Curt’s Cannabis Corner: What Are Flavonoids?

Welcome to the next installment of Curt’s Cannabis Corner, a new series of educational articles from technical writer Curt Robbins at Higher Learning LV and MJNews Network. This collection is intended for cannabis and hemp industry professionals who wish to gain a better understanding of the nuanced biochemistry of this specialand newly legalherb. 

This week readers learn about flavonoids, a third category of wellness molecule produced by the hemp/cannabis/marijuana plantbeyond psychotropic cannabinoids and fragrant terpenes. 

Please remember to #LearnAndTeachOthers™ by sharing this article far and wide!


CURT’S

CANNABIS

CORNER

What are Flavonoids?

By Curt Robbins

 


Most cannabis consumers are familiar with cannabinoids and, more specifically, the two commercially dominant examples produced by the cannabis/hemp plant, tetrahydrocannabinol (delta-9 THC) and cannabidiol (CBD). However, the herb produces two other families of wellness molecules beyond the set of roughly 146 cannabinoids discovered to date: Terpenes and flavonoids. 

The functional distinction between these two families of phytomolecules is clear. Terpenes employ aroma to protect hemp and cannabis plants from pests and predators while simultaneously attracting pollinators (insects or human cultivators). Likewise, flavonoids perform the same basic evolutionary function, but do so with plentiful pigment rather than abundant aroma. 

Modern peer-reviewed research has revealed that both terpenes and flavonoids possess value in the treatment of literally hundreds of disease states and adverse health conditions. All three families of chemical compounds produced by hemp have exhibited significant anti-inflammatory and antioxidant properties. This makes these phytomolecules potential therapeutic agents in the treatment of common diseases such as cancer, arthritis, epilepsy, Alzheimer’s disease, depression, chronic pain, anxiety, and a variety of eating and sleeping disorders. 

The following excerpt from the Higher Learning LV™ course Cannabis Core Concepts will teach you more.


Overview

Flavonoids, sometimes called bioflavonoids, are the third major family of wellness molecules produced by the hemp plant. The lack of attention to flavonoids by hemp industry professionals and the scientific community has inspired some thought leaders to label them “the red headed stepchildren of phytomolecules.” 

Flavonoids are a diverse group of plant chemicals found in a large number of flowers, fruits, and vegetables. These special compounds are responsible for the sometimes vivid colors of the plants that produce them. Perhaps of greater value to humans, they also have demonstrated significant medicinal efficacy—most notably anticancer and anti-inflammatory benefits.

Like terpenes, flavonoids are produced by thousands of plant types in nature beyond cannabis. In fact, tens of thousands of plant species collectively make more than 6,000 types of flavonoids. Of these, about 20 appear in the hemp genome (DNA). 

Flavonoids = Pigmentation

The Latin root of “flavonoid” is flavus. Literally interpreted, flavus means “yellow” (it is sometimes translated as “organic/natural yellow”). Despite the understandably common misinterpretation of the root term’s meaning as “flavor” in modern English, flavonoids serve the pigment-driven evolutionary function of attracting pollinators and dissuading pests for the plants that produce them (flavor, for the most part, is provided by terpenes).

In this respect, flavonoids are the visual equivalent of the aroma produced by terpenes. Both serve as sensory siren songs for pollinating insects (of critical value to the propagation of the species) while simultaneously warning predators to stay away and seek their meal elsewhere.

The Butterfly Effect

Interesting, flavonoids provide the color for not only thousands of plants in nature, but also some of the insects that feed on them. In fact, one of the most photographically coveted insects in nature, the butterfly, maintains an intimate relationship with flavonoids and the plants that produce them.  

According to a 1994 article by Nicolas Wade entitled “How Nature Makes a Butterfly Wing” that appeared in The New York Times, flavonoids are responsible for the sometimes vibrant dyes in the wings of butterflies. 

“In the pupil stage, the patterned wing cells develop a rainbow of tones as each crafts a scale of a single hue,” wrote Wade. It seems that butterflies are among insect species that are incapable of producing flavonoids. “The rich palette of dyes in butterflies’ wings are all derived from…flavonoids, which the insects cannot make themselves and must sequester from their food plants,” he continued. 

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Kentucky Agriculture Commissioner Quarles Praises New USDA Hemp Rule

Will submit new state plan to USDA for 2022 growing season

KENTUCKY: Kentucky Agriculture Commissioner Dr. Ryan Quarles applauded the U.S. Department of Agriculture’s (USDA) announcement that it will implement the final rule on hemp production developed under the Trump Administration.

