U.S. health authorities are signing off on human trials of CBD to treat opioid addiction.

The U.S. Food and Drug Administration gave the green light this week to Ananda Scientific to start human testing of its CBD drug Nantheia ATL5, the company announced.

The trials will be run out of UCLA and are funded by the U.S. National Institute on Drug Abuse.

The federal clearance for CBD opioid-addiction research “further re-enforces our vision of developing CBD as a therapeutic for a number of key indications.” Ananda Scientific CEO Sohail R. Zaidi said in a statement.

The clearance comes two years after the FDA issued a warning letter to Massachusetts-based Curaleaf for marketing its CBD product’s potential to treat opioid addiction. Curaleaf scrubbed its website, though national drugstore chain CVS Health dropped some Curaleaf products anyway.

Ananda Scientific is privately held and has offices in Los Angeles and Greenwood Village, Colorado. A company spokesman reached by Hemp Industry Daily did not immediately say where the CBD comes from or if it is naturally derived or synthetic.

The only plant-derived cannabinoid medicine approved for human use in the United States remains Epidiolex, a CBD drug that treats rare forms of epilepsy and is owned by Ireland’s Jazz Pharmaceuticals.

An Idaho man is accusing his onetime partner of foiling a hemp-processing venture in Montana and making off with some $2 million.

Jeremiah Skaggs says in the lawsuit that Clinton Boone was hired by Isotex Health LLC of Texas in 2019 to start a CBD processing facility in Lincoln, Montana.

Isotex promised locals that the CBD facility would eventually employ 120 people.

Skaggs says he moved to Montana to start the project and was supposed to receive 45% of its proceeds. However, Skaggs says, Boone diverted funds and machines intended for the Montana facility.

The project was terminated in 2020. Skaggs is asking a federal court in Montana to award him unspecified damages.

Law 360 first reported the lawsuit. Boone’s attorneys did not immediately reply to the complaint.

As research broke over the past two weeks that cannabis products including CBD, cannabinoid acids and even synthetic cannabis compounds may prevent or treat COVID-19 infections, excitement among hemp entrepreneurs spread.

Interest in the seemingly stagnant hemp biomass, CBD and CBG markets soared to highs not seen in three years. Prices are on the rise again and hemp producers are fielding calls from a slew of interested parties hoping to cash in on the news.

Considering the ups and downs the hemp industry has struggled through since it became a legal commodity in December 2018, it’s easy to understand the enthusiasm.

It’s good to see positive COVID-19 headlines for once, especially when they are about cannabis.

But is it too early for hemp entrepreneurs to profit from research that hasn’t yet been tested in human clinical trials?

And what are the compliance and legal risks for cannabinoid product makers peddling products as COVID cures?

Researchers and industry leaders have urged caution among consumers and industry alike.

“Science is not the result of one or two studies. It’s a long process based on peer review and the opportunity for replication of results,” said Hemp Industries Association executive director Jody McGinness.

“As much as we are encouraged by studies that open up people’s eyes to the possibilities, we want to caution anybody against extrapolating from the results of early studies to any type of claims about the efficacy of cannabinoids.”

Industry ramping up anyway

For Bend, Oregon-based hemp producer Wesley Ray, Oregon State University’s study showing cannabinoid acids can prevent COVID-19 from entering human cells has validated his own work growing and processing CBDA and CBGA over the past few years.

Since news broke about the research, Ray and his partner Shannon Little have been inundated with calls and emails from retailers, formulators, distributors, recreational marijuana businesses, and even government entities, looking for raw material, crumble and tinctures to produce white label products and more.

“And then you have the bigger companies that are wanting to do some pretty crazy numbers (like) 25 kilos every two weeks,” Ray said.

He’s selling CBGa and CBDa crumbles in bulk for $2,900 per kilo or $5,000 per single kilo.

“The prices on that are obviously up. And if farmers are smart, they would hold back their biomass and not just liquidate it,” Ray said.

“I would put $20 a pound on my CBG biomass right now, just because I know how many pounds are going to go in to make a kilo and I know the input costs, and I don’t think the lab should be the only one making margins.”

