Cannabidiol, or CBD, is the most common phytocannabinoid (plant cannabinoid) in hemp plants. CBD-rich cannabis plants make cannabinoids for many reasons, including protection against insects that want to eat the plant, protection from frost damage, minimizing water loss, thermoregulation, and for attracting pollinators.

CBD is a non-euphoric cannabinoid that does not cause a ‘high’. CBD is a naturally-occurring compound found in most species of Cannabis sativa, although it has mostly been bred out of high-THC cultivars of cannabis. CBD is associated with a wide range of health benefits.

According to the World Health Organization's November 2017 report:

1. CBD exhibits no effects on humans indicative of any abuse or dependence potential.

2. CBD has been demonstrated as an effective treatment of epilepsy in several clinical trials, with one pure CBD product (Epidiolex®) currently in Phase III trials.

3. To date, there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD.

4. CBD was deemed non-addictive and it has "been demonstrated as an effective treatment for epilepsy.” This recommendation extends to adults, children, and even animals.

Source: World Health Organization, WHO Expert Committee on Drug Dependence, Thirty-ninth Meeting Geneva, 6-10 November 2017.

While the Food & Drug Administration (FDA) prohibits any claim being made about the use of CBD to treat medical conditions, CBD has been used for conditions such as seizures, autoimmune conditions, pain, anxiety/depression, addiction/withdrawals, inflammation, neuroprotective, memory enhancement and post-traumatic stress disorder.

Cannabidiol (CBD) has many health benefits, without producing the psychoactive, "euphoric" effects of THC. CBD modulates the endocannabinoid receptor network in the body and has been shown to have many beneficial actions. These include: neuroprotective, antiepileptic, anxiolytic (nervous system calming), anti-addiction, antipsychotic, analgesic, anti-inflammatory, anti-asthmatic, and anti-tumor properties.

Sources:

Fasinu PS, Phillips S, ElSohly MA, Walker LA. Current Status and Prospects for Cannabidiol Preparations as New Therapeutic Agents. Pharmacotherapy 2016;36(7):781-96.

Campos AC, Fogaça MV, Scarante FF, Joca SRL, Sales AJ, Gomes FV, Sonego AB, Rodrigues NS, Galve-Roperh I, Guimarães FS. Plastic and Neuroprotective Mechanisms Involved in the Therapeutic Effects of Cannabidiol in Psychiatric Disorders. Front Pharmacol. 2017 May 23;8:269.

The "endocannabinoid" system is an integral part of our neuro-immuno-endocrine network. This is the system of organ and tissue signaling in the human body that sends and receives chemical messages and is responsible for many aspects of human health.

Currently, there are two known primary cannabinoid receptors: CB1 and CB2 receptors. CB1 receptors are located in the central nervous system, and in some peripheral tissues. They affect appetite, muscle control, pain, cognition, thermoregulation, and our stress response. CB2 receptors are primarily found in immune cells, and at a lower density in the central nervous system. CB2 activation is associated with immune function and immune cell proliferation, inflammation, and pain. Although these two cannabinoid receptors have been studied relatively extensively, there are more cannabinoid receptors being examined.

Our bodies produce their own cannabinoids – endocannabinoids – primarily anandamide, and 2-AG (2-arachidonoylglycerol). These messenger molecules regulate bodily functions by affecting the CB1 and CB2 receptors. Interestingly, CBD does not directly stimulate the CB receptors, but is thought to affect how the other cannabinoids interact with the endogenous cannabinoid network. “There is strong evidence that THC acts via the cannabinoid receptor CB1. The mechanism of action of CBD is less clear but is likely polypharmacological.”

Source:

Szaflarski JP, Bebin EM, Cannabis, cannabidiol, and epilepsy--from receptors to clinical response. Epilepsy Behav. 2014;41:277-82

Although both hemp and “marijuana” are technically variants of the Cannabis sativa plant, there are significant differences between them. Hemp is considered “industrial” under current regulations, and is defined as having less than 0.3% THC by the Oregon Department of Agriculture (ODA).

In the US, the legal definition of “industrial hemp,” (as defined in Section 7606 of the Agricultural Appropriations Act of 2014), is "the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” In Oregon, the cultivation of hemp is regulated by the ODA, whereas the cultivation of marijuana is regulated by the Oregon Liquor Control Commission (OLCC).

