Study: CBD a “Therapeutic Candidate for Stroke Prevention”

Study: CBD a “Therapeutic Candidate for Stroke Prevention”

Cannabidiol (CBD) may help to prevent strokes, according to a new study published by the U.S. National Institute of Health.

“The endocannabinoid system (ECS) regulates functions throughout human physiology, including neuropsychiatric, cardiovascular, autonomic, metabolic, and inflammatory states”, begins the study’s abstract, which was published in-print by the journal Cannabis and Cannabinoid Research. “The complex cellular interactions regulated by the ECS suggest a potential for vascular disease and stroke prevention by augmenting central nervous and immune cell endocannabinoid signaling.”

Cannabidiol (CBD), a nonpsychoactive constituent of Cannabis, “is an immediate therapeutic candidate both for potentiating endocannabinoid signaling and for acting at multiple pharmacological targets.” According to reseachers, this “speculative synthesis explores the current state of knowledge of the ECS and suggests CBD as a therapeutic candidate for stroke prevention by exerting favorable augmentation of the homeostatic effects of the ECS and, in turn, improving the metabolic syndrome, while simultaneously stalling the development of atherosclerosis.”

The full study, conducted by researchers at Mayo Clinic’s Department of Neurology, can be found by clicking here.

About Anthony Martinelli

Anthony, co-founder and Editor-in-Chief of TheJointBlog, has worked closely with numerous elected officials who support cannabis law reform, including as the former Campaign Manager for Washington State Representative Dave Upthegrove. He has also been published by multiple media outlets, including the Seattle Times. He can be reached at TheJointBlog@TheJointBlog.com.

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Published at Sun, 12 Nov 2017 09:00:04 +0000

Cannabis May Treat Migraines, Finds New Study

Cannabis May Treat Migraines, Finds New Study

Findings from a new study published in the journal European Journal of Pharmacology shows that cannabis may serve as an effective treatment for migraine headaches.

“Current anti-migraine treatments have limited efficacy and many side effects”, begins the abstract of the study. “Although anecdotal evidence suggests that marijuana is useful for migraine, this hypothesis has not been tested in a controlled experiment.” Thus, the present study “tested whether administration of ∆9-tetrahydrocannabinol (THC) produces anti-migraine effects in the female rat.”

The results from the study “suggest that: 1) THC reduces migraine-like pain when administered at the right dose (0.32mg/kg) and time; 2) THC’s anti-migraine effect is mediated by CB1 receptors. These findings “support anecdotal evidence for the use of cannabinoids as a treatment for migraine in humans and implicate the CB1 receptor as a therapeutic target for migraine.”

The full study, conducted by researchers at Washington State University and Washington State University Vancouver, can be found by clicking here.

About Anthony Martinelli

Anthony, co-founder and Editor-in-Chief of TheJointBlog, has worked closely with numerous elected officials who support cannabis law reform, including as the former Campaign Manager for Washington State Representative Dave Upthegrove. He has also been published by multiple media outlets, including the Seattle Times. He can be reached at TheJointBlog@TheJointBlog.com.

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Published at Sat, 11 Nov 2017 06:59:13 +0000

Voters in Athens, Ohio Vote to Depenalize up to 200 Grams of Marijuana, 10 Grams of Hash

Voters in Athens, Ohio Vote to Depenalize up to 200 Grams of Marijuana, 10 Grams of Hash

By NORML

The Athens Cannabis Ordinance – better known as “TACO” – to completely remove all penalties for possessing, cultivating, and gifting of up to 200 grams of marijuana was approved by voters on election day by a vote of 77 percent to 23 percent.

In November 2016, four Ohio municipalities – Newark, Logan, Roseville, and Bellaire – passed similar depenalization ballot measures. Under Ohio state law, minor marijuana possession offenses are classified as a minor misdemeanor, punishable by a fine, but no jail time or criminal record.