Prices haven’t seemed to go up across the board yet in response to recent research results, but it’s still early and the interest is clear, according to Julie Lerner, the founder and CEO of Denver-based commodity selling platform PanXchange.

“There is no doubt that demand and inquiries are picking up for several processors in the country, but so far activity has been mostly directed toward CBDA and CBGA products,” Lerner told Hemp Industry Daily in an email.

“Demand has not yet picked up in biomass; our January prices are on par with December. However, a late-month rally pushed winterized crude prices up $5/kg this month.”

Compliance matters

The research findings supporting the role of cannabis in human health “moves the scientific conversation forward” and show the industry is one step closer to “unlocking the many benefits of cannabis,” said Asa Waldstein, principal of Boulder, Colorado-based Supplement Advisory Group, which advises herbal products and cannabis entrepreneurs on federal compliance.

That said, “it is a prohibited act to promote non-drug products as a cure for any disease or virus,” Waldstein cautioned in an email to Hemp Industry Daily.

“I urge companies to fight the urge to exploit this news to sell products.”

As has been the case with all other claims that have prompted the U.S. Food and Drug Administration and the U.S. Federal Trade Commission to sanction cannabis product manufacturers, anything on a commercial website or social media is considered marketing, he pointed out.

“Although unadvisable, if a company must risk posting about (cannabinoid and COVID research), they should ensure there is no mention of their product or company in the post or blog,” Waldstein said.

“This includes removing any shopping cart-linked call to actions and product pictures.”

Waldstein added that FDA and FTC authorities consider the “reasonable consumer takeaway,” which means if consumers think a company’s blog or post is about its products, the authorities do, too.

“I asked a top FTC official about ‘educational’ blogs on commercial websites. He responded, ‘What is the purpose of posting an educational blog on a commercial website, if not to sell products?’” Waldstein said.

“This further demonstrates the authority’s position when posting about disease therapies on a supplement site.”

And with the number of “cringe-worthy product claims” aiming to cash in on scientists’ research, companies promoting COVID research with links to products should consider FDA and FTC enforcement “a given,” Waldstein said.

Waldstein pointed to 25 COVID-related warning letters that the FTC sent earlier this month, showing the regulator’s “renewed dedication” to stopping companies from making misleading claims.

“The FDA/FTC makes examples of companies not following the rules, especially in areas they want to highlight,” he explained in an email.

“I predict we should see a batch of CBDA and COVID warning letters coming out in the next couple of months.”

Universities could push back, too

It’s not just government compliance companies need to consider.

Cannabis entrepreneurs that are openly promoting products in the name of university research may also be violating intellectual property laws provided to researchers, said Jay Noller, director of the Global Hemp Innovation Center at Oregon State University.

“There’s this presumption that because it was published, it’s theirs to use,” Noller told Hemp Industry Daily.

“International and U.S. patent law is such that to not check in with the publisher or that institution, we’ve seen that in other industries where the presumption leads to downstream reaches for violation of that IP.”

Even in cases of publicly financed research, scientists and universities have IP rights on findings that can produce results such as inventions, scholarly publications, new plant varieties, confidential information and more – even if they are proof-of-concept or laboratory-scale prototypes that require additional research and development before they can be commercialized.

Hemp entrepreneurs therefore need to do due diligence that they aren’t violating prior IP, Noller said.

Perhaps because the makers of the only CBD drug sanctioned by the FDA, Epidiolex, aren’t in headlines suing over-the-counter CBD makers, some cannabis operators may assume they are safe to market their own CBD products.

But that’s a risky assumption, Noller said, pointing out that such cases can take years to build, as in the seven-year patent battle over smart phones between Apple and Samsung.

Further, cannabis companies should consider that investment in research could yield faster industry development than investments in marketing, Noller said.

“We saw that for three years: branding, marketing. And then you have one science paper come out on a very, very limited budget. …That’s how it’s going to work.”

“So I think we’ve we’ve been able to demonstrate, if not shame, the industry into its disproportionate attention to fantasy versus reality, and that’s truth in science.”

Laura Drotleff can be reached at laura.drotleff@hempindustrydaily.com

Thailand’s Health Ministry recent removal of marijuana from the country’s list of controlled drugs is opening business opportunities only for low-THC hemp operators for now, because the country has retained a cap on allowable THC.

