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What Cannabis Can (and Can’t) do for Chronic Pain. Pot for Pain Relief?

What Cannabis Can (and Can’t) do for Chronic Pain. Pot for Pain Relief?

(Story by Karen Weintraub, USA TODAY) reprinted 1/26/2023. 

A growing, but still incomplete body of research suggests the cannabis plant, the source of marijuana, can help fight some kinds of pain.

Rob Sims grew up hearing stories about what opioid addiction could do. The former Detroit Lions guard, whose father, Mickey, also played in the NFL, watched a number of his dad’s friends get hooked. Some died. He vowed his own story would be different.

Then, playing for the Seattle Seahawks in 2008, early in his pro football career, Sims tore a pectoralis muscle in his chest. Primed for his best year ever, Sims was sidelined.

After surgery, he received an open-ended prescription for opioids. “Take when you have pain,” the bottle read. “That’s seared in my memory,” he said. As a football player, “I have pain all the time.”

Scared by the lesson he had learned as a child and with little to do besides focus on his recovery, he remembers thinking: “This could go in a bad way.”

That’s when he turned to marijuana.

It remains unclear whether cannabis can be an effective treatment for pain. Plenty of circumstantial evidence supports the idea, but exactly how, what kinds of products and what can be expected from them has yet to be determined.

“There’s some caveats before it’s ready for broad, prime-time usage for chronic pain,” said Dr. Devan Kansagara, a professor of medicine at Oregon Health & Science University and a staff physician at the VA Portland.

It’s possible that cannabis helps with the psychological aspects of pain, said Dr. Nora Volkow, head of the National Institute on Drug Abuse. “Cannabis may improve pain indirectly, for instance, through decreasing anxiety so that someone may be able to deal with pain better,” she said.

Rob Sims was a guard with the Detroit Lions and now runs a cannabis business with fellow former Lion Calvin Johnson Jr., right. © Carlos Osorio, AP

Detroit Lions guard Rob Sims during the game against the Green Bay Packers at Lambeau Field, Dec 9, 2012.

Detroit Lions guard Rob Sims during the game against the Green Bay Packers at Lambeau Field, Dec 9, 2012.© Benny Sieu, USA TODAY Sports

One recent examination of previous studies found the benefits of cannabis were equal to the benefits of a placebo, which means that if people thought it would help, it did.

“There’s very limited evidence out there to support that cannabis is effective against pain,” said Karin Jensen, the Swedish neuroscientist who led the study. So far, most of the information showing its usefulness is anecdotal.

“People who use cannabis to relieve pain may have the experience that it helps – there is no doubt about that,” she said. “What’s needed is solid scientific evidence to determine how much of the relief is due to the cannabis and how much is due to other things, such as the placebo effect.”

The general public is already largely convinced.

Marijuana remains illegal in 12 states, but as of 2019, 18% of U.S. adults reported using cannabis at least once in the previous year, and 4% to 5% use it daily or nearly daily, Kansagara said.

In a 2017 study, the majority of people who used medical marijuana or self-medicated with the drug said they did so to relieve pain, and 65% of those who requested medical marijuana licenses said they wanted it to treat pain.

The marijuana plant provides a wide range of chemicals, including THC, which has psychotropic effects.

The marijuana plant provides a wide range of chemicals, including THC, which has psychotropic effects/

But cannabis comes with cautions.

At least 5% of Americans ages 12 and up abuse or are dependent on marijuana, and the risk for dependence increases the younger someone starts. Marijuana use directly affects parts of the brain responsible for memory, learning, attention, decision-making, coordination, emotion and reaction time. And long-term or frequent marijuana use, particularly at higher doses, has been linked to increased risk of psychosis or schizophrenia.

It’s not possible to predict ahead of time who will react badly to marijuana, said Dr. Charles Berde, co-founder of a pediatric pain clinic at Boston Children’s Hospital.

THC, the part of the plant that has psychotropic effects, “has narrow uses for nausea and appetite stimulation in patients with severe weight loss due to AIDS or cancer,” but the data for CBD for treatment of chronic pain is “murky,” Berde said. “All the more reason to be hesitant to prescribe it.”

