Study: With CBD, 80% of Children With Autism Saw Improvement

Leafly/August 8, 2018/Jacqueline Havelka

Israeli researchers have found more compelling evidence that medical cannabis is an effective therapy for children on the autism spectrum. In this soon-to-be-published study in the journal Neurology, researchers treated autistic children with high concentrations of CBD, a non-intoxicating cannabinoid found in the cannabis plant.

Conditions in 80% of the children improved. Alternatively, the children had not shown improvement with conventional drug therapies.

Conditions in 80% of the children improved. Alternatively, the children had not shown improvement with conventional drug therapies.

The Study Up-Close

The study was led by the director of pediatric neurology at Jerusalem’s Shaare Zedek Hospital, Dr. Adi Aran, who treated the 60 children with a high-CBD cannabis oil (20% CBD and 1% THC). The children were treated for at least seven months with the oil.

After the treatment period, parents answered assessment questionnaires to characterize their child’s condition. Questions were asked about behavioral changes, anxiety levels and ability to communicate.

Here’s what they reported:

  • 80% of parents noted a decrease in problematic behaviors, with 62% reporting significant improvements.
  • Half of the children had improved communication.
  • 40% reported significant decreases in anxiety. (Note: one-third of the study participants began the study with no anxiety.)

The Pioneer

Just as Israel is a pioneer in medical cannabis research, Aran is a pioneer in cannabinoid therapy for autism. Aran originally began a 2017 project to test 120 autistic children. It was the first study of its kind worldwide, and was made possible by the Israeli government’s funding and progressive approach to cannabis research.

Aran said that when word of the study got out, his waiting lists were soon full with many families from all over Israel who wanted to participate.

Aran said that when word of the study got out, his waiting lists were soon full with many families from all over Israel who wanted to participate.

Autism spectrum disorders are neurodevelopmental in nature, usually appearing in infancy or early childhood and lasting a lifetime. More severe cases have debilitating symptoms including compulsive, repetitive behaviors and impaired social skills and communication. Some children cannot speak at all. Autism affects around 1% of people worldwide.

The causes of autism are not understood and there is no cure—and the prevalence is climbing. In April 2018, the CDC updated its autism prevalence estimates to 1 in 59 children, up from 1 in 166 children in 2004. Doctors traditionally treat symptoms with antipsychotic medications, which have harmful side effects. Some children do not respond to these medications.

Aran began small autism research studies after similar cannabis studies on epilepsy, a disease that affects about 20% of autistic children. While studying epilepsy, researchers discovered that certain cannabis compounds would likely also help some autism symptoms. Less than 2% of the general population has epilepsy, but up to 33% of people with autism also suffer from epilepsy.

Neuroscientist Dr. Thomas Deuel of the Swedish Hospital in Seattle says there is definitely a connection. While scientists do not clearly understand the reasons behind the relationship, they suspect that the different brain development that occurs in autistic children is more likely to create circuits that cause epileptic seizures.

That link has caused many parents to seek out cannabis treatments for their autistic children. Parents certainly have anecdotal evidence of the effectiveness of CBD oils on their autistic children, but mainstream medicine has remained skeptical due to the lack of data. With most conditions treated with cannabis, anecdotal evidence and personal experience far outweigh actual peer-reviewed scientific research.

What’s Next for CBD Research?

In 2015, Harvard University and Boston Children’s Hospital published a baseline review of cannabis and autism studies to date, showing that the research did show promise, but nothing definitive could be said about cannabis’ ability to improve pediatric patients. The Harvard review stated that most research was animal-based and did not yet show translational impacts to human subjects. In fact, the review concluded with the cautionary statement that cannabis treatments should be used as a last resort after all conventional therapies have failed. Indeed, a widespread reluctance exists within the pediatric community to study the effects of cannabis in children, due to the potential of harmful side effects.

Since 2015, only a few small studies have been conducted, with promising results. One of the biggest impacts to spur on future research has been the U.S. Food and Administration (FDA) approval of Epidiolex, a CBD oil-based elixir manufactured by British drug developer GW Pharmaceuticals as a treatment for two rare types of childhood epilepsy. Scientists took notice at the amazing body of evidence that GW Pharmaceuticals presented regarding the effects of the drug.

Now, New York University (NYU) neurologist Dr. Orrin Devinsky, the same scientist who did research on Epidiolex, is now conducting two studies on CBD effects on children aged 5 to 18 with moderate to severe autism. The only other doctor who is currently doing studies like this is Aran.

Since autism and epilepsy go hand in hand, CBD is showing promise for treating both conditions.

