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Safety Assessment of a Hemp Extract using Genotoxicity and Oral Repeat-Dose Toxicity Studies in Sprague-Dawley Rats

Cannabinoids are extracted from Cannabis sativa L. and are used for a variety of medicinal purposes. Recently, there has been a focus on the cannabinoid Cannabidiol (CBD) and its potential benefits. This study investigated the safety of a proprietary extract of C. sativa, consisting of 9% hemp extract (of which 6.27% is CBD) and 91% olive oil. The mutagenic potential of the hemp extract was evaluated with the AMES assay inclusive of a hepatic drug metabolizing mix (S9) rich in CYP enzymes. The…

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Cannabinoids are extracted from Cannabis sativa L. and are used for a variety of medicinal purposes. Recently, there has been a focus on the cannabinoid Cannabidiol (CBD) and its potential benefits. This study investigated the safety of a proprietary extract of C. sativa, consisting of 9% hemp extract (of which 6.27% is CBD) and 91% olive oil. The mutagenic potential of the hemp extract was evaluated with the AMES assay inclusive of a hepatic drug metabolizing mix (S9) rich in CYP enzymes. The test article did not elicit evidence of bacterial mutagenicity. GLP compliant 14-day and a 90-day toxicity study were conducted. Olive oil was used as a control. The 90-day study had a 28-day recovery period. Treatments for the 14-day non-recovery range-finding study were 0, 1000, 2000 and 4000 mg test article/kg body weight (bw)/day for 14 days. There was a non-statistically significant (p > 0.05) decrease in body weights for the male and female rats receiving the test article. Hypoactivity, hyperactivity, reduced food consumption and piloerection were observed in the rats receiving 4000 mg test article/kg bw. Histopathology showed an increase in the size of liver cells (hypertrophy) around the central vein (centrilobular) in Groups 3 (3/10) and 4 (5/10) that correlated with increased liver weights. In the 90-day study, 8 groups of rats were dosed with 0, 200, 400 and 800 mg test article/kg bw/day. Groups 5 to 8 had a 28-day recovery. There were no test article-linked changes in clinical observations, physical examinations, Functional Observation Battery, ophthalmology, Motor Activity Assessment, hematology, clinical chemistries and macropathology (all groups). With the exception of the liver and adrenal gland, no test article-linked pathology was observed. For all rats receiving the test article, histopathology showed hypertrophy of liver cells around the central vein. The increase of liver weight is most likely caused by hypertrophy due to up-regulation of the hepatic drug metabolizing enzymes. The hepatocellular hypertrophy was completely reversed in 28 days and was not considered to be an adverse effect. Vacuolization of the adrenal zona fasciculata was observed in the control and 800 mg test article/kg bw groups. The vacuolization of the zona fasciculata was of the same incidence and severity in treatment and control male rats and correlated with an increased in the weights of the adrenal glands. In addition, a statistically significant increase (p<0.05) in adrenal-to-body weight ratios was observed for females receiving 800 mg test article/kg bw. This increase in adrenal-to-body weight ratio did not correlate with any of the pathology findings. The NOAEL for the test article is 800 mg/kg bw/day for female and 400 mg/kg bw/day for male Sprague Dawley rats.

Keywords: CBD; CW hemp; CYP; Cannabis sativa; Charlotte’s Web, Inc.; cannabidiol; cannabinoids; hemp extract; liver; mutagenicity; olive oil; toxicology.

Source: https://pubmed.ncbi.nlm.nih.gov/32123668/?utm_source=no_user_agent&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1TUbR4JfRTv1rbahLd1HaiF0w5ryO5ocWB3_xk3Prq78L0AEhI&fc=20200804222312&ff=20200812014004&v=2.11.5

Heartland

Does cbd/cbg interact with prozac?

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I've read that the ssri prozac and cbd/cbg/thc are metabolized by the same enzyme in the liver and can cause the ssri to build up in the blood stream and I was wondering if this is a proven fact. It's been very difficult to find research on this. I started taking Prozac but I want to smoke too. If what I've read is true then smoking or consuming any cannabis product will hurt me more than it helps and that means no more cannabis anything..

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Heartland

Can CBD oil cause heartburn?

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Visit our community site for vetted suppliers at http://theCBD.place. It’s time that this subject was given more internet exposure. We are here to discuss topics related to medical marijuana and our experiences using CBD. Please do not assume that anyone here is a medical professional.

Source: https://www.reddit.com/r/CBD/comments/k1t13y/can_cbd_oil_cause_heartburn/

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Heartland

Not All Hemp Products Are Created Equal

What is the difference between Hemp and Marijuana?

