Search Results for: CBG

Washington State Liquor and Cannabis Board Action

Washington State Liquor and Cannabis Board Action

Yesterday, during a regularly scheduled meeting, the Washington State Liquor and Cannabis Board took the following action:

Adopted final rules (CR 103) to implement final rules for Cannabis License Applicant Background Checks. The rules take effect October 2, 2021.

Please contact Cannabis Policy and Rules Coordinator Jeff Kildahl at rules@lcb.wa.gov with any questions or concerns about this action.

Curt’s Cannabis Corner: Cannabis for Inflammation

Welcome to Season 2, Episode 3 in the multi-media educational series Curt’s Cannabis Corner from technical writer Curt Robbins at Higher Learning LV and MJNews Network.

This series is intended for cannabis and hemp professionals—and the enterprise organizations that employ them—who wish to gain a better understanding of the nuanced biochemistry, volatile business environment, and detailed regulatory oversight of this newly legal herb.

This week, readers learn about how cannabis and its constituent molecules may be of therapeutic value to humans—particularly in the treatment of conditions based in inflammation—from Sunil Pai, MD, a veteran clinical practitioner.

Pai is an internationally recognized expert in integrative medicine based in Albuquerque, New Mexico and author of the critically acclaimed 2016 book An Inflammation Nation. He is a lecturer and a contributing author to a number of medical textbooks and scientific journals.

Pai is a practicing doctor who combines an evidence-based approach with 20 years of clinical experience. Each year, he educates thousands of physicians and medical professionals about the nuanced biochemistry involved in the administration of hemp-derived cannabinoids and terpenes for the treatment of a variety of disease states and conditions.


CURT’S

CANNABIS

CORNER 

Cannabis

for

Inflammation

By Curt Robbins


In August 2021, Higher Learning LV conducted the following exclusive interview with Pai.

Higher Learning LV: “As a medical expert on the management of inflammation and author of the 2016 book An Inflammation Nation, how can the cannabis/hemp plant species help humans in terms of managing their inflammation and achieving improved health?”

Sunil Pai, MD: “The use of cannabinoids from cannabis and hemp can help with the self-regulatory process of lowering inflammation through a variety of biological mechanisms. These include stimulation of certain endocannabinoid system receptors, such as CB1 and CB2, in many organs. These include the brain, all bones and muscles, the GI tract, and many other areas. Cannabinoids provide immunomodulation by repairing and protecting the tissues in these organs. This, in turn and over time, can balance inflammatory conditions and achieve homeostasis, which is critical for overall health improvement.”

HLLV:  “CBD is being touted for treatment of a range of disease states and ailments. Is limiting one’s therapeutic viewpoint to a single phytomolecule wise?”

SP: “Limiting one’s consumption to one phytochemical has both benefits and disadvantages. The benefit is that, sometimes, using a single molecule can provide a stronger clinical response due to the ability to achieve a more potent and focused dose.

“However, the disadvantage is a lack of biochemical balance. Like a pharmaceutical, CBD can feature side effects and a relatively small therapeutic window before side effects begin to occur. The pharmaceutical industry likes single phytomolecules due to the ability to patent them and own the extraction process or resulting compound. It also allows them to make a medical claim because drug studies employ only single molecules. Like pharmaceuticals, the cannabis and hemp industries also like single molecules such as CBD. They allow them to advertise a new product and increase SKUs with new indirect claims to the general public.”

HLLV: “What other cannabinoids, beyond CBD, should wellness professionals and patients be paying attention to, Dr. Pai?”

SP: “That’s a great question. Here’s a few phytocannabinoids that have my attention currently and that I’m integrating into my clinical practice:

  • CBC (cannabichromene): Possibly helpful for brain health via support of the process of neurogenesis. Reduces inflammation and may target more CB2 receptors in gastrointestinal conditions (such as Crohns or IBS) and neuropathy.

  • CBG (cannabigerol): Interacts with both CB1 and CB2 receptors in the brain and indirectly elsewhere. May reduce inflammation and tumor growth.

  • CBN (cannabinol): Possible sedative and anti-inflammatory effects.”

HLLV: “There’s been plenty of talk recently about the THC isomer delta-8. What are your thoughts on the medicinal efficacy and utility of this molecule that is being adopted by many patients and lifestyle consumers, especially in states where delta-9 THC remains prohibited?”

SP: “Many companies are providing delta-8 products for two primary reasons. First, the public wants something close to THC, with aspects that deliver euphoria and pain control, with less feeling of being ‘high.’ This is particularly true in states where delta-9 remains illegal.

Delta-8 THC is commonly called ‘weed lite’ or ‘diet weed’ because, for most consumers, it features lower potency and fewer side effects than delta-9 THC. Just as important, the industry is now oversaturated with CBD products, which is causing prices to drop really low. To remain competitive, cannabis and hemp companies need new product segments featuring new items.

“Unfortunately, to obtain adequate amounts of delta-8 from hemp, a process of synthesis must take place. This puts delta-8 in a grey zone in terms of regulation.

“Many delta-8 products on the market have been found to contain either delta-9 THC or other adulterants and chemicals. Until better regulations ensure safety and quality and its legal status is clarified, I prefer not to recommend delta-8 to my patients or colleagues. As you are aware, when it comes to hemp, I prefer to use the plant holistically, taking advantage of as many of the entourage mechanisms of these efficacious compounds as possible.”

HLLV: “Terpenes are often hailed for their medicinal properties, including their anti-inflammatory prowess. What are your thoughts about the usefulness of terpenes, particularly in the realm of their effectiveness for treating inflammation?”