In general, marijuana is a term that we do not use at Green Earth Medicinals. We consider Cannabis sativa, whether rich in CBD or THC, to be a medicinal plant. Marijuana generally refers to Cannabis sativa plants that have a high concentration of THC, and the word stems from the recreational use of THC rich cannabis for the purpose of getting “high.” Hemp plants possess a high concentration of CBD, with only traces of THC, and hemp extracts are associated with medicinal use.

We have adopted the term "CBD-rich cannabis" to describe our high-CBD, low-THC cultivars. In recent years, terpene profiles have been used to distinguish cultivars of Cannabis sativa. We test our cultivars for both cannabinoid and terpene profiles to help us maintain phenotypic integrity, and to develop cultivars more targeted to specific physiological actions.

Green Earth Medicinals products are produced by Indomira, Inc., a vertically-integrated company. We grow our own CBD-rich medical hemp in the Rogue Valley in Southern Oregon, under the auspices of the Oregon Department of Agriculture (ODA). (Since we are regulated by the ODA, this is technically referred to as “industrial hemp”). We use organic farming practices to protect the environment and to ensure that no harmful chemicals are present in our products.

Our laboratory, equipment, and instrumentation are owned and operated by our parent company, Indomira, Inc., where we apply the highest-quality processing standards to our production. At Green Earth Medicinals, we extract not only CBD, but a full range of cannabinoids and terpenes from our plants using either supercritical CO2 or ethanol extraction, depending on the product. There are no harmful solvents involved.

In the history of pharmacology there was a time when all remedies were made from plants, which contain complex mixtures of phytonutrients. As technology progressed, tools that could isolate molecules became available. During this transition it was assumed that isolated molecules would make better medicine.1

In the case of cannabinoids, the expanding understanding of phytopharmaceutical science suggests that the complex dynamics of multiple cannabinoids, terpenes and flavonoids in each cultivar creates evolutionarily-driven combinations.2,3 These have novel and sometimes clinical effects in human physiology through the endocannabinoid system, which in turn promotes the health of many systems and functions such as the brain, immune, metabolic, gut and cardiovascular system.  The experience and practice of plant science suggests that the rich recipe of compounds in medicinal plants exerts healing effects through complementary action.4-5

This supports the idea of the "entourage effect",6 where mixtures of cannabinoids, their co-occurring terpenes, and perhaps other molecules such as flavonoids and stilbenoids, have a greater positive effect than just CBD or THC alone.3-8

Sources:

1. Spelman K. “Silver Bullet” Drugs vs. Traditional Herbal Remedies: Perspectives on Malaria. HG J Am Bot Coun 84:44-55.  

2. Russo EB. Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. Br J Pharmacol. 2011 Aug;163(7):1344-64.  

3. Russo EB, Marcu J. Cannabis Pharmacology: The Usual Suspects and a Few Promising Leads. Adv Pharmacol. 2017;80:67-134.

4. Spelman K. Ecological Pharmacology: Pharmacology Informed by Evolution. In Fundamentals of Complementary and Integrative Medicine, 4ed. Elsevier.  2009.

5. Hopkins, Andrew L. Network pharmacology: the next paradigm in drug discover. Nature Chemical Biology. 2008:4;682-690

6. Shimon Ben-Shabat S, Fride E, Sheskin T,Tamiri T, Rhee MH, Vogel Z. Bisogno T,De Petrocellis LD, Di Marzo V, Mechoulam R. An entourage effect: inactive endogenous fatty acid glycerol esters enhance 2-arachidonoyl-glycerol cannabinoid activity. Euro J Pharmacol. 1998;353:23–31

7. Spelman K. Cannabinoid-Opioid Interaction in Chronic Pain. Nat Med J June 2012.

We are well aware that CBD can be synthesized from Olivetol sourced from lichen using, among other things, citric acid, which is commonly sourced from lemon peels. However we do not see this as a cost-effective, efficient, or environmentally friendly option for producing CBD. Instead, we choose to continue to source our CBD from the Cannabis plant, allowing nature to synthesize CBD for us, which is more efficient, more environmentally friendly, and provides a symphony of minor cannabinoids, terpenoids and other compounds in Cannabis which we find leads to more efficacious products. To our knowledge, there are absolutely no confirmed reports of cannabidiol in any plants other than Cannabis, though there are compounds that are chemically very similar to CBD found in other plants. There is little to no clinical data about such CBD-like compounds. If data about CBD from alternative natural sources exists, it has not been peer-reviewed, and we would invite any companies making such claims to share the data and engage in repeatable third-party verification of such claims.

