Tags Posts tagged with "Schedule 1"

Schedule 1

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Cannabidiol otherwise known as CBD is a compound found in marijuana. Though there are dozens of cannabinoids, which are the chemical properties found in marijuana products that create the effects linked with cannabis consumption, CBD is one of the most plentiful. It’s second only to THC.

On December 15 the DEA concluded their decision to add CBD oil to the Schedule 1 drug list, which means it must meet certain standards.

The federal government named marijuana a Schedule I drug in 1970 primarily for the psychoactive effects of THC. Prior to December, CBD remained in a regulatory gray area.

A Schedule I drug must meet three criteria to be included on the list:

1.The drug or substance has a high potential for abuse.
2.The drug or substance has no currently accepted medical use in the United States.
3.There is a lack of accepted safety standards for use of the drug or other substance under medical supervision.

The CBD classification was made despite recent investigative studies that has preliminarily shown CBD to have anti-inflammatory, analgesic as well as anti-anxiety properties without the psychoactive effects of THC.

Most of the investigative research is still in its beginning stages and opponents of the reclassification complain that CBD fails to meet the Schedule I criteria based on the initial discoveries.

Although CBD is a cannabis component, the CBD-specific industry is a little different from the larger cannabis industry.

“We do have THC-CBD products, but in the recreational industry we are not allowed to sell anything that doesn’t also have THC in it,” said Amanda Woods, Compliance Officer and Marketing Manager for Choice Organics. “So, a lot of the CBD products free-floating throughout the market were derived from hemp, which does not have the same regulations that cannabis does.”

Hemp is most commonly defined as a legal cannabis product derived from the plant’s stem. Hemp has been used for many different purposes from rope to textile fibers to nutritional supplements to medicinal oils. To be defined as hemp, the product must contain very little THC — less than one percent. For comparison, THC levels in medical cannabis are anywhere between five and 20 percent.

Hemp that contains minimal THC can still contain high amounts of other cannabinoids, like CBD. In Colorado and nationwide, you can walk into a gas station—not even a licensed dispensary— and find CBD products made from hemp. However, these products come from unregulated sources and may pose a public safety hazard.

“[Before December], CBD-only products derived from hemp could be distributed nationwide. You could send CBD in the mail and you could order it on Amazon,” Woods said.

Without the THC, hemp products avoided the strict regulations legal cannabis advocates have fought for.

“On one hand, the [rescheduling] is a step in the right direction in that it forces regulation of this gray market. Like cannabis, it will be up to the State to decide to regulate hemp like cannabis if there is to be an intra-state market. Regulation is good for everyone,” Woods said. “But it is also unfortunate because it was made into a Schedule I drug which only reinforces the federal prohibition on cannabis products… So, there was no real change for the cannabis industry in Colorado, but it has a major impact on the hemp industry.”

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Although legislation has been introduced into the United States House of Representatives to amend the Controlled Substances Act to no longer classify cannabis as a Schedule I substance and to exclude cannabidiol (CBD) from the federal definition of cannabis, we continue to wait for further action.

29 states now permit physicians to authorize medical cannabis to qualified patients. Companies now sell cannabis based pharmaceutical products. And now, countries around the world continue to legalize medical cannabis at the Federal level.

Even though cannbais clearly has medical benefits, it remains a Schedule I substance alongside heroin, LSD, ecstasy, and bath salts under the Controlled Substances Act (CSA). According to the United States Drug Enforcement Agency, Schedule I substances have the following characteristics:
• The substance has a high potential for abuse.
• The substance has no currently accepted medical treatment use in the U.S.
• There is a lack of accepted safety for use of the substance under medical supervision

Five overlooked benefits of marijuana

Five overlooked benefits of cannabis include its potential to treat the following debilitating and deadly diseases:

1) Cancer

Cannabinoids, the active components of marijuana, inhibit tumor growth in laboratory animals and also kill cancer cells. In April 2015, the National Institute on Drug Abuse (NIDA) reported that marijuana can kill certain cancer cells. The monthly publication was revised to say the following:

“Recent animal studies have shown that marijuana can kill certain cancer cells and reduce the size of others. Evidence from one animal study suggests that extracts from whole-plant marijuana can shrink one of the most serious types of brain tumors. Research in mice showed that these extracts, when used with radiation, increased the cancer-killing effects of the radiation.”