Perhaps as doctors begin to see the effects of Epidiolex, and review research like that of Aran’s and Devinsky’s autism studies, many more will begin to delve further into use of medical cannabis.

Trump Tariffs Expected to Increase Cannabis Industry Prices

Ganjapreneur/August 13, 2018/Pat Beggan

The prices of cannabis retail items like vapes, batteries, filters, cartridges, and packaging may soon increase thanks to President Trump’s proposed tariffs, Forbes reports.

The tariffs will force vape manufacturers to locate new American suppliers or be quickly out-competed by the companies that do. American-made equipment in this category is far more expensive.

The increase in prices is expected to decrease sales and tax revenues, hurting not only the private companies’ bottom lines but also the budgets of states with legal sales. Colorado logged more than $247 million in tax revenue from cannabis sales in 2017; 25 percent of those sales were in the category of cannabis vaporizers.

Other components beyond vapes — such as construction and grow equipment and even cell phones — will also increase in price.

Companies in the cannabis space are especially vulnerable to product cost increases as they are unable to deduct the usual business expenses before paying taxes due to the federal status of cannabis; those business deductions are fundamental to how the vast majority of business works in the United States.

Growers are expected to suffer the most with the tariffs because, of all operators in the cannabis space, their margins are typically the slimmest and many already struggle to make ends meet.

 

 

Can Wildfires Impact Cannabis Quality and Test Results?

Cannabis Business Times/August 3, 2018/Melissa Schiller

As more than a dozen wildfires continue to burn across California, cannabis cultivators affected by the blaze face challenges ranging from the health and safety of their employees to the potential destruction of their facilities and crops. Consumer safety and lab testing will also become significant concerns as cannabis grown in affected areas hits the market.

“When you start getting into how [it’s] going to affect product and manufacturing and production, this is the big variable,” Jon Vaught, CEO of Front Range Biosciences, a Colorado-based agricultural biotech company, told Cannabis Business Times. “It depends on where the wind’s blowing, what your situation is, where you’re located. You could be right next to a fire and have no issues at all, or you could be ten miles from it and have your building filled with smoke. It really just depends on the weather.”

Smoke can stress or even kill the plants—especially those in outdoor or greenhouse operations—and the residue left behind can pose problems for lab testing and consumer health.

“Smoke taint is the most obvious and the most apparent threat to cannabis as [it’s] exposed to these forest fires, and that’s something you’re going to be able to readily tell from just qualitatively examining the cannabis,” said Josh Wurzer, president of SC Labs, which has operations in both California and Oregon. “So, that’s certainly a concern—just ruining the flavor of the cannabis.”

Smoke from municipal fires that burn buildings and other man-made structures can be more harmful than forest fires that burn trees and foliage, Wurzer added. “[When] cannabis [is] growing indoors in city limits or near other buildings and the fire comes into the city like it is in Redding or like it did last year in Santa Rosa, you have concern that when you have buildings on fire, the smoke … has a lot more potential to contaminate the cannabis with toxic chemicals.”

Pressure-treated wood, for example, contains chemicals like chromium and arsenic, which can settle on cannabis crops in the soot and ash from fires.

Fire retardant can also pose threats to cannabis crops and their water sources, said Lydia Abernethy, director of cultivation science for Steep Hill Labs, which has a California office in Berkeley. “If your product has been exposed to [a fire retardant], you should not consume it or release it into the cannabis market. If Phos-Chek or other fire retardants were dropped on or near your property, it’s important to monitor your waterways to make sure there’s no persistent problem with chemicals in your water.”

Each lab uses its own validated testing methods, Vaught said, so it is difficult to predict if these chemicals would be detected during testing and how fire damage could impact state-mandated product testing overall. “It depends on how well-aware they are of it,” he said. “Are they testing for potential contaminants that might come in through the smoke, or do they recognize that they need to test for other contaminants, and that’s an additional contaminant that they wouldn’t normally test for? There are so many questions around the specifics of that that it’s hard to give a super clear answer on how it might affect it, but it certainly could, and it’ll have to be taken on a case-by-case basis.”

Testing labs are required by their particular state regulatory agencies to test for a specific list of contaminants. Anything outside of that list—which in California, for example, contains a very specific roster of cannabinoids, mycotoxins, pesticides and more—will not likely show up in laboratory test results.

Beginning on Jan. 1, 2019, California labs will be required to test for heavy metals in cannabis, including arsenic, Wurzer said, and the state labs currently test for other chemicals that could potentially be produced during municipal fires, such as benzine, but only in concentrates. California labs are also currently conducting required foreign material inspections, which would detect soot or ash from fire damage, Wurzer added.

