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

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

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

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

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

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

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.

The Mainstream Growth of the Cannabidiol Market

NEW YORK: The legal cannabis market is expanding at a rapid pace. This year five states voted to legalize cannabis for recreational use. In four of these states the proposition passed. Currently 15 states only allow Cannabidiol and alongside that, there are 28 states and District of Columbia that have legalized all forms of medical marijuana.

According to a recent report published by The Hemp Business Journal, the Cannabidiol market will grow to a $2.1 billion market in consumer sales by 2020 with $450 million of those sales coming from hemp-based sources. That’s a rapid increase from 2016, as projections for 2016 indicate the hemp-derived CBD market is poised to reach a value of $115 million by the end of the year. 

What Is CBD? The Everyday Guide To Cannabidiol

COLORADO: CannaInsider.com has published a comprehensive guide to CBD, the miracle cannabinoid endorsed and made popular in 2013 by a documentary produced by mainstream media health expert, Dr. Sanjay Gupta of CNN.

Cannabidiol (CBD) is one of over 80 chemical compounds found in the cannabis plant called cannabinoids. Cannabinoids bind to receptors in the brain and body and are responsible for the effects of cannabis, like feeling high, relaxed, or euphoric. The most popular cannabinoid, THC, is widely known as the compound that produces a high feeling.

CBD, which is rapidly gaining popularity, is known for its immense healing properties that are just being discovered as scientific research into the cannabis plant expands. Gupta’s documentary profiled five-year-old Charlotte Figi, who reduced her 300 seizures a week to just one a day with CBD treatment. CannaInsider’s Guide details what the scientific community knows about CBD and explains how the legal marijuana industry is responding. Learn more about CBD with CannaInsider’s Guide: http://www.cannainsider.com/reviews/what-is-cbd/.

“CBD is quickly expanding beyond the medical marijuana community and into totally new demographics (senior citizens and athletes, to name just two). This rapid growth is certain to continue as more and more individuals discover how CBD can play a positive role in their own healthcare outcomes,” said Patrick O’Malley, President of Good Life Colorado — the world’s only marijuana product incubator.

Dr. Noel Palmer, Ph.D., The Chief Scientist at Mary’s Medicinals, an infused products company in Denver is equally enthusiastic the excitement around CBD, “CBD has amazing therapeutic efficacy for a large variety of conditions, but it doesn’t get you stoned. For those who want a plant-derived medicine, CBD is an great option with very few negative side effects.”

In the CNN documentary, Figi treated her severe Dravet Syndrome with a CBD oil produced by the popular Colorado-based brand, Realm of Caring, made from a strain of high CBD cannabis plants. However, CBD can also be found in the hemp plant. Hemp products are distributed nationally and are regulated by the Department of Agriculture. You can purchase CBD online and have it shipped to your home within the United States.

So, how do you distinguish between what’s quality and what’s not? CannaInsider.com also reviews CBD oil and products with in-depth analysis and pictures at: CO.

As America’s fastest growing industry, the legal cannabis industry is navigating unchartered territory by producing and selling products made from a versatile plant that has been in the shadows for the last 80 years. CannaInsider.com has published a glossary of terms related to the marijuana plant and industry to educate those interested in learning more. Explore this dictionary at: http://www.cannainsider.com/reviews/glossary/.

DEA Eases Requirements For FDA-Approved Clinical Trials On Cannabidiol

WASHINGTON: The United States Drug Enforcement Administration (DEA) recently eased some of the regulatory requirements imposed by the Controlled Substances Act (CSA) for those who are conducting FDA-approved clinical trials on cannabidiol (CBD), an extract of the marijuana plant.  These modifications will streamline the research process regarding CBD’s possible medicinal value and help foster ongoing scientific studies.  The DEA notified affected researchers by letter of the changes, which take effect immediately.

Federal Regulation (21 CFR 1301.18) requires researchers conducting CBD-based clinical trials under an FDA Investigational New Drug Application to have a DEA research registration.  This registration permits the possession of an approved amount of CBD for a specific research protocol.  Prior to now, researchers who expanded the scope of their studies and needed more CBD than initially approved for had to request, in writing, a modification to their DEA research registrations – potentially delaying that research while the modification underwent an approval process that includes both the DEA and the Food and Drug Administration (FDA).  Under these changes, a previously registered CBD clinical researcher who is granted a waiver can readily modify their protocol and continue their research seamlessly.  This waiver effectively removes a step from the approval process.

Marijuana is a Schedule I controlled substance because of the presence of tetrahydrocannabinol (THC), marijuana’s psychoactive ingredient.  Because CBD contains less than 1 percent THC and has shown some potential medicinal value, there is great interest in studying it for medical applications.  Currently, CBD is a Schedule I controlled substance as defined under the CSA.  Though the FDA approves drugs for medical use in the United States, the DEA regulates the handling of all controlled substances, including those being used by researchers to conduct studies.

Florida Lawmaker Agrees To Work To Legalize Medical Marijuana High In Cannabidiol

FLORIDA:  Hope came Thursday for families whose children suffer from epileptic seizures, as the chairman of a key legislative committee agreed to file a bill to legalize the medical use of marijuana that has a high content of the chemical compound cannabidiol.

“Our work is only beginning,” said Rep. Matt Gaetz, R-Shalimar, after the House Criminal Justice Subcommittee heard testimony for nearly two hours from parents of children from Miami, Weston, Tampa, Pensacola and even Colorado. [Read more…]