases provides further prospects for the future potential, and the ability to make an impact on the lipid lowering field.  

CannaLean plans to commence a 2nd separate phase 2a clinical trials to clinically evaluate and confirm the safety and efficacy of the new formulation in patients with high levels of Triglycerides (hypertriglyceridemia) during 2022.

Thanks to its unique proprietary formulation which is IP protected, CannaLean plans pursuing sales in parallel to the drug development in FDA route. CannaLean has the ability to go to immediate sales around the world in the wellness/medical cannabis/edible markets, pending on local regulations.

CannaLean is a part of the Cannabis Innovation Center (The CIC), a group of companies that has established an active partnership with Mor Research Applications, the technology transfer company of CLALIT health services. CLALIT is unique since it provides community and hospital health services to 4.7 million people (52% of the Israel population). It has 11,000 physicians, 11,500 nurses, 1,300 pharmacists, 4,400 paramedics and laboratory/imaging technicians, 9,400 administrative personnel, a total of 14 general and special care hospitals and over 1500 primary care clinics, as well as a network of pharmacies and dental clinics.

For further information, contact mail@cannaleanbio.com.

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SOURCE CannaLean Biotechs Ltd.



Senate Passes Feinstein, Grassley, Schatz Cannabidiol, Marijuana Research Legislation

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DISTRICT OF COLUMBIA: Senators Dianne Feinstein (D-Calif.), Chuck Grassley (R-Iowa) and Brian Schatz (D-Hawaii) today applauded Senate passage of their legislation to expand scientific and medical research on marijuana and its compounds, including cannabidiol. 

“Current rules and regulations make it hard for researchers to study how marijuana and marijuana-derived medications can best be used to treat various conditions,” said Senator Feinstein. “This important legislation will cut the red tape around the research process, helping get FDA-approved, marijuana-derived medications safely to patients.”

“This bipartisan bill is critical to better understanding the marijuana plant and its potential benefits and side effects. It will empower the FDA to analyze CBD and medical marijuana products in a safe and responsible way so that the American public can decide whether to utilize them in the future based on sound scientific data. Researching marijuana is widely supported by my colleagues on both sides of the aisle, and it’s a smart step forward in addressing this current schedule I drug,” Senator Grassley said.

“The medical community agrees that we need more research to learn about marijuana’s potential health benefits, but our federal laws today are standing in the way of us finding those answers,” said Senator Schatz. “We are now one step closer to removing excessive barriers that make it difficult for researchers to study the effectiveness and safety of marijuana, and hopefully, give patients more treatment options.”

In addition to Feinstein, Grassley and Schatz, the bill is cosponsored by Senators Dick Durbin (D-Ill.), Amy Klobuchar (D-Minn.), Thom Tillis (R-N.C.), Tim Kaine (D-Va.), Joni Ernst (R-Iowa), Kevin Cramer (R-N.D.), Jon Tester (D -Mont.) and Lisa Murkowski (R- Alaska).

Full text of the bill is available here.

At 21.5% CAGR, CBD Oil Market Size & Share | Cannabidiol Oil Industry Report, 2020-2025 | Covid-19 Impact Analysis

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In its latest report on CBD Oil Market provides a concise analysis of the recent market trends. The report further includes statistics, market forecasts and revenue estimations, which in addition highlights its status in the competitive domain as well as expansion trends adopted by major industry players.

Cannabidiol Oil (CBD Oil) Market: Global Market Size, Trends, Competitive, Historical & Forecast Analysis, 2019-2025.Cannabidiol Oil Market is valued at USD 23.37 Million in 2018 and expected to reach USD 1068.54 Million by 2025 with the CAGR of 21.5% over the forecast period.

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The detailed market intelligence report on the Global Cannabidiol Oil (CBD Oil) Market applies the most effective of each primary and secondary analysis to weighs upon the competitive landscape and also the outstanding market players expected to dominate Global Cannabidiol Oil (CBD Oil) Market place for the forecast 2019- 2025.

FDA Advances Work Related To Cannabidiol Products With Focus On Protecting Public Health, Providing Market Clarity

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DISTRICT OF COLUMBIA: Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.

Today, we are providing updates on our efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.

Educating the Public About Potential Risks of Using CBD

We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons.