“As far as I know, none of the labs have developed a test that is specialized for indicators of fire,” Wurzer said. “To test for other things, you have to develop and then validate a method for that testing, so … unless there’s a need for … the tests, chances that someone can do the test are pretty unlikely. So, all we have really at our disposal is looking at the test results [and being] on the lookout for those certain indicators—is there an elevated level of arsenic? Is there an elevated level of benzine?”

It also remains unclear whether contaminants from wildfires could cause false positives or false negatives in pesticide testing, Vaught said. “The likelihood that specific pesticide residues could show up and trigger a false positive [is] definitely a realistic possibility. … I think the likelihood of it would depend on what was actually burning.”

For example, if a forest of pine trees that has never been sprayed with pesticides burns, it is unlikely that smoke or soot from that blaze would cause false positives in cannabis pesticide testing, Vaught said. On the other hand, if a field of corn that has been heavily sprayed is burning, by-products and combustions of those pesticides could show up in the test results of nearby cannabis products.

The bigger issue, however, is contamination from these potentially toxic substances and how it might affect consumer safety, Vaught said. “Some of them can be extremely toxic, so getting large amounts of soot and combustion by-products on your plants or on your product would definitely be something you would want to avoid, whether it triggers a regulatory test failure or not. That would just be good manufacturing practice and putting out safe products for your consumers and minimizing your risk and potential liability should something go wrong.”

And even if cannabis affected by the fires is safe for sale into the market, it may not be desirable for consumption or even extraction, Wurzer added.

“Typically, heavy smoke or particulate exposure degrades the product quality to such a degree that most people won’t knowingly purchase it,” Abernethy agreed. “As fires continue to affect cultivators across the state, I’m sure we’ll see products (especially flower) fail regulatory testing—like filth and foreign materials testing due to the presence of ash, cinders, dirt and mold. If people are interested to determine if their product might fail regulatory testing, we encourage them to contact Steep Hill for pre-regulatory analysis. Don’t lose hope entirely—if your crop has been affected by fire exposure, there are a few remediation routes to making successful, market-appropriate products.”

If a product does fail testing, California has a remediation policy that allows cultivators two remediation attempts and additional re-tests, she said. Steep Hill warns growers against using chemical products to strip away smoke and ash particulates, however, as these can cause additional product quality and safety issues. “We strongly caution anyone from further contaminating product by stripping it with chemicals to try to wash off the smoke,” she said. “That’s not a sound way to go about remedying this problem.”

To avoid the possibility of ongoing testing failures and consumer safety issues, a cultivation facility needs to be cleaned on some level after being exposed to a wildfire, Vaught said, depending on the amount of damage—how much smoke and soot has been deposited. “It could be everything from a low-level of contamination and cleaning required, where you have to go in and just wipe down your walls and get rid of all your plants and clean out your hydroponic systems … or whatever … different components that could absorb soot and smoke, all the way to heavy contamination which requires pressure washing, replacing dry wall, replacing ceiling tiles—replacing anything that absorbs large amounts of contaminants.”

There are professional fire remediation companies that can be consulted, he added, and operators should not take this responsibility lightly. “As soon as you have something like this happen, … talk with your insurance adjuster, … talk with a local fire remediation company, … [and] get some experts on the scene so that they can help you quickly address the problem, as opposed to trying to say, ‘Well, maybe we don’t need to worry about it.’ It’s always better to err on the side of caution for something like this, and yes, it can cost a little more money, but in the long run, it protects you from creating a liability for your company with your consumers, which is never a good thing.”

Furthermore, there are the consumer-facing issues to consider. A cultivator’s testing lab should be able to have an open and transparent conversation about what it is doing in its business practice to account for the wildfires, Vaught said. “That’s what I would recommend, across the industry—more open dialogue about these important issues for not only for the industry, but for the consumers and the safety of consumers,” he said. “It’s so very critical, whether we’re talking about pesticides or combustion by-products that are toxic from forest fires, or potential food additives that may or may not be approved for human consumption—all of these different issues affect the whole industry.”

New York Takes Another Step Toward Legalization, Pennsylvania Starts Selling Flower: Week in Review for Different States

Cannabis Business Times/August 3, 2018

This week, New York took a big step toward legalizing adult-use in the state with Gov. Andrew Cuomo announcing that he has set up a working group to write a bill to legalize and regulate cannabis, implementing recommendations from the state Department of Health. Elsewhere, in Pennsylvania, patients were able to buy medical marijuana in flower form for the first time.

Here, we’ve rounded up the 10 headlines you need to know before this week is over.