The nation of almost 70 million plans to limit products above 0.3% THC to highly regulated medical sales channels, experts say.

One North American business that isn’t waiting to capitalize on opportunities in Thailand is Las Vegas-based Audacious Brands.

Earlier this month, Audacious entered the Thai market via a strategic partnership with Golden Triangle Health.

Marc Lakmaaker, senior vice president at Audacious, said the companies plan to sell isolate and white label products, as well as developing its own brands, leveraging GTH’s broad distribution networks.

GTH is setting up a retail franchise under the name Hemp House, and plans significant expansion this year.

“Longer term, we intend to get into the medical THC business by establishing cultivation in Thailand,” he said.

“For now, the products will be sold to the government, but it is anticipated that in the coming two years or so, recreational use will be permitted also. We will then convert the Hemp House stores into dispensary style outlets, as well as use our network in the country to secure broad distribution.”

By removing cannabis from the country’s list of controlled drugs, Thailand is also allowing home cultivation for noncommercial use.

When it comes to commercial cannabis, the changes benefit mostly health and beauty cannabis companies, said Chaiwat Sowcharoensuk, an analyst at Bangkok-based Krungsri Research.

“Producers of soaps, beauty products and cosmetics … will likely be the ones to benefit the most,” Sowcharoensuk told Hemp Today.

Hemp-derived CBD giant Charlotte’s Web Holdings is positioning itself to enter THC and marijuana markets.

The Boulder, Colorado, company says it has signed a five-year, $8 million purchase agreement option with a marijuana company started by its founders, Stanley Brothers USA Holdings Inc.

The deal allows Charlotte’s Web to take over the marijuana business after the U.S.  legalizes marijuana nationwide for a total price to be determined based upon revenue and EBITDA figures.

Charlotte’s Web CEO Deanie Elsner says the company made the deal because of signs that federal marijuana reform is nearing.

“Consumer attitudes, market trends and laws surrounding cannabis and its role within the wellness category continue to trend positively,” Elsner said in a statement.

Stanley Brothers founders Jared and Joel Stanley are also members of CW’s board of directors but will step away from those positions to oversee the future acquisition.

Stanley Brothers USA Holdings makes cannabis products that don’t qualify as legal hemp but are lower in THC than many formulations in adult-use cannabis markets.  The company has operations in Colorado, California and Florida.

Charlotte’s Web trades on the Toronto Stock Exchange as CWEB.

Minor cannabinoids have been gathering interest among growers and extractors over the past year, with research on CBG, CBN, CBC and THC-V showing unique health benefits for consumers.

But are consumers even aware of these molecules and is there demand in the marketplace? And are there genetics available that can yield enough of these minor cannabinoids to make them worth the investment?

Jonathan Vaught, CEO and founder of Front Range Biosciences, a hemp and cannabis genetics producer in Lafayette, Colorado, said that although consumer awareness and interest is still in the early stages, the genetics are coming online for growers to begin producing hemp for minor cannabinoids.

His company is launching a new line of THC-V genetics in collaboration with partners in the marijuana space in California and Colorado as well as working on developing THC-V genetics along with genetics that are dominant in other minor cannabinoids.

Hemp Industry Daily caught up with Vaught to discuss his viewpoints on the future of minor cannabinoids.

How does THC-V differ from other minor cannabinoids?

THC-V is a separate molecule than THC or CBD. It’s very closely related structurally to THC – it’s just got a different side chain on it, so it makes it a different molecule than THC – either delta-9 or delta-8 or other cannabinoids.

That being said, THC-V has been rarely observed … and it’s generally produced at fairly low levels because, for multiple reasons, biologically, it’s a mutation in the pathway that allows it to produce THC-V.

Most plants that do have this mutation generally don’t produce very much, and when they do – if they’re bred to produce that much – then the plants are generally fairly poor performing. They don’t produce very good weight, they don’t produce high overall cannabinoids and terpenes, they’re just generally not very easy plants to grow and produce.