Cannabis and pain relief

When a body is in pain, the brain releases its own pain relievers. There are special receptors in the brain designed to take in these natural cannabinoids and offer relief.

Ingesting or inhaling weed fills up those receptors, too.

Providing more cannabinoids than these receptors can accept overloads them making the person’s own internal cannabinoids ineffective, said Dr. Jordan Tishler, a cannabis specialist physician in Cambridge, Massachusetts, and founder and president of the Association of Cannabinoid Specialists.

That’s why higher doses don’t provide any additional pain relief compared with lower ones and can have “all sorts of risks,” he said. Side effects from cannabis can include increased heart rate, dizziness, impaired concentration and memory, slower reaction times and, more rarely, increased risk of heart attack and stroke and dependence.

Tishler said many patients come to him taking far too much cannabis, which increases the risk for side effects. He works to convince them that 5 mg to 20 mg a day will treat their pain better than the 200 mg they’re using.

Cannabis is now sold in many different forms.

Cannabis is now sold in many different forms.

“Just because (cannabis) doesn’t lead to breaking the law and incarceration and those sorts of troubles doesn’t mean people can’t have their lives significantly altered by getting overly involved with this particular substance,” he said.

There are also open questions about cannabis, including whether the pain-killing benefits seen in short-term studies will last. Some painkillers, like opioids, can actually make people more sensitive to pain. It’s not yet clear whether cannabis can have this effect.

“You’d like to see what happens with these products over a longer period of time, ideally,” Kansagara said. “I would like to see that before recommending wholesale to patients.”

Although legalization and decriminalization are making a difference, cannabis remains hard to study. Until recent years, it was extremely difficult to gain access to cannabis for research, and there was little federal funding for such work. In early December, President Joe Biden signed a law that will make it easier to research cannabis.

Dr. Donald Abrams, speaking in support of the Adult Use of Marijuana Act ballot measure in San Francisco on May 4, 2016.

Dr. Donald Abrams, speaking in support of the Adult Use of Marijuana Act ballot measure in San Francisco on May 4, 2016. © Jeff Chiu, AP

Gold-standard studies compare a treatment versus a placebo, but it’s impossible to keep people in the dark about whether they’re getting high, said Dr. Donald Abrams, an oncologist and professor emeritus at University of California, San Francisco, who studies cannabis.

When Abrams studied cannabis use in his HIV patients, some critics thought patients must be too stoned to notice their pain. But Abrams said the patients reported that it did alleviate their pain.

Dosages of cannabis aren’t standardized, which adds to the difficulty of comparing one study against another, he said.

That’s why trials of cannabis for pain relief have shown mixed results, said Wil Ngwa, an associate professor of radiation oncology at Johns Hopkins Medicine, who’s working to create such standards for drug trials.

This lack of standardization also means people have to use trial and error to find an effective dose for them, according to Staci Gruber, who directs the Marijuana Investigations for Neuroscientific Discovery (MIND) program at McLean Hospital, a Harvard-affiliated psychiatric hospital outside Boston.

In one study, Gruber followed 37 volunteers using cannabis for chronic pain. After six months of treatment, participants reported lower levels of pain, better sleep, more coherence and less use of conventional painkillers.

‘Positives, not negatives’

Sims experienced the same benefits.

Daily marijuana use after his pec injury helped cut the pain, allowing him to lift more weight and recover faster. “I was able to come back stronger than I was before.”

Playing NFL ball, Sims said, is like living through a train wreck every Sunday. The best players – the ones whose careers last the longest, he said – “have learned how to recover quicker and get ready for that next train wreck.”

During his career, marijuana helped Sims rebound and improved his sleep, which allowed him to push his workouts.

Asked about side effects from his marijuana use, Sims pointed to his athletic and financial successes. “I wouldn’t call those side effects,” he said, laughing. “I see positives, not negatives.”

In 2021, Sims co-founded the cannabis company Primitiv Group with fellow former Lion Calvin Johnson Jr. Sims and Johnson acknowledge they used cannabis during their professional careers, though there was a zero tolerance policy then, which has loosened only slightly since. Both men believe the restrictions should be lifted.

About a decade ago, Sims persuaded his wife, Natalie, to try cannabis, when a bout with the bowel syndrome Crohn’s disease left her on a morphine drip in an emergency room.