“Voters overwhelmingly approved of TACO because the continued criminalization of adult marijuana use is out-of-step with the views of the vast majority of adults in the United States, 64 percent of whom now endorse legalizing and regulating cannabis,” said Justin Strekal, NORML Political Director. “While politicians continue to drag their feet, citizens are showing leadership at the local and state level in jurisdictions where the ability to achieve marijuana reform is possible at the ballot box.”

About Anthony Martinelli

Anthony, co-founder and Editor-in-Chief of TheJointBlog, has worked closely with numerous elected officials who support cannabis law reform, including as the former Campaign Manager for Washington State Representative Dave Upthegrove. He has also been published by multiple media outlets, including the Seattle Times. He can be reached at TheJointBlog@TheJointBlog.com.

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Published at Fri, 10 Nov 2017 04:14:51 +0000

Michigan Seeks Comment on Tax Treatment of Marijuana Sales

Michigan Seeks Comment on Tax Treatment of Marijuana Sales

Michigan Seeks Comment on Tax Treatment of Marijuana Sales

The Michigan Department of Treasury (the “Department”) recently released a draft Revenue Administrative Bulletin (“RAB”) entitled Marihuana Provisioning Center Tax and Sales and Use Tax Treatment of Marihuana. An RAB is a directive issued by the Bureau of Tax Policy. The following is an excerpt from the Department’s website describing RABs, generally:

Its purpose is to promote uniform application of tax laws throughout the State by the Bureau of Tax Policy personnel and provide information and guidance to taxpayers. A Revenue Administrative Bulletin states the official position of the Department, has the status of precedent in the disposition of cases unless and until revoked or modified, and may be relied on by taxpayers in situations where the facts, circumstances and issues presented are substantially similar to those set forth in the Bulletin. A taxpayer must consider the effects of subsequent legislation, regulations, court decisions and Bulletins when relying on a Revenue Administrative Bulletin. See RAB 1989-34 for further information.

The draft RAB explains the marihuana provisioning center tax imposed by the Medical Marihuana Facilities Licensing Act (the “MMFLA”) and the sales and use tax treatment of marihuana and marihuana-derived products under both the MMFLA and the Michigan Medical Marihuana Act (“MMMA”). While the draft RAB makes conclusions (discussed below) regarding significant marihuana tax issues, it has not been finalized and thus should not yet be relied upon by taxpayers. The draft RAB is open for review and comment to the general public until November 6, 2017.     

The draft RAB makes conclusions on the following three issues: (i) a provisioning center tax, (ii) return and remittance requirements, and (iii) sales and use tax.

Provisioning Center Tax

The MMFLA imposes a tax on gross retail receipts of a provisioning center (dispensary) at a rate of 3 percent. Because the tax applies to all gross receipts, the Department concludes that the provisioning center tax is not limited to marihuana-derived products. Rather, the tax also includes non-marihuana sales such as paraphernalia, clothing, food and other tangible personal property or service. In essence, under the Department’s interpretation, all retail sales made by licensed provisioning centers are subject to the provisioning center tax.

Return and Remittance Requirements and Procedures

The MMFLA requires provisioning centers to remit the provisioning center tax to the Department by 30 days after the end of the calendar quarter for the preceding calendar quarter. The draft RAB states that the remittance must be accompanied by a form prescribed by the Department. The form will require a disclosure of the provisioning center’s gross quarterly retail receipts as well as the amount of provisioning center tax due.

The Department is proposing that the return and remittance of tax will be required to be submitted electronically through Michigan Treasury Online. One significant issue not addressed in the draft RAB is how unbanked businesses are supposed to make payments if the only means the State allows is an online system.

Sales and Use Tax

Under current law, the General Sales Tax Act (the “GSTA”) imposes a 6 percent sales tax on the gross proceeds of all persons engaged in the business of making sales at retail. Similarly, the Use Tax Act (the “UTA”) imposes a 6 percent tax for the privilege of using, storing or consuming tangible personal property in Michigan, if no sales tax has been paid on that property.