SP: “I like the use of terpenes—either that occur naturally in the product or that are added. However, our knowledge of terpenes is still in its infancy. We understand the range of different types of terpenes and, to a certain degree, the effects derived from them. Some are anti-inflammatory, which I naturally appreciate. I believe we should strive to preserve the natural terpenes that occur in loose-leaf cannabis and hemp flower samples and other products. We also have the opportunity to enhance CBD with terpenes, especially those that possess anti-inflammatory effects.

“That said, I must stress that controlling terpene dosage remains a major challenge. Terpenes are sold to manufacturers and processors for addition to their CBD products. However, this must be performed with expertise and caution.

“Terpenes can be dangerous; some consumers are allergic to certain terpenes! When companies in the industry use them, many lack formulation and manufacturing expertise and treat terpenes as merely another casual ingredient. With the growth of the use of terpenes in CBD and other cannabis and hemp products, there is increased danger of adverse responses from some patient and consumer populations to these compounds.

“Unfortunately, many manufacturers and distributors are focused on selling products in bulk and are not seeking safety and true medicinal efficacy. As an integrative medicine physician, I always consider how we can best use natural products like CBD safely and with maximum efficacy. If used properly, terpenes enhance the overall benefits of the other compounds, both directly and indirectly.”

HLLV: “Thanks for your time and sharing your deep clinical experience with our readers, Dr. Pai.”

SP: “Certainly. Thank you for the opportunity to help clarify the real science of how the phytocannabinoids and terpenes from cannabis may aid some patients and lifestyle consumers.”

WATCH THE FULL PODCAST ON MARIJUANA CHANNEL ONE

Curt’s Cannabis Corner: CBD For Epilepsy

Welcome to Season 2, Episode 2 of Curt’s Cannabis Corner, an education series from technical writer Curt Robbins at Higher Learning LV and MJNews Network intended for cannabis and hemp professionalsand the enterprise organizations that employ themwho wish to gain a better understanding of the nuanced biochemistry, volatile business environment, and detailed regulatory oversight of this newly legal herb. 

This week, readers learn about the recent scientific investigative work of Dr. Nicolas Schlienz, a research scientist and clinical psychologist. Schlienz was recently appointed to the position of Research Director for Realm of Caring, a pioneering non-profit cannabinoid research organization based in Colorado Springs with ties to the popular vertically integrated brand Charlotte’s Web.  


CURT’S

CANNABIS

CORNER 

CBD

For

Epilepsy

 

By Curt Robbins

 


 

Dr. Nicolas Schlienz & CBD for Epilepsy

In July 2021, Schlienz coauthored a study entitled “Cross-sectional and Longitudinal Evaluation of Cannabinoid (CBD) Product Use and Health Among People with Epilepsy” that was published in the peer-reviewed journal Epilepsy & Behavior

“This study represents a refreshing collaboration of scientists, clinicians, patients, and advocates,” said Jay Salpekar, MD, Associate Professor of Psychiatry and Neurology at Johns Hopkins University. Salpekar said that the study affirms that “cannabinoid products have value in the treatment of epilepsyas well as associated neuropsychiatric conditions.”

The study observed that cannabis “and select chemicals found in the cannabis plant have received significant clinical attention as evidence accumulates suggesting potential utility for varied health conditions.” It noted that multiple recent studies have “demonstrated the safety and efficacy of CBD in the reduction of seizures for several specific epilepsy syndromes.”

The study stated that the efficacy of CBD for those who suffer epilepsy goes beyond seizure control. “CBD products may prove valuable for their effects on psychosocial function and psychiatric health,” stating that a variety of behavior issues, including psychiatric disorders, are “overrepresented among people with epilepsy.”   

This study is of importance because it was conducted on human participants, not in test tubes or on animal subjects. Participants were “predominantly Caucasian (74 percent) with a roughly even split by gender (55 percent female), an average of 21 years old (51 percent were under 18), and the majority (90 percent) had no history of non-medicinal (‘recreational’) cannabis use.” 

93 percent of the study participants reported epilepsy as their primary medical condition. “The other seven percent reported epilepsy secondary to cancer, autoimmune conditions, neuropsychiatric conditions, chronic pain, insomnia/sleep disorders, or other conditions.” 

How They Did It 

The study participants employed a variety of cannabis-based products in the treatment of their epilepsy, including inflammation-reducing CBD, psychoactive tetrahydrocannabinol (THC), and several other cannabinoids that spanned anti-inflammatory cannabigerol (CBG), relaxant and sedative cannabinol (CBN), anti-nausea agent cannabidiolic acid (CBDA; the acidic precursor to CBD), and tetrahydrocannabivarin (THCV; the varin version of THC), which is known to reduce appetite. 

“For purpose of analysis, it is assumed that these participants were using an artisanal CBD product. A subset of artisanal CBD users reported also using known THC-dominant products containing high concentrations of both CBD and THC or products in which the primary chemical constituent was a minor cannabinoid such as CBG, CBN, tetrahydrocannabinolic acid (THC-A), CBD-A, or THC-V.”

The study also found the safety profile of CBD to be acceptable for patients and consumers, particularly for those using it to treat epilepsy. “Among the 280 baseline artisanal CBD users, the majority did not report an adverse effect.” 

What They Found

For those who suffer epilepsy and are seeking relief from CBD, the results of this scientific investigation reveal potentially limited efficacy of this popular cannabinoid for seizure management specifically. “No group differences were observed in seizure control based on self-reported number of past month seizures,” concluded the study’s authors.

Elaborated the scientists: “Seizure control did not differ based on artisanal CBD product use in this study. This may be related to a number of factors, including those that could not be controlled in [an] observational setting.”

