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A rescheduling that makes CBD-based drug Epidiolex legal has been applauded as a win for cannabinoid-based therapies, but critics say the ruling is another case of the U.S. Drug Enforcement Administration (DEA) overstepping its bounds.

Epidiolex, which recently won U.S. Food & Drug Administration (FDA) approval, is in a classification of CBD-derived “finished dosage formulations.” It has been moved from Schedule 1, the most restricted class of drugs, to schedule 5, the least restrictive. Schedule 5 substances are considered those with “a proven medical use and low potential for abuse.”

DEA ‘overreaches’ again

“In rescheduling Epidiolex, (the) DEA also makes several over-reaching statements beyond simply the scheduling of Epidiolex,” Colorado-based cannabis attorneys Hoban Law Group said in a release. The firm pointed specifically to DEA assertions that “all cannabinoids from cannabis (versus when derived from “marihuana” as defined in the Controlled Substances Act) are controlled substances, seemingly contrary to acts of Congress, judicial decisions and DEA’s own statements.”

The rescheduling sets up an apparent conflict in that the current U.S. Farm Bill makes all products derived from hemp, including CBD, exempt from the DEA’s authority, the Hoban firm noted. The Farm Bill of 2014, which awaits updating to a 2018 version, allows the cultivation, transport, processing and sale of all parts of the plant.

Earlier FDA approval

“While DEA’s handling of Epidiolex was expected, the agency’s penchant for disregarding the law, court orders and its own admissions and directive regarding the lawfulness of hemp continues unabated,” the Hoban statement noted.

The American hemp lobby and other farm groups have been left waiting as the U.S. Congress failed to pass a new Farm Bill under a deadline that ended Sept. 30.

House and Senate Farm Bill conference committee leaders acknowledged last week that they failed to agree on final language for the bill, and indicated they’ll now look to pass a conference report after U.S. midterm elections in November, industry group Vote Hemp noted in a release.

Eager anticipation

Hemp industry stakeholders in the USA are eagerly awaiting renewal of the U.S. Farm Bill, expected to include language that will categorize hemp as an agricultural commodity and remove it from the Drug Enforcement Agency’s list of schedule 1 drugs. Passage is expected to significantly boost CBD sales and advance other hemp sub-sectors

The missed deadline also means a range of farming programs managed under the present Farm Bill do not have any new funding until a new bill is passed or an extension to the current bill is granted. Several thorny political issues still burden the bill.

‘Constituents not happy’

“Farm Bill negotiations can be unpredictable but we do still expect the Hemp Farming Act language to be included in the final bill and are still hopeful that the bill will be signed into law before the end of this year,” Vote Hemp said in the statement. “There is pressure to get a Farm Bill done and members will hear from constituents who are not happy about the failure to make a deal.”

Elixinol Global Ltd. has raised its stake in subsidiary Elixinol Japan from 35% to 50.5% after a restructuring of the business.

The company paid AUS$2.2 million ($1.6 million) for the additional shares, with the investment funded out of Elixinol’s AUS$14.2 million ($10.2 million) cash bank, the company said in a release.

Elixinol Japan made AUS$600,000 ($433,000) in revenue and broke even in the first half of 2018.

Looking to expand distribution

“Japan is a health conscious market and one which is quickly starting to recognize the nutritional and health benefits of hemp-derived CBD and hemp food products,” said Paul Benhaim, Elixinol Global’s CEO, who reported positive ongoing discussions with Japanese distribution partners, some of whom have suggested moving Elixinol products into more mainstream outlets. The company’s products have so far been in limited distribution at high-end retailers. Benhaim also said “regulatory support” in Japan should support market growth.

“This investment will enable us to further grow the market and retain our reputation as the No. 1 hemp-derived product supplier in the Japanese marketplace,” said Makoto Matsumaru, CEO of Elixinol Japan.

The U.S. Drug Enforcement Administration has taken some cannabidiol off the most restrictive class of controlled substances, a move that allows the sale of the first nonsynthetic, cannabis-derived medicine to win federal approval.

It's a decision that immediately affects CBD producers but also signals the agency’s first admission that the plant has medical value.

DEA moves CBD medicines off Schedule 1, a limited expansion of cannabis access is a post from: Marijuana Business Daily: Financial, Legal & Cannabusiness news for cannabis entrepreneurs

With projections for the growth of the U.S. CBD market diverging wildly, what’s an investor to do?

On the far-out upside, Tampa, Florida-based research firm Brightfield Group, recently told Rolling Stone it expects U.S. CBD sales to hit $22 billion by 2022.