“The final rule on hemp production is much improved over the interim final rule previously issued by USDA,” Commissioner Quarles said. “The improvements were the results of work conducted by the Kentucky Department of Agriculture and other state agencies to provide feedback to the USDA. I am grateful for all of the work done by the previous administration, including that of former Under Secretary of Agriculture Greg Ibach and his team, to have an open line of communication with state leaders.”

The 2018 Farm Bill defined hemp as the plant cannabis sativa with not more than 0.3 percent tetrahydrocannabinol (THC) measured on a dry weight basis and directed USDA to develop a regulatory framework for states to manage hemp programs. The final rule comes after state agencies, industry groups, and hemp growers across the nation provided feedback to USDA on the interim final rule. The final rule for hemp production was released Jan. 19, but the new Biden Administration paused implementation for a temporary review. With the review complete, the final rule will take effect March 22.

Commissioner Quarles sent two rounds of comments to the USDA about the interim final rule, highlighting potential sticking points with Kentucky’s current hemp program. USDA adjusted the rule to address nearly every concern raised by the Commissioner.

As noted in the Commissioner’s comments submitted in October 2020, one of the major concerns about the previous rule was that it would have eliminated a key feature of Kentucky’s hemp program, the ability of growers to remediate elevated THC content through a post-harvest retest. The post-harvest retest gives growers an opportunity to realize a financial return on their harvests by giving them a second chance to achieve a compliant THC test result. Under the final rule, remediation and a post-harvest retest is allowed.

Other successful policy changes included:

  • On-farm disposal of non-compliant hemp material;
  • New rules which standardize and simplify sampling procedures for the part of the plant to be tested for compliance; and
  • An increase in the “negligent” level of THC in the plant.

With these positive developments, Commissioner Quarles plans to submit a revised state plan to USDA for the 2022 growing season.

“I am encouraged by the progress USDA has made and have confidence in our ability to move into the federal framework as envisioned by the 2018 Farm Bill,” Commissioner Quarles said. “Additional challenges remain for the nation’s hemp industry, especially in light of the continued lack of action by the Food and Drug Administration. If this industry is to be successful, we need FDA to deliver clarity on hemp-derived cannabidiol products and their guidance cannot come soon enough.”

New Additive Rules Take Effect April 1, 2021

New Rules Provide Opportunity for Limited Product Sell Down

Updated Compliance Information:

Labeling Example, Metrc Guide

OREGON:  The OLCC is providing additional information regarding the implementation of and compliance with new additive rules. The rules, enacted in December 2020, impact all OLCC marijuana licensees and industrial hemp certificate holders. The first of these rules takes effect April 1, 2021. A more detailed explanation of the requirements can be found in Compliance Bulletin CE2020-07 along with links to the rules.

These rules apply to “Inhalable Cannabinoid Products with Non-cannabis Additives” (“ICP”). Generally speaking, ICPs are cannabinoid products that are meant for human inhalation and have been combined with non-cannabis ingredients like non-cannabis terpenes or flavorings. The most common example is a vape cartridge with flavorings. See the definitions in 845-025-1015(44) and (64).

There are two important dates for licensees in these rules: April 1, 2021 and July 1, 2021:

  • On and after April 1, 2021, all ICPs manufactured or processed must comply with the new rule requirements.
  • On and after April 1, 2021, all ICPs (including those made before April 1, 2021) must be correctly categorized in Metrc and, in the case of items held by processors, have their ingredients properly recorded in Metrc. (See 845-025-3270 for the requirements regarding categorization and ingredient tracking.)

Licensees with these products in their inventory must make these changes by April 1, 2021. Licensees are able to create the requisite item category in Metrc; an upcoming system enhancement in Metrc will provide the functionality for entry of ingredient tracking by processors. See this Metrc guide for more information.

  • There is a limited “sell down” period for ICPs made before April 1, 2021. Processors may transfer ICPs made before April 1, 2021 that do not comply with the new rule requirements until June 30, 2021. As of July 1, 2021 licensees can neither transfer nor possess products that do not meet the new rule requirements. See Compliance Bulletin CE2020-07 for more detail.

There are required labeling changes:

  • All labels for ICPs created on and after April 1, 2021 must have labels that are compliant with the new rules (and meet the other applicable rule requirements);
  • The product identity must contain the words “non-cannabis additive”;
  • All ingredients in the product must be listed either on the label or an insert accompanying the label. The ingredient listing must also contain the words “non-cannabis additive.” An example of a new label can be found here and an example of an old label can be found here;
  • Licensees must submit “manufacturer documentation” that adheres to the requirements of 845-025-3265(1) and “Non-cannabis Additive Documentation” as part of their label submissions; and
  • Licensees may no longer utilize generic labels for ICPs created on and after April 1, 2021.