2) Fibromyalgia

Zynerba Pharmaceuticals (ZYNE: NASDAQ) is a specialty pharmaceutical company focused on developing and commercializing synthetic cannabinoid therapeutics formulated for transdermal delivery. Zynerba is developing two therapeutic candidates based on proprietary transdermal technologies.

The company’s THC Pro-Drug Patch is a pro-drug of THC that enables transdermal delivery via a patch. Zynerba is studying ZYN001 in patients with fibromyalgia and peripheral neuropathic pain.

3) Epilepsy

In 2016, GW Pharmaceutical’s (GWPH: NASDAQ) Epidiolex product passed Stage 3 Clinical trials for the treatment of Dravet Syndrome. In this study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo. Epidiolex has both Orphan Drug Designation and Fast Track Designation from the FDA.

4) Glaucoma

In late 2015, Nemus Bioscience Inc. (NMUS) reported that Dr. Soumyajit Majumdar, an Associate Professor of Pharmaceutics at the University of Mississippi, presented data at the American Association of Pharmaceutical Scientists (AAPS) that showed that a pro-drug formulation of delta-9-tetrahydrocannabinol (THC) significantly lowered intra-ocular pressure (IOP) in an open-angle rabbit glaucoma model.

The rabbits that received the THC pro-drug saw a greater percentage drop in IOP when compared to timolol, and an even greater percentage drop when compared to pilocarpine. The THC pro-drug resulted in an IOP lowering effect of 45%-50%.

5)Multiple Sclerosis

Cannabis can be used as a treatment for multiple sclerosis. GW Pharmaceutical’s (GWPH: INSY) Sativex product is sold as a treatment for multiple sclerosis and is derived from cannabis. Sativex is sold in 27 countries and it is currently in Stage 3 FDA testing (results expected late 2015/early 2016).

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The battle between the DEA and the Hemp Industries Association was brought back to life after the change last week. Marijuana advocates believe that since hemp isn’t called out under the Controlled Substance Act, it’s legal. The HIA stated, “Cannabidiol is not listed on the federal schedule of controlled substances.” The DEA believes it is since it comes from the same plant.

Executive Director of the Cannabis Business Alliance, Mark Malone states, “This is a huge step backwards for cannabis prohibition and especially for patients who live in states without established medical cannabis laws.”

Manufacturers of CBD products are battling back. Dr. Titus said, “The ninth circuit court of appeals has conclusively held that hemp products such as those marketed by the company [Medical Marijuana] which are derived from the part of the cannabis plant, which is exempt from the controlled substances act is legal for import from Europe.” Dr. Titus believes the products are legal.

Courts ruled that hemp was not a schedule one drug and that the DEA had no right to control it. It also said that hemp was legal to import and sell in the United States. The DEA said it came up with the new internal drug code for extracts of cannabis as a more accurate way to track scientific research on it. Baer stated, “Creating an internal record keeping system allows us to distinguish the extracts from other parts of the cannabis plant and ultimately makes our work more efficient.”

The CBD producers believe the DEA is overstepping the line. New laws cannot be created by the DEA, they can only crack down on laws that already exist created by Congress. Consequently, by making an administrative change they can then include a product that hadn’t been incorporated before.

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”There are too many lives at stake, not to mention scientific integrity and a burgeoning field of medical discovery requiring much freer access to the marijuana plant.” From Huffington Post.

Following a 40-year argument regarding the placement of cannabis as a Schedule I drug; in January the U.S. Court of Appeals, ruled on a petition to reschedule cannabis in the case of AMERICANS FOR SAFE ACCESS (ASA) v. DRUG ENFORCEMENT ADMINISTRATION (DEA). The court ruled that the DEA had not acted arbitrarily and capriciously when it denied ASA’s petition filed nine years prior requesting to remove cannabis as a Schedule I. Schedule I drugs have “no currently accepted medical use in treatment in the United States” and “a lack of accepted safety for use under medical supervision” This classification ranks cannabis as a greater danger than cocaine, morphine or methamphetamine which are all listed as Schedule II drugs with accepted medical uses. The court’s ruling stated “research needed to move marijuana out of Schedule I does not exist.” We respectfully do not agree.

