ARTICLES

Thailand legalizes marijuana for medical use, research

Published December 26, 2018

Just one month after a proposed law breezed through a key hurdle, Thailand’s National Legislative Assembly voted 166-0 (with 13 abstentions) to allow medical marijuana and cannabis research. [1]

The move came as a year-end surprise because the Assembly was expected to take 60 days to deliberate the draft.

The Southeast Asia nation could be sitting on a $4 billion medical cannabis industry within a decade, according to analysts.

Concern that non-Thai medical marijuana companies could come to dominate the country’s MMJ sector still needs to be addressed, as several patent requests from foreign entities have already been filed.

“We’re going to demand that the government revoke all these requests before the law takes effect,” said Panthep Puapongpan, dean of the Rangsit Institute of Integrative Medicine and Anti-Aging, told Reuters.

Recreational use of marijuana remains illegal in Thailand.

[1] Marijuana Business Daily

With Trump’s signature on the Farm Bill, hemp gains federally legal status

Published December 20, 2018 | By Kristen Nichols

President Donald Trump has signed hemp legalization into law, a change expected to unleash seismic market changes for the hemp industry. [1]

Trump’s signature on the 2018 Farm Bill immediately removes hemp – defined cannabis below 0.3% THC – from the Controlled Substances Act.

The change also applies to extracts from hemp, including CBD and other cannabinoids.

“This is unbelievable,” said Cory Sharp, a hemp consultant in Washington state who sells hemp seeds and advises new hemp producers. “This industry is blowing up faster than anybody could have guessed.”

Federal drug authorities will have to treat hemp like any other agricultural commodity, such as wheat or potatoes, and hemp farmers will no longer face legal or regulatory burdens of being classified as an illegal drug, such as difficulty getting crop insurance or barriers to getting loans.

Here’s what you need to know about implementation of the new law, which is likely to take months or years.:

  • Hemp producers holding cultivation licenses in the 42 states with existing pilot programs won’t see an immediate change. Those state laws will remain in effect until the U.S. Department of Agriculture (USDA) has time to review the state regulations to decide which pass muster.
  • The USDA must come up with national hemp regulations “as expeditiously as practicable,” an uncertain timeframe. The national plan must include procedures for checking THC content and plans to destroy plants that test “hot.”
  • The U.S. Food and Drug Administration retains authority over foods, drugs and cosmetics. That means that while CBD is legal in Jan. 1, that doesn’t necessarily mean it is legal to add hemp or CBD to food products or dietary supplements.
  • States, territories and Indian tribes have no deadline to submit hemp-regulation plans to the USDA. But once a plan is submitted, the USDA has 60 days to approve or reject it.
  • If a state’s oversight plan is rejected, hemp growers will be “subject to a plan established by the (USDA) to monitor and regulate that production.”
  • The USDA has one year to study progress in the 42 states and “determine the economic viability of the domestic production and sale of industrial hemp.” Those findings will then be presented to Congress.

The hemp industry has been pushing for legalization for decades, but the plant’s long association with high-THC varieties kept it locked alongside heroin and marijuana in Schedule 1 of the CSA, the most restricted drug classification in the U.S.

CBD entrepreneurs say the Farm Bill’s passage opens up unbelievable business opportunities, especially because interstate commerce is ensured. In other words, no state will be allowed to intercept or impound hemp products.

But hemp entrepreneurs caution that the industry must now follow the new overseers of the hemp plant and its products, the USDA and the FDA.

“Hemp may be federally legal with the passage of the Farm Bill. However, more importantly, where is it sourced? How is it processed?” asked Lisa Richard, co-CEO of L’eela CBD Body Care of Denver. “The passage of the Farm Bill,” she said, “is only the first chapter.”

[1] Hemp Industry Daily

Chart: How the 2018 Farm Bill addresses top hemp industry challenges

Published December 17, 2018 | By Eli McVey and Maggie Cowee

Several major hurdles undermining hemp cultivators’ ability to run successful, profitable businesses are set to crumble once President Donald Trump signs the 2018 Farm Bill. [1]

Challenges such as finding processors or accessing banking services – problems attributable to the patchwork of state laws and regulations that have so far underpinned the industry – will be directly addressed by the 2018 Farm Bill.