Questions related to the rules or labeling should be directed to marijuana.packaging@oregon.gov.

Questions related to Metrc should be directed to marijuana.cts@oregon.gov.

 

 

Curt’s Cannabis Corner: What Is Delta-8 THC?

 

UPDATE: “Understanding Legal Status”

Editor’s Note:  Welcome to the first installment in the new series of educational articles from technical writer Curt Robbins at Higher Learning LV and MJNews Network. This collection is intended for cannabis and hemp industry professionals who wish to gain a better understanding of the nuanced biochemistry of this specialand newly legalherb.  

For the next two weeks, Curt teaches readers about the hot new phytomolecule delta-8 THC that is causing such a stir among consumers, entrepreneurs, and medical professionals.


CURT’S CANNABIS CORNER

What is Delta-8 THC?

By Curt Robbins

For years, the producers, processors, distributors, marketers, regulators, and consumers of cannabis have focused primarily on only two molecules produced by the plant: Tetrahydrocannabinol (THC) and cannabidiol (CBD). Both are sold by thousands of companies in the United States, United Kingdom, and Canada.

 

As a wave of medical and adult use marijuana legalization reaches beyond North America to the far corners of the globe, companies are beginning to promote and exploit additional wellness molecules produced by cannabis and hemp. Creative entrepreneurs and product formulators are seeing the advantages, both financially and legally, of leveraging molecular options beyond CBD and THC. 

The Big Picture

The cannabis/hemp plant species produces three primary families of wellness molecules that, together, number in the hundreds. There are approximately 146 cannabinoids, 20 flavonoids, and 200 terpenesthe majority of which have demonstrated significant medicinal efficacy, as revealed by thousands of peer-reviewed research studies since the late 18th century. 

Before delving into the details of delta-8 THC, it is important to properly frame the topic.   

Understanding Molecular Analogs 

Most cannabis consumers are ignorant of the fact that the chemical compounds produced by cannabis are members of small groups called analogs (sometimes cited as isomers in research literature). In fact, the CBD family features seven distinct analogs, as does the cannabinoid cannabigerol (CBG).    

 

THC is no exception. The analog with which most consumers are familiar is the infamous delta-9 variant (technically called the neutral analog), which produces sometimes significant psychoactivity. There’s also the acidic precursor THCA, which conveys no psychoactivity but significant wellness benefits and is popular as a juiced edible.

Yet another THC analog is the varin version, THCV, which conveys greater psychoactivity than delta-9, but only at more potent doses. An Italian research study published in December 2019 discovered additional THC and CBD analogs, THCP and CBDP, respectively (the researchers dubbed them the phorols). Delta-8 THC is yet another member of this collection of molecular analogs.

While molecular analogs sometimes share many of the same effects when consumed by humans (such as decreased systemic inflammation or an alleviation of depression or pain), such homogeneity cannot be assumed. For example, while delta-8 and delta-9 THC both stimulate appetite, THCV decreases it! Another frequently confusing feature of cannabinoids is a characteristic called the biphasic response curve. This mechanism involves a molecule producing one effect at a low dose and a differentand sometimes polar oppositeeffect at a stronger dose. 

A good example of the mechanism of biphasic response curves is delta-9 THC. At low doses, this molecule is known for helping consumers manage stress and decrease anxiety (“Netflix and chill, dude”). At more potent doses, however, the same molecule can cause increases in anxiety and paranoia and even result in panic attacks. 

In the end, the differences between cannabinoid analogs are good because they provide additional options to patients and lifestyle consumers. Crohn’s disease and cancer patients undergoing chemotherapy experience sometimes extreme nausea and lack of appetite, which can lead to malnutrition and worsen their health. Wellness molecules that function as effective appetite stimulants are of obvious value to such consumer populations. 

Understanding Hemp vs. Cannabis

To properly understand the characteristics of delta-8 THC relative to the myriad molecules produced by the cannabis plant, one must first gain insight into the legal and technical differences between hemp and cannabis. Hemp is considered any sample of the plant that tests below 0.3 percent (one-third of one percent) delta-9 THC in weight by volume (research has indicated that psychotropic effects do not manifest in most adult consumers until samples feature at least one percent delta-9 THC). 