Significant CBD Benefits Identified

However, the researchers noted that participants enjoyed a range of significant benefits from CBD, including “generally higher quality of life, lower psychiatric symptom scores, and improved sleep.” The study also reported that “artisanal CBD users” displayed considerably “better epilepsy medication tolerability.”    

Concluded the study, “Compared with controls, artisanal CBD users had greater health satisfaction.” It also found that the CBD-using epilepsy patients who participated in the research displayed “lower anxiety and depression.”

Despite its efficacy for many of the symptoms that accompany epilepsy, including psychological disorders like anxiety, depression, and insomnia, this particular study did not find that the cannabinoid CBD lowered the incidence or severity of seizure activity as experienced by those with epilepsy. 

Based on the observational and participant self-report nature of the study, the scientists noted that their results may be influenced by the loss of control that is inherent in observation research of this type. For a more comprehensive understanding of the topic, readers are encouraged to enroll in the Higher Learning LV seminar Understanding Cannabis.

Thanks for reading. Remember to #LearnAndTeachOthers at http://HigherLearningLV.co 

Proposed Cannabis Standard Will Support Change Control Process Management

PENNSYLVANIA:  An ASTM International standard guide will cover change control process management for the cannabis and hemp industry. ASTM International’s cannabis committee (D37) is developing the proposed standard.

This guide (WK77590) seeks to create a clear change control process within cannabis organizations, allowing them to maintain, document, and track critical decisions within manufacturing and quality system operations.

“As the cannabis industry grows, the quality, expectations, and control challenges grow within,” said Maribel Colón, quality assurance consultant. “The creation and implementation of this standard guide will increasecannabis business efficiency and minimize risk, time, and potential cost of poorly managed changes.”

According to Colón, vice chair of the ASTM subcommittee on cannabis quality management systems, cannabis producers and service industries, such as test laboratories, will benefit most from this proposed standard guide.

ASTM International welcomes participation in the development of its standards, specifically individuals with knowledge in change control interested in the advancement of this cannabis industry guide. To learn more about cannabis committee participation and membership, visit www.astmcannabis.org.

ASTM International is a not-for-profit non-governmental organization that develops voluntary consensus standards and defers to appropriate government authorities to determine the legal and regulatory framework regarding the control and use of cannabis.

Curt’s Cannabis Corner: What is Delta-10 THC?

Welcome to the next 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. 

This week we’re dealing with a newcomer to the world of commercial cannabinoids, delta-10 THC. Please remember to #LearnAndTeachOthers™!


CURT’S

CANNABIS

CORNER 

What is Delta-10 THC?

By Curt Robbins

 

 


All cannabis consumers and industry professionals are familiar with the phytomolecule THC that is produced by the cannabis plant. Many, however, aren’t aware that this popular psychoactive chemical compound is but one of several similar THC molecules produced by the plant called analogs (or, more technically, isomers).

The version of THC that differentiates hemp and cannabis, the measure of which has determined the market value of cannabis flowers and related products for decades, is delta-9 THC. However, a variety of analogs of the THC molecule exist. These include THCA (no psychoactivity), delta-8 THC (about two-thirds the psychoactivity of the delta-9 isomer), and THCV (the varin version that delivers psychoactivity, but only in relatively potent doses).  

Other cannabinoids are produced by the plant as similar isomer families, including cannabidiol (CBD) and cannabigerol (CBG). In fact, each of these cannabinoids manifests as more than half a dozen isomers. (For CBD, these include CBDA, CBDV, CBDVA, and CBDP. Similarly, CBG offers the isomers CBGA, CBGVA, and CBGV, among others.)   

Recently, the delta-8 isomer of THC has gained attention. A variety of companies in the U.S. have begun selling delta-8 products, mostly in an effort to skirt the federal regulations that prohibit delta-9 THC. Meanwhile, an additional isomer of THC has attracted the attention of entrepreneurs: Delta-10 THC. 

History in California

The story of delta-10 THC is rife with irony. The phytomolecule was recently discovered by Fusion Farms in Adelanto, California. During a wildfire, a batch of outdoor grown plants became contaminated by fire retardant chemicals. These chemicals caused one or more of the cannabinoids in the plants to convert to delta-10 (most likely from cannabichromene [CBC], CBD, or delta-9 THCall of which feature very similar molecular structures). 

Thus, delta-10 THC has been dubbed an “artificial cannabinoid” because it may occur very rarely, or almost never, in nature. Modern manufacturing processes, however, offer the ability to produce the molecule in volume by converting closely related cannabinoids.

Some industry professionals believe that, during testing, delta-10 THC is commonly misidentified as similar cannabinoids, including CBC. “A lot of people had been seeing this mystery compound show up as a minor component on their distillate COAs [Certificates of Analysis], but they thought it was CBC,” said Josh Jones, an organic chemist who consults for Fusion Farms.

 

Business Opportunity

The tenuous nature of regulatory oversight of hemp and cannabis products in the United States means that the legal status of delta-10 is both ambiguous and could change at any time. 

The challenge for companies wishing to produce products rich in delta-10 THC is use of a production method that synthesizes the molecules in sufficient volume to satisfy potential market demand and cause true efficacy in consumers.   

The saga of delta-10 THC illustrates how industrious entrepreneurs and managers within the industry will pursue opportunities to develop novel cannabinoid isomers. These molecules will naturally feature a different binding affinity, which is the exact method by which they attach to specialized cellular receptors in the human body (part of the endocannabinoid system). As such, wellness professionals seeking novel approaches to the management of particular disease states and conditions may be able to fine tune the efficacy of molecules to match use case scenarios and bolster the safety profiles of molecules or particular products. 