In addition, issues such as finding adequate harvesting equipment or qualified management could be resolved over time as a result of hemp and CBD’s new federally legal status.

Expanding access for the hemp side of the cannabis industry could also have a positive effect on the marijuana industry, as well, in that it will provide a pathway for growers to experiment with a variety of the plant that is federally legal – which could lead to improved processes for all cultivators.

Data regarding hemp cultivators’ top challenges was published earlier this year in the Hemp & CBD Industry Factbook, before any significant movement on the federal level.

The report showed that the top challenge – by a wide margin – was finding processors, largely a function of the inability to look outside their home states.

But once the 2018 Farm Bill is signed, growers will be free to ship their products to processors across the nation.

“While the new provisions allow states to adopt their own plans for regulating hemp, no state can prohibit the transport of hemp across its lines,” said Shawn Hauser, chair of the hemp and cannabinoid group at Denver’s Vicente Sederberg law firm.

“There’s an express protection in the final language prohibiting interference with interstate transport, regardless of what kind of plan states choose to adopt.”

That provision allows growers in a state such as North Dakota – where just five hemp processors were licensed in 2018 – to ship their crop to Oregon, which has more than 150 licensed processors.

The 2018 Farm Bill will also directly alleviate hemp cultivators’ lack of banking services, opening the door to increased access to investment capital and low-interest loans – financial vehicles businesses in the mainstream economy can readily employ.

It is worth noting, however, that while concerns around federal laws and intervention are directly addressed in the Farm Bill, uncertainty around the legality of CBD remains. (Emphasis added)

The Farm Bill removes hemp and its derivatives from the Controlled Substances Act, though CBD will still be regulated by the Food and Drug Administration (FDA).

That means CBD will still be subject to the provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), which may ultimately limit the ways the extract can be marketed and sold commercially.

“It’s significant to acknowledge that the 2018 Farm Bill expressly doesn’t do anything to amend the FFDCA that still governs all food and drugs, cosmetics and devices sold in commerce,” Hauser said.

While these direct impacts will likely play a significant role in moving the hemp industry forward, multiple other challenges will be indirectly impacted as well.

Access to equipment, managing growth and scalability as well as to qualified labor may improve through the introduction of new public and private investment.

Financial losses to pest and weed pressure can also be reduced by allowing hemp cultivators access to traditional crop insurance products.

[1] Marijuana Business Daily

Farm Bill compromise allows nationwide hemp production for any use – including CBD

Published December 11, 2018 | By Kristen Nichols
1.7k SHARES

(This story has been updated with the full Senate approving the 2018 Farm Bill.)
A long-awaited end to five decades of hemp prohibition has been approved by a House-Senate panel, potentially opening the door to hemp production in all 50 states for any use – including CBD. [1]
The measure is included in the 2018 Farm Bill, which passed the Senate 87-13 on Tuesday and still must pass the House before work is concluded for the year and all pending legislation dies.
BREAKING: Senate approves 2018 Farm Bill compromise 87-13, sending measure to House for one more vote. Then to President Donald Trump. #hemp industry anxiously awaiting final approval.

In addition to lifting restrictions on advertising, marketing, banking and other financial services, the passage of the measure would:
Allow hemp production in all 50 states for any use, including flower production and CBD or other cannabinoid extraction. States will have the option to submit their own plans to regulate hemp. (Emphasis added)
Allow interstate commerce for hemp and hemp-derived CBD.
Give the U.S. Department of Agriculture (USDA) the job of overseeing hemp production, with direction to come up with rules “as expeditiously as practicable.”
Legalize hemp production in U.S. territories and on Indian tribal land – which was not included under the 2014 Farm Bill.
Give the industry access to federally backed farm support programs, including crop insurance, federal water access and low-interest loans for new farmers.
Allow hemp producers to “bring foreign nationals to the United States to fill “temporary agricultural jobs.”
Remove barriers to getting intellectual property protections under federal law, such as patents and trademarks.
Set a 10-year ban under which state or federal drug felons cannot participate in the hemp program, except for people already growing hemp under a state pilot project (as established by the 2014 Farm Bill).
Require the USDA to consult with the U.S. attorney general on the hemp rules.