Hemp and cannabis have been illegal in the United States since August 1937, when the Marihuana Tax Act was passed by Congress. In December 2018, Congress reversed course after 81 years of prohibition by enacting the Farm Bill, which legalized samples of the plant containing below the 0.3 percent delta-9 THC standard employed in North America. Europe features a stricter 0.2 percent delta-9 THC limit, although this may change to 0.3 percent, in alignment with global market leaders such as the U.S. and Canada, in the near future.    

Delta-9 THC is currently considered a Schedule I drug which, by definition, implies that it provides zero medicinal benefit while displaying a strong propensity for abuse. Delta-8 THC, however, is legally categorized as a component of hemp, meaning that it falls under different regulatory oversight and can be sold in dozens of U.S. states. Legally, delta-8 and delta-9 THC are in different universes. From a regulatory perspective, delta-8 THC is managed more similarly to CBD. 

This important legal distinction means that companies can formulate and market products containing delta-8 THC and sell them in most states. Delta-9 THC products, on the contrary, can be produced and sold in only 15 U.S. states, with no interstate commerce or merchant banking permitted under the current scheme of federal prohibition. 

Understanding Legal Status

Hemp and cannabis have been illegal in the United States since August 1937, when the Marihuana Tax Act was passed by Congress. In December 2018, Congress reversed course after 81 years of prohibition by enacting the Farm Bill, which legalized samples of the plant containing below the 0.3 percent THC standard employed in North America, which it defines as “hemp.” Europe features a stricter 0.2 percent THC limit, although this may change to 0.3 percent, in alignment with global market leaders such as the U.S. and Canada, in the near future.    

Both delta-9 and delta-8 THC are currently considered Schedule I drugs by the U.S. Drug Enforcement Agency. This means that all regulatory oversight and legal restrictions placed on delta-9 THC also apply to delta-8. Some of the companies producing delta-8 products are doing so legally under the laws of their home state, but, just as with delta-9 products, in defiance of federal oversight. 

It must be emphasized that such companies remain legal only if they restrict sales of their product to within the borders of their home state. Any interstate commerce activity falls under the strict purview of federal authorities, including the DEA, and Schedule I status.   

Confusion regarding these relatively new laws surrounds many interpretations of the legal status of delta-8 THC and emerging products. Some parties believe that delta-8 derived from hemp (samples of the cannabis plant genome that feature <0.3 percent delta-9 THC) are a legal loophole that allow them to narrowly skirt any laws of prohibition at the state or federal level. 

“You have a drug that essentially gets you high, but is fully legal. The whole thing is comical,” said Lukas Gilkey, CEO of Hometown Hero CBD in Austin, Texas, during an interview with the New York Times

However, many legal authorities paint a different picture. “Dealing in any way with delta-8 THC is not without significant legal risk,” said Alex Buscher, a Colorado lawyer who specializes in cannabis law, during an interview for the New York Times article cited above.

Some companies have invested in production and multi-state marketing of delta-8 products. Unfortunately, they are doing so under the false belief that their formulations are categorized as hemp under the Farm Bill and, thus, legal.

Unfortunately, this is not the case. Delta-8 and delta-9 THC fall under the identical categorization and carry the same enforcement mechanisms and penalties.     

Understanding Delta-8 THC

Regardless of the legal status of delta-8 THC, let’s compare and contrast the medicinal efficacy of both compounds. Despite its reputation for helping consumers unwind from a stressful day, delta-9 THC has a nasty reputation for causing the opposite when consumed in strong doses: Elevated anxiety, paranoia, and sometimes panic attacks. Disorientation, confusion, and other forms of distress resulting from too much delta-9 have been documented by hospital emergency rooms and psychologists for decades. 

Delta-8 THC has been reported, through both formal research and anecdotal testimony, to deliver roughly two-thirds of the psychoactivity of the delta-9 isomer, but without the paranoia. This provides an option for those who avoid delta-9 THC or cannabis overall due to a previous negative experience with the herb. 

That said, it should be noted that the potential for consumers, especially novices, to experience increased anxiety or paranoia when consuming any psychotropic substance, especially in potent doses, always exists. Doctors and wellness professionals should experiment over time and “start low and go slow” with the dosing of delta-8. Many consumers have reported positive experiences when consuming delta-8 THC, especially in comparison to delta-9. 

One distinct difference between these two analogs is their relative volumes in plant samples. Most modern cultivars and chemovars (“strains”) of cannabis have been bred to increase delta-9 THC levels (which typically range from 10 to 30 percent), not CBD or delta-8. As such, delta-8 THC is found in small quantities in natural plant samples (typically well under one percent, similar to CBG). Delta-8 is sometimes extracted and concentrated by complex processing equipment requiring specially trained technicians. More often, however, it is synthesized from molecules that feature similar molecular structures, such as CBD and delta-9 THC. 

