Kill Cliff Ignite will be the only energy drink sold in bars, restaurants and concessions throughout Truist Park in Smyrna. This lock on the ultra-competitive energy drink category will serve nearly 2.5 million annual visitors to Truist Park.

“We are absolutely thrilled with the Braves partnership and the opportunity that it presents for the company. Founded in 2011 by local entrepreneur Todd Ehrlich, our roots are here in Atlanta. I grew up here and have fond memories of watching games with my dad. This really is a dream come true for us personally and as a brand,” said Kill Cliff CEO John Timar. “I’d like to thank Josh Kirssin, national sales manager for Kill Cliff, for making this deal happen. Without him, we wouldn’t have this opportunity.”

John Brenkus, Kill Cliff CMO, said that “there are very few organizations in any sport with the national appeal of the Braves. This partnership provides us with a unique platform to build our brand in the region and further our mission supporting military veterans and their families, especially through the Navy SEAL Foundation. We are looking forward to activating with our retail and distributor partners across Braves Country.”

The deal with the Braves also includes perks like an in-ballpark promotion for every game called Kill Cliff: Ignite The Crowd, which will be played during key moments of the game, in addition to permanent signage throughout the stadium. The two partners will also be collaborating on a co-branded Ignite beverage to launch in the coming months.

Jim Allen, Braves SVP of corporate and premium partnerships, said that The Atlanta Braves “are proud to partner with Kill Cliff to provide our fans with the single best clean energy drink on the market while supporting a homegrown, trailblazing brand.”

Kill Cliff will be available throughout Truist Park starting on opening day, April 7.

To learn more, visit killcliff.com.

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The seltzer is a non-alcoholic, zero-calorie and zero-sugar sparkling water. Ranch Water contains 25mg of hemp-derived CBD and is designed as a ready-to-drink beverage or cocktail mixer. 

The CBD used in Mixer Elixir’s Ranch Water is a naturally occurring compound found in the hemp plant.

Cannabis beverage sales in the U.S. are expected to hit $421 million in 2021, more than double 2019 figures, and will double again to nearly $1 billion by 2025, according to Brightfield Group, a consumer insights and market intelligence company for cannabis industries.

“There is a fast-emerging trend of ‘sober-curious’ and ‘cannabis-curious’ consumers. It is the perfect time to introduce our very accessible seltzer, infused with our nanoemulsion innovation to make it easier for the body to absorb the CBD and feel the effects faster,” said Ben Meggs, Bayou City Hemp co-founder and CEO.

Mixer Elixir’s fast-acting CBD seltzer is complemented with a citrus-lime and agave taste. The beverage is the first seltzer to launch in a series of cocktail-inspired drinks to be enjoyed as a standalone beverage for any time of the day or as an additive with its complementary spirit.

“Our first partnership with Chris Shepherd helped us better understand the demand for non-alcoholic alternatives from restaurants and how to tailor the flavor notes of our additives to complement cocktails,” Meggs said.

For more information and available locations, visit themixerelixir.com.

For more news on CBD/Hemp from The Shelby Report, click here.

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The study examined 13 U.S. brands to determine whether botanical products containing CBD deliver therapeutic benefits across five health outcomes, including well-being, quality of life, longer-term pain, feelings of anxiety and sleep quality. A full report of the anonymized, aggregate findings will be released in early 2022.

Initial findings indicate a significant number of participants experienced clinically meaningful improvements, meaning they realized distinct and palpable improvements in quality of life through improvements in the respective health outcomes studied. Across all health outcomes, the largest improvements were observed within the first week.

Key findings include:

• Participants experienced a 71 percent improvement in their well-being, on average;
• 63 percent experienced a clinically meaningful improvement in anxiety;
• 61 percent experienced a clinically meaningful improvement in sleep quality;
• 47 percent experienced a clinically meaningful improvement in pain; and
• 61 percent reported an effect within one to four hours of taking their product.

“With Radicle ACES, we are finally rigorously studying the real-world effectiveness of natural health products people encounter every day,” said Pelin Thorogood, co-founder and executive chair of Radicle Science. “Our audacious mission is to create the new standard of trust and transparency consumers deserve and healthcare providers demand on these widely accessible potential therapies. The large scale and intentional heterogeneity of our studies can transform these consumer health products into democratized precision solutions.”

Radicle ACES, which launched in August and was completed in record time prior to Thanksgiving, employed validated, standardized health indices to gather real-world health outcomes from a diverse population across a variety of ethnicities, age groups, geographies, behavioral habits and pre-existing health conditions.

The four-week study leveraged a virtual, direct-to-consumer approach to achieve the desired participant population heterogeneity and study execution speed.

“Despite the massive and growing market size, there is still scant data on the effectiveness of over-the-counter cannabinoid products due to the cost, speed and scale limitations of the current approach to scientific research,” said Jeff Chen, MD/MBA, co-founder and CEO of Radicle Science. “Radicle Science re-imagined clinical trials resulting in 10 [times] cheaper, faster and larger studies that can finally prove or predict which nonprescription health products to use for a desired effect, benefiting consumers, healthcare providers and brands.”

The Radicle Science platform recruited, screened and consented nearly 3,000 diverse participants from across the U.S. in less than four days. The Radicle approach eliminates all physical infrastructure and instead collects data directly from participants as they go about their day-to-day life, in their real world environment.

Radicle ACES is IRB approved and registered on ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT05003882). It uses validated indices to accurately track health outcomes, randomization and a control group who took no product to reduce confounding and to help determine causality, and appropriate statistical power to ensure the results were unlikely due to random chance.