WATCH CURT’S CANNABIS CORNER THE PODCAST ON MARIJUANA CHANNEL ONE

EPISODE 12: DELTA-10 THC (featuring Curt Robbins, David Rheins, Alana Armstrong & Matt Grimshaw)

Curt’s Cannabis Corner: What is Nanoemulsion Technology? Part 2

Welcome to the third installment in the series of educational articles from technical writer Curt Robbins at Higher Learning LV and MJBA’s 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 past two weeks, Curt has been teaching readers about the hot new manufacturing process for cannabis- and hemp-infused products called nanoemulsion

What is nanoemulsion? How can it help patients and consumers while offering additional marketing opportunities for entrepreneurs? How does it compare to traditional formulation technologies? Read on to learn!


CURT’S

CANNABIS

CORNER 

What is Nanoemulsion Technology?

Part 2

By Curt Robbins

 

 

Read What is Nanoemulsion Technology?: Part 1. In Part 1, readers learn the definition of nanoemulsion and how it is being employed in the cannabis and hemp industries for the creation of consumer products that feature enhanced bioavailability (including greater potency and faster onset). This formulation tech also allows more accurate dosing, a large advantage to millions of patients and their caretakers. 

In Part 2, let’s dive deeper into this excerpt from the Higher Learning LV course Cannabis Core Concepts by further exploring bioavailability issues, examining some real world metrics, and learning the latest scientific research about nanoemulsion technology! 

End Game: Increased Bioavailability

The purpose of packaging a medicine, wellness tonic, or lifestyle beverage in the form of a nanoemulsion is straightforward: To improve bioavailability. This includes not only greater potency, but also faster onset. 

Onset is an important issue for consumers who require quick relief from conditions such as chronic pain, nausea, seizure activity, and social anxiety, to name only a few. Most within this population cannot tolerate the approximately two-hour wait that characterizes the onset of standard infused edible products (especially given that peak potency requires an additional one to three hours). 

The exact onset period of a particular nanoemulsion depends on several factors, including consumption avenue and the biophysical circumstances under which it is consumed by users. This includes their age, relative health, genetic makeup, medical history, and use of commingling drugs.  

Edible cannabis products formulated with nanoemulsions typically involve an onset period of roughly 10-30 minutes, with 15-20 minutes being a common claim among companies offering infused beverages and edibles featuring nanoencapsulated cannabinoids and terpenes.   

A 2014 study entitled “Enhancement of the Oral Bioavailability of Breviscapine by Nanoemulsion Drug Delivery System” that was published in the journal Drug Development and Industrial Pharmacy explored the ability of a “nanoscale drug delivery system to realize the improvement of its oral bioavailability.” 

Reported the study, “the relative bioavailability of [the nanoencapsulated drug] reached 250 percent.” The researchers concluded that the nanoemulsion enhanced the oral absorption of [the drug] due to “improved stability and permeation.”  

A 2017 study entitled “Nanoemulsion-based Delivery System for Enhanced Oral Bioavailability” that was published in the journal Drug Delivery investigated the relative bioavailability of various formulation approaches, including nanoemulsion. “Nanoemulsion of BBH showed a relative bioavailability of 440 percent compared with unencapsulated BBH.” The study’s authors also reported that the nanoencapsulated liquid remained stable following a six-month evaluation period.  

If performed properly and depending on the exact compounds involved, nanotechnology can result in faster onset and greater potency at lowerand significantly more accuratedoses. This approach offers not only more efficient treatment of conditions such as pain and seizures, but also the economy resulting from smaller volumes of a particular compound or drug that yield greater potency.

Detailed Definitions

Research has revealed that bioavailability of cannabinoids such as CBD and CBG may be increased from as low as six percent in traditional, non-nanoemusified preparations (revealed by this study) to as great as 90 percent with nanoemulsified products (demonstrated by another study). 

According to a 2010 study entitled “Nanoemulsion: A Pharmaceutical Review,” nanoemulsion-based products are “by far the most advanced nanoparticle systems for the systemic delivery of biologically active agents for controlled drug delivery and targeting.” The study noted that nanoemulsion droplet sizes within a particular sample, when accomplished successfully, feature “narrow size distributions” (variance).  

“Nanoemulsions are the thermodynamically stable isotropic system in which two immiscible liquids (water and oil) are mixed to form a single phase by means of an appropriate surfactant [or emulsifying agent] or its mix with a droplet diameter in the range of 0.5-100 nm,” reported the study’s authors. The research concluded that “nanoemulsion shows great promise for the future of cosmetics, diagnostics, drug therapies, and biotechnologies.”

According to a 2014 study published in the journal 3 Biotech, a nanoemulsion is a “fine oil/water or water/oil dispersion” featuring a droplet size range of 20–600 nm. The study explained that three primary types of nanoemulsions exist: “(a) oil in water nanoemulsion in which oil is dispersed in water, (b) water in oil nanoemulsions in which water droplets are dispersed in oil, and (c) bi-continuous nanoemulsions.”

Nanoemulsion Research Studies

Although a relatively new technology, serious peer-reviewed research reports have begun to emerge regarding nanoemulsions. These study results consistently demonstrate significantly greater bioavailability, including shorter onset periods and enhanced peak potency. Nanoemulsion tech has shown this effect for a variety of cannabis-derived compounds, including CBD.

A 2016 study entitled “Nanoemulsions: Formation, Properties, and Applications” that was published in the journal Soft Matter noted a number of advantages to the use of nanoemulsion technology for delivery of drugs, including a small size that “leads to useful properties such as high surface area per unit volume, robust stability, [and] optically transparent appearance.” 