Some doctors, including Dr. Benjamin Caplan (a clinical practitioner in Boston who recommends legal cannabis to his patients), are finding superior results with their patients when they mix the correct doses of delta-8 and delta-9. Some wellness professionals are employing such a formulation instead of the more traditional delta-9 and CBD mix. 

“While the combination of delta-8 and delta-9 often yields a less euphoric experience, it can be a very pleasant alternative to blends of delta-9 THC and CBD,” Caplan told me during an exclusive interview.

In addition to appetite stimulation, delta-8 THC delivers anxiety reduction, can help treat pain, has shown antioxidant efficacy, and is a powerful tool in the treatment of nausea. Caplan described delta-8 THC as a “fan favorite” among his patients. 

Delta-9 Tolerance Break Tool?

Some companies and caregivers have begun exploring the use of delta-8 THC as a tool to help daily users, especially heavy cannabis consumers, to lower their tolerance to delta-9 THC. Even slight improvements in the relative potency of delta-9 based on reduced tolerance can equal significant monetary savings for such large volume consumers. 

“It’s not uncommon for those who use delta-9 THC to find that efficacy wanes after a long period of consistent use,” said Dena Putnam, President and co-founder of Leafwize Naturals in Orange County, California. Leafwize Naturals sells a variety of vape cart products featuring the dominant ingredient of delta-8 THC.  

Putnam explained how the delta-8 isomer of THC “may offer a way to circumvent the body’s tolerance of delta-9 while delivering similar benefitsall while taking a break from delta-9 in an effort to bring back the full effectiveness” she explained during an exclusive interview. 

Putnam said that delta-9 THC tolerance breaks “can be scary for those who depend on it for daily pain relief and mood management,” but explained that it is “sometimes necessary to reset the effectiveness of the medicine.” She explained how “delta-8 may offer a way to take a delta-9 break while providing a level of medicinal relief that is similar to delta-9.”

When queried about the success of this approach, Putnam explained how she and her staff noted two positive outcomes from their experiment: Delta-8 efficacy that mirrored that of delta-9 and the overall goal of achieving a lowered tolerance for delta-9 THC. Both target outcomes were achieved, somewhat of a unicorn in the world of science-based health and wellness.      

“We found that, after a period of switching from delta-9 THC to delta-8, that delta-8 helped in a manner similar to delta-9,” said Putnam. “More important, when the user resumed consumption of delta-9, the effects were greater, as if they had taken a conventional tolerance break,” she added.

It’s a Wrap

Delta-8 THC, only one of several THC analogs that includes THCA, THCV, and THCP, offers a number of advantages over its sibling delta-9. From the perspective of medicinal efficacy, delta-8 provides 60-70 percent of the psychotropic (psychoactive) effects of delta-9 THC while, typically, delivering little or none of the paranoia and anxiety that may result from delta-9.

Medical practitioners and business entrepreneurs are beginning to recognize the advantages of a world in which phytocannabinoids beyond CBD and delta-9 THC are readily available in thousands of products from hundreds of companies. If businesses like Southern California’s Leafwize Naturals have anything to say about it, that world will be here sooner rather than later.   

Kaycha Announces Three New Labs In Massachusetts, Nevada & Oregon

With locations across the U.S., Kaycha Labs is establishing a national network of Cannabis and Hemp labs that provides essential product quality and safety information

FLORIDA: Kaycha Labs, a leader in Cannabis and Hemp testing technologies and methods, is adding three new states to its national network of labs. The company’s nine labs are in California, Colorado, Florida (Fort Lauderdale/Davie and Gainesville), Massachusetts, Nevada, Oklahoma, Oregon, and Tennessee.

In recent weeks, Kaycha has acquired Evio Labs in Medford, Oregon, signed a definitive agreement to acquire DB Labs in anticipation of Clark County and Nevada Cannabis Compliance Board approvals, and received a provisional license to open and operate a lab in Natick, Massachusetts. Both the Oregon and Nevada labs were early entrants to their respective markets; Evio Labs Medford commenced operations in 2014 and DB Labs was organized in 2014 and operates its ~11,500-square-foot lab several blocks away from the Las Vegas Strip. The Massachusetts lab is a new build and is strategically located in Natick near major interstate highways within a couple hours driving time to all major customers.