  • Federal: State legislators from Oregon and across the nation are calling on Congress to lift the federal prohibition on cannabis and remove it from the Controlled Substances Act so legal businesses in this industry can begin accessing banking services. The National Conference of State Legislators passed a directive Aug. 1 at the group’s annual conference in Los Angeles, urging Congress to help legal cannabis businesses access banking services and let states determine their own path forward on cannabis regulation. Read more
  • A bipartisan house bill introduced July 26 would prevent federal agencies from firing employees for using marijuana when they reside in a state where doing so is legal. The Fairness in Federal Drug Testing Under State Laws Act, introduced by Reps. Charlie Crist (D-FL) and Drew Ferguson (R-GA), would ensure that federal employees who live in states where recreational or medical marijuana use is legal cannot face adverse action if tested positive for past marijuana use. Read more
  • Oklahoma: The group Green the Vote announced July 29 that it reached the required amount of petition signatures to put recreational marijuana on Oklahoma’s ballot in November. Once all of the petitions and signatures are submitted to the state, officials with the Oklahoma Secretary of State’s office will count the petitions and determine if enough legal signatures have been gathered. Read more
  • The Oklahoma State Board of Health voted unanimously to adopt a new set of medical marijuana rules after the passage of State Question 788. The new set of regulations excludes the controversial ban on selling smokable products and the requirement of pharmacists at dispensaries. Read more
  • Florida: Christian Bax, the embattled director of the Florida’s Office of Medical Marijuana Use, is resigning after a three-year stint marked by rule-making delays, rocky litigation and continued criticism over patients’ problems accessing the drug since medical cannabis was broadly legalized more than a year ago. In his resignation letter, Bax wrote that he intends to step down no later than Aug. 10, though he did not provide a reason for his departure or its timing. Read more
  • Pennsylvania: Medical marijuana in dry leaf and flower form became available to registered patients in Pennsylvania for the first time this week. Gov. Tom Wolf’s office said dry leaf cannabis would be available at about a dozen dispensaries starting Aug. 1. Read more
  • Pennsylvania has awarded 13 additional permits to grow and process medical marijuana. The Health Department on July 31 named the chosen entities that will bring the total number of growers and processors in the state to 25, the most currently allowed under Pennsylvania’s medical marijuana law. Read more
  • Mississippi: The woman whose daughter’s name is on Mississippi’s marijuana oil law has begun a drive for a state constitutional amendment allowing medical marijuana use. Her group, called Mississippians for Compassionate Care, must collect at least 86,185 certified signatures over the next year from across the state to get Medical Marijuana 2020 on the statewide ballot in 2020. Read more
  • New York: New York Gov. Andrew Cuomo took a big step toward legalizing marijuana for recreational use in the state Aug. 2, announcing that he has set up a working group to write a bill implementing recommendations from the state Department of Health to legalize and regulate cannabis. Once the group comes up with a proposal, it will be up to the legislature to pass it before Cuomo can sign it into law. Read more
  • Canada: Molson Coors Brewing Co. is starting a joint venture with Hydropothecary Corp. to develop non-alcoholic, cannabis-infused beverages for the Canadian market. The partnership will be structured as a standalone company with its own board and management team, and a chief executive officer will be named in the coming weeks. Read more

Red States Are Embracing Cannabis Legalization, Expanding Access

Leafly/July 10, 2018/Bruce Barcott

Last month’s vote in Oklahoma to legalize medical marijuana caught a lot of people by surprise. Who knew such a deeply red state would embrace cannabis in a 57% landslide?

Legalization has passed an ideological tipping point in law-and-order states.

But it was no fluke. Yesterday we got two more indications that legalization has passed some sort of ideological tipping point in historically law-and-order states.

In North Dakota, leaders of the North Dakota Marijuana Legalization Initiative delivered more than 18,000 signatures to the secretary of state’s office in Bismarck. If state officials verify at least 13,482 of those autographs (and barring a legal challenge), voters will decide in November whether to legalize cannabis for adults 21 and older.

Surprised? Don’t be. Less than two years ago, North Dakota voters caught national legalization advocates off-guard when they passed a medical legalization measure.

An even bigger win came last night in Maine, where state legislators vigorously overrode Gov. Paul LePage’s veto of a medical marijuana bill. With a nearly unanimous vote, the Maine Legislature eliminated qualifying conditions altogether (leaving it entirely up to the physician’s discretion), allowed dispensaries to operate as for-profit enterprises (like drug stores and pharmacies), and increased the allowed possession limit for patients from 2.5 ounces of cannabis to 8 pounds.

With a nod to local control, the new law allows new medical cannabis dispensaries only in municipalities that vote to allow such stores. The law will become effective 90 days after the legislature’s current special session ends.