The bill also states that licensed hemp producers who grow cannabis plants that exceed the THC limitation of 0.3% will not be guilty of a drug crime but instead must submit a plan to correct the “hot” hemp.
Hemp entrepreneurs have been intensely anticipating the changes, based in large part on support from Senate Majority Leader Mitch McConnell, a Kentucky Republican.
Senators signed off on the updated Farm Bill measure Tuesday afternoon, calling it a good compromise.
“This may not be the best possible bill. But it is the best bill possible,” said Sen. Pat Roberts, a Kansas Republican.
The Farm Bill must still make its way through the House and to President Donald Trump’s desk before Jan, 3, when a new Congress takes over.
It’s a tight timeline, especially considering that Congress must address a larger spending measure to avoid a government shutdown, a measure that is far more controversial because it could include money to build a wall along the Mexican border.
Still, hemp entrepreneurs are cheering the compromise Farm Bill release as a watershed moment for the entire cannabis industry.
“As a small business this is incredibly exciting,” said Robert Leaker of Vitality CBD Natural Health Products, a Montana hemp producer and manufacturer that is thought to be the nation’s single largest hemp producer, with 20,000 acres grown this year.
Leaker’s company recently announced a plan to go public in Canada via a reverse takeover, a common route for U.S. cannabis producers to trade on a public stock exchange.
The Farm Bill passage would end the need for U.S. hemp companies to list in Canada, instead allowing them to directly access U.S. exchanges such as the Nasdaq or New York Stock Exchange.
“We see access to capital, as well as access to large potential buyers of CBD, to be all opening up because of this,” Leaker said.
“Until it’s federally recognized that CBD is not a Schedule 1 drug, it’s very difficult for banks and investment capital to come into this space.”
[1] Hemp Industry Daily

New York state bans CBD foods, vape products

Published December 10, 2018 | By Kristen Nichols

New York state is banning CBD vape and food manufacturing and asking 2019 hemp licensees to sign a waiver acknowledging the “inherent risk” of making a dietary supplement considered off-limits by federal health authorities. [1]

The New York State Department of Agriculture and Markets also will require hemp-derived CBD supplements to go through the same testing as medical marijuana products.

The rules were posted as the state announced a new license category for processing hemp for CBD.
The new permits cost $500, the same price as licenses to grow hemp and process it for grain and fiber.
Along with the new licenses, New York is adding a long list of limitations on CBD producers.
Here’s what you need to know about the new rules:

  • CBD extraction must be performed using only “CO2 or human-grade ethanol.”
  • Products must be “properly labeled and packaged for sale pursuant to FDA regulations for dietary supplements,” even though New York requires processors to acknowledge that the FDA considers them illegal.
  • CBD products can’t go in food. Infused chocolate can be sold, but as a dietary supplement rather than as a food, a distinction that relates to production standards. CBD beverages must also be sold as dietary supplements.
  • New York bans any “vaping product or product introducing CBD through inhalation.”
  • Suppositories are banned, too.
  • Production of “ready-to-eat food with additional CBD infusions or CBD extracts, such as CBD chocolate syrup or CBD soda or CBD-infused frosting-drizzled cookies” will not be allowed.

In addition to the waiver regarding FDA rules, CBD producers must acknowledge that “the state of the law with respect to industrial hemp is in flux, at both the federal and state level.”

New York’s new rules are giving the state’s young CBD industry a scare.

“I looked at this new application and thought, ‘Oh, my gosh. What are they doing?’ They just threw out these new rules without thinking about it, I guess,” said Chris VanDusen, president of Empire Hemp Co., a vertically integrated hemp grower, processor and retailer near Rochester.