James Horvath, CEO of Kaycha Labs, commented, “We know that the Cannabis industry is rapidly consolidating and that national Cannabis companies are working hard to build national brands. As they grow, we appreciate that there is a need for a testing partner who can provide and apply a uniform and consistent process.  Furthermore, all Kaycha labs will be equipped with back-up instrumentation so that client testing is not interrupted by an outage.” Chris Martinez, Kaycha Labs’ President, added, “We know clients value quality testing, fast turnaround times, and attractive pricing. And by adding to our network, we will be achieving even more scale, which will allow us to continue to lower our cost structure and pass these savings along to our clients.”

Hemp Feed Coalition Submits The First Ingredient Application In The United States For Hemp To Be Federally Approved As A Feed Ingredient For Poultry

COLORADO:  The Hemp Feed Coalition (HFC) is proud to announce the first submission for hemp to become an approved animal feed ingredient has been put forward for consideration by the Association of American Feed Control Officials and the U.S. Food and Drug Association-Center for Veterinary Medicine (FDA-CVM). Once approved, this ingredient application will allow hempseed meal and cake to be legally used as commercial feed for laying hens.  Led by Coalition leadership, hemp and feed industry experts, and researchers; the submission is a culmination of a two-year long effort, consisting of an ingredient investigation of hemp seedcake and meal and a clinical trial to demonstrate the safety and efficacy of hemp for laying hens.

“The first one is always the hardest; and it was definitely a group effort to submit the first ever application in the US for hemp as an official feed ingredient,” Hunter Buffington, Executive Director of the HFC, said of the first submission. To meet the FDA-CVM rigorous standards of safety and efficacy, the hemp industry shared Certificates of Analysis from across the United States to demonstrate hempseed cake and meal can be consistently grown and processed. This effort was combined with expertise from hemp and feed industry leaders, research from our principal investigators and the support of our Project Champion-IND HEMP to bring the submission to the FDA-CVM for scientific review.

“The coalition has worked hard over the last two years and we are finally getting our first steps behind us in the world of federal approval; something that most every day Americans would be shocked to know is so heavily regulated. HFC doesn’t just represent the hemp industry but all the farmers and ranchers out there that deserve the opportunity to monetize their efforts and compete on the global market of industrial hemp.”  – Morgan Elliott, Co-Founder of IND HEMP.

Now that the first application has been submitted, the HFC will turn its focus to research on other hemp by-products: oil, sediment, hulls, pulp and screenings to investigate their benefit and safety as feed ingredients. In addition, this work will include the clinical trials necessary to add ruminates to the hempseed meal application that was submitted. “Opening new markets is our secondary mission,” said Buffington “Commoditizing safe and healthy by-products from hemp processing will provide farmer and processor revenue and a build a steady supply as the industry matures in the next few years.” The HFC will be leading those efforts by bringing researchers, hemp and feed industry experts and coalition advisors together for additional applications and Federal regulatory approval for new hemp ingredients as feed for animals.

The Hemp Feed Coalition (HFC) began in 2018 as a pilot project under the Colorado Hemp Industries Association (COHIA) before forming its own non-profit organization in 2020. The HFC intends to continue its mission to gain federal approval for additional hemp by-products as commercial animal feed. To support the work of the HFC, visit our website and become a member. Members receive discounts, special offers, invitations and member only communications. For more information on current research and ingredient data collection contact Hunter Buffington at hunter@hempfeedcoalition.org

Jazz Pharmaceuticals To Acquire GW Pharmaceuticals, Creating An Innovative, High-Growth, Global Biopharma Leader

UNITED KINGDOM: Jazz Pharmaceuticals plc and GW Pharmaceuticals announced the companies have entered into a definitive agreement for Jazz to acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares, for a total consideration of $7.2 billion, or $6.7 billion net of GW cash. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.

Upon close of the transaction, the combined company will be a leader in neuroscience with a global commercial and operational footprint well positioned to maximize the value of its diversified portfolio.

GW is a global leader in discovering, developing, manufacturing and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company’s lead product, Epidiolex® (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy. Epidiolex was the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA). This product has also been approved, under the tradename Epidyolex®, by the European Medicines Agency (EMA) in patients two years of age and older for the adjunctive treatment of seizures associated with LGS and Dravet syndrome in conjunction with clobazam and is under EMA review for the treatment of seizures associated with TSC. In addition to the approved indications for Epidiolex, there are considerable opportunities to pursue other indications within the epilepsy field, including other treatment-resistant epilepsies where significant unmet needs of patients exist.