But as the agency has stated before, we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.

We remain focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.

In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks. For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.

We will continue to expand our educational efforts on this front. This includes consumers broadly, specific populations where there are additional, important health considerations, as well as health care professionals who must understand these risks when talking to their patients. We will also continue to update our online resources for consumers, researchers and industry, as well as sustain multiple lines of communication with Congress, industry, researchers and our regulatory partners at the federal, state, local, territorial, tribal and international levels to share and collect needed information and hear a variety of perspectives.

Closing Knowledge Gaps in Both Safety and Potential Benefits

The marketplace for CBD-containing products is quickly evolving and it is critical that we work together with stakeholders and industry to develop high-quality data to close the knowledge gaps about the science, safety and quality of many of these products, as well as further evaluate any potential benefits outside of the one FDA-approved drug product to treat two rare, severe pediatric epilepsy disorders.

To address the questions and concerns we’ve already raised, we’re seeking reliable and high-quality data. This includes data on, among other things: the sedative effects of CBD; the impacts of long-term sustained or cumulative exposure to CBD; transdermal penetration and pharmacokinetics of CBD; the effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile; the safety of CBD for use in pets and food-producing animals; and the processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.

Given the importance of answering these questions, we’re exploring a number of ways to address the data gaps as quickly as possible. This includes encouraging, facilitating and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with our federal partners at Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and National Institute on Drug Abuse on this important issue.

Importantly, the Agriculture Improvement Act of 2018 – which, among other things, changed federal law so that cannabis and cannabis derivatives with very low levels of the psychoactive intoxicating component of cannabis, delta-9 tetrahydrocannabinol (THC) are no longer controlled substances – has opened significant new opportunities for research, and as that body of research develops and grows, there will be considerably more information available. In particular, there’s been an increased interest in drug development from CBD and other compounds found in cannabis and we are working to support drug development as much as possible.

First, given all the research and activity in this space, we are taking new steps to provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available. To this end, in the coming days we are re-opening the public docket we established for our May 2019 public hearing. The docket provides a valuable conduit for submission of scientific data on CBD to the agency, so we have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. As the agency continues to move forward to explore viable pathways for CBD products outside the drug context, this extension will allow stakeholders to continue to provide relevant data as research in this area evolves.

This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential. We hope that this will enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with the FDA – including information about specific products, which could help inform appropriate regulatory steps.

We also are working to generate data to help inform our work in this area. For example, the FDA’s Office of the Chief Scientist recently awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. Additionally, we’ve initiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess sensitization of THC and CBD topically, and dermal penetration.

As data become available that are high-quality, reliable and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine – and, perhaps in some cases, revise – our thinking and approaches.

Monitoring the Marketplace with a Focus on Greatest Risk to Public Harm

As we work to educate the public and close the knowledge gaps to further guide our approach to CBD products, we will continue to monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public.

We have seen many CBD products being marketed with claims of therapeutic benefit, such as treating or curing serious diseases such as cancer and Alzheimer’s disease, or other drug claims, without having gone through the drug approval process. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.

We also have serious concerns about products that put the public at risk in other ways. For example, we are aware of the risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. We also have significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk.

As we move forward, we are currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.

Conclusion

Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Warning Letters And Test Results For Cannabidiol-Related Products

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MJLegal

DISTRICT OF COLUMBIA: Over the past several years, FDA has issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD).

As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products.

FDA WARNING LETTTERS

FDA, FTC Warn Company Marketing Unapproved Cannabidiol Products With Unsubstantiated Claims

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FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

DISTRICT OF COLUMBIA: The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.

“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children,” said Acting FDA Commissioner Ned Sharpless, M.D. “We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements. As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority. We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products.”

As described in the warning letter issued to Rooted Apothecary, the company used product webpages, through its online store and social media websites, to make unfounded claims about its CBD products, and some of the products were also unlawfully marketed as dietary supplements. The agency has determined that CBD products cannot be marketed as dietary supplements.