Maine has voted Democratic in presidential elections since the 1990s, but the state’s famously independent-minded residents installed LePage, an erratic Tea Party Republican, in the governor’s mansion in 2010—and re-elected him in 2014. LePage is a die-hard cannabis prohibitionist, but the same voters who put him in office just keep on legalizing despite the governor’s best efforts to hold back the tide of change.

Utah, Missouri Are on the Way

Meanwhile, Utah’s campaign to legalize medical marijuana hums quietly along, surviving every legal challenge the state’s prohibitionists lob at it. Barring anything unexpected, voters will have their say come November. And in Missouri, there are at least three (and maybe four) active medical marijuana initiatives aiming to make November’s ballot.

Those fighting the losing battle are increasingly tossing up Hail Mary attempts to discredit the growing evidence on medical cannabis. “Medical marijuana activists, just drop the charade of pretending there is a shred of science backing this medicine-via-pot-shops model,” Maine prohibitionist Scott Gagnon recently tweeted.

The science backing the cannabis-as-medicine model, in fact, can be found in a number of reputable journals. They include The New England Journal of Medicine, The Lancet, reports by the World Health Organization, the Proceedings of the National Academy of Sciences, and papers published by the London School of Economics.

The steady march toward legalization by red states—and in particular, by citizen voters—is yet another sign that the partisan divide on cannabis is disappearing. While Republican voters might side with legalization for slightly different reasons than their Democratic neighbors, the gap between them is closing. Rather than cling to Drug War era propaganda, elected officials would do well to respond to their constituents’ evolving views.

Northern California Cultivators Plant Seeds for Recovery After Wildfires

Culture Share/July 17, 2018/Keiko Beatie1

The blazing heat of summer is here, and while we’re feeling the climate change, barely a year has passed since the Northern California fires torched Napa, Sonoma, Lake, and Mendocino counties. These areas are well-known for cannabis cultivation farms, and many were destroyed or impaired in these wildfires.

Families are still attempting to put the fragile pieces back together and bring normality back to their lives. The effects of the California wildfires on cannabis producers has gone beyond the damage to crops and loss of revenue — for some, it’s resulted in the loss of life, too.

Between Oct. 8 and Oct. 31, 2017, 250 wildfires burned across California. During the fires, more than 245,000 acres of land were burned and 8,900 buildings destroyed. The damage toll of these fires is estimated at $9.4 billion.

Once the smoke and ashes settled, communities came together to support those were affected by the devastation of the raging fires. The Redwood Credit Union set up a fire relief fund for the four Northern California counties and, to date, $32 million was raised from people all over the world. The funds were distributed to two dozen nonprofit groups. The outreach focused on assistance and recovery for the affected individuals, which included housing support, consulting and health services. A few of the nonprofits supported by the North Bay’s Fire Relief funds are St. Vincent De Paul Santa Rosa, Redwood Empire Food Bank, Community Action Partnership of Sonoma County, Jewish Community Free Clinic, and Santa Rosa Community Health Center.

Anticipating the Jan. 1, 2018, legalization of cannabis after the passage of Proposition 64, many longtime cultivators abandoned their longtime cannabis businesses as they waited for licensing, permits, and regulations to be ironed out. New cultivators are making a change to the once-artisanal landscape, with automated large-scale farms.

The community in these burn areas continues the healing process, but it has a long way to go before returning to normal. With counseling and business support, the Northern California cultivation communities hope to recover and participate in future harvests.

While the North Bay Fire Relief Fund is closed, those interested in providing aid can still help  by supporting the American Red Cross California Wildfire Relief Program. During the October wildfires, the Red Cross provided mental health services to more than 5,500 people.

Mitch McConnell: Drug Warrior, CBD Champion?

The Rolling Stone/June 29, 2018/Amanda Chicago Lewis

Yesterday, the Senate passed a version of the 2018 Farm Bill that would legalize so-called “industrial hemp” – legislation that has long been a pet project of one of the most powerful men in America, Senate Majority Leader Mitch McConnell (R-KY). His office immediately issued a self-congratulatory press release about the sanctity of the American farmer and the enormous economic opportunity that will soon be available to former tobacco growers in his home state of Kentucky. These are the talking points McConnell has been pushing since the beginning of the year: that hemp is “a completely different plant than its illicit cousin,” marijuana, and that Americans are clamoring for more hemp products, spending $820 million last year on “everything from clothing to auto parts,” mostly made out of hemp grown overseas.

But hemp and marijuana are not actually different plants, and some experts say that McConnell’s desire to legalize hemp is not really about hippie rope necklaces and home insulation. It’s about a drug – a compound with such immense medical potential that the FDA just approved a pharmaceutical-grade version for children suffering from intractable seizures. We are talking, of course, about cannabidiol, or CBD.