Beyond Epidiolex, GW has a scientific platform and deep innovative pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise, developed over two decades of pioneering and building leadership in cannabinoid science. This pipeline includes nabiximols, for which the company is in Phase 3 trials to seek FDA approval for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.

“Jazz is proud of our leadership position in sleep medicines and rapidly growing oncology business. We are excited to add GW’s industry-leading cannabinoid platform, innovative pipeline and products, which will strengthen and broaden our neuroscience portfolio, further diversify our revenue and drive sustainable, long-term value creation opportunities,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “We are joining two teams that share a passion for, and track record of, developing differentiated therapies that advance science and transform the lives of patients. This will help facilitate a successful integration and bring added capabilities to Jazz. Given the strength of our balance sheet and the meaningful financial drivers of the transaction, we are confident in the value we can deliver to both companies’ shareholders and patients. We look forward to welcoming the GW team to Jazz to build an even stronger company.”

“Over the last two decades, GW has built an unparalleled global leadership position in cannabinoid science, including the successful launch of Epidiolex, a breakthrough product within the field of epilepsy, and a diverse and robust neuroscience pipeline. We believe that Jazz is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs,” said Justin Gover, CEO of GW Pharmaceuticals. “We have a shared vision of developing and commercializing innovative medicines that address significant unmet needs in neuroscience and an approach of putting patients first. Together, we will have an opportunity to reach and impact more patients through a broader portfolio of neuroscience-focused therapies than ever before.”

Charlotte’s Web Secures U.S. Utility Patents For Two New Hemp Varietals With Superior Cannabinoid Expression

COLORADO:  Charlotte’s Web Holdings, Inc. (“Charlotte’s Web” or the “Company”), the market leader in hemp CBD wellness products, announces that Charlotte’s Web, Inc., a wholly-owned subsidiary, has been granted U.S. Utility Patents for its hemp genetics by the United States Patent and Trademark Office. The newly issued patents cover two of the Company’s new feminized seed hybrid hemp varieties developed under the Company’s breeding program; ‘Kirsche’ (US Patent No. 10,888,060) and ‘Lindorea’ (US Patent No. 10,888,059).  ‘Lindorea’ and ‘Kirsche’ are the world’s first two allowed U.S. Utility Patents reading on feminized hybrid hemp plants.

TSX:CWEB - Charlotte's Web is the market leader in hemp CBD extract products and is a Certified B Corp publicly traded company with five patent awards.. (CNW Group/Charlotte's Web Holdings, Inc.)

The Company now has earned a total of five U.S. hemp variety patent grants: one Plant Patent and four Utility Patents as it advances the science of hemp horticulture.

“Achieving the first patented hemp hybrids demonstrates that it is possible to improve hemp through similar methods as other agronomic crops using natural breeding techniques.  We believe that ‘Kirsche’ and ‘Lindorea’ are some of the hardiest botanical hemp varietals under cultivation.” said Bear Reel, Charlotte’s Web vice president of cultivation and R&D and the developer of the new varietals.

‘Kirsche,’ having a naturally rich phytochemical profile and good disease resistance, has an excellent plant structure and a flower-to-stem ratio that is compatible with mechanical harvesting innovations. ‘Lindorea,’ developed for the Kentucky climate, exhibits broad resistance to fungal pathogens in the North and South Appalachian regions but also in the wetter autumn climate in Ore. while delivering record breaking yields.

“The ‘Kirsche’ and ‘Lindorea’ U.S. patents represent more than four years of scientific research and trials, and some of the most cutting-edge work being conducted in genetics in the hemp CBD industry today,” said Deanie Elsner, Charlotte’s Web president and CEO. “Charlotte’s Web will continue to advance and protect our prized hemp varietals to build consumer confidence in the consistency of our hemp extract products. This is at the heart of our mission to advance the science of hemp for the greater benefit of the people who choose these products for their wellness needs.”

Virginia Governor Northam Announces Industrial Hemp Company to Locate In Rockingham County

Governor Northam Announces Industrial Hemp Company to Locate in Rockingham County

VIRGINIA:  Governor Ralph Northam today announced that Shenandoah Valley Hemp, LLC dba Pure Shenandoah will invest nearly $3.3 million to establish an industrial hemp fiber processing and cannabidiol (CBD) oil extraction facility in the historic Casey Jones building in the Town of Elkton. The company will create 24 new jobs and has committed to purchasing 100 percent of its industrial hemp from Virginia growers, resulting in nearly $5 million in payments to Virginia farmers over the next three years. Pure Shenandoah will become the first participant in the Virginia’s Finest trademark program to source the hemp used in its products exclusively from the Commonwealth.