The draft RAB states that all retail sales of marihuana and marihuana derived products by a provisioning center will be subject to sales tax. Further, a registered caregiver under the MMMA “may receive compensation for costs associated with assisting a registered qualifying patient in the medical use of marihuana.” Under the MMMA, the compensation received by the caregiver does not constitute the sale of controlled substances. Accordingly, a caregiver’s service is a non-taxable service and not subject to sales tax. The Department, however, is taking the position that a patient who receives marihuana from a caregiver will be subject to a use tax at a rate of 6 percent of the purchase price of the marihuana. The use tax is supposed to be remitted and reported annually on the patient’s Michigan Individual Income Tax Return.

Finally, the draft RAB states that marihuana-infused products (i.e., edible substances, beverages, etc.) are not eligible for the sale/use of food exemptions under the GSTA and the UTA because they are consumed for their medicinal value rather than nutritional purposes.

When it comes to calculating the amount of sales and use tax, the draft RAB states that the sales and use tax bases include the 3 percent provisioning center tax. By way of example, the draft RAB sets forth the following illustration:

“ABC, Inc. is a provisioning center. ABC sells marihuana to Customer for a sales price of $100. ABC is liable for $3 in tax under the MMFLA (i.e., provisioning center tax). ABC also is liable for sales tax based on 6 percent of $103, which amounts to a sales tax liability of $6.18.”

As noted above, the draft RAB is open for review and comment to the public until November 6, 2017. Anyone wishing to offer comments to the Department should email the Department’s tax policy division at treas_tax_policy@michigan.gov .       

As always, check back with Dykema’s Cannabis Law Blog for further updates.

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Published at Mon, 23 Oct 2017 16:00:00 +0000

Historic First: California Awards First Commercial Insurer For Cannabusinesses

Historic First: California Awards First Commercial Insurer For Cannabusinesses

Historic First: California Awards First Commercial Insurer For Cannabusinesses

CANNABIS INSURANCE

Another sign of the times – for the first time in history, a state no other than California, approves an insurance provider for the cannabis industry.

California Insurance Commissioner Dave Jones announced in a press release that Golden Bear Insurance has been approved to write policies to cover cannabis businesses in the states. Golden Bear can now offer coverage immediately says a Huffington Post article, although it’s too late for the businesses affected by the California wildfires although it will provide protection from future disasters.

“This is the first of what I hope will be many commercial carriers filing insurance products to fill insurance coverage gaps for the cannabis industry,” said Jones in the statement. “Consumers who visit cannabis businesses, workers who work there, businesses who sell products to or rent property to cannabis businesses, and the investors, owners, and operators of cannabis businesses all should have insurance coverage available to help them recover when something goes wrong just as any other legalized business does.”

Although Golden Bear Insurance is the first commercial insurance provider for the cannabis industry, Dave Jones hopes to see the numbers grow.

Insurance, just like banking, has long posed a struggle for the cannabis business community. Since cannabis is still illegal at the federal level, insurance providers and banks in general prefer not to have anything to do with cannabusinesses. However, in the recent years, there have been some changes as some insurance providers started to provide policies to businesses that operate in states where recreational or medical cannabis is legal.

CALIFORNIA RECREATIONAL CANNABIS PICTURE

This is especially significant for the California cannabis industry, since the Golden State is responsible for producing massive amounts of cannabis for the rest of the country. Back in 1996, California was the first state to legalize MMJ and 20 years later, 28 other states have followed suit.

This new development is the fruit of Jones’ labor, since early this year he’s been working hard to get insurance companies to fill coverage gaps for California’s cannabis industry. While Golden Bear is the first “admitted commercial carrier”, they aren’t the first insurer in the state willing to cover cannabis businesses. According to Jones, there are 25 other carriers providing “surplus lines insurance” which is basically insurance policy offering protection from high risks that regular insurers likely don’t take on.