The research also noted the different forms of drug delivery in which nanoemulsion technology can improve bioavailability, which include “topical, ocular, intravenous, internasal, and oral delivery.” 

The study reported that most nanoemulsions are transparent in appearance because the droplet size employed “is significantly smaller than the wavelength of visible light.” However, the researchers noted that product and drug formulators “can easily tune the appearance of nanoemulsions to range from transparent to milky white” through the adjustment of droplet size. 

A 2017 study entitled “Biocompatible Nanoemulsions Based on Hemp Oil and Less Surfactants for Oral Delivery of Baicalein with Enhanced Bioavailability” that was published in the International Journal of Nanomedicine aimed to “probe the potential of nanoemulsions consisting of hemp oil in ameliorating [improving] the oral bioavailability of [the flavonoid] baicalein.” 

The study involved a particle size of 90 nm and an impressive bioavailability (what the study called an “entrapment efficiency”) of 99.31 percent. It reported that the flavonoid’s oral bioavailability was increased by “up to 524.7 percent and 242.1 percent relative to the suspensions and conventional emulsions, respectively.” 

The research determined that the safety profile of the flavonoid-based nanoemulsion revealed safe oral consumption. “Our findings suggest that such a novel…preparative process provides a promising alternative to current formulation technologies” and that nanoencapsulation is suitable for “oral delivery of drugs that feature…bioavailability issues.”

A 2017 study entitled “Nanoemulsion: A Novel Eon in Cancer Chemotherapy” that was published in the journal Mini Reviews in Medicinal Chemistry investigated the role of nanoemulsions in the effective treatment of cancer. 

The study’s authors observed that nanoemulsions offer a new approach to improving the sometimes poor bioavailability issues that have plagued traditional preparations and formulations for generations. Reported the study, “the research fraternity has acknowledged nanoemulsions as…capable of effectively addressing the low bioavailability…issues associated with conventional anticancerous chemotherapeutic dosage forms.”

A 2019 study entitled “Development of a Novel Nano­emulsion Formulation to Improve Intestinal Absorption of Cannabidiol” that was published in the journal Medical Cannabis and Cannabinoids observed the relatively poor bioavailability of CBD when ingested orally. “Cannabidiol (CBD) is highly lipophilic [fat loving] and its oral bioavailability is known to be very low in humans.” 

The study developed a novel nanoemulsion preparation of CBD involving a droplet size of approximately 35 nm “to improve the poor solubility and absorption of CBD.” The research reported that significant improvements in bioavailability were afforded by the nanoemulsification process. The period to achieve peak bioavailability (delay from time of consumption) was shortened by 330 percent and its potency was increased by 65 percent compared to a traditional non-nanoemulsified CBD oil. 

The study’s authors observed that their research was “the first to develop a CBD-based nanoemulsion formulation for testing,” which they observed to “extensively enhance the absorption of CBD and improve its bioavailability.”

A 2019 study entitled “Quercetin Loaded Nanoemulsion-based Gel for Rheumatoid Arthritis” that was published in the journal Biomedicine & Pharmacotherapy explored the advantages of a nanoemulsified topical application for the treatment of arthritis. 

The study found the nanoemulsified gel to feature improved bioavailability and “confirmed adequate rheological behavior with a good texture profile and improved drug permeation.” The report’s authors concluded that the nanoemulsified gel featuring the flavonoid quercetin “is an efficient topical treatment strategy for rheumatoid arthritis.” 

A 2019 study entitled “Emulsiogenesis and the Emergence of Nanoemulsions” that was published in the journal Matter investigated “the origin of the first natural emulsions and the evolution in production, classification, and nomenclature of extremely fine colloidal emulsions.”

The study reported that the first emulsions in nature appeared without the help of homo sapiens (and long before their appearance on the planet), about three to four billion years ago. It detailed how the emergence of waterborne microbes “produced organic hydrocarbon molecules, which were large enough in molar mass that collections of [them] formed liquid oil droplets surrounded by water.”

The researchers explained how the history of human-crafted emulsions dates back more than one hundred years. “Small-scale emulsions have been the subject of serious scientific investigations for more than a century, leading to very important milestones in condensed matter.”

The study emphasized how nanoemulsion tech remains in its infancy and that future developments will lead to novel and commercially enticing methods of encapsulating particular types of molecules for storage, distribution, and consumptionall while maintaining maximum bioavailability. 

“Regardless of the trends in nomenclature used for classifying emulsions, it is clear that emulsions having the smallest attainable droplet sizes, increasingly complex chemical compositions, and even multiple internal compartments represent a fertile area for basic research and important applications over many decades to come,” concluded the study’s authors. 

It’s a Wrap

Nanoemulsion technology offers patients and lifestyle consumersand the companies that serve thema way to encapsulate wellness molecules such as CBD, CBG, and THC that features improved stability and greater bioavailability than more traditional formulation techniques, including standard oils and liposomes. 

Heavily regulated industries such as hemp and cannabis benefit significantly from products that are formulated in a manner that leads to maximum shelf life and that can ensure sometimes lengthy storage periods. Greater bioavailability, in turn, offers both lifestyle consumers and multiple patient populations the advantage of rapid onset and enhanced potency. Medical professionals and caretakers are demonstrating an affinity for nanoemulsions based on not only enhanced bioavailability, but also more accurate dosing.   

Copyright © 2021 Higher Learning LV™. All Rights Reserved. 