“The cannabis-based medicine industry has notably advanced the science supporting the efficacy and safety of CBD thanks to the Radicle ACES study,” said Ethan Russo, MD, study collaborator and scientific expert for Radicle Science, and founder and CEO of CReDO Science. “Radicle Science has delivered much-needed clarity to a confusing marketplace where consumers are baffled as to which products and dosages might best serve their needs. Radicle is charting a compelling and innovative course toward offering personalized predictive data on the health effects of cannabidiol products consumed by millions of Americans every day.”

Radicle Science is a public benefit corporation committed to transparency and public service, and the anonymized aggregate results of the study will be published in a peer-reviewed journal to democratize the findings. For more information on the Radicle ACES study, initial results and methodology, see this Radicle Resources article. Additional studies focused on CBN, THCV and other minor cannabinoids will be kicking off in early 2022. Consumers interested in enrolling in future studies can sign up here to be notified.

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“Our mission is to provide high-quality, effective and affordable CBD for anyone who needs it, and this commitment has driven all our business decisions,” said CEO and Founder Sequoia Price-Lazarus. “Even though we are in the unregulated CBD industry, we continue to set a high standard for conscientious and ethical business practices that use business as a force for good.”

Certified B Corps. are for-profit companies that use the power of business to build an inclusive and sustainable economy. B Corps. are legally required to consider the impact of their decisions on customers, workers, communities and the environment. These criteria align with Lazarus Naturals’ socially conscious founding principles of CBD that’s made to work and made for all.

“Lazarus Naturals is an exciting addition to our B Corp. community, given the company’s pioneering role within the industry and its loyal customer base,” said Lindsey Wilson, manager for business development for B Lab U.S. and Canada.

To achieve B Corp. Certification, companies meet credible, comprehensive, transparent and independent standards. The rigorous assessment to obtain B Corp. certification measured impact areas such as governance, workers, community, environment and customers.

As Lazarus Naturals looks ahead, it will continue its commitment to make its CBD widely available to all, support its communities and grow responsibly. The company remains deeply committed to sustainability – even recently earning USDA Organic Certification.

Founded in 2014 with the belief that CBD should be accessible to everybody, Lazarus Naturals produces high-quality products that are effective, not expensive.

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Truss CBD USA, a joint venture majority owned by Molson Coors Beverage Co. and operated in partnership with HEXO Corp, has launched Veryvell, a new line of non-alcoholic, sparkling CBD beverages, exclusively available in Colorado.

Veryvell is a hemp-derived, adaptogenic, sparkling CBD water infused with a crisp taste, zero calories and zero sugar. Veryvell is now available to Colorado-based consumers both online and at select retailers in Colorado in three flavors: Focus (Grapefruit Tarragon), Mind & Body (Strawberry Hibiscus) and Unwind (Blueberry Lavender).

“Last year, we redefined ourselves as Molson Coors Beverage Co. and in doing so, laid out a clear vision of leveraging the competitive strengths of our storied foundation in beer to grow in new spaces beyond the beer aisle,” said Pete Marino, president of the emerging growth division for Molson Coors. “Truss’ entry into the CBD market in Colorado and the launch of Veryvell, a brand we believe will resonate well with Colorado consumers, is another example of Molson Coors’ expansion into new beverage categories.”

Veryvell marks Truss CBD USA’s first entry in the American CBD market and is another example of Molson Coors’ moves to cultivate the company’s beverage offerings. The diversification of the Molson Coors portfolio includes an exclusive agreement with The Coca Cola Co. to manufacture, market and distribute Topo Chico Hard Seltzer in the U.S. as well as an expanding roster of non-alcoholic innovations. This includes an investment in ZENWTR, created by beverage entrepreneur Lance Collins, a distribution agreement with La Colombe for its RTD line of canned coffees and a recently announced North American distribution partnership with ZOA, a new energy drink being launched by a multi-faceted team of fitness, health and beverage industry changemakers including Dwayne “The Rock” Johnson.

“Whether you’ve dabbled in CBD before or are curious to try something new, Veryvell invites a moment of self-care to your day through a refreshing and balanced mix of hemp extracts and natural flavors,” said Jane Armstrong Hockman, Truss CBD USA general manager. “Each beverage in the product line offers a unique blend of CBD and adaptogens, giving consumers the freedom to pick the combination that best meets them in the moment. We are thrilled to bring our beverage expertise and commitment to quality to this emerging wellness category.”

Crafted and exclusively available in Colorado, Veryvell comes in three distinct varieties, each infused with 20mg of hemp-derived, non-psychoactive CBD and adaptogens:

• Focus, a combination of grapefruit and tarragon with ginseng and guarana;
• Mind & Body, a blend of strawberry and hibiscus with ashwagandha and elderberry; and
• Unwind, a mix of blueberry and lavender with ashwagandha and L-Theanine.

Veryvell is now available for purchase by Colorado-based consumers at trusscbdusa.com and on shelves at select Colorado retail stores in a variety of SKUs including individual 12-oz. cans, four-packs as well as online-exclusive eight-packs and 12-pack variety packs. Suggested retail price for a 12-oz. can of Veryvell is $3.99 and $14.99 for a four-pack.

Veryvell is produced and distributed within Colorado state lines following the state’s established regulatory framework for hemp-derived CBD in food and beverages and is exclusively distributed by Coors Distributing Co. Truss CBD USA is distinct from Truss Beverages, Molson Coors and HEXO’s joint venture in Canada that focuses on non-alcoholic, cannabis-infused beverages.

