How Does Epidiolex Work? And How Does It Differ From Hemp Oil?

It’s official, the FDA has approved the first cannabis derived prescription drug. Based on years of research, Epidiolex

How Does Epidiolex Work? And How Does It Differ From Hemp Oil?

It’s official, the FDA has approved the first cannabis derived prescription drug. Based on years of research, Epidiolex has proven benefits in treating two rare forms of epilepsy (Dravet Syndrome and Lennox-Gastaut Syndrome). So what does that mean for everyone else? Epidiolex contains CBD isolate, which is also found in a number of nutraceutical hemp products. Up until now, all forms of CBD (with exception to Farm Bill Compliant hemp derived CBD) have been classified as a Schedule I drug. Although we can’t be certain how the FDA’s approval will affect the cannabis industry, we can offer our thoughts. So, let’s look at the facts.

CBD Isolate vs Full Spectrum Hemp Oil

CBD isolate (the cannabis derived ingredient in Epidiolex) is a refined version of full spectrum hemp oil containing only pure CBD. While proven to show health benefits, CBD isolate is just one of numerous cannabinoids that our body is made to absorb, along with numerous flavonoids and terpenoids that are stripped away in the refining process.

Hemp extract contains a variety of cannabinoids, such as CBD, that target specific cannabinoid receptors throughout the body. When using full spectrum hemp products, multiple cannabinoids, terpenoids and receptors work together to increase the efficacy of cannabis based products. This process is often referred to as the “entourage effect”. Although CBD isolate found in Epidiolex is proven to show health benefits for two specific forms of epilepsy, some will still prefer (and be limited to) wholistic full spectrum hemp oil.

How the FDA’s Approval helps the CBD Industry:

CBD being reclassified to Schedule II or III (within 90 days)
Making the cannabinoid industry as a whole more credible
Higher quality standards and oversight
Proves that CBD has medicinal value
Opens the door to more research

Concerns

Regardless of being FDA approved, the question “How much will it cost?” is still a top concern. A year’s prescription of Epidiolex is estimated to cost upwards of $32,000. Even after insurance, it’s likely that Epidiolex will have a cost comparable to over-the-counter alternatives. Before any of that can happen, the DEA still has to reclassify CBD. Currently marijuana and CBD are considered a Schedule I drug. The FDA granted Epidiolex Fast-Track designation for use with Dravet syndrome, and Orphan Drug designation for both Dravet syndrome and Lennox-Gastaut syndrome. With the FDA’s approval of epidiolex, the DEA now has 90 days (as of June 25, 2018) to reclassify CBD as a Schedule II or Schedule III drug. “We don’t have a choice on that,” DEA public affairs officer Barbara Carreno told Business Insider.

cbd-oil-epidiolex-epilepsy With exception to “off label prescribing”, this new drug will be limited to individuals with either of the two previously mentioned types of epilepsy. This means that for those of you looking to use CBD as a remedy for anxiety, appetite, pain, immunity and memory (among others), you’ll likely have to stick with alternative over-the-counter supplements. And while we’re here, it’s worth mentioning the potential negative side effects of Epidiolex, “sleepiness, sedation and lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise and weakness, insomnia, sleep disorder and poor quality sleep, and infections.”

With CBD products now being verified to have medicinal benefits, the industry might be approaching a renaissance. A restructuring of the legalities for CBD in a medical environment just might be the validation this industry needs. The FDA’s approval of the first cannabis derived drug will likely open up new opportunities, especially for brands who’ve gone the extra mile to ensure a quality product. As more cannabis derived FDA drugs are introduced, it will become increasingly harder for cannabinoid supplement companies to guarantee pharmaceutical-grade quality. Early trail blazers will have to adapt, refine processes, and have clear oversight of their supply chain and manufacturing.

Not All Hemp Companies are Equal

The cannabis industry has grown to where it is today because of early pioneers who were able to look passed common misconceptions and saw potential in the complex cannabis plant. Now with tensions lightening up, larger retailers offering natural supplements will likely take on CBD brands as this industry gains more validity. Hemp companies that set higher standards will be positioned for long-term success as the industry continues to grow.