Curt’s Cannabis Corner: What is Nanoemulsion Technology? Part 1

Welcome to the second 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 will teach readers about the hot new manufacturing process for cannabis- and hemp-infused products called nanoemulsion

What is nanoemulsion? How can it help patients and consumers while offering additional marketing opportunities for entrepreneurs? How does it compare to traditional formulation technologies? Read on to learn!

The following is an excerpt from the Higher Learning LV instructor-led course Cannabis Core Concepts


CURT’S

CANNABIS

CORNER 

What is Nanoemulsion Technology?

Part 1

By Curt Robbins

Those who work in the cannabis industry know that there’s plenty of hype regarding a relatively new molecular infusion technology called nanoemulsion (sometimes labeled miniemulsion, ultrafine emulsion, or submicron emulsion). 

Operating at the extreme microscopic size level that scientists call nanoscale, nanoemulsion offers a slew of advantages over traditional formulation technologies such as non-emulsified oils, macroemulsions, and microemulsions involving liposomes. Unfortunately, nanoemulsion tech has also resulted in significant marketing hyperbole and marketplace confusion.    

For engineering nerds, an interesting fact of nanoemulsion tech is that various underlying methods can be employed to create a nanoparticle emulsion liquid. All of these approaches, including ultrasonic generators, rotor devices, and high pressure homogenizers, are intended to result in a lifestyle beverage or liquid medicine that efficiently delivers wellness molecules, including cannabinoids and terpeneswithout degradation or other loss of potency during their path from processing and packaging to consumption and onset of effects. 

Another major reason companies are excited about nanoemulsions: Speed of onset. This molecular encapsulation approach results in significantly faster onset of bioavailability. In some cases, nanoencapsulation reduces the onset wait period from two or more hours (a traditional infused product) to about fifteen minutes (a roughly 800 percent improvement). 

It should be noted that nanoemulsion technology does not magically make hydrophobic fat-soluble molecules like cannabinoids and terpenes water soluble (as the marketing materials of some companies would lead one to believe). Rather, it is a method by which these fat-loving, water-fearing chemical compounds can be efficiently stored and transported on the way to their biophysical destinations (in the case of cannabis and hemp, microscopic CB1 and CB2 cellular receptors within the brain, central nervous system, and tissues of the immune system).  

Overview

Nanoemulsion technology is quickly gaining popularity with wellness professionals, consumers, and emerging hemp and cannabis brands. This approach to the consumption of some types of molecules that display poor water solubilityincluding the cannabinoids, terpenes, and flavonoids produced by cannabisis complex in detail, yet easily grasped in general theory. 

Many cannabis and hemp companies, especially those offering products intended to enhance health and wellness, are flocking to nanoemulsion tech for two primary reasons: Improved stability and faster onset of bioavailability (with the bonuses of significantly greater potency and more accurate dosing). The potential downside of nanoemulsions? Production cost (especially at smaller volumes).

Improved stability is important for heavily regulated industries like hemp and cannabis that involve supply chains featuring detailed distribution cycles and sometimes lengthy storage periods. Faster onset is critical for patient populations where conditions such as pain, nausea, social anxiety, or seizures demand the fastest possible onset of efficacy.

Nanoemulsion involves use of an agitative force (such as ultrasonic sound waves) to break up a solution containing two liquified substances (often an oil and an aqueous [water] element) that, under normal circumstances and in traditional preparations, would not form a homogeneous mixture. 

The compound of medicinal or therapeutic focus, such as a cannabinoid like cannabidiol (CBD) or delta-8 tetrahydrocannabinol (THC), is infused into an oil. Despite their differences, cannabinoids, flavonoids, and terpenes share one trait: They are fat soluble but not water soluble. Because of this important biochemical characteristic, these molecules must be infused into a lipid (fat) or oil for practical consumption by humans.

This marriage of oil and water, with the oil acting as a carrier for medicinal wellness compounds such as cannabinoids like CBD and THC, is accomplished with the assistance of a third element called an emulsifying agent (a common example of which is lecithin). This relatively technical concoction produces what scientists and product formulators dub a “single phase” mixture that is comprised of extremely small particles that fall within the nanoscale range (described below).

Understanding Nanoscale

Nanoscale (and the entire model for scientific measurement) is based upon the metric system, not the English scheme of inches and feet. A nanometer is one billionth of a meter (a meter being 3.3 feet). The root term nano is derived from ancient Greek, where it means “dwarf.” 

A micron, or micrometer, is the unit of measure directly above nano and is 1,000 nanometers (nm). To better gain a sense of the size of nanoscale, consider that a human hair is about 75 microns (75 μm), or 75,000 nanometers, in diameter. A sheet of standard notebook paper is just slightly thicker, at about 100,000 nanometers. 

According to the U.S. federal government’s National Nanotechnology Initiative:

  • A strand of human DNA  is 2.5 nanometers in diameter
  • An inch contains 25,400,000 nanometers
  • A gold atom is about one third of a nanometer in diameter

Infused beverages or tinctures containing broad-spectrum (involving molecular filtering) and full-spectrum (lacking filtering) nanoemulsions of hemp or individual cannabinoids (such as CBD or cannabigerol [CBG]) are defined as chemically and physically stable liquid-in-liquid dispersions featuring relatively minuscule droplet sizes of approximately 100 nm. 

Some strict sources define particle (droplet) sizes that exceed 100 nm to be outside of the nanoscale. However, technically speaking, 50-999 nm serves as an acceptable industry standard for nanoencapsulation particle size. A February 2021 market analysis defined nanoemulsions as “oil-in-water emulsions with mean size ranging from 50 to 1000 nm” that feature an average droplet size of “between 100 and 500 nm.”