“It’s undermining opportunities for farmers if they can’t grow (hemp CBD) for food products. They seem like they’re trying to let big business come in and wipe us all out.”

But one New York manufacturer, Andrew Rosner of HR Botanicals in Long Eddy, said the state’s stricter CBD regulations could provide a market advantage.

“If people are getting high-quality products and New York is able to protect consumers, for us that’s a win-win,” said Rosner, who just harvested his first hemp crop and is in the process of extracting its CBD for a line of tinctures.
New York agriculture authorities did not immediately respond to messages from Hemp Industry Daily about the new rules and how they would be enforced. New York reported about 3,500 acres in hemp production this year, up from roughly 2,000 acres in 2017.

The state’s changes put it alongside Oregon, California and Ohio in requiring that CBD products be produced according to regulations governing MMJ products.

[1] Hemp Industry Daily

Academia joins CBD research boom, offering new market opportunities

Published October 26, 2018 | By Kristen Nichols

Lack of significant research on the effect of cannabinoids has long been a bane to the CBD and hemp industries. But in the wake of the U.S. Drug Enforcement Administration’s decision to reschedule some cannabis-derived products, researchers are looking for ways to open and capitalize on new markets and uses. [1]

Two Stanford University researchers, Jonathan Rothbard and Lawrence Steinman, announced last week they are starting a medical cannabis company to pursue treatments targeting cannabinoid receptors to treat inflammatory diseases such as Crohn’s disease.

Their company, Katexco Pharmaceuticals, plans to combine plant-derived cannabinoids with synthetic ones to target CB2 receptors, which don’t produce an intoxicating “high” feeling when stimulated.

Patient trials, they noted, will be conducted outside the United States.

“We’re very interested in exploiting the capacity of the cannabinoid compounds to reduce inflammation,” Steinman told Hemp Industry Daily. He did not say why the new company plans to source CBD from outside the U.S.

The U.S. Food and Drug Administration’s approval in June of a cannabis-derived medicine, followed by the DEA’s rescheduling in September of cannabinoid medicine that has FDA approval and no more than 0.1% THC, is opening up research opportunities, Steinman said.

“The environment is really heading toward acceptance of its medical use,” he said. “We want to develop a licensed drug that can be used in combination with cannabidiol.”

Industrywide thaw

The Stanford researchers aren’t the only ones looking to tap into cannabis’ increasing acceptance for profitable research opportunities.

Michigan State University also announced last week that a faculty toxicologist received $2.4 million from the National Institutes of Health to study how cannabinoids affect brain cells in HIV patients.

And a Winchester, Kentucky, hemp producer, Atalo Holdings, is awaiting federal approval to send some of its hemp seeds to the International Space Station (ISS) through a for-profit research firm.

The research firm, Space Tango of Lexington, Kentucky, is seeking NASA approval to take the seeds onto the ISS to study how hemp germinates in micro-gravity, research that could help scientists better understand the plant.

“We think there’s some really interesting potential in CBD and other cannabinoids,” Space Tango chairman Kris Kimel said.

There’s a noticeable thaw in academia and the federal government in terms of their approach to cannabis, said David Bush, founder of the Denver-based Industrial Hemp Research Foundation, which was started in 2015 to raise money to fund experimentation with the plant.

“CBD research in general is going on quite a bit,” said Bush, who added that the Stanford approach to form a company to market cannabinoid-based medicine may be a first.

“The mere fact that the FDA has approved a cannabis drug and the DEA has taken it upon itself to reschedule at least a kind of CBD drug – to put that on a reduced schedule – speaks volumes to the direction we’re moving.”

How to capitalize

Expanding CBD research signals more interest in the cannabinoid’s medical potential.

But CBD companies still need to take a careful approach to see their products used in academic research, said Robert Chavez, a former director of medical business development for the University of Miami Health System.