What Cannabinoid Companies Should Focus On:

GMP manufacturing processes
Increased self-regulation
3rd party testing
Being open and transparent
Customer service
Education

Final Thoughts

Overall, the FDA’s approval of Epidiolex is likely a good move for the cannabis industry as a whole. It helps the industry become more credible, sets higher quality expectations, proves that CBD has medicinal value, and will likely encourage further research on cannabinoids and their potential health benefits. As we always say here at Green Lotus Hemp, #LetsGrowTogether.

Aug 2018

Limited Release – Maui Sunrise 500mg CBD Oil Vape Cartridge

If you or your customers have been fans of our Girl Scout Cookies vape cartridges, then you’re going

Limited Release – Maui Sunrise 500mg CBD Oil Vape Cartridge

Hemp News, Hemp Tips Clay

If you or your customers have been fans of our Girl Scout Cookies vape cartridges, then you’re going to love our limited edition of Maui Sunrise Hemp Oil Cartridges. Sweet, smooth and creamy – these pre-filled vape cartridges have a flavor profile similar to that of a freshly cut pineapple blended into a vanilla smoothie.

You won’t find any additives here – instead, you’ll get 500 mg of full spectrum hemp oil rich in naturally occurring CBD and other natural phyto-cannabinoids. Green Lotus cartridges are great for focus, overall well-being and can be taken at any time of day. Kickstart any part of your day with the refreshing, yet calming sensation of Maui Sunrise CBD Hemp Oil Cartridges.

Our limited supply is ready to ship for wholesale across the U.S., so be sure to get your orders in ASAP. Just login to your wholesale account at GreenLotusHemp.com and place your order.

As for non-wholesale customers, you can purchase a personal Maui Sunrise vape cartridge, by sending over an email to info@greenlotushemp.com, or give one of our customer advocates a call at 1-888-811-HEMP (4367).

Login to your wholesale account and place your order here.

Jul 2018

The Senate Legalizes Hemp: The Farm Bill Enables Hemp Legalization

Hello Green Lotus Family! As many of you have now probably seen in a monumental move, the Senate

Hello Green Lotus Family!

As many of you have now probably seen in a monumental move, the Senate legalized hemp through the passing of modifications to The Farm Bill last Thursday.

I know what some of you may be thinking. I thought hemp was already legal? How is it that Green Lotus Hemp is selling products if this is barely passing? All great questions. Let me further explain.

The 2018 Farm Bill passed with a vote of 86-11, the changes essentially enable hemp legalization federally for the cultivation, processing, and sale of industrial hemp; this includes a few provisions and pending President Trump review of course.

How Is It Legal To Grow Hemp today for Green Lotus?

As we have covered before, certain states, like Colorado, already allow hemp to be grown under provisions in the 2014 Hemp Farm Bill. This provision means that hemp plants, think of it as a non-psychoactive cousin to marijuana, can be grown under a pilot program for purposes of research under each respective state’s department of agriculture. Research can be conducted on the growth, cultivation, and marketing of industrial hemp. The hemp strains must contain less than .3% THC to be legally defined as hemp, so essentially, it won’t get you high. All of our hemp is grown in CO by our licensed farm and we partnered with a major Texas State Accredited university to conduct research.

How Is Hemp Legal?

An early champion of the hemp cause, Senate Majority Leader Mitch McConnell (R-KY) believes deeply in hemp legalization; in April of 2014 he introduced the current provision under the Farm Bill (section 7606) and in April 2018 he introduced the Hemp Farming Act of 2018. The bill would completely remove hemp from the Controlled Substances Act. It also looks at restrictions and regulation, but perhaps more interestingly makes the plants eligible for crop insurance.

If Hemp is legal now under the current Farm Bill, why is this a big deal?