Bioavailability & Delivery Dynamics

Nanoemulsions manifest as liquid solutions packaged as tinctures, infused beverages, eye drops, topicals (creams, lotions, balms, etc.), or transdermal patches. They are designed to circumvent the relatively lengthy process of digestion that is performed by the stomach and liverwith the overall goal of improving bioavailability compared to conventional “edibles.” 

Nanoencapsulated liquids also avoid the potential harms caused by inhalation of smoke and vapor. While research has revealed cannabis vapor to be considerably safer than the combustion involved in smoking the herb, chronic consumption via either method of inhalation may lead to lung damage and conditions such as bronchitis. Nanoencapsulated edibles and sublingual tinctures, while slower in onset than inhalation (the fastest consumption avenue at only 2.5 minutes), offer an improved safety profile that, in many use cases, justifies the slower onset.    

Methods of creating nanoemulsions include sonication (the application of ultrasonic sound) and high-pressure homogenization. Nanoemulsions produce significantly greater overall bioavailability (described in detail below), including faster onset and enhanced potency. This is true not only when nanoemulsions are eaten, but also when they are consumed sublingually (as with tinctures) or via transdermal patches. This fact gives this particular emulsion technology an unusually broad application range within the cannabis industry. 

A 2015 research study entitled “Nanoemulsion: An Advanced Mode of Drug Delivery System” reported that nanoemulsions “are manufactured for improving the delivery of active pharmaceutical ingredients” and that the process involves a “thermodynamically stable isotropic system in which two immiscible liquids are mixed to form a single phase by means of an emulsifying agent.” 

The improved stability of nanoencapsulated formulations makes them of significant interest to wellness professionals because they can increase the precision of dosing. This is of importance for many conditions, including those whose treatment involves compounds that feature biphasic response curves or other peculiarities that can be exploited by a lack of dosing accuracy. 

Tune in next week for What is Nanoemulsion Technology?: Part 2 when we’ll dig into the hard research evidence behind the value of nanoemulsion tech for both companies and consumers and learn more about bioavailability. Don’t miss it! 

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.   

Cannabis Reduces Blood Pressure In Older Adults, According To Ben-Gurion University Of The Negev Researchers

ISRAEL:  A new discovery by researchers from Ben-Gurion University of the Negev (BGU) and its affiliated Soroka University Medical Center shows that medical cannabis may reduce blood pressure in older adults.

The study, published in the European Journal of Internal Medicine, is the first of its kind to focus on the effect of cannabis on blood pressure, heart rate and metabolic parameters in adults 60 and above with hypertension.

“Older adults are the fastest growing group of medical cannabis users, yet evidence on cardiovascular safety for this population is scarce,” says Dr. Ran Abuhasira of the BGU Faculty of Health Sciences, one of Israel’s leading medical faculties, and the BGU-Soroka Cannabis Clinical Research Institute. “This study is part of our ongoing effort to provide clinical research on the actual physiological effects of cannabis over time.”

Patients were evaluated using 24-hour ambulatory blood pressure monitoring, ECG, blood tests, and body measurements ─both before and three months after initiating cannabis therapy.

In the study, researchers found a significant reduction in 24-hour systolic and diastolic blood pressure values, with the lowest point occurring three hours after ingesting cannabis either orally via oil extracts or by smoking. Patients showed reductions in blood pressure in both daytime and nighttime, with more significant changes at night.

The BGU researchers theorize that the relief from pain, the indication for prescription cannabis in most patients, may also have contributed to a reduction in blood pressure.

“Cannabis research is in its early stages and BGU is at the forefront of evaluating clinical use based on scientific studies,” says Doug Seserman, chief executive officer of American Associates, Ben-Gurion University of the Negev. “This new study is one of several that has been published recently by BGU on the medicinal benefits of cannabis.”

Additional researchers who participated in the study include: Prof. Victor Novack, director of the BGU-Soroka Cannabis Clinical Research Institute and BGU-Soroka Clinical Research Center and Research Authority; Prof. Yosef Haviv, director of the Department of Nephrology at Soroka; Prof. Merav Leiba, Prof. Adi Leiba and Dr. Larisa Ryvo of the Assuta Ashdod Academic Medical Center.

FTC Announces Crackdown On Deceptively Marketed CBD Products

Companies made unsupported claims that their oils, balms, gummies, coffee, and other goods could treat serious diseases such as cancer and diabetes

DISTRICT OF COLUMBIA: The Federal Trade Commission today announced the first law enforcement crackdown on deceptive claims in the growing market for cannabidiol (CBD) products. The FTC is taking action against six sellers of CBD-containing products for allegedly making a wide range of scientifically unsupported claims about their ability to treat serious health conditions, including cancer, heart disease, hypertension, Alzheimer’s disease, and others.

The FTC is requiring each of the companies, and individuals behind them, to stop making such unsupported health claims immediately, and several will pay monetary judgments to the agency. The orders settling the FTC’s complaints also bar the respondents from similar deceptive advertising in the future, and require that they have scientific evidence to support any health claims they make for CBD and other products.

“The six settlements announced today send a clear message to the burgeoning CBD industry: Don’t make spurious health claims that are unsupported by medical science,” said Andrew Smith, Director of the FTC’s Bureau of Consumer Protection. “Otherwise, don’t be surprised if you hear from the FTC.”

The crackdown, Operation CBDeceit, is part of the Commission’s ongoing effort to protect consumers from false, deceptive, and misleading health claims made in advertisements on websites and through social media companies such as Twitter.