Other forecasters beg to differ. Statista, a highly regarded statistical portal among blue-chip companies including fast-moving consumer goods producers, is projecting CBD sales will gradually grow to $1.8 billion by 2022. That’s in line with cannabis industry research specialist New Frontier Data’s Hemp Business Journal, which in 2016 projected the market would hit $2.1 billion by 2022.

Farm Bill would mean tectonic shift

While U.S. hemp stakeholders anticipate the real opening of the domestic market with the passage of this year’s Farm Bill – a tectonic shift for sure – some industry veterans say Brightfield’s outlook is nonetheless over the top.

“Twenty-two billion seems very high, especially if you compare it with other numbers,” said veteran industry consultant Daniel Kruse of Dusseldorf, Germany-based HempConsult GmbH. Kruse noted, for example, that the entire U.S. dietary supplements market is projected to generate only $57 billion by 2024 – up from $31.7 billion in 2016, according to Statista.

An initiative by hemp stakeholders has been successful in reversing a potential ban on the trading of certain cannabis stocks including CBD and hemp food companies by the German stock exchange.

Initiated and guided by Germany’s HempConsult GmbH, the European Hemp Association have successfully petitioned the clearinghouse Clearstream to shield several CBD companies who were in danger of losing trading services managed by the Luxembourg firm, a wholly owned subsidiary of Deutsche Börse.

Among other companies cleared for trading are Naturally Splendid Enterprises, New Age Farm, Inc., Nutritional High International Inc., all of Canada; and CV Sciences, Inc., of the USA.

More than 100 other cannabis companies had already been excluded from a recently announced Clearstream provision that would stop the deposit of shares, due to take effect Sept. 28, 2018, by putting settlement restrictions on “companies primarily, directly or indirectly, active in the field of medical cannabis.”

Industry sources had said the changes at Clearstream were caused by recently updated guidelines from the local controlling authority, the Commission de Surveillance Financier (CSSF), that are based on outdated cannabis laws in Luxembourg.

Paul Benhaim, CEO at Elixinol Global Ltd., is confirmed as among featured speakers at next year’s first Asian Hemp Summit in Nepal. The event is Feb. 1-2, 2019 at the Gokarna Forest Resort, Kathmandu.

Organizers also announced the launch of a special supporting partnership program designed for small and medium hemp firms, and a call for sponsors for the event.

Benhaim led Elixinol Global’s launch on the Australian Securities Exchange (ASX) last January just as national legislation was opening export possibilities for medical cannabis. Then the company launched on the OTCQX Best Market exchange in the USA just ahead of anticipated changes in federal legislation that could supercharge the CBD sector in North America.

Global expert in food, CBD

One of the world’s leading experts in hemp foods and CBD, Benhaim led efforts to open the Australian market for hempseed-based food for humans — which happened last spring.

Elixinol Global’s Hemp Foods Australia (HFA) unit is the southern hemisphere’s biggest hemp food player, and has expanded into four facilities in five years; the company deals in hemp seeds, oil and protein. Elixinol has CBD operations on four continents.

Plenty of barriers still face the startup of a hemp industry in South Africa, but last week’s decriminalization of all cannabis by the country’s constitutional court means new hope for development based on the crop, stakeholders said in the wake of the ruling.

“Coupled with the recent moves by the South African Department of Trade and Industry (DTI), it helps put S.A. on track for a vibrant hemp economy,” said Tony Budden, long-time South African cannabis activist who managed to change his travel plans last minute to attend the court’s judgment, and the celebration that followed.

The DTI recently announced that it is investigating the potential for hemp in a number of applications and sectors, with Minister Rob Davies saying his department recognizes South Africa can become an innovative player in the fast-growing global markets for hemp.

Parallel initiatives afoot

Other initiatives are advancing as well, with the court’s judgment coming at the same time the Cannabis Development Council of South Africa (CDCSA), a new industry body, was celebrating its official launch with a festival in Chintsa, Eastern Cape, one of the country’s poorest provinces but famed for its cannabis growing. CDCSA’s aim is to create viable frameworks for cannabis production and incentivize hemp value chains, while assisting policy making in reshaping current laws.

And the S.A. Department of Agriculture, Forestry and Fisheries recently announced it established an interdepartmental team to help set up regulatory frameworks for industrial hemp.

The director of Poland’s government-owned Institute of Natural Fibers and Medicinal Plants (IWNiRZ) has left his position to become vice-president for financial affairs at Grupa Lotos, a state-held petroleum company.