Both Hemp and Marijuana are in the cannabis family. Human intervention has produced variation within the species in terms of THC and CBD levels. Simply put, hemp is designated by a man-made definition of THC levels at or below 0.3%. Marijuana is always harvested from female plants and typically has high THC levels with little to no CBD, although some strains can contain verifying levels of CBD/THC ratios. Hemp has over 10,000 known uses, which can be made from both the female or male plant depending on the desired product. Mana Artisan Botanics uses only female hemp plants in our products, with lab testing guaranteeing below 0.3% THC levels.

Hemp extract is the phytocannabinoid concentrate, created through some form of extraction process, most commonly either with supercritical carbon dioxide or ethanol. The extract’s potency will depend on the levels of cannabinoids in the plant, so each batch of extract will have different levels of cannabinoids.

Why should you care where your hemp is sourced from?

The demand for hemp extracts is rapidly increasing in the U.S. However, there is still limited supply of U.S.-grown hemp, resulting in high prices that cannot compete against imported hemp extract from places like China or Eastern Europe. Consumers seeking quality products may find a lack of transparency when it comes to the origin of the hemp extract in their products. And unfortunately, there is limited data behind the volume and quality control behind these imported hemp extracts.

At Mana Artisan Botanics, we take great care to source high-quality hemp that is grown in the U.S., with the specific intention to facilitate health and wellness.

Do hemp cultivation methods matter?

In the cannabis industry much of what is grown, unless it is organic, is sprayed with varying levels of pesticides and fungicides. Most consumers don’t realize this is a common practice. Given the increasing demand for hemp and cannabis, many conventional farmers are transitioning their fields to these high value crops. Yet, hemp’s cultivation environment is critical as it can act as a bio-remediation crop, absorbing contaminants from the soil while it grows. If the hemp was grown in poor or misused soil, that plant might contain toxins you won’t want to ingest.

This is why at Mana Artisan Botanics, we source our CBD-rich hemp extract only from farms that have never had any toxic agriculture on the land or use any harmful pesticides or fungicides. All our products are purity and potency tested at multiple lab facilities such as Steep Hill Labs Hawaii and Hawaii Pharm Labs for cannabinoid levels as well as pesticide residue, heavy metals and other contaminants. State of the art testing methods are used and THC levels are guaranteed to be under the federal limit of 0.3%. If you want to review the lab results, please contact us!

Do different hemp strains deliver varying results?

Many of the hemp products on the market derive their CBDs as a by-product from other types of hemp varieties such as fiber or seed for hemp food products. The levels of CBD-rich hemp extract in these products are lower and lack the diverse spectrum of cannabinoids one would ideally want for an “entourage effect” that delivers the possible synergies made available by whole plant therapies.

At Mana Artisan Botanics, the hemp we source is grown with great care to facilitate high levels of the non-psychoactive cannabinoids.

What is the entourage effect?

The “entourage effect” or “plant synergy” is the idea that cannabinoids, terpenoids and flavonoids in cannabis interact synergistically to magnify the therapeutic benefits of the plant’s individual components—so that the medicinal impact of the whole plant is greater than the sum of its parts.

Are whole plant extracts superior to single-compound alternatives?

Do you know the difference between isolates and whole plant extracts? “Whole plant extract” has a wide range of cannabinoids. Most scientists agree that there is between 80-120 cannabinoids plus additional terpenes, in addition to the better know CBD and THC compounds. With a “whole plant” extract you are getting access to the much wider spectrum of cannabinoids in your hemp infusion for that entourage effect.Isolates are not known to be effective as a whole plant extracts for that very reason. Additionally, isolates can be over processed, sometimes with added chemicals for purification.

Mana Artisan Botanics uses “whole plant extracts” only, with full range of cannabinoids making our infusions superior to single-compound alternatives.

Why does Mana Artisan Botanics include Turmeric in our hemp infusions?

Curcumin, the yellow pigment of turmeric (Curcuma longa) is one of the most intensely researched natural products available today. With over 6,000 peer-reviewed studies, including clinical and scientific research, turmeric is shown to have powerful anti-inflammatory effects. We add turmeric in our hemp infusions to further augment the anti-inflammatory effects of cannabinoids.

Why does Mana Artisan Botanics include Passionflower in our Hawaiian Sleep Hemp Tincture?

Passionflower extract has been shown in studies to be helpful for relieving general anxiety and improving sleep quality. We add passionflower in our sleep hemp tincture to further augment the anti-anxiety effects of cannabinoids.

Republished by Plato

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What is the difference between Hemp and Marijuana?