The current farm bill only legalizes hemp for purposes of research, but it never really defines what research is. This has led to confusion among some in the law enforcement community. Certain agencies have raised the concern that general commerce is not lawful under the research provision. In the original Farm Bill, Congress made it very clear that “marketing” research is lawful, and thus companies like ours can legally sell products as part of our “marketing” research. This new Farm Bill clearly allows for general commerce. Thus, removing any confusion from any law enforcement agency.

Now let me tell you more about this new Farm Bill!

Hemp generally enjoys bipartisan support currently, however staunch opponent Sen. Charles Grassley (R-IA) tried to add an amendment on the Senate floor to exclude CBD from the bill. CBD is already legal as a naturally occurring part of the hemp plant in roughly 48 states; Grassley never ended up filing an amendment.

McConnell is hopeful about the economic benefits of utilizing hemp as a crop from America for America. “Consumers across America buy hundreds of millions in retail products every year that contain hemp,” McConnell said in a floor speech on Thursday. “But due to outdated federal regulations that do not sufficiently distinguish this industrial crop from its illicit cousin, American farmers have been mostly unable to meet that demand themselves. It’s left consumers with little choice but to buy imported hemp products from foreign-produced hemp.” Consequently, farmers in McConnell’s home state of Kentucky farmers are hopeful as they view hemp as another, perhaps better alternative to tobacco farming.

Legalizing Hemp once and for all!

Indeed, the Hemp Farming Act currently has 29 cosponsors signed on—17 Democrats, nine Republicans and two independents. Democrats are especially enthusiastic about hemp legalization, “…. it opens up untold economic opportunity for farmers in Oregon and across the country,” states Sen. Ron Wyden (D-OR). Maybe the real potential is the economic growth in rural communities for blue collar, white collar, and many other jobs.

The Congressional Research Service report released last week says that the “global market for hemp consists of more than 25,000 products.” This demonstrates both the breadth and depth of an industry the U.S.A could be dominating as a producer, not only as a consumer. Earlier this month, the Senate approved a nonbinding resolution recognizing hemp’s “growing economic potential”.

History of Hemp Legalization in the U.S

Historically, most people forget that hemp was widely grown in the United States throughout the mid-1800s, Senator Michael Bennet (D-CO) said in a floor speech on Wednesday. “… the government treated industrial hemp like any other farm commodity until the early 20th century”. There is an opportunity to diversify our farms and manufacture high-margin products for the American people.

Subsequently, broader amendments have been added to the Farm bill even though Rules Committee Chairman Pete Sessions (R-TX) has made a consistent practice of blocking cannabis measures from advancing over the past several years. But now that the language is included in the version approved by The Senate Committee on Agriculture, Nutrition, and Forestry with a vote of 20-1 two weeks ago. It will be part of discussions by the bicameral conference committee that will merge both chambers’ bills into a single piece of legislation to be sent to President Trump’s desk.

This week, the White House released a statement of administration policy outlining concerns with the Farm Bill but it does not mention its hemp legalization provisions. All of this news is good news for the American public in general, who have had to move states to purchase cannabinoids products. Naturally occurring CBD in hemp is legal in roughly 48 states, but this move would make it explicitly federally legal as well and remove any confusion for any overreaching federal agencies.

If you would like more information on how to legally purchase CBD Oil or Cannabinoid products please visit our website. We don’t just make quality products, we make remedies for life… #LetsGrowTogether

Jul 2018

FDA Approves Epidiolex CBD Medicine To Treat Epileptic Seizures

A revolutionary move by The Federal Drug Administration, the FDA approves of the first plant-based marijuana medicine Epidiolex.

FDA Approves Epidiolex CBD Medicine To Treat Epileptic Seizures

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A revolutionary move by The Federal Drug Administration, the FDA approves of the first plant-based marijuana medicine Epidiolex. This essentially opens up the possibilities in the future for medical marijuana for treatment for conditions like epilepsy.

Does CBD Oil Help Epilepsy?