“This can’t be how we live for the rest of our lives,” he told her. She uses cannabis now and finds relief, Sims said.

“It made me very passionate about pain and help for pain.”

Challenges of cannabis care

Cannabis doesn’t make pain go away, like Advil might get rid of a headache, Tishler said.

Instead, “it makes it so it doesn’t bother you so much,” he said. “It divorces the pain from the suffering.”

Whether it’s the THC or the CBD in cannabis or both that might be helpful against pain remains an open question, Kansagara said. THC is what makes people feel “high.” CBD appears to have anti-inflammatory properties, which may be useful to some.

Smoking joints isn’t a good approach for relieving chronic pain, said Tishler, who recommends his patients use edibles instead. The effect of inhaled cannabis wears off in three to four hours, while a gummy might last eight to 12 hours.

The yo-yo effect, when pain comes and goes over a few hours, can exacerbate suffering, Tishler said. “Short-acting actually turns out to be a bad approach in general in pain management.”

In Massachusetts, where medical cannabis has been legal since 2013 and recreational since 2016, doctors are more comfortable giving their patients permission to use cannabis, Tishler said. But they rarely bring it up themselves.

So, Tishler is trying to educate his peers. “If you were thinking the patient needs opioids, think cannabis first. Don’t wait for the patient to bring it up – it’s your job to bring it up,” he tells them.

Similarly, he’d like to get cancer patients on cannabis early in their care, rather than waiting until agony sets in. “Once people are at the end of their rope, things are worse and harder to treat than if we had started when things were still kind of OK.”

Most of the advice on what product to use now comes from the patient care advocates or “budtenders” who work behind the counter at dispensaries, Gruber noted with some concern. They typically don’t know the person’s medical history or history of cannabis use or whether they use other substances such as alcohol, other drugs or prescription medication. Product labels can often be misleading about their THC and CBD content.

The trial-and-error approach can be difficult and challenging for patients with major medical problems.

“Knowing what’s in your weed is critical, but also how you’re going to respond to it is an important consideration. And that’s something we don’t spend a lot of time on,” Gruber said. “You have to educate patients. They’re desperate for it, but it’s not easy, because we’re all different and cannabis is not a ‘one size fits all’ solution.”

Research may change future use.

For cannabis to reach its full potential as a painkiller, more research is needed, experts say.

“It’s really untapped right now, because of that lack of research,” Johnson said.

That’s why NFL players and owners have been supporting cannabis research. Owners have donated more than $1 million this year to two cannabis research programs.

“We need to become better educated about all these issues,” said Dr. Allen Sills, the NFL’s chief medical officer.

Dr. Allen Sills, the NFL's chief medical officer

Dr. Allen Sills, the NFL’s chief medical officer© Rebecca Blackwell, AP

Ngwa, at Hopkins, collaborates with Sims and Johnson to lead some of that research.

He’s also looking at better ways to treat cancer pain with cannabis.

His studies suggest that not enough of the painkiller gets to a tumor when the cannabis is inhaled or ingested, so he has been exploring smart-drug delivery systems than can target the drug directly to the tumor. So far, he has tested only pancreatic tumors but hopes to rapidly expand to other cancer types.

Ngwa is concerned that preliminary research like his will encourage people to self-medicate, taking doses that may not be helpful. “You really have to wait for the clinical trials, but when people are desperate, they just do (anything). I definitely worry about that,” he said.

Until more is known, Sims will keep up his cannabis routine.

Now 39, he has dropped 50 pounds from his 320-pound playing weight, which has helped reduce the lingering bone-on-bone pain in his right knee. He rubs a Primitiv topical on it knee every day.

“My passion behind the plant and what it’s done for my family reigns supreme.”

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Cannabis Global – CBGL. We are an emerging force in the cannabis marketplace with a growing product and proprietary intellectual property portfolio.

Cannabis Global (CBGL) Closed Q2 2022 and Sees Healthy Continued Revenue Increases, Provides Investor Updates


LOS ANGELES, CA July 21, 2022 Cannabis Global, Inc. CBGL Cannabis Global, Inc., a licensed Los Angeles-based manufacturer and distributor in the cannabis sector, today provides an update for its investors and the marketplace after reporting its third fiscal quarter ending in May 31, 2022.