Ever since Sanjay Gupta showcased the healing powers of CBD in his August 2013 CNN special Weed, America has been obsessed with the stuff. For the uninitiated, CBD is a cannabis compound that doesn’t really get you “high,” as THC does. Instead, CBD has a calming, anti-inflammatory effect that advocates and salespeople claim can do everything from reduce anxiety to kill cancer cells. At health food stores and marijuana dispensaries across the country, you can now find CBD lotions and CBD capsules and CBD beard balms and, yes, even smokeable cannabis that is high in CBD.

But CBD’s legality is complicated, to say the least. Without getting into the mind-numbing specifics, let’s just say that reasonable people disagree about whether it is possible for any CBD to be legal, and shops selling CBD products in states like Indiana and Tennessee have been raided by local law enforcement. So in order for mainstream retailers to feel comfortable carrying CBD products and Kentucky’s farmers to subsequently cash in on the CBD craze, McConnell put together legislation making it official. Though he’s focused his hemp legalization rhetoric on helping farmers and bland-sounding industrial products, his true intentions became abundantly clear about two weeks ago, when Sen. Chuck Grassley (R-IA) proposed an amendment that would exclude CBD and other major compounds (called cannabinoids) from the definition of legal hemp.

McConnell shot the proposal down, saying, “I’ve declined to include suggestions that would undercut the essential premise of the bill, namely that hemp and its derivatives should be a legal agricultural commodity.”

At no point did he refer directly to the “derivative” that was up for discussion. But anyone paying close attention understood what he was talking about.

“McConnell’s omission of CBD is not a denial of it. It’s simply a tactical political move,” says Carl Cameron, a former Fox News commentator who now works for New Frontier Data, a D.C.-based firm that provides information on the cannabis industry to investors. “He’s trying to help potential supporters avoid criticism in places where opposition to marijuana might be misconstrued and then undermine support for hemp.”

Leslie Bocksor, who runs the cannabis consulting firm Electrum Partners, agrees that McConnell has downplayed the fact that CBD is a primary motivation for legalizing hemp so as to fly below the radar of anti-pot donors and voters.

“This is just a way for McConnell to be able to move this forward without taking the political risk in talking about what’s going on, which is, yes, CBD is in so much demand that the supply can’t possibly equal the demand any time in the foreseeable future,” Bocksor says. “This is part of the Kabuki theater of the political environment we’re in today.”

Bocksor himself has embraced this kind of winking reference – hemp as a euphemism for CBD – as a business strategy. For the past few years, he’s been advising the companies he works with to avoid mentioning CBD directly or making any medical claims about what the product can do in order to avoid interference from law enforcement or warning letters from the federal government. Label everything as “hemp extract,” Bocksor says, and the consumer will know you mean CBD, as well as what kinds of health benefits can be expected.

Culturally, hemp has long been seen as a taller and more fibrous cannabis plant than marijuana, but the legal distinction is based only on THC content. Once CBD started to enter the mainstream consciousness about five years ago, pot farmers in states like Colorado and California began to breed strains of cannabis that were high in CBD but contained so little THC that they could be reclassified as “hemp.” Around the same time, the 2014 Farm Bill created a pilot program where state departments of agriculture and universities could register farmers to grow “hemp” — meaning, cannabis that was less than 0.3 percent THC.

McConnell’s home state of Kentucky is the second biggest producer of hemp under this program – behind only Colorado. And while most people believe that the hemp pilot program in the 2014 Farm Bill was not created with the intention of causing a boom in CBD products, that is exactly what happened.

“Almost all of the hemp growers in Kentucky are doing so for CBD production right now, and I know that because we either represent them, or we’ve been to the farms to see what they’re doing,” says Colorado-based cannabis attorney Bob Hoban, who recently argued in federal court on behalf of the Hemp Industries Association. “Cannabinoids are the cash product that comes out of hemp.”

So even if he doesn’t want to say so outright, McConnell’s desire to allow more American farmers to legally grow hemp is rooted in the popularity of CBD. This is a significant turning point in cannabis politics: one of the most powerful Republicans in the country is pushing for the legalization of a major compound found in marijuana. And in 2018, this isn’t that surprising. Red states like Oklahoma and Arkansas have voted to legalize medical use, and prominent GOP leaders like John Boehner and Orrin Hatch have publicly reversed course, supporting legal weed after decades of supporting prohibition. A recent Center for American Progress poll showed that a majority of Republicans now support the full legalization of the cannabis plant. Still, other polls have shown that support for pot among the evangelical base remains low, and a few major conservative donors – including casino magnate Sheldon Adelson – remain staunchly anti-cannabis.