The move came at a right time, after dozens of California farmers are mourning the loss of their livelihood and homes after the destructive wildfires that rampaged the northern part of the state – home to the biggest cannabis cultivation farms in the country. The fires cost $1 billion in damages, with over 600,000 pounds of cannabis up in smoke. Now that Golden Bear is in the picture, cannabis businesses have less to worry about in case of future losses to their cannabis crops.

The HuffPost article also mentions that Jones was asked if there was a risk of federal intervention, he replied, “We believe the risk of federal intervention with an insurer is low. The fact that 25 surplus lines carriers are writing insurance currently demonstrates this.”  

“This is yet another sign that marijuana is becoming more mainstream,” says Tom Angell, chairman of Marijuana Majority. “From polls showing increasing voter support for legalization to major corporations becoming more comfortable working with the industry, it’s clear which way things are headed – away from the prohibition era, and fast.”

This year marked several significant developments for cannabis legalization. One of the most notable is that support for legalization in the country is at an all-time record high, with the last Gallup poll revealing that 64% of Americans are in favor of legalizing cannabis. Public support for cannabis legalization has never been this high since 50 years, when Gallup first began asking Americans about their stance on legalization.

“Our mission remains insurance protection for all Californians, which includes insurance for California’s legalized cannabis businesses and customers,” Jones says. “We encourage more insurance companies to file cannabis business insurance products with the department to meet the needs of this emerging market.”

While it remains to be seen how the feds will react, the largest state for the cannabis industry has already signed off on an admitted market insurance product which, no matter way you look at it, is definitely groundbreaking.

OTHER STORIES YOU MAY ENJOY…

DISPENSARY INSURANCE

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Published at Tue, 07 Nov 2017 06:00:00 +0000

Alcohol industry targets pot with Constellation-Canopy deal

Alcohol industry targets pot with Constellation-Canopy deal

The Columbian / Associated Press

Alcohol industry targets pot with Constellation-Canopy deal

Alcohol giant Constellation Brands is making a foray into marijuana, a precedent-setting move for an industry that has mostly stayed on the sidelines during the cannabis boom.

Constellation will pay about $191 million (C$245 million) for a 9.9 percent stake in Canopy Growth Corp., a Canadian seller of medicinal-marijuana products. The deal kicked off the biggest rally in nearly a year for Canopy, which trades on the Toronto Stock Exchange under the ticker WEED.

The legalization of marijuana in Canada and a growing number of U.S. states is opening up a huge potential market — just as demand for alcohol is slowing. Still, pot remains prohibited at the U.S. federal level, meaning American companies have to tread carefully.

Constellation, based in Victor, New York, said it has no plans to sell cannabis in the U.S. or other markets until it’s legal “at all government levels.” For now, it’s more a matter of identifying markets with growth potential, said Chief Executive Officer Rob Sands, whose company sells Corona beer, Svedka vodka and other brands.

“Our company’s success is the result of our focus on identifying early-stage consumer trends, and this is another step in that direction,” he said in a statement.

The deal values Canopy at roughly C$2.5 billion, catapulting the business into the highest echelons of the marijuana industry. Constellation would become the company’s biggest shareholder.

As part of the Constellation agreement, the two companies will collaborate on cannabis-based beverages that can be sold as adult products — but only in places where the products are legal at the federal level.

Canada plans to legalize recreational marijuana by July 2018, but the initial product offerings such as edibles and cannabis-infused beverages will be limited, Canopy CEO Bruce Linton said. Such products will be phased in as Canada moves to extinguish the black market in the coming years.

“This looks a lot like the new normal,” Linton said by phone, noting that Canopy and Constellation have a “blank sheet” to create cannabis-infused beverages. “There’s no need to include alcohol, nor is there an intent to include alcohol in how we follow through with things.”

In the U.S., 64 percent of the population now wants to lift the ban on cannabis, according to a Gallup poll released last week. That’s the widest margin since the firm began asking about the topic in 1969, when only 12 percent of the population approved.