Both Hemp and Marijuana are in the cannabis family. Human intervention has produced variation within the species in terms of THC and CBD levels. Simply put, hemp is designated by a man-made definition of THC levels at or below 0.3%. Marijuana is always harvested from female plants and typically has high THC levels with little to no CBD, although some strains can contain verifying levels of CBD/THC ratios. Hemp has over 10,000 known uses, which can be made from both the female or male plant depending on the desired product. Mana Artisan Botanics uses only female hemp plants in our products, with lab testing guaranteeing below 0.3% THC levels.

Hemp extract is the phytocannabinoid concentrate, created through some form of extraction process, most commonly either with supercritical carbon dioxide or ethanol. The extract’s potency will depend on the levels of cannabinoids in the plant, so each batch of extract will have different levels of cannabinoids.

Why should you care where your hemp is sourced from?

The demand for hemp extracts is rapidly increasing in the U.S. However, there is still limited supply of U.S.-grown hemp, resulting in high prices that cannot compete against imported hemp extract from places like China or Eastern Europe. Consumers seeking quality products may find a lack of transparency when it comes to the origin of the hemp extract in their products. And unfortunately, there is limited data behind the volume and quality control behind these imported hemp extracts.

At Mana Artisan Botanics, we take great care to source high-quality hemp that is grown in the U.S., with the specific intention to facilitate health and wellness.

Do hemp cultivation methods matter?

In the cannabis industry much of what is grown, unless it is organic, is sprayed with varying levels of pesticides and fungicides. Most consumers don’t realize this is a common practice. Given the increasing demand for hemp and cannabis, many conventional farmers are transitioning their fields to these high value crops. Yet, hemp’s cultivation environment is critical as it can act as a bio-remediation crop, absorbing contaminants from the soil while it grows. If the hemp was grown in poor or misused soil, that plant might contain toxins you won’t want to ingest.

This is why at Mana Artisan Botanics, we source our CBD-rich hemp extract only from farms that have never had any toxic agriculture on the land or use any harmful pesticides or fungicides. All our products are purity and potency tested at multiple lab facilities such as Steep Hill Labs Hawaii and Hawaii Pharm Labs for cannabinoid levels as well as pesticide residue, heavy metals and other contaminants. State of the art testing methods are used and THC levels are guaranteed to be under the federal limit of 0.3%. If you want to review the lab results, please contact us!

Do different hemp strains deliver varying results?

Many of the hemp products on the market derive their CBDs as a by-product from other types of hemp varieties such as fiber or seed for hemp food products. The levels of CBD-rich hemp extract in these products are lower and lack the diverse spectrum of cannabinoids one would ideally want for an “entourage effect” that delivers the possible synergies made available by whole plant therapies.

At Mana Artisan Botanics, the hemp we source is grown with great care to facilitate high levels of the non-psychoactive cannabinoids.

What is the entourage effect?

The “entourage effect” or “plant synergy” is the idea that cannabinoids, terpenoids and flavonoids in cannabis interact synergistically to magnify the therapeutic benefits of the plant’s individual components—so that the medicinal impact of the whole plant is greater than the sum of its parts.

Are whole plant extracts superior to single-compound alternatives?

Do you know the difference between isolates and whole plant extracts? “Whole plant extract” has a wide range of cannabinoids. Most scientists agree that there is between 80-120 cannabinoids plus additional terpenes, in addition to the better know CBD and THC compounds. With a “whole plant” extract you are getting access to the much wider spectrum of cannabinoids in your hemp infusion for that entourage effect.Isolates are not known to be effective as a whole plant extracts for that very reason. Additionally, isolates can be over processed, sometimes with added chemicals for purification.

Mana Artisan Botanics uses “whole plant extracts” only, with full range of cannabinoids making our infusions superior to single-compound alternatives.

Why does Mana Artisan Botanics include Turmeric in our hemp infusions?

Curcumin, the yellow pigment of turmeric (Curcuma longa) is one of the most intensely researched natural products available today. With over 6,000 peer-reviewed studies, including clinical and scientific research, turmeric is shown to have powerful anti-inflammatory effects. We add turmeric in our hemp infusions to further augment the anti-inflammatory effects of cannabinoids.

Why does Mana Artisan Botanics include Passionflower in our Hawaiian Sleep Hemp Tincture?

Passionflower extract has been shown in studies to be helpful for relieving general anxiety and improving sleep quality. We add passionflower in our sleep hemp tincture to further augment the anti-anxiety effects of cannabinoids.

Source: https://www.finallycbd.shop/not-all-hemp-products-are-created-equal

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