InvestInMJ Admin

On Monday cannabidiol (CBD) producers and distributors in the UK started to receive letters from the Medicines and Healthcare Products Regulatory Agency (MHRA) demanding that they cease to sell, supply, promote, advertise or process orders for CBD products within 28 days. The letters stated that CBD now satisfies the definition of a medicinal product. The revised definition will leave UK patients with no legal access to CBD.

Officials with the MHRA are due to release a statement tomorrow, Oct. 7, to clarify the position. A spokesperson from the agency released the following statement:

We have come to the opinion that products containing cannabidiol (CBD) are a medicine. Products for therapeutic use must have a medicines’ licence before they can be legally sold or supplied in the UK. Products will have to meet safety, quality and effectiveness standards to protect public health.

We have written to UK CBD stockists and manufacturers to inform them of our view. These products will require a marketing authorisation to be granted before they can be legally sold, supplied or anywhere advertised in the UK.

Individuals who use CBD for treatment should take questions to a health care professional, the MHRA said, adding, “We can provide regulatory guidance to any company who may wish to apply for a licence.”

Peter Carroll of the End our Pain campaign, a UK medical cannabis patient advocacy group, said that “we agree that there is a need for more control in the CBD market to protect people from unscrupulous suppliers and to make sure that people understand what they are taking.” But, he added, “we fear that today’s sudden move will cause huge distress to people who rely on these products.  It will drive many people to look for CBD on the black market. It is a sledgehammer to crack a nut.”

This decision further complicates the status of medical cannabis in the UK. The definition of CBD, one of the main active ingredients in cannabis, as a medicinal product is in stark contrast with The Misuse of Drugs Regulations 2001 scheduling of cannabis as having “no medicinal value”. This adds another exception to the 2001 Regulations, the other being Sativex, a cannabis-extract which is available in very limited circumstances for some MS suffers.

CBD has been soaring in popularity recently as many people purchase it in a variety of forms either as an aid to relaxation, in an attempt to quit nicotine, or for a number of serious ailments and medical conditions. CBD has been linked to a number of potential medical applications with strong anecdotal evidence of its efficacy in treating epilepsy, anxiety, depression, and multiple sclerosis, among many other conditions.

GW Pharmaceuticals, producer of Sativex, released the results of its latest phase III clinical trial for Epidiolex, a liquid formulation of CBD, on September 26. The company hopes to achieve approval in Europe, but the product is still at trial stage and not available for patients. The product is in development for the treatment of a number of conditions, specifically rare pediatric epilepsy disorders including Dravet Syndrome and Lennox-Gastaut Syndrome.

It is unclear how long, or costly, the license application will be for current CBD vendors and whether any will in fact be successful. Medicinal products must meet certain standards before being granted a marketing authorization. Interestingly, the MHRA states that “proof of efficacy generally relies heavily on clinical trial evidence, and no products must be marketed pending any license application.” To date there have been some exciting but very limited trials around CBD but there is a lack of full clinical trial evidence. The process could take years, and it is unclear whether the results of the Epidiolex trials will be relevant to other CBD products or limited to a unique GW Pharmaceutical formulation.

There have been many concerns over the unregulated CBD market. Until now, companies were able to sell CBD products so long as they did not make any medical claims about the product. There were stories of companies breaching this condition as well as providing products of dubious origin and quality. Regulation and standards of some sort will likely be welcomed by the industry but there are serious concerns over the cost, time and process involved in making license applications.

The short deadline of 28 days will come as a worrying shock for the thousands using CBD. Many will question whether this very short deadline is in the best interests of patients. For the time being we simply don’t know how long it will be before patients relying on CBD will be able to legally access their medicine in the UK.

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The following news release was issued by the Oregon Liquor Control Commission, they have provided a guide for potential entrepreneurs and businesses interested in applying for a recreational marijuana license.  If you are considering opening up a marijuana business in Oregon, please reach out to us at www.investinmj.com and contact us if you need assistance in financing, marketing or setting up your commercial grow operation.  We have many contacts in the industry that are very interested in helping you succeed.  We can leverage out contacts with many other commercial marijuana growers to assist you, some of which may even consider a joint venture with you.

We wish you all the best in opening up a marijuana operation in Oregon, these are very exciting times but they do come with some risk, Invest In MJ is here to help you mitigate them.  
IMJ Admin.

 http://www.oregon.gov/olcc/marijuana/Documents/BusinessReadinessGuide_RecreationalMarijuana.pdf

State Produces Guide for Recreational Marijuana Businesses

Designed to Help Navigate State and Local Government Requirements

November 20, 2015

Portland, Oregon – The Oregon Liquor Control Commission has released a “Business Readiness Guidebook for Oregon Recreational Marijuana Operations” for individuals interested in applying for a recreational marijuana license.  The guidebook was produced under the guidance of Governor Kate Brown’s office, with contributions from more than a dozen state agencies that directly regulate the marijuana industry or regulate business.