In a 2006 report from the US Dept. of Health and Human Services, the DEA stated that there are no “adequate and well-controlled studies” proving marijuana’s effectiveness. Even though they mentioned a variety of U.S.-based small-to-medium sized randomized, double-blind, placebo-controlled studies of smoked cannabis for severe pain, spasticity and wasting syndromes of which all revealed valid medical benefits; they said these were not significant enough. DEA wants Phase III clinical trials — large studies, involving hundreds of subjects, comparing cannabis to placebo in a double-blind, randomized fashion for a specific indication — just like what the FDA wants when approving interstate drug marketing applications. The problem is: studies of that nature have been done and published in peer-reviewed scientific literature. However; the DEA, HHS, nor the Court ever noticed. Large, multicenter, randomized, double-blind, placebo-controlled studies involving hundreds of patients in America and abroad that are in some cases lasted a year, have been published in U.S. National Library of Medicine indexed journals showing that cannabis, orally administered in extract form, can treat intractable pain in cancer and improve mobility and symptom control in multiple sclerosis. What is strange and unreasonable is federal agencies chose to ignore these studies due to the fact they have been done primarily in the private pharmaceutical sector where cannabis-infused products are produced, tested and at times conveniently renamed. This smoke and mirrors effect has resulted in rigorous research having practically no bearing on public scientific understanding of the medical use of cannabis.

Cannabis extracts have been made for thousands of years for consumption and the public has a great interest and right to know that these cannabis studies exist and their results should have bearing on how we as a society understand, utilize, value and ultimately classify cannabis.

Therefore; why do the feds not include cannabis resin extract studies when considering cannabis’ evidence base? At times, it is as simple as a name game. Congress’s definition of marijuana (since 1937) has always included any compound, extract or manufactured mixture containing a detectable amount of marijuana resin. If cannabis resin has been extracted and dissolved into a solvent or concentrated, that new substance is still named marijuana, hash, or hash oil and this form of marijuana many times has stricter penalties, like the life sentence penalty currently adopted by Oklahoma in 2011 for first-offense hash production. Millions have been punished due to this full definition of marijuana for possessing or distributing cannabis-infused edibles like brownies or hash oil. Cannabis medicines are concentrated forms of the cannabis plant with cannabis resin as a base.

Cannabis, marijuana’s proper name, is a commonwealth medicinal plant belonging to no government or private entity. Licensed producers of cannabis extracts in the private sector have a distinct and desired wide range of scientific freedom to explore and discover, in a rigorous way, many of the medicinal benefits inherent to marijuana. The government should not ignore the peer-reviewed published evidence about cannabis’ medical abilities which is accumulated in the pharmaceutical sector who enjoys privileged access to cannabis for research and development. Private industry does not have the right to demand that cannabis not be rescheduled based in part on their collected data, which they recently achieved in the UK, presumably to protect company market share and pricing by avoiding competition from future cannabis producers who would be empowered by a rational reclassification of marijuana in federal law. Marijuana should not be off limits for the sake of private patents, monopolies or FDA drug marketing applications.

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Right after the DEA decided to classify cannabis extracts (in particular classifying CBD, hemp and all their derivatives as Schedule 1 substances), the Hemp Industries Association (HIA) stated Monday that it’s “strongly considering legal action” to stop the DEA’s move.

The HIA is saying that CBD products should be classified as “supplements,” not drugs or pharmaceuticals. They said the DEA abused its authority. Stating that Congress or the U.S. attorney general are the only ones authorized to add CBD oil to the list of banned substances.

The non-profit trade association who represents businesses, farmers, researchers and investors working with industrial hemp, stated in a press release that the DEA was not right in classifying all CBD products as “marijuana extracts” considering the oil can be made from both marijuana and hemp plants.

“Additionally, the ruling is based on an incorrect and incomplete understanding of how CBD is derived from the cannabis plant,” the HIA said in a statement. “While CBD may be derived from forms of cannabis that contain high amounts of THC, the cannabinoid associated with ‘marijuana,’ CBD may also be produced from industrial hemp plants that meet the legal standards of less than 0.3 percent THC by dry weight, and which may be cultivated in 32 states in the U.S. per Sec. 7606 of the Farm Bill. Hence, not all CBD products may be classified as extracts from ‘marijuana.’”

Executive director of HIA; Eric Steenstra, says that Congress already ruled on the subject when they allowed hemp farmers to produce CBD oil in a bunch of states under the 2014 farm bill.

Steenstra reiterated that the “DEA has no authority whatsoever to impede the production, processing or sale of hemp products, including CBD products, grown under the Farm Bill.”