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CbdMD, a cannabidiol (CBD) brand, has retained former US Food and Drug Administration (FDA) official Dr. Sibyl Swift as a regulatory consultant to oversee the company’s regulatory initiatives and prepare its products for further certifications.

From 2014 to 2020, Swift served in various capacities at the FDA, most notably as the associate director for research and strategy in the FDA’s Office of Dietary Supplement Programs, where she worked closely on the agency’s science, research, compliance, enforcement and policy initiatives. In 2020, she served as the SVP for scientific and regulatory affairs for the Natural Products Association (NPA), where she addressed regulatory policies related to NDI notifications, FDA guidance and claims substantiation.

“We are grateful to Dr. Daniel Fabricant and the NPA for allowing Dr. Swift to join our team. Dr. Swift’s experience and science-based approach demonstrates to our customers, the FDA and global regulatory authorities that cbdMD is committed to having our products meet the highest regulatory standards for quality and safety,” said Chairman and Co-CEO Marty Sumichrast.

CbdMD Inc. is one of the most trusted and most recognized cannabidiol (CBD) brands, whose current products include CBD tinctures, CBD capsules, CBD gummies, CBD topicals, CBD botanical skincare products, CBD bath bombs and CBD pet products. CbdMD is a member of the NPA, a partner of Bellator MMA and Life Time Inc., and has one of the largest rosters of professional sports athletes who are part of “Team cbdMD.”

CbdMD is headquartered in Charlotte, North Carolina.

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The Flaming Joe contains 25mg of CBD, derived from 125mg of broad-spectrum hemp, B-vitamins, electrolytes and plant extracts. As with all Kill Cliff drinks, there is no sugar or artificial ingredients.

Rogan, one of the world’s top podcaster, is a longtime advocate of CBD for mental and physical well-being. It is a regular topic and shared interest with a multitude of celebrity guests, ranging from Mike Tyson and Miley Cyrus to military veterans like Andy Stumpf. 

“It’s amazing how much good you can get out of a 24-kilogram kettlebell and a can of Kill Cliff CBD,” Rogan said.

“Working with Rogan on this drink was a really cool experience for the entire Kill Cliff team,” said John Timar, president of Kill Cliff. “Our guys, Jerry Barker and Mitch Brown, did a remarkable job nailing the flavor concept and creating an awesome can design worthy of this product.”

Since entering the CBD market last year, Kill Cliff has pioneered the industry, gaining massive distribution, accelerating brand engagement and attracting top athletes and high-profile celebrities. John Brenkus, the six-time Emmy Award-winning creator, host and producer of ESPN Sport Science, joined Kill Cliff as chief marketing officer earlier this year.  

“Today’s consumer is rightfully more aware than ever of what they put in their bodies. Kill Cliff is by far the best tasting and healthiest energy drink available,” Brenkus said. “I’m honored to be part of the clean energy drink company that is literally disrupting the industry.”

The new Flaming Joe is available to order now at killcliffcbd.com. Other Kill Cliff CBD flavors include Flaming Joe, Strawberry Daze, Mango Tango, The G.O.A.T and Orange Kush.

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2020 has been a year where America’s nightly news reports consist of the number of COVID-19 cases and resulting deaths from the virus. Although the number of fatalities is large, growing and causes fear about disease contact, there is another widespread condition that is associated with more than 800,000 deaths annually: metabolic syndrome.¹

While there are several medications and dietary supplements to address various aspects of metabolic syndrome, there is currently no single cure. Recent research into industrial hemp extracts and various cannabinoids suggest that this natural CBD hemp oil may be able to help patients and physicians deal with many symptoms of this prevalent condition, according to Golden, Colorado-based Panacea Life Sciences.

What is metabolic syndrome?

Metabolic syndrome is a cluster of symptoms that include increased blood pressure, high blood sugar, excess body fat around the waist and abnormal cholesterol or triglyceride levels.² These conditions are correlated with additional comorbidities (as shown in figure one) increasing the risk of heart disease, stroke and type 2 diabetes. The prevalence of this condition is rather high, with an estimated 37 percent of Americans having metabolic syndrome – a number that increases each year. One of the causes for this high degree of incidence is the western diet (high in sugars and fats) coupled with an increasingly sedentary lifestyle.

First line therapy to treat metabolic syndrome and reduce comorbidities is to diet and exercise. Losing 10 pounds is a great start to reducing symptoms of this syndrome, however, additional medications may be needed to control blood pressure, cholesterol or blood sugar. Anyone who has tried diets, fad diets or lifestyle changes may find losing weight or keeping the weight off is not an easy task. Multiple pathways help determine how much we eat and even steer us toward specific food types such as those with high sugar content when a sweet tooth kicks in. The body even has a complex regulatory system that keeps body weight at a steady-state or set point through communication between the brain, liver, adipose tissue and digestive system.

Over the past quarter century, pharmaceutical companies have worked to discover potential treatments for metabolic syndrome to decrease appetite and food intake as well as other specific treatments for each of the comorbidities listed in Figure 1. The key to minimizing health issues due to metabolic syndrome is to address the four main symptoms: reduce body weight, reduce blood pressure and control blood levels of sugar and fats (triglycerides and cholesterol)₂.

How do cannabinoids come into the picture?

Just as the body has its own weight regulation system, it also has another recently discovered complex physiological system called the endocannabinoid system (ECS), which mediates balance, or homeostasis, for a wide range of processes including mood, inflammation and metabolism.^3,4,5,6 The ECS is a collection of more than 70 receptors and enzymes throughout the body that help boost underactive pathways or dampen others. Taking cannabis or hemp oil extracts (e.g. hemp oil rich in cannabidiol) can stimulate the ECS to provide health benefits in multiple areas, including some aspects of metabolism.