Epidiolex is made from CBD extracted from marijuana to treat certain forms of epileptic seizures. CBD is simply a cannabinoid that does not get you high. Epidiolex is used in patients 2 or older that struggle with rare and severe forms of epilepsy, like Lennox Gastaut Syndrome and Dravat syndrome. This is the first time a drug to help with Dravat syndrome has been approved.

The decision was passed Monday, June 25^th, but only a handful of states will dispense the agency approved cannabis-based medicine.

CBD and Epilepsy

The FDA has previously approved a synthetic cannabis medicine, but Epidiolex is different as it is manufactured from marijuana extract.

The FDA noted in its announcement that it informs and advises the DEA about scheduled substances such as marijuana. In April, an expert advisory panel for the FDA voted unanimously to recommend Epidiolex’s approval and determined that “CBD has a negligible abuse potential.” The potential for CBD to help with ailments with negligible abuse potential means that perhaps it could replace addicting pain medication like opioids.

GW Pharmaceuticals Epidiolex

Epidiolex was developed by a subsidiary of GW Pharmaceuticals which is a London based company. Skirting the harsh American restrictions on medicinal research for cannabis, this British company is now at the forefront of scientific treatment. It seems the laxer restrictions on medical cannabis research have put European countries at the forefront of research.

States’ rights will allow the ignoring of federal bills and allow patients to use health insurance to pay for the medication as early as September. This basically means that because states have ratified marijuana, the states’ rights override federal rights; this works much like issues of property taxes and speed limits for safety in a state. Legalizing marijuana isn’t enough protection in certain states; additional legislation has been added as doctors can recommend the plant extract, but dispensaries are not allowed to legally dispense it. In Colorado, The Colorado General Assembly passed HB 1187 in April to allow doctors to prescribe the drug upon the FDA’s approval; this creates protections similar to those for synthetic THC medication, like Marinol. This flies in the face of decades of political rhetoric, public policy and the legal standards underpinning cannabis prohibition.

The FDA approval was an essential step for Epidiolex, but being made from marijuana still defies the DEA’s rules; It will continue to be federally illegal to prescribe the drug until marijuana’s Schedule I status is changed or abolished.

CBD for Epilepsy

Colorado’s preemptive move will allow its’ doctors to prescribe the drug while other states with legal cannabis may have to wait. The passing of HB 1187 lifted previous prohibitions on pharmacists from being able to dispense marijuana-based medicine. However, similar restrictions in other states have to be taken by on a case-by-case basis. Hopefully, other states will look at Colorado as a template. It allows for not only prescription-strength CBD but full-spectrum hemp extracts as nutritional and wellness products. Similar to omega fatty acids, there exists prescription-strength and over-the-counter supplements.

Many hemp CBD businesses are based in Colorado thanks to the state’s relatively friendly laws for hemp farming and processing. CBD products are regulated through the Hemp Farming Bill.

GW said it expects that the DEA will reschedule CBD within 90 days.

In a statement, GW CEO Justin Gover said: Today’s approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies… These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.

The question remains: Will the government take this potentially transformational opportunity?

CBD Medicine

This is the first time the FDA has admitted that cannabis has medical value, specifically to treat serious epilepsy disorders. Approving Epidiolex directly refutes the legal basis for the absolute prohibition of cannabis in the United States.

Epidiolex is essentially a CBD tincture made for oral ingestion, and there are many counterparts available on the retail market today, like Green Lotus Hemp. The majority of CBD extractors use whole-plant infusion and CBD isolate techniques to make their products. Epidiolex is made by refining the marijuana concentrate down to a single molecule, which removes all THC before becoming the base for the medication.

Making Epidiolex legal does not legalize medical cannabis, nor does it authorize the medicine in the 30 states that have approved medical cannabis programs. In fact, it doesn’t even legalize CBD. The law continues to hold the vast majority of those substances illegal; the only exception being products developed from industrial hemp, as per the 2014 farm bill which Green Lotus Hemp products comply.