Sobków, who was in the IWNiRZ position for two years, led the commercialization of Institute assets worth more than $1 million annually, and early this year engineered government financing of a 14.5 million zloty ($4.2 million) project to expand production of Polish hemp.

Also during Sobków’s tenure, IWNiRZ signed a contract with two U.S.-based hemp firms to sell certified planting seed in The Americas in what the Institute in January called “the largest contract for the sale of industrial cannabis seeds in the history of Poland.”

The post Director of Polish institute departs for position with state oil company appeared first on HempToday.

Denver, Colorado-based Elixinol Global Limited today debuted on the OTCQX Best Market in the USA just ahead of anticipated changes in federal legislation that could supercharge the CBD sector.

Elixinol, which started trading on the Australian Securities Exchange this past January, has interests in the hemp-based CBD, nutraceuticals, food supplements, skincare and medical cannabis sectors. The company has CBD distribution operations in 40 countries across North and South America, Europe, Asia and the Pacific Region.

Farm bill on the cusp

Elixinol’s launch in the USA comes as the 2018 U.S. Farm Bill, expected to include language that will categorize hemp as an agricultural commodity and remove it from the DEA’s list of schedule 1 drugs, is before the U.S. Congress. Passage is expected to significantly boost CBD sales. Deadline for passage of the Farm Bill is the end of September.

Elixinol said in a release that it was the only company in its sector to post a profit in the first six months of 2018, driven mainly by CBD sales via private label, e-commerce, mid-market and bulk channels.

Major advancements in Colorado

“Our Colorado location enabled us to get our seed-to-sale verticalization operational earlier this year, giving us a competitive advantage,” said Gabriel Ettenson, Elixinol General Manager.

The U.S. Hemp Industries Association has issued a call for candidates for the organization’s board of directors, with five seats open in the next election.

Applications are due Sept. 28, with voting to run from October through the Association’s 25th Conference & Trade Show in Los Angeles Nov. 2-5, according to a recent HIA notice.

Candidates must be HIA farming or business members who’ve been in the Association for two consecutive years, under HIA bylaws.

Current HIA officers and other board members are: President, Joy Beckerman, Hemp Ace International, a Seattle-based consultancy; Vice President, Rick Trojan, Hemp Road Trip, Colorado; Treasurer, David Bush, DavidLaw, a Wheat Ridge, Colorado attorney specializing in hemp industry law; Secretary, Tyler Frank, Hemptopia Apparel, a Solvang, California hemp apparel retailer; Larry Serbin, Hemp Traders, a California-based marketplace for hemp products; Anndrea Hermann, The Ridge International Cannabis Consulting, and Hemp Technologies; Rick Krantz, Tahoe Hemp Company, a South Lake Tahoe, California hemp retailer; and Dustin Cosgrove, Hemp Oil Canada, British Columbia, an industrial scale hemp food maker.

The terms of Bush, Serbin, Herman, Cosgrove and Krantz all expire this year, according to HIA’s web site.

American hemp entrepreneur Eric McKee will share his experiences as an eco-entrepreneur at this year’s Hemp2020 Business Summit Oct. 19-20 at HempToday Center in Poland.

McKee’s company, Colorado-based Windr LLC, specializes in hemp based solutions to combat global problems, and has worked in Haiti demonstrating hemp’s potential for humanitarian purposes at the Wynne Farm Nature Reserve. A U.S. Marine veteran, McKee later worked for major brands in the outdoor/ski sector where he discovered hemp’s disruptive potential in the plastics industry. He oversaw construction of the first fully permitted hempcrete structure in Denver, Colorado in 2017.

So far: Reps from 9 countries

Representatives from nine countries have so far confirmed attendance at the third annual Hemp: 2020 Summit: Poland, Germany, USA, Haiti, Nepal, Latvia, Lithuania, Ireland and the Czech Republic.

A limited number of accreditations remain available for the two-day event, which hosts a maximum 25 participants.

An International Cannabis Policy Conference Dec. 7-9, 2018 in Vienna is the last opportunity for stakeholder input into crucial international regulations that will go to the United Nations next year.

The Conference overlaps with a UN Commission on Narcotic Drugs (CND) meeting Dec. 5-7, also in Vienna, during which WHO representatives will give the definitive outcome and recommendations for the re-scheduling of cannabis, and guidelines for cannabidiol to the UN’s Commission on Narcotic Drugs (CND). CND is the only United Nations body dealing with cannabis policy.

Potential for development

Recommendations coming out of the Policy Conference will supplement WHO re-scheduling guidelines by emphasizing the potential for the development of cannabis and industrial hemp markets as well as products and innovations that meet the 2030 UN Sustainable Development Goals (SDG), a global framework for eco-responsible societies.