Chavez – who now leads a Miami-based cannabis company that makes CBD products, Avant-Garde Holdings – advised companies seeking business opportunities in academic cannabinoid research to:

  • Be patient.Academia moves more slowly than a startup business, and academic institutions are fiercely protective of their reputations, meaning that cannabis research approval could be downright glacial. “It’s such a high-profile thing that a university is not going to research this without the president knowing. There are a lot of layers of bureaucracy.”
  • Not oversell CBD’s potential.Just as a retailer can’t promise consumers any medical benefit, CBD producers should tread carefully when approaching a research entity. “Even inferring your product is a cure for anything is dangerous, a slippery slope.”
  • Avoid money talk.A potential business partner may be dazzled by promises of future profits, but academia requires a different pitch. “I would not approach a university saying you can make a lot of money on this, because they want integrity. Any university has plenty of legal and financial backing. You need to approach them with honesty and integrity above all.”

Brace for change

Academia’s increased interest in cannabis brings huge new opportunities for cannabinoid producers – but it also presents challenges. Scientists may be looking at the plant differently than a cannabis user-turned-entrepreneur.

The Stanford researchers, for example, are testing plant-derived cannabinoids in conjunction with the synthetic compound they’re creating.

Synthetic cannabis is anathema to many in the cannabis industry, according to Rothbard, but it’s likely the future of pharmaceutical applications for the plant.

“The future of medical marijuana is very limited because of reproducibility and the fact that it’s a mixture of multiple pharmaceutical agents,” he said.

“The future will be to segregate and isolate (cannabinoids), define them and synthesize them and distribute them. … There’s going to be a natural progression in cannabis products.”

[1] Hemp Industry Daily

‘Potential is limitless’: Nevada CBD manufacturer inks nationwide deal with drugstores

Published December 19, 2018

A manufacturer making topical pain relievers with hemp-derived CBD plans to distribute its products nationwide through a network of independent drugstores, a deal announced in advance of expected Farm Bill approval by President Donald Trump in coming days. [1]

Leading Edge Pharma of Henderson, Nevada, announced Monday that its Cannavera line of CBD-infused creams, sprays and oils will be sold in some 100 Care Pharmacy stores in 22 states.

The pharmacies are a cooperative and operate under unique names, with locations in California, Maryland, New York and elsewhere.

Leading Edge CEO David Chadwick told Hemp Industry Daily that the Cannavera topicals are already on shelves in network stores in the southeastern U.S.

“After the signing of the Farm Bill … I believe the potential is limitless when it comes to distribution,” Chadwick said.

“Drug stores are a quality, credible location, and from there (CBD) can go just about anywhere.”

The looming Farm Bill would leave CBD products under the regulatory purview of the U.S. Food and Drug Administration. The agency has said repeatedly that CBD cannot be added to foods or dietary supplements because it is an active ingredient in an approved pharmaceutical drug, Epidiolex.

Chadwick said his company’s topical formulations fall outside the FDA’s ban, but it still intends to seek the ageny’s approval.

“FDA has a big job to do in keeping the public safe, and with that in mind, companies like ours are focused on research … and will take that route of submitting products for approval,” Chadwick said.

[1] Hemp Industry Daily

Cannabis tech firm Eaze opens online CBD marketplace to meet growing demand

Published November 15, 2018

San Francisco-based tech company Eaze launched a new online marketplace, Eaze Wellness, to ship hemp-derived CBD products to 41 states across the U.S. and the District of Columbia. [1]

CBD sales more than doubled among the company’s customers last year, Sheena Shiravi, Eaze’s director of consumer communications, told Fortune, highlighting a key business opportunity.

This marks the company’s first expansion outside California, Eaze reported in a press release.

Eaze will only ship CBD to 41 states right now because of regulatory challenges tied to the extract’s legality. (Emphasis Added)

“Consumers can visit the Eaze Wellness website to learn more about CBD, browse the menu and purchase products,” the release said. “Purchases will be shipped via a third-party provider and will arrive in 4-6 business days.”

According to online publication Quartz, Eaze Wellness is launching with about 100 different products from roughly 20 brands and will include CBD offerings for pets.