Although scientific and medical understanding of the ECS is in its infancy, it is clear that the ECS and cannabidiol therapy may provide benefit directly to metabolic syndrome and comorbidities.

The cannabis paradox and weight loss

Studies have shown that natural cannabis extracts have beneficial effects that can potentially help diabetic patients with improved glycemic control through increased insulin sensitivity, inducing weight loss in diet-induced obese rates and protective effects on hyperglycemia in vivo.^7,8 A paradox seems to exist where it is well known that using cannabis creates the munchies, increased appetite and higher calorie consumption, but cannabis users show lower incidence of obesity and diabetes.^9,10,11

These observations led researchers in the late ’90s to develop a drug called Rimonobant, a blocker of the THC response through the cannabinoid 1 receptor (CB1R).¹² While this drug was shown to be effective in Europe for causing the desired appetite suppression and weight loss¹³, Rimonobant was never approved in the U.S. and was actually removed from the market as it was associated with depression and suicidal tendencies in a portion of patients taking the drug.¹⁴

While Rimonobant demonstrated that the ECS does have an effect on metabolic syndrome, it also negatively affects mood. Instead, researchers are now focused on looking into other cannabinoids that may have positive effects on both mood and appetite.

Cannabidiol and THC-V

The industrial hemp plant, Cannabis sativa L., expresses as many as 113 different cannabinoids, the most well known being Tetrahydrocannabinol (THC) and Cannabidiol (CBD). Each of these cannabinoids have different chemical structures and are anticipated to have distinct effects in the body. Two of these cannabinoids, CBD and tetrahydrocannabidivarin (THCV), have shown promise in modulating various aspects of metabolic syndrome.

Cannabinoids are very well tolerated with side effects only observed at very high levels of dosage (>10 mg/kg) in a majority of patients.¹⁵ For the average CBD consumer this would be close to a gram of CBD, whereas dosing recommendations are less than 100 mg (note that the Food Standards Agency in the UK recommends a maximum serving size of 75 mg).¹⁶

There are not many studies on THCV, but this cannabinoid has been shown to decrease appetite through a mechanism different than through CB1, which may allow appetite suppression without the side effects observed with Rimonobant.¹⁷ Preclinical studies demonstrate that THCV decreases food intake but also decreases fat uptake into adipocytes and hepatosteatosis (fatty liver, one comorbidity in metabolic syndrome patients).¹⁸ In one small human clinical trial, THCV showed effect in several glycemic and lipid parameters indicating that this cannabinoid should be pursued as a potential therapeutic agent for glycemic control.¹⁹Currently, THCV is a minor cannabinoid that will be present in very small amounts in CBD hemp oil. As plant genetics and other technologies evolve, THCV may become more prevalent in products.

Cannabidiol has been shown through multiple preclinical models and limited clinical studies to slightly lower blood pressure and help lower levels of blood sugar, cholesterol and fatty acids, including cholesterol.^18,19 In a small human clinical study, CBD lowered blood pressure significantly by 5 mm Hg.²⁰ While this is not a dramatic effect for those diagnosed with high blood pressure where lowering pressure more than 20 mm Hg may be needed, this is a small benefit added to the other properties of CBD, like its ability to improve cardiovascular health as shown by other studies.²¹

Although cannabinoids have multiple actions in the body, they would be best described as general anti-inflammatories or antioxidants.²² Aside from the effects on major aspects of the metabolic syndrome, cannabinoids also may help provide additional health benefits such as providing protection from oxidative tissue damage, lessening pain experienced by diabetics and potentially helping diabetic retinopathy.^23-25

Starting a CBD regimen

While CBD hemp oil provides many health benefits, those on prescription medications should consult with their physician before starting a CBD or cannabinoid regimen. Although CBD is very well tolerated unless taken at a very high dose, it may interfere with the metabolism of certain prescription medications which could elevate the prescription medication in the body.^25,26

Patients could experience side effects not from the CBD, but from having a higher concentration of the prescription medication in their blood than normal. Conversely, the addition of CBD may render the prescription medication inactive as some drugs require conversion by liver enzymes to be active.

There are no set guidelines for how much CBD to take to achieve health benefits, mostly because of the lack of prolonged research. When starting with CBD, it is best to begin with a low dose (such as 10 mg) to determine how well individuals tolerate the CBD oil, then increase as needed to achieve desired benefits. As mentioned above, the UK FSA recommends the maximum daily dose of 75 mg CBD per day.

On the path toward a healthier lifestyle

For those experiencing the metabolic syndrome and the numerous conditions that stem from this condition, there is a natural product that can help increase health. While the first line of therapy is almost always diet and exercise,  a CBD hemp oil regimen may be able to help by potentially decreasing appetite, lowering blood sugar, increasing insulin sensitivity and lowering triglyceride levels. The overall antioxidant properties of the components in CBD hemp oil can potentially help those who are working to eliminate their metabolic syndrome while gaining multiple health benefits.