All of our products are tested by an independent lab, Kenevir Research, that checks for heavy metals, pesticides, microbial presence and potency. If needed, we would be delighted to provide a Certificate of Analysis (CoA) for the lot number of your product. Simply send an email with the lot number of the product you purchased to info@greenearthmedicinals.com and we will respond within 48 hours.

In the future, we will have an online database that allows you to look up the lot number of the product you have purchased.

The fatty oil isolated from hemp seeds is loaded with polyunsaturated fatty acids which are beneficial for human health. However because polyunsaturated fatty acids can go rancid within weeks,1 hemp seed oil does not make products that are stable for product shelf-life. Rancid polyunsaturated fatty acids are also detrimental to human health. MCT has shown multiple benefits in human health.2,3

Sources:

1. Vieira SA, McClements DJ, Decker EA. Challenges of utilizing healthy fats in foods. Adv Nutr. 2015;6(3):309S-17S. doi: 10.3945/an.114.006965.

2. Wang Y, Liu Z, Han Y, Xu J, Huang W, Li Z. Medium Chain Triglycerides enhances exercise endurance through the increased mitochondrial biogenesis and metabolism. PLoS One. 2018 Feb 8;13(2):e0191182.

3. McCarty MF, DiNicolantonio JJ. Lauric acid-rich medium-chain triglycerides can substitute for other oils in cooking applications and may have limited pathogenicity. Open Heart. 2016;3(2):e000467

Our products do not contain allergens, animal products or night shades. Nonetheless, we recommend checking with a health practitioner regarding the use of a Green Earth Medicinals product for your particular condition.

At Green Earth Medicinals, we take pride in our evidence-based approach. We strive to create the best products based on clinical observation and the latest research results.

Water-soluble forms of CBD are not naturally-occurring products. The process of making a fat-soluble compound, such as CBD, soluble in water, involves a process called nano-emulsion. Nano-emulsion uses high frequency ultrasound to induce a process called cavitation, in which small, water soluble spheres (called liposomes) are formed. The CBD molecules are suspended in the liposomes which float in the water.

The dosing of CBD is dependent on many factors, such as your overall health, disease condition, medications, and nutritional status. Our CBD Oral Formula has a very safe dosing range and patients can try doses of 0.25 mL to 0.5 mL of the Regular Strength Formulas (20 mg/mL) or 0.25 mL of the Extra Strength Formula (50 mg/mL) taken between once and four times daily depending on severity of illness or desired effects.

We strongly recommend that patients seek expert advice from their healthcare practitioner.

Green Earth Medicinals products have been formulated to be safe and easy to use. We have oral formulas designed to increase absorption by holding the solution in one's mouth to allow for "buccal" and/or sublingual absorption. These are available in both MCT (medium chain triglyceride) and alcohol-based formulas, to provide options for individual preference. We also offer regular and extra strength versions of our MCT-based formulas. Our topical formulas are intended to be used on affected areas by applying to the skin.

Green Earth Medicinals CBD Oral Formula is an MCT-based product, in which our CBD extract is mixed into the MCT oil along with a natural emulsifying agent for increased absorption and improved flavor.The dropper provides a more convenient method for administering higher doses of CBD (20-40 mg), while the spray is excellent for low dose applications.

Green Earth Medicinals CBD Sublingual Spray is an alcohol-based formula that contains several additional herbal agents used to improve flavor and absorption. Both formulas are effective and great tasting, and choosing between them comes down to both individual preference, as well as dosing needs.

Our "buccal" spray for the inner cheek area of the mouth – CBD Sublingual Spray is better suited for lower dosing regimens (5-20 mg), especially when dosing is needed more frequently.

The CBD we use to make our products comes from plants grown under the auspices of the Oregon Department of Agriculture hemp program. This means that no medical card is required.

Unless doses above our label recommendations are taken, there should be no euphoric effects.

Because we do not use isolated CBD, our extracts contain a broad spectrum of compounds, including a high concentration of CBD. It is important to note that all hemp flower products also contains trace amounts of THC. Hence, it is possible that with high doses of CBD-extracted products, traces of THC could be detected in the blood.

Our products meet the required state and federal guidelines for the use of hemp extracts. Our Certificate of Authenticity (CoA) meets the requirement that our hemp oil extracts must contain less than 0.3% THC. However, depending on dose and time from administration, it may be possible that a drug-screening test detects THC.

There are several variations on how to test for THC, and individual metabolism varies greatly from one person to the next. Because we do not have pharmacokinetic data to inform us of the amount of THC one can consume before testing positive for THC on a drug test, we recommend a prudent and cautious approach to taking CBD rich cannabis extracts in the context of regular drug screening.