Eight states and Washington, D.C., have legalized marijuana for adult use. That means one in five Americans over 21 are allowed to eat, drink, smoke or vape cannabis — even though it remains illegal at the federal level. The states are Alaska, California, Colorado, Maine, Massachusetts, Nevada, Oregon and Washington.

Twenty-one additional states allow it for medicinal purposes. The legal cannabis market was $6 billion last year and is expected to reach $50 billion by 2026, according to Cowen & Co.

The Constellation deal includes warrants that will let it eventually double its stake. The purchase is expected to close during the company’s third fiscal quarter.

Constellation is paying C$12.98 a share, 1.5 percent above Canopy’s closing price of C$12.79 at the end of last week. Shares of the marijuana seller, which is based in an old Hershey chocolate factory in Smiths Falls, Ontario, had already surged 40 percent this year.

“We see this transaction as a game-changer for Canopy, as well as the industry at large,” Beacon Securities analyst Vahan Ajamian said in a note. He recommends buying Canopy shares and raised his target price to C$16.50 from C$14.

The Constellation transaction could be the first of many, Ajamian said.

“We suspect more alcohol companies may look to accelerate plans to enter the industry — as well as pharmaceutical and tobacco companies,” he said.

— Jennifer Kaplan and Jen Skerritt contributed to this story.

(Why?)

Published at Tue, 31 Oct 2017 13:00:30 +0000

Ontario Announces the First 14 Cities to Have Legal Marijuana Stores

Ontario Announces the First 14 Cities to Have Legal Marijuana Stores

The Liquor Control Board of Ontario has announced the first cities that will be home to legal marijuana stores.

Last month Ontario officials unveiled their framework for the legal marijuana industry, which includes having 150 marijuana stores open by 2020, with online sales beginning next year. Yesterday, the Liquor Control Board announced the first 14 cities where legal marijuana outlets will be open.

Those cities will be:

  • Brampton
  • Vaughan
  • Toronto
  • London
  • Mississauga
  • Hamilton Barrie
  • Kingston, Kitchener
  • Sault Ste. Marie
  • Ottawa
  • Thunder Bay
  • Windsor
  • Sudbury

Ontario is the first province or territory in Canada to put forth a comprehensive plan for the legal marijuana industry. The plan includes allowing those 19 and older to legally purchase marijuana from marijuana stores overseen by the Liquor Control Board.

About Anthony Martinelli

Anthony, co-founder and Editor-in-Chief of TheJointBlog, has worked closely with numerous elected officials who support cannabis law reform, including as the former Campaign Manager for Washington State Representative Dave Upthegrove. He has also been published by multiple media outlets, including the Seattle Times. He can be reached at TheJointBlog@TheJointBlog.com.

(Why?)

Published at Sun, 05 Nov 2017 06:50:49 +0000

The Future of Canadian Cannabis

The Future of Canadian Cannabis

Despite no evidence of organized crime in the illegal cannabis industry, that growers, dispensaries, and other value-added producers are “paper criminals” interested only in producing a quality product or service in a free and fair market — the government still insists on eradicating this current industry.

Looks like the future of Canadian cannabis rests on perpetuating the licensed producer scheme the Harper government set up.

Oh, sure, Justin’s Liberals plan to ease the regulations so that “anyone” can become an LP, but even this promise (assuming they keep it) buckles under scrutiny.

For starters, the future of Canada’s cannabis industry is in intellectual property rights, not producing an agricultural product like a pharmaceutical (and badly too, as the recalls have indicated).

Since everyone will be entitled to grow, and since no one will follow the mandatory government seed program, crafting your own plant genetics is what will separate the winners from the losers.

And assuming the rest of the world catches up with Canada on legalization, the idea that Canada’s cold climate will somehow be a beacon of cannabis production is downright laughable.