“Virginia’s industrial hemp industry continues to experience tremendous growth, creating a wealth of opportunity across our Commonwealth,” said Governor Northam. “Projects like this one are an important part of diversifying our economy and developing new markets for industrial hemp. Our administration remains committed to supporting growers and processors as we work to ensure this crop has a sustainable future in Virginia.”

Pure Shenandoah operates as a vertically integrated “seed to sale” company providing customers with safe and consistent hemp products of the highest quality. This includes strict regulatory control of crops, the application of certified good manufacturing practices, and complete traceability of each product back to the seed and farm from which it came.

“Pure Shenandoah is a great example of the many ways we are able to help innovative, agriculture-based companies grow and thrive in the Commonwealth,” said Secretary of Agriculture and Forestry Bettina Ring. “I am pleased to see continued job creation and investment in Virginia’s industrial hemp industry and excited for the new market opportunities the industry is creating for our farmers.”

“Industrial hemp is gaining momentum across the country, and we are excited for Virginia to be a player in this up-and-coming industry,” said Secretary of Commerce and Trade Brian Ball. “Pure Shenandoah will provide quality jobs and enable the Commonwealth’s hemp growers to source extraction and processing within Virginia, further benefiting our economy and agricultural ecosystem.”

As part of its strategic marketing efforts, Pure Shenandoah is a participating member of the Virginia’s Finest® program. Created more than 30 years ago with more than 500 participating companies, this program helps consumers know they are purchasing top-quality Virginia-produced specialty food products whenever they see the classic blue and red VA check mark logo.

“We are honored to receive these funds and to work with such influential state programs that are helping push the industrial hemp industry forward in the Commonwealth,” said Pure Shenandoah CEO Tanner Johnson. “With this support, we will continue to educate and provide safe and effective products to consumers. We are excited to do our part and help expand the future of industrial hemp and all of its potential.”

The Virginia Department of Agriculture and Consumer Services (VDACS) and Virginia Economic Development Partnership (VEDP) worked with Rockingham County and the Rockingham County Economic Development Authority to secure this project for the Commonwealth. Governor Northam approved a $50,000 grant from the Governor’s Agriculture and Forestry Industries Development (AFID) Fund for the project, which Rockingham County will match with local funds. Funding and services to support the company’s job creation will be provided through VEDP’s Virginia Jobs Investment Program.

“Rockingham County is pleased with the announcement of 24 new jobs and the investment of $3.3 million in eastern Rockingham County,” said Chairman of the Rockingham County Board of Supervisors Bill Kyger. “This is a new and exciting industry that offers a great opportunity to diversify the agriculture base of the county for the future.”

“We should never forget or take for granted Virginia’s tremendous agricultural heritage and its economic viability that continues to push Virginia forward,” said Senator Emmett Hanger. “I am pleased the AFID funds will further promote industrial hemp and that Pure Shenandoah is committed to exclusively sourcing Virginia agriculture products for this project. Of course, there is no better county to partner with on this funding than the number one agricultural county in the Commonwealth, Rockingham County. We are proud of our deep agricultural roots here in Virginia and this economic announcement adds yet another facet to our diverse agriculture operations.”

FDA Warns Companies Illegally Selling CBD Products

DISTRICT OF COLUMBIA:  The U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). All five warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions. The warning letters include CBD products that are especially concerning from a public health perspective due to the route of administration, including nasal, ophthalmic and inhalation. In addition, they address violations relating to the addition of CBD to food, and the impermissible marketing of CBD products as dietary supplements. Two of the letters also address CBD products illegally marketed for pets, including a product for use in the eye.

“The FDA’s first priority is to protect the health and safety of Americans. Many questions remain regarding the science, safety, effectiveness and quality of products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose the greatest risk of harm to the public.”

The warning letters were issued to:

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food, and some of the products were impermissibly marketed as “dietary supplements.”

The products that are the subject of the letters issued today have not gone through the FDA drug approval process and therefore are considered unapproved new drugs. It is not known whether they are effective for the uses claimed in labeling, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of these unapproved CBD-containing drug products has not been subject to FDA review as part of the human or animal drug approval processes, so it is not known what the manufacturing conditions of, or contaminant levels in these products may be.

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. New human and animal drugs must be approved by the FDA or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review, before they can be legally marketed as drugs. CBD was not an ingredient considered under the OTC Drug Review.

The FDA has not approved any CBD products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in human patients. CBD has not been approved as a food additive and does not meet the statutory definition of a dietary supplement.

The FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

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.