With the technology that we’ve developed, we are now unlocking that. There’s a variety that’s producing 20% plus total cannabinoids and it’s close to 1:1 THC-V to THC. That’s why the first launch, with our partners out in California, are taking this to market in the regulated cannabis space there.

So that’s just Step One – biologically, it makes more sense for high THC-V to be in the cannabis bucket. We are working on helping develop hemp-compliant versions, as well, but because of the biology, it is more challenging.

We’re discovering things about the genome and about how this plant works, from an underlying biology perspective, that will enable us to directly develop hemp-compliant versions of high-THC-V-producing plants as well.

What excites you most about THC-V, for both consumers and the industry?

We see THC-V as such an interesting cannabinoid. People are reporting really exciting characteristics – things like appetite suppression, stimulant qualities and a less-intoxicating type of experience.

This is a really exciting new ingredient from a consumer-product perspective because it really can begin to change the landscape of the type of experiences that are available to consumers through cannabis.

By improving not only the total amount of THC-V that gets produced in the plant but also some of the other characteristics – high terpenes and total cannabinoids – it produces more weight and more flower, and it’s more vigorous.

Those are all the things that are going to make it easier for growers to produce this and introduce it in the supply chain.

So, you combine that with the excitement on the consumer-product side and the opportunity for brands and consumer cannabis products to be available that provide customers new experiences – that combination is what is so exciting here.

And I think we’re honestly just getting started.

How aware would you say consumers are about THC-V and other minor cannabinoids, and do you feel that the market for minor cannabinoids has improved over the past year?

In general, it’s been somewhat elusive to growers and breeders and in the supply chain, so you just don’t see a lot of THC-V products out in the market yet – consumers generally don’t know much about it.

There’s a fair amount to learn about it from a consumer education and total market perspective, but it’s the same for other cannabinoids, too.

You could say the same thing about CBD six or seven years ago. … All that changed once it was discovered that there’s a real medical benefit, and now CBD is a whole industry.

Growers have been excited about some of the minor cannabinoids, but they’ve held back because the genetics haven’t been there or they weren’t sure of the demand. Is it safe to go ahead and start growing for minors now?

The underlying philosophy is the same for all cannabis growers. A lot of companies learned this the hard way, but, generally speaking, before you grow something, you want to know where that crop is going to go, right? What is your market for the end-use product? Is it a flower crop? Is it a CBG crop? Is it a THC crop?

If you look at it through the lens of traditional agriculture and other crops and other supply chains, it really is about, is there a market, who’s going to buy it, and what are the reasons they’re going to buy it for? And that’s why growers should be growing things.

How do minor cannabinoids fit within the growing wellness category?

I think there’s a huge opportunity.

It’s a big trend on the consumer side but also from the medical research side that we can be healthier as a society and as people if we eat better, if we take things that are more preventative in terms of wellness versus waiting to have a real problem and then trying to treat it.

We know that the endocannabinoid receptor system is throughout almost every major organ system in our body, and we know that it’s involved in a number of different physiologic processes that are happening in our bodies that either affect disease or wellness.

Combine that with the fact that there are well over 130 unique cannabinoids produced in this plant – maybe even more at this point – and some we haven’t even discovered.

Also, cannabinoids have been generally safe compounds. There are no reported examples of extreme adverse events or deaths, and there are limited clinical studies. But in the ones that are out there, cannabinoids seem to be fairly safe.

So all that together is the recipe for an incredibly exciting area of growth in the wellness sector.

How could companies developing synthetic cannabinoids affect the market for naturally occurring minor cannabinoids?

I think there’s room for both in the supply chain.

If you’re talking about an active pharmaceutical ingredient that needs to be 99% pure, there may be applications where synthetic biology is the right way to support that supply chain.

Whereas, if you look at a full-spectrum or a broad-spectrum extract, that’s more of a wellness product.

You don’t want a pure compound. You’re looking for the combination of cannabinoids, flavonoids and terpenes – and the other amazing things that are found in this plant – all together in a consumable package.

This interview has been edited for length and clarity.

Laura Drotleff can be reached at [email protected]

This story first appeared at Marijuana Business Daily.

The development of new genetic-editing technology offers cannabis companies a cost-effective way to make specific changes to marijuana and hemp plants – such as more disease resistance – without creating a genetically modified organism.