FDA CBD

Epidiolex remains a Schedule I substance so other action is still required. To bring this product to market, the FDA, in conjunction with the Justice Department, must take another historic step: rescheduling a cannabis-based compound.

The decision to approve this drug effectively forces their hand on rescheduling. GW Pharmaceuticals’ assessment of the drug’s abuse potential, demonstrating it to be low, Epidiolex may be rescheduled from Schedule I to Schedule III or IV.

A combination of bureaucracy and politics has meant that researchers like GW pharmaceuticals abroad are beating U.S. researchers in studying this plant. Cannabis used in research is typically supplied by a single domestic source, namely a farm at the University of Mississippi. However, the DEA is becoming more open to expanding domestic producers. Despite dozens of applications from legitimate institutions, the Justice Department under Attorney General Jeff Sessions has refused to approve a single one.

FDA has signaled to the rest of the government, specifically the DEA, that cannabis-based medicines can have medicinal value and can be regulated for safe use in this country. Don’t let politics, but let medical and health professionals guide the department’s choices on federal cannabis policy. When federal regulators stand in the way of high-quality research, they are standing between patients and treatments that could improve or save lives.

May 2018

Congress & Hemp: The Hemp Farming Act 2018

Washington, D.C: Republican Majority Leader Mitch McConnell submits to Congress the Hemp Farming Act which aims to remove

Congress & Hemp: The Hemp Farming Act 2018

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Washington, D.C: Republican Majority Leader Mitch McConnell submits to Congress the Hemp Farming Act which aims to remove non-psychoactive cannabis varieties from legislation.

This bill is to empower American farmers and the economy, while simultaneously removing non-psychoactive varieties from the Controlled Substances Act.

Currently, with the exception of the farm bill, any product, hemp or marijuana, from the plant cannabis sativa is illegal; there are over 100 cannabinoids in the plant material, yet the only cannabinoid that is psychoactive is THC. Federal law prohibits human consumption and possession of schedule 1 controlled substances.

McConnell comments harken back to early American days, comparing hemp to the history of tobacco in Kentucky. Although McConnell is Republican, this legislation is presented by a group of bipartisan cosponsors; the group comprises over 10 people so far including Senator Schumer and Senator Jeff Merkely, both Democrat.

Under the Controlled Substances Act, it is illegal to grow hemp as it is classified under the same definition as marijuana. However, it is legal in some states, under a pilot program, to grow and process industrial hemp. Hemp products themselves are legal to possess and sell in roughly 47 states. It should be legal for the farmers in every state to be able to grow their own hemp as a crop. That way, the state can directly benefit.

The Hemp Farming Bill also seeks to remove restrictions on banking and water restrictions. Currently, companies have trouble with federal banks and turn to state banks for their banking needs. Under this outline, hemp would be eligible for crop insurance, just like rice or corn.

Regulation would be through the U.S Department of Agriculture, as well as oversight of all plans for growth.

This is not the first time that McConnell advocates for hemp; in 2014, he was a part of the Farm Bill that regulates states ability to grow medical marijuana. Specifically, he inserted language that would shelter research programs from the federal government. The Farm bill also has a larger effect of regulating all agriculture and food policy in the United States.

This issue is so important to America, that minority whip Democrat Schumer, who rarely agrees on issues with McConnell, is reaching across the aisle to pass this legislation. At the end of April, he signed on as a cosponsor of the bill.

Sen. Schumer called the current laws prohibiting the cultivation of hemp “a crock,” Forbes reports. “It makes no sense that the DEA is the primary regulator, and that they stop farmers and investors from growing hemp,” Schumer continued. “Why are we buying hemp from other countries, when we have hundreds of acres that could be grown right here in our backyard?”

In fact, Schumer aims to remove marijuana completely from the Controlled Substances Act, although McConnell does not agree with this sentiment. Schumer introduced this bill on 4/20 of this year.