Allan Brochstein, a financial analyst, said it best when he told the Globe and Mail,  “There’s a lot of people that are in the marijuana industry – [but] they’re not in the marijuana industry. They’re in the stock-promotion industry.”

He was, of course, referring to the LPs.

LP valuations aren’t based on cannabis production, but rather, an over-reliance on balance sheets. Investors are buying their debt. Even with recreational legalization, there aren’t enough Canadian consumers to cover their debt and financial leverage commitments.

And with legalization around the world, the Canadian LPs will become irrelevant. Unless, of course, they protect their brand while shipping production off to Mexico.

Sorry, Smith Falls. Looks like Canopy/Tweed is going the way of Hershey Chocolate.

As financial investor Anthony Wile wrote in the Toronto Sun, “Canada does not offer the appropriate climate to produce these products in either an environmentally friendly and natural manner or a cost structure necessary to eliminate the black market… Embracing international trade with countries better suited to marijuana cultivation is the right thing to do on all counts — environmental, cost and social impact.”

Canada’s domestic cannabis industry is akin to the dot-com bubble from the late 90s/early 2000s.

Soaring stock prices with valuations in some cases exceeding $1 billion is lunacy.

However, from the ashes of the dot-com bubble, companies like Amazon, Godaddy and eBay, emerged intact.

Therefore, some of Canada’s LP will likely survive. In fact, home-growers will probably find it lucrative to sell their popular genetics to LPs to be mass-produced in Mexico or California.

Visit any community in this country and you see the same thing — Walmart, Canadian Tire, Tim Hortons, Boston Pizza and other corporate chain-stores.

Local mom and pop small-businesses are becoming fewer and farther between. Instead of becoming entrepreneurs, this generation is burden by real estate at bubble prices and crippling student loans.

Already established entrepreneurs are suffering from excessive bureaucratic red-tape and a complicated tax-code.

Corporate concentration is as Canadian as maple syrup and the Mounties.

Why would the legal cannabis industry be any different?

(Why?)

Published at Thu, 02 Nov 2017 22:08:29 +0000

Florida congressman slams Gov. Chris Christie for “outrageous” medical marijuana position

Florida congressman slams Gov. Chris Christie for “outrageous” medical marijuana position

A freshman Republican congressman on Thursday condemned New Jersey Gov. Chris Christie for “outrageous” statements he made comparing medical cannabis legalization efforts to the origins of the current opioid epidemic.

“It is shortsighted, it is inaccurate and it is indefensible to suggest that the proliferation of medical cannabis — that is saving lives and improving quality of life for people — somehow is analogous to the plague of the opioid crisis,” Rep. Matt Gaetz (R-FL) said at a press conference organized by the American Legion, which is calling for legalization and research of medical marijuana for U.S. military veterans.

Christie, a Republican, is chairman of President Donald Trump’s Commission on Combating Drug Addiction and the Opioid Crisis. In a letter announcing recommendations made by the commission Wednesday, Christie compared the recent proliferation of medical cannabis laws to the over-prescribing of opioids that led to the current epidemic.

“There is a lack of sophisticated outcome data on dose, potency, and abuse potential for marijuana,” Christie wrote towards the end of a seven-page cover letter accompanying the commission’s report. “This mirrors the lack of data in the 1990’s [sic] and early 2000’s [sic] when opioid prescribing multiplied across health care settings and led to the current epidemic of abuse, misuse and addiction. The Commission urges that the same mistake is not made with the uninformed rush to put another drug legally on the market in the midst of an overdose epidemic.”

Gaetz dismissed Christie’s logic on Thursday, asserting that to stem the ongoing crisis, the country should have the maximum number of options available — including medical cannabis — to prevent people from turning to opioids.

“The federal government has lied to the American people for a generation about cannabis in asserting that it has no medical value,” Gaetz said. “I can tell you it is not true.”