1. cdc.gov/pcd/issues/2017/16_0287.htm
2. mayoclinic.org/diseases-conditions/metabolic-syndrome/symptoms-causes/syc-20351916
3. C.I. Bih et al. Neurotherapeutics 2015 v12 p 699
4. A. Ligresti et al. Physiol Rev 2016 v96 p1593
5. Panacea Life Sciences, unpublished molecular pharmacology study
6. Y. Simon and D. Cota Eur. J. Endocrinol. 2017 176, p. R309.
7. S. Ramlugon et al. Phther. Res. 2018, 32, p. 1080.
8. R-A. Levendal et al. Phytomedicine 2012 19, p 575.
9. O.A. Anthony Epidemiology 2015 26, p. 597.
10. A.C. Adejumo et al. PLoS One 2017 12, e0176416
11. D. Kim et al. PLo One 2017 12, e0186702.
12. A. Porcu et al. Neuropharmacology 2018 133, p. 107.
13. R. Christensen et al. Lancet 2007 370, p. 1706.
14. A.H. Sam et al. J. Obes. 2011, e432607.
15. epidiolehcp.com/efficacy-and-safety/safety
16. food.gov.uk/business-guidance/cannabidiol-cbd
17. G. Reidel et al. Br. J. Pharmacol. 2009 156, p. 1154
18. C. Silvestri et al. J. Hepatol. 2015 62, p. 1382
19. K.A. Jadoon et al. Diabetes Care 2016 39, p.1777.
20. K.A. Jadoon et al. JCI Insight 2017 2 e93760.
21. R. Jiang et al. Life Sci. 2011 89 p165.
22. S. Atalay et al. Antioxidants 2019 9,p 21.
23. S.Atalay et al. Redox Biol. 2020 36, e101613
24. G. Gruden et al. Br. J. Pharmacol. 173, p. 1116.
25. R. Jiang et al. Life Sci. 2011 v89 p165
26. O. Zendulka et al. J. Curr. Drug Metab. 2016 v 17 p 206

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The signing of the 2018 Farm Bill – which legalized the growth and manufacturing of industrial hemp – generated an explosion of products available to the consumer. Since the passing of that bill and up to today, there are no consistent regulations for how industrial hemp products, currently focused on cannabidiol (CBD) content, are manufactured and marketed, according to Golden, Colorado-based Panacea Life Sciences.

The lack of rules and regulations has created quality issues as demonstrated in the June 2019 FDA Meeting where 70 percent of products failed to meet quality control standards, thus leading to consumer and retail confusion. One of the current misconceptions is regarding claims of products being Tetrahydrocannabinol (THC)-free. When labeled as such, CBD consumers are led to believe they would not experience psychogenic effects while attaining other health benefits from CBD, and furthermore, the claim would ensure that these products will not cause individuals to test positive for THC use. Gaining a greater understanding of how these products are made and why there has been a recent change in reported THC levels will allow retailers and consumers to make informed decisions on which products they should choose for maximum health benefits, and if needed, to minimize THC consumption.

Industrial hemp plant processing

The industrial hemp plant, a sub-breed of Cannabis sativa L., has been selectively bred to have high cannabidiol (CBD) content and low THC levels. To be classified as industrial hemp, the THC levels must be below 0.3 percent. These plants contain a rich mixture of more than 500 distinct compounds reported to provide numerous health benefits. Of these compounds, there are more than 113 identified cannabinoids, two of which are becoming more well-known to the general consumers: CBD and THC.

Cannabidiol is a non-psychogenic cannabinoid possessing many reported biological assets including anti-inflammatory and antioxidant properties. THC is a psychogenic cannabinoid that produces the euphoric high associated with cannabis use. Throughout the process of growing and manufacturing hemp products, the THC level is constantly tested to ensure the THC content is compliant with federal law.

While each state where hemp is grown will have slightly different rules and procedures for farming hemp, in Colorado, growers work closely with the Department of Agriculture (CDA) to register each plot of land where hemp will be planted. The plants are randomly tested by the CDA to ensure that the THC content is less than 0.3 percent before permission is granted to harvest the plant. Non-compliant crops are destroyed, and growers face potential fines and limitations on the ability to plant hemp in the following season.

Once the hemp is harvested, the crop is transferred to an extraction facility where, through a variety of methods, the oil is separated from the plant material. The most commonly used methods are ethanol or carbon dioxide extraction. In each approach, a solvent (ethanol or liquid CO2) is mixed with hemp plant material to solubilize the oil. The plant material is then separated from the oil by filtration, and the solvent is removed to create CBD-rich hemp oil. The oil can be further refined through distillation, at which point the CBD can be enriched to create CBD-isolate through selective precipitation and filtering. This creates a solid powder of >97% purity that looks much like powdered sugar. It can also be refined by using chromatography which removes the THC from the oil to create “THC-FREE,” or broad spectrum, distillate.

Different forms and definitions of CBD ingredients

Manufacturers will utilize three main CBD ingredients to create finished goods — each of which will appeal to different consumers:

Full Spectrum Oil: This is hemp oil that contains all of the components of the plant including minor cannabinoids, terpenes and flavonoids. These products will contain THC that should not exceed 0.3 percent. The terpenes and flavonoids give hemp oil its marijuana smell and taste and offer additional health benefits.

Consumers choose full spectrum oil because of the entourage effect, where the multiple components in the help oil work synergistically to reportedly provide greater health benefits than CBD alone. Consumers who do not like the earthy taste of hemp oil or are concerned about testing positive for THC use should choose a product that has the THC removed.

Broad Spectrum Oil:  This is oil that has been processed to remove as much THC as possible while keeping as many of the other cannabinoids and terpenes in the oil. This allows consumers to benefit from the entourage effect while minimizing any THC exposure.