[1] Hemp Industry Daily

One day you’re legal, the next day you’re not’: Confusion from spotty CBD enforcement

Published September 21, 2018 | By Hemp Industry Daily staff

CBD producers and retailers in some of the nation’s largest markets say they’re pressing on despite hostile statements from their state regulators that CBD won’t be allowed. [1]

Bans in several markets have largely been met with spotty enforcement, CBD entrepreneurs say, and the impact to business has been mixed.

Ohio is one of the latest states to join the movement against the cannabinoid, with the state’s Board of Pharmacy last month announcing that the product is legal only in medical marijuana dispensaries. (Emphasis added)

The agency sent letters to pharmacists and to show organizers instructing them to not allow CBD products.

The letters tripped up Cannabinoid Creations, which makes a CBD product for horses and had been showing its wares for several years at the All American Quarter Horse Congress, a monthlong horse show in October in Columbus, Ohio.

When company founder Scott Leshman asked about parking at this year’s event, the show replied that his company could no longer participate.

“They forwarded me a copy of the CBD ruling and said, ‘Sorry, we can’t have you here,’” Leshman said.

Leshman founded his company in Michigan but planned to move to Ohio after Michigan said CBD products must be sold in marijuana dispensaries.

Now that Ohio appears to be cracking down, too, he has moved his manufacturing to Denver. He’s also in the process of getting new labels that use the word “hemp” instead of the letters C-B-D.

“One day you’re legal, the next day you’re not,” Leshman said. “In this industry, you have to be ready with a Plan B at all times.”

Other Ohio businesses see a sales opportunity in the confusion.

“We’re seeing people stocking up for the worst. A lot of our customers are buying more than they typically would,” said Kent Dockus, operations manager for Clean Remedies, a Cleveland company that makes CBD tinctures and bath salts from hemp grown in Oregon.

California keeps it low-key

In California, the world’s largest cannabis market, the state Department of Public Health (CDPH) said in July that CBD is legal only if it comes from marijuana and is sold in that state’s MJ system.

Hemp-derived CBD is considered illegal to put in foods or nutritional supplements, the most common use of CBD extracts, in part because the California health department does not consider hemp to be covered under the state’s cannabis regulations.

Two months after the announcement, the agency told Hemp Industry Daily that it has not taken any direct enforcement action beyond posting notice of the ban on its website and sending a copy to local environmental health agencies.

Local responses have been mixed, according to CBD operators in the state.

Erika Valentina Doria said her Carlsbad company that makes CBD products for pets, Cannimal, was turned away from a Dog Days of Summer festival in Encinitas, just north of San Diego.

But nearby jurisdictions didn’t balk at her selling the products at similar events across the state.

“CBD is well known here. There is more regulation coming from government bodies, but some are enforcing it, some aren’t,” she said. “I haven’t had much trouble.”

Other CBD entrepreneurs also say their companies are continuing as before.

“There hasn’t been any enforcement,” said Joseph Dowling, CEO of CV Sciences, a publicly traded California company that makes PlusCBD supplements.

Texas takes a break

The state of Texas is taking a different approach.

In March, the state health department that CBD could not be sold but failed to take action against many retail outlets already selling it.

By May, Texas formally put its CBD rule on hold pending further review.

Regulators have not announced any further decisions, prompting some in the industry to plow ahead and hope that rules break their way.

“We have been able to sell our products without any real resistance,” said Maurice Salazar, co-owner of Go Green Botanicals, a CBD retailer near San Antonio.

Still a burden

Clean Remedies’ Dockus and others in the hemp industry still want to see the limits formally rescinded or overruled by the federal government through taking CBD out of the Controlled Substances Act.

“We think they’re confused,” Dowling said of California regulators. “We will eventually convince them that they’re sort of, maybe, out of step with where things are from a regulatory standpoint.”

Patrick Goggin, a San Francisco attorney who specializes in hemp, said California and other states are likely intentionally going slow enforcing CBD bans, given the products’ popularity.

“They’re probably continuing to gather information and strategize their approach,” he said. “We intend to continue talking to folks about why they’re off base.”

[1] Hemp Industry Daily