The Policy Conference is organized by FAAAT, an international lobbying organization and think tank.

Penultimate step

The Vienna events mark the penultimate step toward re-orientation of international norms addressing cannabis, with input from both forums to be considered during the UN session on drug policy in March 2019. That session is to set new Cannabis Treaty scheduling and establish a 2019-2029 joint plan of action on drugs for all countries. The 10-year plan is an opportunity to guide countries in developing innovative policies and new market perspectives for cannabis, FAAAT said.

Pamela Bosch, founder of Highland Hemp House (USA) will reflect on her odyssey retrofitting a 1970s era stick frame home with hempcrete during this year’s International Hemp Building Symposium Oct. 16-17 in Brussels.

Bosch stripped away the toxic layers from the walls of her 1970s-era traditional stick-frame Bellingham, Washington home last spring, and through the summer replaced that material with a hempcrete mixture carefully sourced from suppliers and consultants in Europe.

She also convinced local authorities about hemp’s viability and successfully worked her project through local building codes – complex undertakings she’ll share at IHBA.

Other speakers at IHBA

The IHBA Symposium, which is hosted in a different part of the world each year, is led by veteran hemp builder Steve Allin, the Association’s Director. This year’s host and co-organizer is Wolf Jordan & Co, which is based in Brussels and Kalmthout, Belgium.

PART ONE: Jacek Kramarz, Sales Director at HemPoland, talks about the evolution of the company before it was acquired in August 2018 by The Green Organic Dutchman Holdings Ltd., Canada in a $15 million deal in August 2018.

PART TWO: HempToday Editor & Publisher Kehrt Reyher talks with cannabis veterans Boaz Wachtel, CEO at Creso Pharma and Pavel Kubu, CEO of the International Cannabis and Cannabinioids Instititute about global challenges to the CBD sector; and old times in Israel & the Czech Republic.

Time stamp guide to the episode:

01:11 – Begin: Interview with Jacek Kramarz
01:28 – Execution of the strategy since 2016
02:25 – Biggest such deal in Europe
03:10 – Main markets for CannabiGold
03:40 – Looking at other promising markets
04:08 – Contrasting EU and U.S. markets
08:00 – Changing profile of the CBD consumer
08:22 – What now for HemPoland & CannabiGold

09:23 – Looking back and ahead with Pavel Kubu and Boaz Wachtel.
10:33 – Why Israel was so advanced in the early days.
11:32 – United in early cannabis struggles.
12:10 – Czech Republic’s role in European medical cannabis.
12:55 – Overview: Mission of the International Cannabis and Cannabinoid’s Institute.
13:55 – The need to properly inform patients of basic data on cannabis products.
14:33 – Problems revealed in ICCI study of CBD products this year.
16:00 – Creso Pharma strategy to ensuring high-quality products.
17:00 – Quality is in focus, some growers may get squeezed.
18:53 – The challenges facing CBD.
20:50 – Europe’s problem with allowable THC levels.
22:45 – Global markets that hold promise.
25:04 – What’s ahead for ICCI.
26:30 – What’s ahead for Creso Pharma.

Canada-based Aurora Cannabis has purchased two Lithuanian hemp companies for a total of €6.3 million ($7.3 million) in cash and stock. Aurora bought seed contractor and processor Agropro UAB, and Borela UAB, a processor and distributor of hemp-based food products, the company announced.

Aurora, Edmonton, Alberta, paid €5,364,000 (approximately $6.2 million) in cash and €960,000 ($1.1 million) in stock to purchase 100% of the two firms.

Second Canadian acquisition in month

It’s the second major acquisition by a Canadian cannabis company in Europe in the past month after The Green Organic Dutchman Holdings Ltd., Ancaster, Ontario, bought Polish hemp firm HemPoland for €15 million ($17.4 million) plus a €10 million ($11.6 million) incentive package in August.

Aurora said it also will refinance existing debt of the acquired firms totaling €2,076,000 (approximately $2.4 million).

“Through Aurora, we gain access to a wider distribution network, as well as access to industry-leading science to help ramp up production, while enhancing margins through the introduction of new products, proven production techniques, and robust genetics,” said Skirmantas Nikstele Co-Founder & CEO at Agropro.

The Canadian Hemp Trade Alliance (CHTA) says it is exploring a research project totaling almost $5 million over the next five years to boost industry standards, explore hemp’s many applications and develop plant genetics.

The project would look specifically at standards for quality and safety; livestock feed applications; and human health applications, CHTA said in a release.