In the meantime; a finding presented by researchers at the American Epilepsy Society’s 70th Annual Meeting in early December discovered that CBD oil reduces the amount and severity of seizures in children and adults with severe, intractable epilepsy.

“Our research adds to the evidence that CBD may reduce frequency of seizures, but we also found that it appears to decrease the severity of seizures, which is a new finding,” said Jerzy P. Szaflarski, M.D., Ph.D., professor in the department of neurology and director of the Birmingham Epilepsy Center at the University of Alabama, who was at the meeting.

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DISCLAIMER: This is a trade opinion based on an CBD restriction catalyst. All ideas are opinions and we have zero positions short or long in companies mentioned above.

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The Society for Neuroscience Annual Meeting was held last month in San Diego. More than 30,000 neuroscientists were in attendance. They featured talks and presentations from scientists across the research spectrum. This is the largest source of contemporary brain research in the world today.

I previously mentioned the obstacles scientist encounter in researching marijuana legally. Among these obstacles is the need to justify the reason for possessing the DEA Schedule I license to research marijuana and its derivatives. Despite the fact their is greater acceptance of medicinal marijuana; its Schedule I classification (by definition), pretty much eliminates its therapeutic potential according to the funding agencies that determine the direction of research (most funding for research of medicinal benefits of marijuana comes from private foundations).

Because of this, most of the researchers focused their THC presentations on public health-related questions such as: how perinatal or adolescent exposure compromised brain development and behavior. I am not surprised when studies discover that manipulating a developing brain with drugs, stress or trauma has negative consequences. It is good if kids do not drink Red Bull, live in abusive homes or play contact sports. Although the negative effects of THC on the developing brain are currently better understood than ever, it is still not clear if strains high in CBD protect against THC’s effects.

Increasing evidence which reveal the benefits of medical marijuana cannot be ignored.

Researchers (with and without Schedule I licenses) are looking to gain a better understanding of the brain’s endogenous cannabinoid system to figure out how marijuana or other drugs work to provide therapeutic benefits. It has been accepted that the CB1 receptor is the main receptor on brain neurons that facilitate the effect of endogenous cannabinoids and exogenous cannabinoids.

Recent evidence reveals a significant contribution of the CB2 receptor; even though it makes up less than 1 percent of the brain’s cannabinoid receptors. A group of scientist from the Barrow Neurological Institute in Phoenix researched the role of CB2 receptors in hippocampus (brain area involved with learning and memory). They discovered that activating CB2 strengthened the signaling rhythms within the hippocampus while rats completed a maze. This finding has important implications for CB2’s role in spatial learning and for disease states because signaling deficits in the hippocampus are associated with depression and anxiety. The hypothesis regarding whether CB2 activation in the hippocampus could act as an antidepressant or anxiolytic remains to be tested.

The CB1 receptor has also become popular as a therapeutic target and it is becoming highly accepted that marijuana may be an effective medication for chronic pain. Many recent reports also suggest that marijuana can be a substitute for opioid-based medications such as OxyCotin and morphine.

THC enhances morphine’s pain-relieving effects, allowing lighter doses of opiates to reach the desired effect. Therefore there are fewer opioid overdoses in states with legal medical marijuana, but the neural mechanisms underlying these effects are not completely understood.

Research presented from the Levi Lab out of Mount Sinai in New York provided hints which revealed that blocking incoming pain signals at the level of the dorsal root ganglia is a common pain relieving strategy. Therefore; with chronic pain, cannabis may decrease the minimum amount of opioid medication needed for pain relief by synergistically acting to block incoming pain signals into the spinal cord. Further research is currently underway.

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Before the federal judge in New York could decide whether or not the classification of pot as a Schedule I drug under the Controlled Substances Act is a civil rights violation; the defendant charged in the case accepted a two-year prison term. The public defenders appointed to represent 58-year-old Randy Wade Kenyon following possession charges of more than 800 marijuana plants, filed a motion with the court stating the DEA’s Schedule I listing for cannabis violated Kenyon’s civil rights; as per the Bradford Era. The motion states this classification indicates the herb has “no medicinal value,” but according to state law, it clearly does.

“Especially irrational, however, is the government’s insistence that marijuana has no ‘currently accepted’ medical use,” the motion declared. “Such a position is simply unsustainable as demonstrated by numerous peer-reviewed studies, the recent passage of regulations by the New York Department of Health governing its medicinal use, the recent publication of an article in the Journal of American Medical Association noting marijuana’s efficacy compared to opioids and its widespread prescribed use of marijuana in states that have permitted the medicinal use of marijuana.”