So instead of openly embracing CBD, McConnell talks about hemp, which sounds less scary — even though CBD derived from “hemp” and CBD derived from “marijuana” is exactly the same thing.

For now, the legal status of CBD is still murky. But with McConnell’s support, there is a good chance that the House’s version of the Farm Bill will include a provision to legalize hemp-derived CBD, and potentially open the door a world where you can find CBD soaps and CBD tinctures on the shelves at Target and CVS. Many entrepreneurs are already bracing themselves for the change.

“Everybody knows on the corporate side that this Farm Bill is it. It’s gonna go through,” says Dan Goldfarb, whose Canna-Pet hemp CBD products can be found at thousands of independent pet stores and veterinarian offices nationwide. “But nobody’s been stopped from actually making these products in the interim. It’s simply a chilling effect. I like the chilling effect, because it keeps away corporate scumbags.”

 

FDA Rejects Petition to Further Restrict Marijuana

Forbes/July 5, 2018/Tom Angell

The U.S. Food and Drug Administration (FDA) has denied a request from an anti-legalization group to place marijuana and its derivatives on a list of restricted substances that are not “generally recognized as safe and effective.”

The move is “not necessary for the protection of public health,” Janet Woodcock, the director of FDA’s Center for Drug Evaluation and research wrote on Monday in a letter to the group, Drug Watch International.

The organization had filed its petition requesting the cannabis crackdown in December, writing that the move would “send an industry-wide warning to the estimated 33,000 marijuana businesses in the U.S., many of which are making unsupported medical claims for marijuana and THC drug products sold as ‘medical marijuana.'”

The prohibitionist organization pleaded with FDA to take action that would “reduce or end the ability of [over-the-counter] sellers of these drugs to assert and advertise unsupported medical claims for their products.”

“It would immediately make such claims unlawful and subject the sponsors to regulatory action, including injunctive seizure of mislabeled and misbranded drugs, as well as other potential sanctions permitted under the [Food, Drug and Cosmetic Act].”

But FDA balked, saying that while it “appreciates the safety and public health concerns that motivate” the request, the agency “already has adequate authority to remove unapproved new OTC drugs containing marijuana or THC from the market.”

“In order for FDA to take enforcement action against illegal marketing of unapproved new OTC drugs containing marijuana or THC, it is not necessary for FDA to establish a negative monograph for marijuana or THC.”

While the decision by FDA not to assign so-called “negative monograph” status to marijuana and THC won’t do anything to make marijuana more available, or change its legal status—which remains prohibited under Schedule I of the Controlled Substances Act—the rejection suggests that the Trump administration is not looking for excuses to go out of its way to deal public relations blows to the cannabis industry.

In fact, despite a move by U.S Attorney General Jeff Sessions this January to rescind Obama-era protections for state marijuana laws, President Trump himself indicated last month that he supports pending congressional legislation to end federal cannabis prohibition.

Last week, the powerful U.S. Senate Appropriations Committee issued a report criticizing roadblocks to research on marijuana that are caused by its ongoing Schedule I status.

The FDA’s negative monograph list currently contains unapproved drug products such as certain daytime sedatives, aphrodisiacs and deterrents to nailbiting or thumbsucking.

The list is “not intended to be comprehensive lists of all classes of OTC products, active ingredients, or conditions of use that cannot be marketed without FDA approval,” the agency wrote in its rejection of the Drug Watch International petition.

“While you suggest that a negative monograph would reduce or end the unlawful marketing of unapproved new OTC drugs containing marijuana or THC, existing law makes very clear that such unapproved products cannot be marketed under the FD&C Act,” the feds said. “FDA has not determined that any OTC drug products containing marijuana or THC are [generally recognized as safe and effective]  for their intended indications. Therefore, these products are ‘new drugs’ per section 201 of the FD&C Act that must be approved by FDA to be legally marketed.”

“That the Agency has not promulgated a negative monograph specific to marijuana or THC does not absolve a drug manufacturer or marketer from its responsibility to obtain an approved NDA or ANDA if one is required by law.”

“It is the responsibility of companies marketing drug products in the United States to ensure that their products are safe and effective and marketed in compliance with the law,” FDA’s Woodcock wrote. “[A]s discussed above, FDA has existing authority to pursue regulatory or enforcement actions regarding unapproved new OTC drugs, including those containing THC or marijuana.”

 

California Cannabis Businesses Brace For New Regulations

Marijuana Retail Report/July 1, 2018

A fire sale took place at marijuana dispensaries on Saturday. Strict regulations go into effect July 1 across the state, which means shops had to sell all non-compliant products by the end of business day Saturday.