Each case the FTC is announcing today is described below:

Bionatrol Health, LLC

According to the FTC’s complaint against Utah-based companies Bionatrol Health, LLC and Isle Revive, LLC, and two former managers and owners, since at least December 2019 the respondents sold a CBD oil to consumers on two websites. Among other things, the respondents allegedly claimed without substantiation that their CBD product is safe for all users, treats pain better than prescription medications like OxyContin, and prevents and treats age-related cognitive decline and chronic pain. The respondents also claimed, without scientific evidence, that CBD oil is “medically proven” to improve a variety of conditions, according to the FTC’s complaint. In addition, the FTC alleges the respondents deceived consumers who ordered one bottle of their CBD oil by changing the order to five bottles without consumers’ consent.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs without human clinical testing to substantiate the claims. It also requires competent and reliable scientific evidence for other health-related product claims, and prohibits the respondents from misrepresenting the cost of any good or service and from charging consumers without their express, informed consent. Finally, it requires the corporate respondents and individual respondent Marcello Torre to pay $20,000 to the FTC and to notify consumers of the Commission’s order.

Epichouse LLC (First Class Herbalist CBD)

According to the FTC’s complaint against Utah corporation Epichouse, LLC, which operated under several names, including First Class Herbalist, and the company’s founder and owner, John Le, since at least September 2019 the respondents sold several CBD products on their website, including oils, a pain-relief cream, coffee, and gummies.

Among other alleged unsupported claims, Epichouse and Le promoted CBD as safe for all users, able to treat pain better than prescription medications such as OxyContin, and able to prevent a wide range of serious conditions, including cancer, diabetes, and heart disease. In their advertising, they also falsely claimed that CBD is scientifically proven to improve many serious health conditions—including chronic pain and hypertension—and provide neurological benefit—such as preventing age-related cognitive decline—according to the FTC’s complaint.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. It requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, the order requires the respondents to pay $30,000 to the FTC and notify consumers of the Commission’s order.

CBD Meds, Inc.

According to the FTC’s complaint against CBD Meds, Inc.; G2 Hemp, Inc.; and Lawrence Moses, a/k/a Lawrence D. Moses, Jr., individually and as an officer of the corporate entities, the two companies advertised CBD oil on their website and on YouTube. In their ads, the FTC contends, the Winchester, California-based firms made a number of false or unsubstantiated claims, including that CBD effectively treats, prevents, or mitigates serious diseases and conditions like artery blockage, cancer, glaucoma, autism, and schizophrenia, among many others. The respondents also falsely represented that some of the efficacy claims were scientifically proven or that the U.S. government has confirmed the health benefits of CBD.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. More broadly, it requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, the order requires the respondents to notify consumers of the Commission’s order.

HempmeCBD

According to the FTC’s complaint against EasyButter, LLC, also d/b/a HempmeCBD, and its owner and officer Michael Solomon, since at least January 2018, the respondents have sold CBD products on their website, including CBD-infused shea butter, gummies, lozenges, honey sticks, vape pens, and oils. The complaint alleges that HempmeCBD claimed its CBD products could treat or cure serious ailments like cancer-related symptoms, substance abuse, and AIDS. The complaint alleges HempmeCBD lacked the scientific substantiation for such health claims and falsely claimed to have studies showing CBD is effective at treating autism.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. It also requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, it requires the respondents to pay the FTC $36,254 and to notify consumers of the Commission’s order.

Reef Industries, Inc.

According to the FTC’s complaint against California-based Reef Industries, Inc.; Cannatera, Inc.; AndHemp, Ltd., and the companies’ three principals, the respondents have sold a variety of CBD products directly to consumers on their website and Twitter accounts since at least January 2019 and misrepresented the health benefits of CBD. The FTC alleges that the respondents made unsubstantiated claims that CBD can prevent, cure, mitigate, or treat diseases and serious health conditions, including Alzheimer’s disease, arthritis, autoimmune disease, and irritable bowel syndrome. The complaint also alleges the respondents falsely claimed that studies or scientific research prove that CBD is effective at treating, curing, or mitigating these diseases and conditions.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. More broadly, it requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, it requires them to pay the FTC $85,000 and notify consumers of the Commission’s order.

Steves Distributing, LLC

According to the FTC’s complaint against Steves Distributing, LLC, d/b/a Steve’s Goods; and the company’s CEO Steven Taylor Schultheis, since beginning operations in 2018, the respondents have sold a variety of products containing both CBD and cannabigerol (CBG), which, like CBD, is a non-psychoactive compound derived from hemp. The company advertises its CBD and CBG products, including tinctures, gummies, capsules, topical balms, suppositories, bath balms, and coffee, on its website and through social media companies like Twitter.

The FTC alleges that the respondents claimed, without adequate substantiation, that their CBD and CBG products are effective alternatives to prescription medications and treat a wide range of diseases and serious health conditions, including Alzheimer’s disease, cancer, and diabetes. The complaint also alleges the respondents falsely claimed that their CBD and CBG products have antibacterial properties, prevent or reduce the risk of heart attacks, strokes, and other diseases, and that certain of these claims were supported by scientific evidence.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. More broadly, it requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, it requires the respondents to pay the FTC $75,000 and notify consumers of the Commission’s order.

The Commission votes approving each of the six administrative complaints and proposed consent orders were 5-0, with Commissioner Rohit Chopra and Commissioner Christine S. Wilson issuing separate, concurring statements. A complete list of respondents can be found in the complaint for each respective case.

The FTC will publish a description of the consent agreement package in the Federal Register soon. The agreement will be subject to public comment for 30 days after publication in the Federal Register after which the Commission will decide whether to make the proposed consent order final. Instructions for filing comments will appear in the published notice. Once processed, comments will be posted on Regulations.gov.

NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $43,280.