Many of Kenyon’s illegal cultivation operations in Cattaraugus and Allegany counties were raided by a statewide weed eradication effort funded by the DEA In August. This caused Kenyon to be charged with a felony under federal law; putting him at risk of being sentenced up to 40 years in prison and fines reaching $500,000.

Even though medical cannabis is legal in New York, only companies with commercial licenses are permitted to cultivate it. As opposed to other legal states, NY patients are not permitted to grow weed at home; especially when hundreds of plants are concerned. Because of this the DEA keeps giving law enforcement agencies all over the state hundreds of thousands of dollars yearly “specifically” to track down illegal growing sites.

New York received $356,000 to cut down more than 11,000 marijuana plants, leading to the seizure of more than $1.6 million in assets, In 2015. Unfortunately, a plea agreement was accepted before the federal judge was forced to address the civil rights argument in Kenyon’s case. Kenyon will now live in a federal prison for the next couple of years. Ironically, no one has ever successfully argued the civil rights defense in connection to a federal cannabis crime. In fact, the Supreme Court has yet to even acknowledge the medical necessity defense.

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Recently, a report from cannabis conveyance platform Tradiv highlights a much more reassuring pattern for purchasers in Colorado. To be specific, legal cannabis costs are getting considerably more competitive with those of the black market. Keep in mind: Black market cannabis has minuscule overhead expenses, as there are none of the expenses connected with duties, control, and customer facing upkeep, which commonly gives it a major advantage over the lawful marijuana market.

Nonetheless, as per Tradiv, wholesale weed costs in Colorado have tumbled from amongst $2,400 and $2,600 per pound in October 2015 to only $1,400 to $1,600 per wholesale pound in August 2016. Costs are generously more focused for the purchaser, and it could bring about more income than anticipated for Colorado’s legislature as more buyers apparently buy the item through legal channels.

However, what’s truly intriguing is the purpose for the falling costs. The run of the mill suspicion would be that developing rivalry is driving down costs as little cannabis dispensaries battle for clients. The U.S. Drug Enforcement Agency as of late kept cannabis arranged as a Schedule 1 (and unlawful) substance, which ought to, in principle, keep enormous businesses out. Businesses required in the offer of weed regularly confront high expense rates, as they’re not able to take typical business reasonings, and most have next to zero access to essential budgetary administrations, such as financial records or credit extensions. The sector doesn’t appear to be exceptionally helpful for enormous businesses.

Nevertheless, that is the accurate regardless of what’s going on in Colorado. In May, the state broadened a ban on the issuance of new cannabis licenses, permitting huge cannabis players in the state to buy the larger part of licenses accessible. Moreover, there are no restrictions on the quantity of plants an office can develop in Colorado, which has permitted these greater organizations to support generation and basically surge the business sector with cannabis, regardless of the fact that interest for the item isn’t there.

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The supporter of a proposed measure to take away Montana’s legal medical marijuana system stated on Wednesday that he is not going to appeal a judge’s refusal to place the bill on November’s ballot, however, will rather focus on getting rid of another measure that would expand the outreach of medical marijuana. Billings car dealer Steve Zabawa stated in an interview that it is not within his current capabilities to appeal the Montana Supreme Court prior to Secretary of State Linda McCulloch’s office validating the ballots and sending them off to be printed.

Rather, he stated that his Safe Montana group is going to rather try to get rid of I-182. I-182 is a ballot measure that would rid some of the restrictions on medical cannabis. Zabawa made the comments a day after District Judge Heidi Ulbricht countered his plea to get in the way and force McCulloch to place his initiative on the ballot after it ended up falling short of 4,100 signatures to qualify for the ballot. Zabawa stated that thousands of signatures gathered for the initiative were either lost or were wrongly invalidated.

“We’ll spend all our efforts now making sure people know what I-182 is all about,” he stated.

Zabawa also would like to lobby the state Legislature in 2017 to pass a bill that gets rid of cannabis as well as all Schedule 1 drugs in Montana. In addition to this, he is going to think of another measure that he hopes will pass in 2018. Zabawa’s current measure, I-176, looked to repeal Montana’s medical cannabis law and would like to clarify that if a drug is federally illegal, it should be illegal under state law. The result would have been a ban on cannabis use as well as possession in the state, including the 13,170 medical cannabis patients on Montana’s registry.

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