2022 Will Be CBGL Year To Watch

During the third fiscal quarter the Company continued to expand its customer base and the number of products manufactured and distributed. Four new products were launched in the edibles space and five in the solventless. New orders grew significantly during the quarter for solventless cannabis concentrates, zero cannabis taste edibles, and concentrate based flower products. Over the coming weeks the Company expects these products to be delivered to both storefront retailers and delivery companies. During the current quarter, which ends on August 31, 2022, the Company also expects to launch its Northern Lights brand consisting of premium flower-based products, edibles and solventless concentrates.

“During this recently reported quarter, we experienced numerous successes relative to product rollouts, customer orders and deliveries. We believe the strong growth in our order pipeline from significantly sized retailers will allow us to continue to experience growth in product revenues,” commented Arman Tabatabaei, Chief Executive Officer of Cannabis Global, Inc. 

Cannabis Global 2022

For the third fiscal quarter, the Company produced revenues of approximately $792,000, a sequential increase of approximately 25% over the previous quarter. Revenue growth during the quarter was a result of increased orders from recently introduced cannabis brands and an expansion of distribution related activities. Total assets rose to $14.9 million as of May 31, 2022 from approximately $11.4 million as of May 31, 2021. 

About Cannabis Global, Inc. 

Cannabis Global, Inc. is a Los Angeles-based, fully audited and reporting Company with the U.S. Securities & Exchange Commission, trading under the stock symbol CBGL. We are an emerging force in the cannabis marketplace with a growing product and proprietary intellectual property portfolio. We are marketing and producing Comply Bag(TM), an innovative solution for cannabis storage, transport and tracking. Our subsidiary, Natural Plant Extract (NPE), is a Southern California licensed cannabis manufacturer and distributor which licenses our technologies to produce edibles for the cannabis marketplace. Cannabis Global has filed three non-provisional and multiple provisional patents for cannabis infusion and nanoparticle technologies and continues an active research & development program.

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Hemp – To Be Used as Livestock Feed – Unlocking More Potential for the Cash Crop

Las Vegas, NV, Dec. 24th, 2021, Happy Holidays from Inspirational Technologies!

Last Minute Thoughts before the New Year’s Celebration Reminds Us of Our Resolution’s and the effects on us post endeavor. In other words, think about Pain Creams, Skin Care and Your Health in General. And not only Your health and care, but also your loved ones. So Inspirational Technologies recognizes hempSMART as our go to product for the New Year 2022. You can find more information below, after our Blog Post on our livestock benefits.  Thank you, for your consideration – Steven Smith, Founder, Inspirational Technologies (2014) 

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Hemp Used as Livestock Feed Unlocks More Potential for the Cash Crop

 

Using Hemp As A Rotational Crop

Recent reports on the benefits of using hemp as livestock feed and how it can unlock more opportunities as this cash crop continues to flourish at an exponential rate. After almost being entirely eliminated from the American landscape in the 1950s, Congress finally made it legal in 2018 to grow hemp in America again.

Recognizing that not all cannabis plants were bred to have high concentrations of THC allows for segments of the agricultural sector to cash in on the hemp crop too.

While hemp is primarily grown to produce seed, fiber, medicine and oil (and has thousands of uses), the byproducts that remain after harvest could serve as feed for animals.

This may include leaves, fodder and residual plant fibers. Since these byproducts are predominantly “cellulose-containing plant materials” the best type of animals to utilize these byproducts are ruminants (cattle, sheep, goats, buffalo, deer, elk, giraffes and camels) because of their unique digestive system.

This opens the door for segments of the agricultural industry to take advantage of opportunities in the hemp market by using hemp as animal feed.

While the 2018 Farm Bill made it legal to grow hemp, feed ingredients, including hemp, fall under the jurisdiction of the FDA (Food & Drug Administration), thus hemp growers are still petitioning the government to approve the plant as livestock feed.