The technology, known as Crispr-Cas9, will allow the cannabis industry to build new, improved plants that promise to introduce hardiness and efficiencies into cultivation.

That, in turn, could boost profits.

Developed by Emmanuelle Charpentier and Jennifer A. Doudna, the Crispr-Cas9 gene-editing technique revolutionizes genetic engineering in many fields, including medicine and agriculture.

They were awarded the 2020 Nobel Prize in chemistry for their work.

In the case of cannabis, Crispr gene editing can produce new testable strains within a matter of weeks – unlike previous, more manual techniques.

Some possible changes to the cannabis genome include:

• Disease resistance: Large-scale agriculture is susceptible to various pests and diseases. The technique should provide a way to quickly create resistant plants.
• Climate tolerance: Climate change will alter how cannabis is grown in the coming decades. Plants that can withstand a wider range of temperature and daylight will be valuable as that occurs.
• Increased trichomes: Researchers are trying to increase the trichome density on the plants as a way to boost the production of terpenes and cannabinoids.
• Terpene manipulation: Changing the terpene makeup of a plant could provide a way to create distinctive and brandable cannabis products.
• CBD-to-THC ratio: Hemp producers use the gene-editing technique to inhibit or eliminate the production of THC in the plants. It can also be used to manipulate the creation of CBD.
• Biomass improvements: The ability to create specific traits and improvements to non-THC and CBD producing biomass of plants could help increase cultivator profits by minimizing plant waste.
• Plant-wide THC production: In the vein of biomass improvements, work has already begun on the development of marijuana plants that produce THC in more parts of the plant.
• Novel cannabinoid production: As the industry begins to understand cannabinoids other than THC and CBD, look for gene editing to be at the forefront of manipulating plants to produce them.

The Crispr-Cas9 process creates new DNA but technically does not create a genetically modified organism (GMO) because it does not introduce foreign DNA to the plant.

The process works by removing the section of the DNA the cultivator is hoping to change.

In addition, a guide piece of RNA is created and attached to an enzyme called Cas9.

Together, these two elements make up the Crispr tool.

The tool finds the targeted section of DNA while the enzyme cuts out the section as scissors would. New genetic material is introduced and attaches to the missing segment.

Companies are already using the technique to manipulate hemp and marijuana plants.

Evergreen, Colorado-based Ebbu, which was acquired by Canada-based Canopy Growth Corp. in 2018, was an early adopter of gene-editing techniques to try to produce single-cannabinoid strains, among other traits.

CanBreed, an Israeli company focused on developing genetically stable seeds, licensed the Crispr technology to enhance the traits of those seeds.

In late 2020, CanBreed announced the purchase of a 3.5-acre farm in San Diego.

High-CBD plants inherit approximately 90% of their genes from marijuana, according to a new cannabis genomics study by the University of Minnesota and hemp breeding company Sunrise Genetics.

The collaborators assembled a complete genome from a new cannabis variety and also examined several different cannabis varieties. They found that by breeding high-THC marijuana plants with lower-THC hemp varieties, breeders can develop new varieties that produce high levels of CBD.

But this breeding feat “poses a challenge” — and a big risk for farmers, according to study co-author CJ Schwartz of Sunrise Genetics.

“The genes that allow for the production of CBD are also a bit ‘leaky,’” Schwartz said in a statement.

“This can result in about 5% of the product ending up as THC instead of 100% CBD.”

Farmers who grow these high-CBD varieties to maturity have a much higher risk of their crops going hot, crossing the federal legal limit of 0.3% total THC.

“These high-CBD plants are genetically marijuana for the most part and they can’t be expected to meet the legal definition of industrial hemp in every situation,” said study co-author George Weiblen, a professor at the University of Minnesota.

“This means that CBD products — such as flowers, extracts and edibles — that are labeled ‘hemp’ could be incorrectly labeled and falsely branded. Fiber hemp and products made from hemp seeds, however, are drug-free.”

The full study is published in the New Phytologist, an online academic journal.

Weiblen and a team of researchers also developed a genetics test in late 2020 that can predict whether a cannabis plant will produce mostly CBD or THC molecules.