Related: Veterans overwhelmingly support medical cannabis research, legalization


The first-term congressman representing the Florida Panhandle is co-sponsor of legislation to transfer marijuana to Schedule III of the Controlled Substances Act from its current standing as a Schedule I substance, the strictest of the classifications.


Rep. Matt Gaetz, R-Florida (Steve Cannon, Associated Press File)

House Bill 2020 would uphold the rights of states that have legalized the medical use of cannabis, allow for banking activities and create a clearer path for research, Gaetz told The Cannabist in April.

When Gaetz was a Florida state legislator in 2014 and 2015, he backed legislation to legalize “non-euphoric” marijuana for medical use and a bill to allow terminally ill patients to access full-strength, non-smokeable cannabis. Both were signed into law.

Christie has repeatedly stated his opposition to legalizing marijuana.

He left no doubt about his opinion of cannabis in an April 2014 radio interview:

“I don’t care that people think it’s inevitable. It’s not inevitable here. I’m not going to permit it — never — as long as I’m governor. You wanna elect somebody else who’s willing to legalize marijuana and expose our children to that gateway drug and the effects it has on their brain, you’ll have to live with yourself if you do that — but it’s not going to be this governor who does it.”

In September 2016, he issued a signing statement to a state measure allowing medical cannabis to treat PTSD to require other means of treatment before a doctor could recommend cannabis in order to prevent “misuse.”

Last June, he called a hearing in the New Jersey Senate on legislation to legalize marijuana a “dog-and-pony show.”

Next week, New Jerseyans will go to the polls to vote for Christie’s replacement. Democrat Phil Murphy, who currently holds a 15 percentage-point lead in the gubernatorial race, has said he will legalize recreational marijuana in the state.

The draft 131-page report and recommendations by the commission chaired by Christie mention marijuana several times in the context of “addictive” and “psychoactive” substances, and the section on drug testing puts marijuana in the same category as coke or meth, referring to “illicit drugs such as marijuana, cocaine, or methamphetamine.”

Read the letter to President Trump from Gov. Chris Christie, Chairman of the Commission on Combating Drug Addiction and the Opioid Crisis:

Opioid Commission Chairman’s Letter (Text)

Read the draft report from the President’s Commission on Combating Drug Addiction and the Opioid Crisis, submitted November 1, 2017:

Opioid Report (Text)

(Why?)

Published at Thu, 02 Nov 2017 20:59:22 +0000

FDA sends warning letters to CBD companies, including Colorado's CW Hemp

FDA sends warning letters to CBD companies, including Colorado's CW Hemp

The Colorado company known for the “Charlotte’s Web” cannabidiol-rich extract and three other businesses that make CBD products were put on notice by the FDA for illegally making unsubstantiated health claims.

The U.S. Food and Drug Administration on Wednesday issued warning letters to four firms: Stanley Brothers Social Enterprises LLC, which does business as CW Hemp, of Colorado Springs, Colo.; That’s Natural Marketing & Consulting, of Pueblo, Colo.; Green Roads Health, of Pembroke Pines, Fla.; and Natural Alchemist, of El Dorado Hills, Calif.

In a statement, FDA officials said they’ve becoming increasingly concerned about the “proliferation” of products that claim to treat or cure diseases such as cancer.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” FDA Commissioner Dr. Scott Gottlieb said in the statement.

The companies subject to the FDA’s warning letters did not respond Wednesday to requests by The Cannabist for comment.

The CBD products in question have not been subject to FDA review or approval, officials said.

In the warning letters, the FDA rejected claims that the products could be classified as dietary supplements, citing the Investigational New Drug Applications submitted for CBD-containing pharmaceutical drug candidates Sativex and Epidiolex.

At the beginning of October, Gottlieb indicated that additional actions against cannabis companies could be in the works. His agency would be looking into the rules around the marijuana plant and claims made by companies that, “marijuana has anti-tumor effects in the setting of cancer,” Gottlieb said at an Oct. 3 hearing before Congress.

The FDA issued similar warning letters to CBD product makers in 2015 and 2016.