CBD isolate: This is pure CBD (typically over 97 percent pure) that has almost all of the other components of CBD removed and is a tasteless and odorless white powder. Consumers may choose isolate products to receive the anti-inflammatory benefits of CBD in a pleasant tasting product that minimizes THC exposure. This is a very versatile ingredient that manufacturers can incorporate into foods, edibles, tinctures and tablets without substantially altering a taste profile.

THC-FREE vs. THC-non-detect

The hemp/CBD industry has only legally been in existence for two years. Initially, testing laboratories employed a methodology that was geared to ensure products and plants met the 0.3 percent THC federal guidelines. This meant that the methods would have a limit of quantification (LOQ), the concentration that could be meaningfully determined, of approximately 0.2 percent THC, which is 2000 parts per million, or two parts per thousand. Two parts per thousand is roughly equivalent to adding two drops of solution into a quart of water. Any product that contains less than this level is reported as having a THC concentration of lower than zero. Manufacturers were reporting based on the information provided by the testing laboratory, so products that returned a value of zero THC could be considered THC-Free.

As the industry has rapidly evolved, testing laboratories have employed more sensitive methods such that the LOQ levels are now 0.01 percent or 100 ppm. This is equivalent to adding a drop of solution to two bathtubs full of water. Recognizing that there are trace amounts of THC that will be present in previously reported THC-FREE products, states like Colorado are in process of defining such products as THC-ND (non-detect) where THC levels must be lower than 100 ppm, or 0.01 percent.

What does this mean for products? Take Panacea’s 25mg F.A.S.T. tablets for example. Before March 2020, this product would have a testing profile that showed below reporting 0 percent THC. The level of detection or quantification for many laboratories at this point was 0.2 percent or 2000 ppm. When individual tablets were evaluated using more sensitive THC quantification methods with an LOQ of 0.005 percent, it can be seen that the tablets do have trace amounts of THC ranging from 80 ppm to 130 ppm, or 0.03mg to 0.0mg THC per tablet. Therefore, under Colorado’s proposed definitions, this product would be labeled as a THC non-detect product.

2019 Cannabinoid Potency Test for Panacea Life Sciences FAST Tablets

Why the concern about THC concentrations?

Consumers are typically worried about the levels of THC in their products for two main reasons: they do not want the inebriation caused by THC, and/or they are concerned about testing positive for THC use.

While each individual responds to THC differently, a dose of 5mg of THC has been reported to get people “high.” The quantity of THC needed to achieve inebriation will vary based on body weight, dosage, method (smoking, oral, tincture), prior use of THC and other non-predictable sensitivities to THC. A 400mg tablet made from full spectrum hemp oil having a legally compliant 0.3 percent THC level would contain approximately 1.2mg THC per tablet. Using the 5mg threshold for inebriation would mean that those consuming 4-5 tablets could potentially get “high.” In contrast, using the example product of F.A.S.T. from above, a person would need to consume 125 F.A.S.T. tablets that contain the non-detect level of 0.04mg THC per tablet, all at one time, which is very unlikely.

For those employed in positions that require routine drug testing, such as first responders, federal employees including armed forces members, or professional athletes, the THC level in products is very important. Using a standard employer urinalysis test, a person would test positive for THC at urine levels greater than 50 ng/mL. Using a worst-case calculation to err on the side of caution, we will assume that 50 percent of the THC present in a product like F.A.S.T. is absorbed (termed bioavailability, and for most products is typically 10 percent of the product dose; this is being studied by Panacea Life Sciences in a pending human clinical trial). The average human urine output is 800mL (can be as high as 2L), and 20 percent of the THC consumed is eliminated in the urine, so the total amount of THC an individual would need to consume to test positive for THC use is 0.5mg per day. Again, using the F.A.S.T. tablet example, this would mean that a subject would need to consume more than 12 F.A.S.T. tablets to even potentially test positive in a drug test. This is six-fold higher than the daily recommended serving size of F.A.S.T.

In a one-person controlled trial where the patient consumed four F.A.S.T. tablets daily for 30 continuous days, a urinalysis tested negative for THC levels. These results are being expanded with more patients and dosages to provide greater consumer confidence regarding drug tests and THC non-detect products.

Regulations will increase consumer confidence and knowledge

As the Food and Drug Administration and individual states like Colorado institute consistent regulations regarding production and labeling, the definitions will become more uniform to give both consumers and retailers a better understanding of CBD oil products. It is equally important to standardize the THC level needed to qualify a product as either THC-Free or THC non-detect.

The overall goal is to raise consumer confidence that these products will not cause inebriation or show as positive for THC on a drug test. Doing so allows consumers to reap the benefits of CBD products without the potentially negative consequence of having trace amounts of THC in their bodies.

The post Primer On THC Levels In Industrial Hemp Products appeared first on Shelby Report.

All of us at some point or another have suffered from an upset stomach or a flu bug that disrupted our everyday lives. For a large number of Americans, currently over 3 million, digestive issues are a chronic occurrence collectively called Inflammatory Bowel Disease (IBD)¹. To make matters worse, those afflicted with various forms of IBD have limited treatments available. Fortunately, new studies are finding that cannabidiol (CBD) derived from industrial hemp may alleviate several symptoms of IBD and may help prevent relapse of this condition. The intent of this article by Golden, Colorado-based Panacea Life Sciences is to summarize the general types of IBD, review current treatments and explain why CBD may be a solution for many sufferers of gastrointestinal issues.

Inflammatory Bowel Disease

IBD is a fairly common condition with the number of patients increasing by approximately 60K per year in the United States. The disease appears to run in families and begins showing symptoms between the ages of 15 and 35, and smokers are more likely to develop specific forms of IBD. (For a full description of disease prevalence, symptoms and treatments, see reference 2.)