“The federal government made a mistake when they labeled hemp as a controlled substance, putting it on par with dangerous substances like heroin. In reality, industrial hemp is an oyster with a pearl of opportunities that could mean millions in economic revenue while also helping to support new local jobs in Sullivan, Orange and Ulster counties,” said Senator Schumer. “Industrial Hemp can be used to make everything from paper, to clothing, to plastics which is why it so important we fix this outdated law as soon as possible so farms, businesses, and partnerships, like the one fostered between The Center For Discovery and SUNY Sullivan can continue to grow, expand, and research benefits of hemp without the onerous and outdated restrictions from the federal government.”

Hemp has the ability to bolster the American agricultural economy, which has been struggling since the 1970s.

Currently, the DEA has run into some trouble over their overregulation of non-psychoactive cannabinoids, when seizing legal hemp products. Supplies and shipments in legal head shops have been seized illegally; stopping revenue of a crop that does not cause psycho-active effects and buying hemp from other countries makes no sense.

May 2018

NEWS ALERT: What is ‘intractable pain’? Georgia Sign into Law Medical Marijuana for PTSD & Intractable Pain

Atlanta, Georgia: A bill now signed into law by Governor Nathan Deal allows Georgians medical marijuana to be

Atlanta, Georgia: A bill now signed into law by Governor Nathan Deal allows Georgians medical marijuana to be used by those suffering from post-traumatic stress disorder or ‘intractable pain’; this are additions to a list of qualifying conditions already legally approved for cannabis oil treatments in Georgia.

The bill, known as House Bill 65, adds to a list of already approved list of conditions that allow residents living in Georgia permanently to access low THC oil; this is done through a medical marijuana registration card from a physician to treat their conditions. The newly added conditions of post-traumatic stress disorder & ‘intolerable pain’ widen the scope of treatment available for those who have ailments where low THC cannabis oil may be helping in treatment.

Marijuana in Georgia

In the past few years, Georgia has become more relaxed over certain weed penalties; for example, in Atlanta, a referendum passed to decriminalize marijuana. Residents of Atlanta cannot be put in jail for possession of marijuana, and the maximum fine is $75. The decriminalization of marijuana does not make it officially legal in the state of Georgia; rather it addresses the disparity of punishment.

As early as 2015, Georgia introduces a medical marijuana bill to aid many illnesses such as seizures, sclerosis, and late-stage cancer. This allows through a physician’s prescription for a patient to have a prescription and legally possess cannabis.

Last year, state legislation made additions of conditions such as Tourette’s, Alzheimer’s, and autism to the growing number of ailments that qualify.

Medical Marijuana Laws Changing

In House Bill 65, people who have PTSD from ‘direct exposure to or the witnessing of a trauma’ and are above the age of 18 are now eligible to qualify for a prescription. In the same document, the definition of ‘intractable pain’ is ‘pain that has a cause that cannot be removed’. Other qualifying aspects of intractable pain include ‘…the full range of pain management modalities appropriate for the patient has been used for a period of at least six months without adequate results or with intolerable side effects.’

To be clear, this is permission for physicians to prescribe low THC cannabis oil, not medical marijuana.

Marijuana Laws Not Changing

It is important to note that it is still illegal in Georgia to grow, buy, or transport marijuana. House Bill 645, sponsored by Representative Peak, was rejected; it proposes legalizing harvesting, and distribution of cannabis oil instate. Although paradoxically, medical marijuana is legal to consume through a physician’s approval, it is not legal to buy. Georgia is in a similar position to Washington D.C. with recreational weed; lawmakers need to find a way to get people to access to a substance they have made legal.

Future of Medical Marijuana in Georgia

Since House Bill 65 is now a law, a 15-member study commission will examine in-state access to cannabis oil; they will consider all aspects of security, manufacturing, product labeling, testing, and dispensing.

For the state of Georgia, there are about 4,000 people on the medical marijuana registry for the state.

Of course, it is legal to purchase CBD products, like Green Lotus Hemp’s capsules, tinctures, lotions, and gummies. This is because CBD is a nonpsychoactive cannabinoid and therefore complies with federal regulations.

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