Examples of the unsupported claims made by the company include:

  • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
  • “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
  • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
  • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
  • “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”

Additionally, under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. The FTC is concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. These products are also misbranded under the Federal Food, Drug, and Cosmetic (FD&C) Act, because the products’ labels and product information fail to include adequate directions for use. Drugs in the United States must contain directions explaining how a consumer can use a drug safely for its intended purpose. Under the law, there is an exemption for this labeling requirement for prescription drugs that have FDA-approved applications in effect. However, none of Rooted Apothecary’s products are FDA-approved.

The FDA and FTC have requested responses from Rooted Apothecary within 15 working days stating how the company will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or administrative cease and desist order, and an order also may require that a company pay back money to consumers.

The FDA continues to be concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the agency. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. 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.

The FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products while maintaining the FDA’s rigorous public health standards.

“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”

Unlike drugs approved by the FDA, the manufacturing process of unapproved CBD products has not been subject to FDA review as part of the drug approval process. Further, there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Consumers may 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.

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

Librede Receives Patent For Cannabidiolic Acid (CBDA) Production In Yeast

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CALIFORNIA: Librede, a leader in natural cannabinoid biosynthesis, has been granted a new patent for the production of cannabidiolic acid (CBDA) in microorganisms.

The patent, Production of Cannabidiolic Acid in Yeast, describes the modification of yeast to produce CBDA from simple feedstocks such as sugar. CBDA is a naturally occurring cannabinoid found in hemp and cannabis which is used to produce cannabidiol (CBD). Cannabidiol has been shown to have a wide range of therapeutic properties, including treatment of epilepsy, for which a CBD-based therapeutic has won recent FDA approval.

 Librede is now in the process of continuing technology development through optimization and scaling for industrial production in large fermenters. Dr. Anthony Farina, Librede’s Chief Scientific Officer, explains: “We have been building our platform around the natural biochemistry in the cannabis plant that gives rise to a diverse set of compounds, with our focus being on therapeutic applications. Having engineered cannabidiol synthesis in the laboratory, we are now beginning the process of scaled up production.”

Fermentation for the production of high value, complex, natural products offers a preferred route to synthesis at an industrial scale. Librede’s biosynthetic approach has several potential advantages over agricultural-based methods including protection from supply volatility, improved consistency, reduced cost, and lower environmental impact. Dr. Jason Poulos, CEO of Librede, explains: “The use of fermentation to produce these compounds represents the future of industrial scale cannabinoid production. As more cannabinoids are shown to have therapeutic value, we must find a way to produce these compounds in a sustainable way. Utilizing the synthetic power of biology allows us economical access to these compounds while minimizing environmental impacts. The future of all cannabinoid production may not be large farm fields but instead compact and highly efficient fermenters.”

Isodiol Signs LOI To Import Cannabidiol To Canada From UK With Nuuvera

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CANADA:  Isodiol and Nuuvera have agreed to import 99%+ pure, bioactive pharma-grade cannabidiol (‘CBD’) isolate into Canada from Isodiol’s GMP-certified production facility in the United Kingdom.  The product, certified as a pharmaceutical-grade, will be imported into Canada through Nuuvera’s subsidiary, ARA – Avanti Rx Analytics, a Health Canada GMP-certified laboratory holding a dealer license under the Narcotic Control Regulations and Office of Controlled Substances.

“Since establishing Isodiol, we have focused on developing and marketing the highest quality, raw material for use in a range of proprietary, pharma grade nutritional and health related remedies,” said CEO of Isodiol, Marcos Agramont.  “We are very pleased that our new partner, Nuuvera, which brings to the table extensive knowledge and expertise in the fields of quality control, cannabis extraction, purification, product development and R&D, shares Isodiol’s vision for an industry built upon quality, consistency, safety, and ultimately, efficacy.  Isodiol and Nuuvera are at the global forefront of innovation in the cannabis industry, and the ability to import to Canada is truly ground-breaking for both companies.”

Under the LOI terms, Nuuvera will import to Canada a Isodiol’s CBD isolate and conduct analytical testing in its Toronto-area laboratory to ensure that the product conforms to Isodiol’s rigorous product specifications. Nuuvera intends, ultimately, to import up to 30,000 kg of CBD isolate per month for the purposes of R&D, product formulation and production of pharma-grade derivative products.  Through its licensed subsidiaries, Nuuvera intends to then sell such products in Canada and via export to appropriately licensed international medical cannabis jurisdictions.