First research project completed

CHTA just completed a $330,500 project that focused on safety and quality in Canadian hemp, with support from the Ministry of Agriculture and Agri-Food Canada under the government’s Growing Forward 2, Agri-Risk Initiatives program.

The project, was a collaboration between the CHTA and Toronto-based Agri-Neo Inc., a food safety specialist, that focused on determining safe and cost-effective prevention and mitigation techniques for the control of pathogens in industrial hemp. The project also delivered Best Management Practices training to producers and processors.

Developing policies

CHTA said it will work with the Ministry of Agriculture and Agri-Food Canada, the Canadian Food Inspection Agency and Health Canada to develop policies and regulations aimed at facilitating growth while at the same time protecting consumers in markets around the world where Canadian hemp products are sold.

Despite significant institutional challenges, the European CBD market will see strong growth for those companies that can navigate the murky waters of EU regulation while managing growth in a fast moving industry.

And while CBD represents huge global potential for the food, pharmaceutical and nutraceutical sectors, some players could end up victims of a shakeout as investors and consumers gravitate toward companies, products and brands that focus on quality and science.

Those were among key conclusions drawn from “The Future of Medical Hemp” Summit as delegates from Europe, Asia and North America met for two days of discussions at HempToday Center in Poland in late August.

Tough slogging but worth it

While varying legal frameworks country-by-country make Europe sometimes tough to navigate, the situation is manageable – and well worth it, said Jacek Kramarz, Chief of Sales at HemPoland, maker of the fast-moving CBD brand CannabiGold. The Elbląg, Poland-based firm was recently sold in what is the biggest acquisition of its kind on the continent to date.

“What’s more difficult is planning the business,” said Kramarz, noting that longer-term forecasting can be a meaningless exercise in a sector that’s growing so fast. Compounding challenges in Europe are things as pedestrian as the packaging and labeling of products – which must be carefully executed to meet local language and marketing needs as well as regulatory considerations, Kramarz noted.

An open letter to the South African constitutional court, endorsed by several South African cannabis NGO’s and businesses, has bemoaned the lack of progress and missed opportunities in establishing a viable hemp industry in the country. This despite “research trials” having been undertaken since 1998, and despite the fact that legalisation of the crop presents a unique ability to address many of the social ills that plague the country, including a clogged criminal justice system, struggling economy and notoriously high levels of unemployment.

South Africa is unique in that it is fighting cannabis prohibition via the country’s strong constitution. Several high profile court cases have and are taking place, including a high court judgment made in March 2017, that deemed the infringements on privacy and freedom of current cannabis prohibition laws unconstitutional. Despite this finding, over 180,000 South Africans have been arrested for cannabis possession, cultivation or consumption since the court judgment, according to some estimates.

Strategy is drag on law enforcement

The open letter presents an overview of cannabis in the criminal justice system, and shows how cannabis legalization could relieve some of the pressure on the courts, freeing up police resources to focus on serious crimes. It also alludes to developments in other sub-Saharan countries and international hemp trends, and describes the state of medical hemp in SA.

The letter details the massive opportunity presented by industrial hemp to the South African economy – in revitalizing agriculture, promoting industry, alleviating poverty and social inequality, to eventually meet the SA government’s own National Development Plan.

Cannabis opportunities missed

According to the plan, South Africa “can realize these goals by drawing on the energies of its people, growing an inclusive economy, building capabilities, enhancing the capacity of the state, and promoting leadership and partnerships throughout society” and according to the open letter, efficient and inclusive regulation of cannabis will go a long way in achieving these lofty goals.

U.S.-based We Are For Better Alternatives (WAFBA) says it has ordered a first shipment of specialized guitars molded from hemp composite as it launches Silver Mountain Hemp (SMH), a new brand.

The guitars are the centerpiece for a line that also includes components and accessories. WAFBA has organized several strategic partnerships to source the products, said Morris Beegle, founder and owner at Ft. Collins, Colorado-based WAFBA.

“We’re demonstrating the potential to establish a supply chain with great partners who are committed to earth-friendly practices,” Beegle said of the development of the products, all of which have hemp in them. “Our entire business model is really centered around that.”

Highly customizable

SMH looks to stand out in the highly competitive musical instrument market by offering guitars built to customers’ specifications. “The plan is to let buyers customize their guitars with different color finishes, electronics, bridges, fretboards, tuners and knobs,” said Beegle, a 30-year veteran of the American entertainment industry. His firm also is owner of the Colorado-based NoCo Hemp Expo as well as Southern Hemp Expo, which debuts in Nashville, Tennessee this month.