IBD is divided into two main types of disease types: Chron’s Disease (CD) and Ulcerative Colitis (UC). CD affects the entire gastrointestinal tract with inflammatory patches that may extend through multiple layers of in the small intestine. UC, on the other hand, presents as continuous damaged segments of the inner lining of the gastrointestinal system (GI), starting from the rectum and spreading further into the colon.The inflammation in IBD interrupts intestinal function by preventing nutrients and water to be absorbed into the body, thus creating irregular waste products. The resulting symptoms are persistent diarrhea, abdominal pain, rectal bleeding, bloody stools, weight loss and fatigue. Those with IBD may also exhibit anxiety and depression while coping with their ailment.

Although the root cause for IBD is not known, this condition arises from a defective immune system where the body attacks innocuous bacteria that naturally occurs in the gut, resulting in inflammation of the GI tract, as mentioned above. Treatments are aimed at reducing the inflammation and restoring normal GI function.

Anti-inflammatories such as amino-salicylates or corticosteroids (e.g. prednisone) are the most common medications prescribed for IBD, with immunosuppressants (e.g. cyclosporine) also having efficacy against the disease. There are also newer anti-Tumor Necrosis Factor biological treatments that appear to be effective for treatment (e.g. Infliximab). Each of these treatments are associated with significant side effects that may make the prescribed treatment intolerable for the patient, and many appear to lose effectiveness over the course of time³.

Irritable Bowel Syndrome

Although Irritable Bowel Syndrome (IBS) sounds similar to IBD, the symptoms, causes and treatments are distinct from IBD. Approximately 40 million people in the U.S. have various forms of IBS.

This syndrome also affects the function and behavior of the intestine, but symptoms are usually caused by irregular muscle contractions of the muscles lining the intestines. IBS symptoms are similar, yet separate from IBD:  cramping, abdominal pain, bloating, gas, mucous in the stool, diarrhea and/or constipation. IBS typically presents in middle adulthood, with a majority of sufferers female, and has a strong genetic link. IBS patients also may suffer from anxiety and depression.

While the cause of IBS is unknown, it is speculated that there is a disruption in the naturally occurring bacteria in the intestinal system that is referred to as the microbiome. Treating IBS is aimed at relieving symptoms or to restore the natural balance in the microbiome. Treatments for IBS include laxatives, anti-diarrheal agents, antidepressants (e.g. Librax), probiotics, antispasmodics (drugs that stop the irregular contraction of intestinal muscles, e.g. Bentyl) and Serotonin 5-HT3 receptor blockers (e.g. Lotronex).

Introduction to the cannabis plant

Marijuana, or cannabis, has been used since 4000 BCE by ancient Chinese as a source of fiber and to treat various ailments such as constipation, mental illness and pain⁴. Fast forward to today, and we now know that the Cannabis sativa L.strain of the cannabis plant, contains over 500 unique compounds that may have a medical use, with 113 of those compounds being cannabinoids.

The two most prevalent and studied cannabinoids from the industrial hemp plant are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the psychoactive component in marijuana responsible for the inebriation associated with marijuana use. CBD, on the other hand, works very differently in the body than THC and does not produce inebriation, but it does have multiple potential medicinal uses, one of those being an aid to digestive health.

Cannabinoids work in the body through an extensive network of receptors and enzymes collectively termed the Endocannabinoid System (ECS)^6,7. The role of the ECS is to restore balance to several physiological systems ranging from cognition to inflammation. When cannabinoids interact with the ECS system they will trigger responses that will either stimulate, such as increasing serotonin levels in the brain to alleviate anxiety and/or depression, or dampen responses, such as inflammation.

The first two receptors that mediate CBD effects in the body are the Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptors. CB1 is expressed primarily in the brain but is also present in peripheral tissues such as the stomach and intestines, whereas CB2 is expressed on immune cells to mediate inflammatory responses. Studies have indicated that both CB1 and CB2 receptors will reduce GI motility as well as immune function in the gut₈. Additional molecular targets will interact with cannabinoids to exert other effects, such as the TRPV1 protein that mediates visceral hypersensitivity signaling and intestinal contractility under inflammatory conditions^9,10.

Much of the understanding of how cannabinoids may help with IBD is obtained from preclinical models. These are studies performed in rodents that predict activity in humans. Preclinical evidence in these models shows a large number of benefits for potentially treating IBD as listed below¹¹.

1. Immunosuppressive effects that decrease inflammation in the gut^12,13.
2. Acceleration of wound healing that restores the intestinal epithelial barrier function¹⁴.
3. Inhibition of GI motility and secretion leading to the reduction of diarrhea^{15, 16, 17}.
4. Reduction of abdominal pain^18,19,20.

Interestingly, in these studies, CBD appears to be effective to both alleviate symptoms as well as prevent the onset of an IBD flare-up.

To date, there have been five clinical studies at various stages to evaluate the ability of CBD to treat IBD, Crohn’s, ulcerative colitis and Irritable Bowel Syndrome²¹. One trial focused on alleviating pain (visceral hypersensitivity) through a low dose of CBD administered by chewing gum. Although the trial has been completed, no information is currently available²².

Another study to evaluating CBD’s effectiveness in treating did not demonstrate improvement in disease activity. However, these negative results may be due to the small number of subjects or the low dose that was given for testing (10mg, oral).