In the respective warning letters, the FDA cited many examples of what the agency considers illegal claims by each company. They included:

CW Hemp

  • Website lists testimonials relating to therapeutic effects for diseases and conditions such as cancer, depression, traumatic brain injury, autism, diabetes, and Alzheimer’s.
  • Website directs visitors to the webpage for Realm of Caring, which provides CBD dosing instructions for child cancer patients.
  • Facebook and Twitter posts extolling the benefits of CBD for athletes with Chronic Traumatic Encephalopathy (CTE).
  • Social media responses to customers questions advising, “…you do not need a RX to buy Charlotte’s Web.”

Read the FDA’s letter to CW Hemp.

That’s Natural

  • Website includes testimonials about CBD products killing of cancer cells and leveling off of blood sugar.
  • Social media posts touting benefits of cannabinoids for treatment of cancer, autism and heart issues.
  • Website section defining CBD oil makes statements that, “CBD makes cancer cells commit ‘suicide’ without killing other cells.”

Read the FDA’s letter to That’s Natural.

Green Roads

  • Product descriptions on webpage claim they’re intended for treatment of one or more diseases and their labels do not provide directions for intended use.
  • The company’s alleged sale of food products containing added CBD across state lines, which the FDA considers illegal.
  • Website includes claims and phrases such as: “Adding CBD oil as part of your daily Alzheimer’s medicine routine has a good chance at delaying the progression of the disease…”

Read the FDA’s letter to Green Roads.

Natural Alchemist

  • Website claims “[C]annabis plant, enriched with CBD, can be used for treating diseases like rheumatoid arthritis, colitis, liver inflammation, heart disease and diabetes.”
  • Testimonial on webpage that stated: “I was pleasantly surprised to find that CBD helped my arthritis…I have shared with my son and he states he is a big believer in CBD for . . . TBI [traumatic brain injury] after being acquainted with military personnel who have tried it.”

Read the FDA’s letter to Natural Alchemist.

The FDA has requested that the companies correct the noted violations, FDA spokesman Michael Felberbaum told The Cannabist via email. Failure to correct the violations promptly could trigger legal actions such as product seizures or a court-filed injunction.

“When a product is in violation of the Federal Food, Drug, and Cosmetic Act, the FDA considers many factors in deciding whether or not to issue warning letters,” he said. “Those factors include, among other things, agency resources and the threat to the public health.”

Following the FDA’s announcement on Wednesday, phones were “ringing off the hook,” said attorney Bob Hoban, managing partner at Denver-based Hoban Law Group, a firm specializing in cannabis business law. The firm is representing the hemp industry in cannabinoid-centric lawsuits against the U.S. Drug Enforcement Administration.

“I don’t believe alarm bells should be sounding,” Hoban said, “but I think this requires that the industry should be looking at itself.”

Manufacturers of CBD-rich extracts and products derived from cannabis, notably hemp, should take a self-policing approach to ensure that what they’re selling falls in line with requirements for food or dietary supplement products, he said.

While Hoban disagrees with the FDA’s position that hemp-derived, cannabinoid-rich products cannot be dietary supplements, he said he agrees with the agency on how these products are allegedly marketed.

“At the end of the day, you can’t make these claims,” he said.


Catch up on all the cannabidiol news with The Cannabist’s special report: CBD, TBD

Part I – Forbidden medicine: Caught between a doctor’s CBD advice and federal laws

Part II – How advocates are inspiring congressional action on CBD legalization

Part III – With DEA digging in its heels on “marijuana extracts,” legality of CBD oil on trial in federal courts

Part IV – CBD research is going to the dogs in quest to legitimize pet products

Part V – CBD on the international stage: WHO committee delving into science, control status of cannabis compound

Part VI – Race for CBD medication breakthrough: Is pharma firm’s boon the hemp industry’s doom?

(Why?)

Published at Wed, 01 Nov 2017 17:40:35 +0000