California is requiring shops to sell only marijuana that has been tested for pesticides, potency and microbiological contaminants.

Many businesses aren’t happy about the new requirements. Nearly 150 marijuana businesses warned they could face crippling financial losses unless the state extends the July 1 deadline.

In a letter to Gov. Jerry Brown, the United Cannabis Business Association said the changes would further unsettle the struggling legal marketplace that launched Jan. 1, potentially forcing businesses to close their doors.

The trade group that represents cannabis companies said there are too few labs to handle the testing, and retailers would have to destroy vast amounts of unsold cannabis that does not meet the new standards.

Association president Jerred Kiloh estimated that businesses could face nearly $400 million in losses if those unsold supplies are destroyed.

“Forcing the industry into compliance … will further cripple the already struggling regulated market,” the letter said.

In a statement, the state Bureau of Cannabis Control gave no indication it would consider rolling back the deadline.

“We issued our emergency regulations back in November, and at that time we were pretty clear about the fact that there would be a six-month transition period for retailers to use up their existing supply. We felt that was a sufficient amount of time to deplete stock on hand and adapt to California’s new rules,” agency spokesman Alex Traverso said in an email.

The regulations are being phased in six months after the state broadly legalized marijuana and required that pot sold after Saturday meets strict quality standards. Retailers have been unloading untested inventory at bargain-basement prices.

The rollout of the nation’s largest legal pot market has been bumpy at best. The black market is still flourishing, and the industry complains about taxes that can approach 50 percent in some areas.

Others fear a shortage of retailers for both adult-use and medicinal marijuana could shut down the supply chain, stranding growers with mountains of unsold pot.

California is operating under temporary regulations, while the largest city, Los Angeles, has been slow to issue licenses.

The change in rules was part of the state’s decision to allow the industry to get a running start at the beginning of the year. Shops were given six months to burn through supplies of cannabis and edibles produced without strict testing requirements.

Any marijuana harvested this year, or for sale July 1, must meet quality and safety standards or be destroyed.

The letter depicted an emerging industry that is struggling to find its footing.

The group said the 30 licensed labs that would test pot would be unable to handle demand, resulting in a shortage of products on shelves. A system intended to track plants from seed to sale has been delayed. And packaging companies are not ready to meet the new rules.

“Customers and patients will turn to illicit market retailers and delivery services who will still have an abundance of products for sale. Licensed retailers will be forced to shut down,” the letter said.

The businesses and advocacy groups that signed the letter represent a fraction of the state’s legal marketplace. For example, over 3,300 cultivation licenses have been issued, and there are more than 400 licensed retailers.

Schumer introduces bill to federally decriminalize marijuana

CNN\June 28, 2018\Annie Geng

Washington (CNN)Sen. Chuck Schumer has introduced a new bill to decriminalize and regulate marijuana at the federal level.

The legislation, which the New York Democrat announced back in April, would remove marijuana from the Controlled Substances Act, where it is classified among drugs such as heroin and LSD.

By striking marijuana from the act, Schumer’s office said in a news release Wednesday, the bill would effectively decriminalize the drug at the federal level. The measure would still allow states to determine their own marijuana laws while maintaining federal law enforcement against trafficking to states where it is illegal.

Several states allow recreational sales of marijuana, including California, Oregon and Massachusetts.

Schumer’s bill would direct a specific amount of tax revenue to a Treasury trust fund for the “small business concerns” of women and “socially and economically disadvantaged” individuals working in the marijuana industry.

Under the bill, advertising for marijuana and related products would be restricted for youths, should joint research conducted by the Department of Health and Human Services, National Institutes of Health and the Food and Drug Administration determine that doing so would be “appropriate for the protection” of the health of those 18 and younger.

In a press statement, Schumer said this legislation is “simply the right thing to do” and that he is hopeful its “balanced approach” will earn bipartisan support in Congress. The bill is co-sponsored by independent Sen. Bernie Sanders of Vermont and Democratic Sens. Tim Kaine of Virginia and Tammy Duckworth of Illinois.

A similar measure aimed at loosening federal guidelines on marijuana and giving states more flexibility in determining their own laws was introduced earlier this month by Sens. Elizabeth Warren, D-Massachusetts, and Cory Gardner, R-Colorado.

In April, President Donald Trump told Gardner he will support efforts to protect states that have legalized marijuana, according to a statement from the senator. The deal, which was first reported by The Washington Post, came after Gardner said he’d block all Justice Department nominees after Attorney General Jeff Sessions rescinded guidance from the Obama administration, known as the Cole memo, that had adopted a policy of non-interference with marijuana-friendly state laws.