A different study used a rich CBD whole-plant extract for evaluation in ulcerative colitis. Although the preparation used was not altogether tolerable (oral capsule with CBD-containing hemp oil) the treatment trended toward an improved quality of life scores²³. This suggests that the extract may have provided therapeutic benefit and a basis for conducting future studies with improved formulations^24,25,26,27.

Additional benefits of cannabinoids: well-tolerated with reduction of anxiety and pain

As mentioned above, currently available prescription medications for IBD or IBS address only the gut symptoms of the diseases, and each medication has numerous side effects and reduce in efficacy over time. An attractive feature of CBD is that this compound is extremely well tolerated²⁸.

In human studies, doses of up to 10 mg/kg/day have been given to subjects with minimal side effects. For the average weight person in the United States (around 170 pounds), this is roughly equal to taking 850 mg per day, which is quite a large pill! At doses higher than 10 mg/kg/day, a percentage of people have reported reversible side effects such as diarrhea, upset stomach, tiredness and elevated liver enzymes. The doses that have been studied for CBD’s effects on IBD are much lower than this, with the maximum at 300 mg per person per day²⁸.

One of the associated conditions with those suffering from IBD or IBS is anxiety and/or depression caused by managing the condition. Cannabidiol has been reported to produce a sense of calm, and numerous clinical studies have evaluated the ability of CBD to treat various forms of anxiety: General Anxiety Disorder, Social Anxiety Disorder and Panic Disorder, to name a few²⁹. There is a large body of preclinical studies, too numerous to discuss fully in this article, indicating that CBD may be a well-tolerated supplement for reducing anxiety with over 12 clinical studies at various stages determining proper dosage, dose form and efficacy of CBD to assist with anxiety³⁰.

At the least, cannabidiol has been reported as an anti-inflammatory and analgesic. Numerous studies have evaluated the ability of marijuana extracts containing THC and CBD to reduce various types of pain, from inflammatory to neuropathic³¹. As an anti-inflammatory, CBD may reduce swelling at the site of injury while also inhibiting pain responses.

Preclinical studies sponsored by Panacea Life Sciences (not published) have indicated that CBD works as an effective analgesic for acute abdominal pain and with significantly more potent effects than ibuprofen. Panacea is extending this study into dairy cattle to evaluate whether CBD may be an effective alternative for addressing pain in animals as well.

In conclusion: cannabidiol is worth exploring for IBD and IBS

Although much more clinical research is needed, to date, cannabidiol research shows much promise as a possible treatment for those with IBD. Initial research indicates that CBD, a well-tolerated supplement, not only helps alleviate symptoms with IBD and IBS, but may even prevent flare-ups of IBD from occurring. Additional uses of CBD to potentially reduce abdominal pain and anxiety make this a very attractive alternative to prescription medications.

1. https://www.cdc.gov/ibd/what-is-IBD.htm
2. https://www.crohnscolitisfoundation.org/
3. IBD drug side effects
4. Abel, E.L. (1980). Marijuana, The First Twelve Thousand Years.New York: Plenum Press.
5. Morales et al. Molecular Targets of the Phytocannainoids: A Complex Picture in Phytocannabinoids. Unravelingthe Complex Chemistry and Pharmacology of Cannabis sativa. (2017) A.D. Kinghorn et al. Eds.; Springer International Publishing, volume 103 p. 103.
6. DiMarzo Nat. Rev. Drug Discov. 2018, 17, p. 623
7. Martinez et al. Int. J. Mol. Sci. 2020, 21, p. 3067
8. Pesce et al. J Cell Mol. Med. 2018, 22, p. 706
9. A. Izzo and K.A. Sharkey Pharmacol. Ther. 2010, 126, p. 21
10. A. Sharkey and J.W. Wiley Gastroenterology 2016, 151, p. 252
11. Kienzl et al. Clinical and Translational Gastroenterology 2020, 11, e00120
12. Abalo et al. Pharmacology 2012, 90, p.1
13. Brusberg et al. J. Neurosci 2009, I29, p. 1554
14. Zoppi Am J. Physiol.-Gastrointest. Liver Physiol. 2012, 302, p. 565
15. Aviello et al. Eur. Rev. Med. Pharmacol. Sci. 2008, 12, p.81
16. A. Izzo et al. Br. J. Pharmacol. 2000, 129, p. 1627.
17. Pagano et al. Front. Pharmacol. 2016, 7, p. 1
18. A. Formukong et al. Inflammation 1988, I12I, p361
19. Sanson et al. Neurogastroenterol. Motil. 2006, 18, p. 949
20. Kikuchi et al. J. Pharmacol. Sci. 2008, 106, p. 219
21. Hasenoerhl et al. Expert Rev. Gastroent. & Hep. 2017, 11, p. 329
22. Naftali et al. Dig. Dis Sci. 2017, 62, p. 1615
23. M. Irving, Inflamm. Bowel. Dis 2018, 24, p.714
24. S. Kafil et al. Cochrane Database Syst. Rev. 2018, 11, p 12954
25. Naftali et al. Clin. Gastroenterol. Hepatol. 2013, 11, p. 1276
26. Naftali, et al. Dig. Dis. 2014, 32, p. 468
27. Naftali Expert Rev. Gastroenterol. Hepatol. 2020, 14, p. 253
28. https://www.epidiolexhcp.com/efficacy-and-safety/safety
29. Oberbarnscheidt and N.S. Miller J. Clin. Med. Res. 2020, 12, p. 393
30. Anxiety clinical trials
31. Babasola et al. Syst. Rev. 2020, 9, p. 167

The post Could CBD Be Answer To Over 3M Americans’ Gastrointestinal Issues? appeared first on Shelby Report.