“Obtaining a license from the OLCC is just one step to establishing a marijuana related business,” said Steve Marks, Executive Director of the OLCC.  “The OLCC wants to help this industry become successful and compliant, and having this guide to help navigate the business regulatory process is an important component of that effort.”

From building codes to odor control, from waste management to workplace safety, the Business Readiness Guidebook provides an overview of the rules and requirements within the larger regulatory framework under which all businesses in Oregon must operate.

By pointing to where up-to-date state and local information can be found the OLCC expects the guide will help businesses be better prepared to establish legal recreational marijuana operations in Oregon and comply with state and local law.

The “Business Readiness Guidebook for Oregon Recreational Marijuana Operations” can be found on the OLCC website and will be updated with current information as it becomes available.

For more information:
Mark Pettinger, Spokesperson
Mark.pettinger@oregon.gov  (503) 872-5115
www.marijuana.oregon.gov

FOR IMMEDIATE RELEASE: OCTOBER 23, 2015

Statement from Chairman Gary Besaw

(Keshena, WI) –Today, Federal Agents improperly and unnecessarily entered the sovereign lands of the Menominee Indian Tribe of Wisconsin and destroyed the Tribe’s industrial hemp crop.

In May 2015, the Menominee Indian Tribe of Wisconsin Tribe legalized the growing of low THC non-psychotropic industrial hemp by Tribal licensees on its lands. Notice of this change in Tribal law was provided to the United States Attorney Office for the Eastern District of Wisconsin. This action was intended to comply with Congress’s actions in 2014 Farm Bill which recognizing a distinction between marijuana and industrial hemp that created an exception to the Controlled Substance Act to allow for growth, cultivation and the study of industrial hemp in certain circumstances. The Tribe’s industrial hemp crop was always intended to be a legal crop as allowed by the 2014 Farm Bill.

In response the federal actions, Chairman Besaw stated the following:

Contributed to The Globe and Mail - Published Monday, Nov. 02, 2015 5:00AM EST
Anthony Wile is chief editor of the economic and investment newsletter The Daily Bell and chief investment strategist of High Alert Investment Management.

The election of Justin Trudeau’s Liberals has had an immediate impact on the investment marketplace, with a rush to invest in the handful of publicly traded Canadian medical marijuana startups – all on the promise of legalization of recreational marijuana use.

However, as with any burgeoning new industry, including the Canadian cannabis industry as it “whitens” from its previous black-market status, investors considering directing their capital there may want to take a temporary respite from hitting the go button.

Investors who make assumptions today about what may be profitable tomorrow will likely find their wallets considerably lightened by a changing set of regulatory circumstances.

While a legalized cannabis industry means a substantial increase in potential profitability for the industry leaders already invested in the marketplace, for all investors the key questions are: What will that new landscape look like? How will the industry be regulated, structured and taxed? And, most importantly for the new or individual investor – how best to navigate the marketplace?

Could it be true, does the U.S. Government own a patent on some Cannabis Cures?  

Yes it does seem like this is a reality.  

Marijuana remains a scheduled I drug and is included with the likes of heroin, LSD, ecstasy, meth and peyote.  Thus Cannabis has been classified as having a "high potential for abuse" and having "no currently accepted medical use'.  Ironically, there is a patent for "Cannabinoids as antioxidants and neuroprotectants" which has be in effect since October 7, 2003 and it is assigned to none other than... you guessed it,  The United States of America as represented by the Department of Health and Human Services (Washington, DC).

So while maintaining the stance that Cannabis is harmful to our health and has no medicinal value, the corporation of The United States of America over a decade ago has been assigned the patent for cannabis as a antioxidants and neuroprotectants.  Here is the Abstract about the patent:

Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and HIV dementia. Nonpsychoactive cannabinoids, such as cannabidoil, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention. A particular disclosed class of cannabinoids useful as neuroprotective antioxidants is formula (I) wherein the R group is independently selected from the group consisting of H, CH.sub.3, and COCH.sub.3. ##STR1## 

If you are interested in reading more about this patent and what it entails, here is the link to United States Patent # 6630507, Cannabinoids as antioxidants and neuroprotectants. 

What are your thoughts, should the United State of America have he rights to this patent?