At high doses of CBD, it is possible that drug-herb interactions can occur. At lower doses of CBD, as suggested on our label, it is unlikely that significant drug-herb interactions will occur. However, always check with a health care practitioner knowledgeable about dietary supplements before using any new supplement.

Unlike THC, CBD has negligible effects on appetite and satiety.

It is possible to overdose with any drug, herb or food. However, no one has ever died from any dose of cannabinoids coming from hemp or medical cannabis. The most common overdose symptom at high doses of CBD is fatigue.

From our field to our final product, there are, at minimum, four major quality-control testing points for purity and potency throughout the manufacturing of all our CBD Botanicals. This does not account for intermediate testing and checking in on our plants throughout the growing season.

Major testing points:

1. After harvest, our CBD-rich hemp plants are tested for their cannabinoid and terpene profiles. At this time we also perform contaminant tests to ensure that our plants are free of pesticides, heavy metals, microbial contaminants and foreign matter.

2. Once we extract cannabinoids and terpenes from the hemp plants, the resulting extract is tested for potency and contaminants like pesticides and solvents.

3. After manufacturing we test the potency of each batch of our final product before bottling to ensure that no formulation or manufacturing errors were made and that no contaminants were introduced in the production process.

4. Once bottled, we pull and test random samples from each product lot for potency to ensure there is consistency between units in a batch. Bottled products also receive a visual inspection to ensure there are no detectable defects. We store several samples of each lot under varying environmental conditions to monitor the stability of our products for up to a year or more after production.

CBD has been shown in multiple studies to be safe for children, but as with any supplement, should be consumed under parental supervision.. The most common side effect at higher doses is fatigue.1-6

Sources:

1. Russo EB. Cannabis and epilepsy: An ancient treatment returns to the fore. Epilepsy Behav. 2017 May;70(Pt B):292-297. doi: 10.1016/j.yebeh.2016.09.040.

2. Gloss D, Vickrey B. Cannabinoids for epilepsy. Cochrane Database Syst Rev. 2014;( 3): CD009270.

3. Insys Therapeutics [Internet]. Insys Therapeutics successfully completes safety and pharmacokinetic (PK) study of cannabidiol oral solution in pediatric epilepsy patients (press release, May 24, 2016). Cited November 20, 2016.

4. Devinsky O, Marsh E, Friedman D, Thiele E, Laux L, Sullivan J, Miller I, Flamini R, Wilfong A, Filloux F, Wong M, Tilton N, Bruno P, Bluvstein J, Hedlund J, Kamens R, Maclean J, Nangia S, Singhal NS, Wilson CA, Patel A, Cilio MR. Lancet Neurol. 2016 Mar; 15(3):270-8.

5. Mateus Machado Bergamaschi, Regina Helena Costa Queiroz, José Alexandre S. Crippa, and Antonio Waldo Zuardi, Safety and Side Effects of Cannabidiol, a Cannabis sativa Constituent. Current Drug Safety, 2011, 6, 000-000

6. Hoggart B, Ratcliffe S, Ehler E, Simpson KH, Hovorka J, Lejčko J, Taylor L, Lauder H, Serpell M., A multicentre, open-label, follow-on study to assess the long-term maintenance of effect, tolerance and safety of THC/CBD oromucosal spray in the management of neuropathic pain. J Neurol. 2015 Jan;262(1):27-40.

CBD has been shown to be safe for pets.^1-2

Sources:

1. Robert J. Silver DVM. Personal communication on current clinical trial on safety in dogs. February 10, 2018.
2. Kogan LR, Hellyer PW, Robinson. Consumers’ perceptions of hemp products for animals. JAHVMA 2016;42, Spring.

Green Earth Medicinals products contain naturally occurring CBD in their hemp extracts. As defined by federal law, hemp is Cannabis sativa with less than 0.3% THC by mass weight. As of January 1st, 2019, Hemp is an agricultural crop regulated by the USDA , it was permanently removed from the list of controlled substances when the 2018 Farm Bill changes went into effect.

The 2018 Farm Bill redefined hemp to include its “extracts, cannabinoids and derivatives”, indicating clear intent for the FDA to allow for sale of hemp extracts including CBD. CBD products are expected to fall under the purview of the Food, Drug & Cosmetics Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA), as a “dietary supplement” specifically as a botanical extract.

States and municipal authorities can regulate the sale of CBD products, and some states have more stringent limits such as a minimum age for purchase. Please check with your local authorities with questions.

All Green Earth Medicinals products contain less than 0.3% THC by weight.