Hemp Feed Coalition

According to the VP of the Hemp Feed Coalition, “large scale hemp production will create inexpensive byproducts that are valuable as animal feed ingredients. Hemp seed meal provides high values of nutrition, such as complete protein, omega-3 and mega-6 fatty acids.” (Source reveals) To realize these benefits, the Hemp Feed Coalition is working to gain federal approval for hemp and its byproducts as an animal feed ingredient. In an article published a few months ago, “prior to prohibition in 1937, wild hemp grew freely across North America and was a natural part of the diet of all grass-grazing animals, including cows, goats, sheep and bison.

Even pasture-raised chickens pecked at the plants, which means CBD, small amounts of THC and all the other cannabinoids we’ve since discovered were also a natural part of the human diet, via meat, milk and eggs.”

Hemp Industry Daily says the animal-feed ingredient approval process typically takes up to four years, but FDA authorities have promised to fast-track it, reducing the process to 1-2 years.

As of today, hemp as a feed ingredient, is not approved by the Association of American Feed Control Officials (AAFCO) or the FDA Center for Veterinary Medicine.

Approval from these entities would unlock more opportunities of what the cash crop has to offer. Industrial hemp has nearly unlimited potential and the surface of that potential has only been scratched. Much more remains to be discovered about the possible uses of the robust, multi-purpose substance.

Federal legislation in favor of hemp and many state approvals across the country, have been a boon to the industry.

And with immense profits to be made, there is no doubt that companies in the industry, will benefit from it.

The number of consumer products made from hemp is already mind-boggling. From personal care items to fuel, the list seems to be endless.

 

 

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Cannabis Global Expands into Solventless Cannabis Extracts at Lynwood Facility

LOS ANGELES, CA – November 23, 2021 Cannabis Global, Inc,. an innovation-oriented company investing in disruptive cannabis technologies, today announces an important enhancement to its cannabis product manufacturing capabilities at its Natural Plant Extract of California facility in Lynwood, a suburb of Los Angeles. The facility is now producing solventless cannabis concentrates for use in its own cannabis products, including edibles, beverages and pre-rolls.

Cannabis Global

Most of the cannabis extract products on the market are prepared using solvents such as butane, propane, and carbon dioxide to extract the oils and cannabinoids from the plant.

These products ultimately have most of the solvents removed, but the taste profile of the original plant material is altered in the overall process. The solvent-less extraction methods used by the Company instead rely 100% on water, ice, heat and pressure to extract the desirable components from the cannabis plant.

“Consumers are increasingly turning to solvent-less products for three reasons: purity, taste and experience,” commented Arman Tabatabaei, CEO of the Company. “We do not have to remove the chemical solvents from these products as none are ever added. It’s just water, heat and pressure. Many consumers prefer the natural taste of solvent-less produced extracts and believe such products offer a superior user experience. We expect continued growth in the marketplace as consumers increasingly gravitate toward these high-quality products.

“Solvent-less operations at the Company’s Natural Plant Extract of California facility include both ice water hash production, which uses water and ice to separate the valuable trichomes from the plant materials, and rosin production, which uses heat and pressure to produce an ultra-premium concentrate.

The Company plans to utilize these solventless concentrates to enhance cannabis products, such as premium pre-rolls, edibles and beverages, which are in various stages of availability and pre-production.

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Surge in the Majority of Cannabis Stocks This Past Friday – Ahead of States Reform Act

Nov. 15, 2021 1st Hemp USA Reposts- The recent surge of cannabis stocks after news of a draft bill, known as the States Reform Act, Rep. Nancy Mace (R-SC) is leading the preliminary marijuana bill, that is set to legalize and tax marijuana.

This news created a surge in the majority of cannabis stocks on Friday, November 12, 2021

According to news sources, Rep. Nancy Mace (R-SC) is leading the preliminary marijuana bill (still being circulated for feedback) and hopes to have a final version officially filed later this month.

This is a huge development in the marijuana industry making this a very active year on the Hill for cannabis reform. “Republican buy in could prove critical to getting something over the finish line, and the Mace measure seems aimed at appealing to the states’ rights and business interests of conservative colleagues on her side of the aisle while also incorporating some restorative justice and tax elements largely favored by progressives,” cited the source.

Cannabis would be federally de-scheduled and treated in a manner similar to alcohol.

A 3.75 percent excise tax would be imposed on cannabis sales. Revenue would support grant programs for community reentry, law enforcement and Small Business Administration (SBA) aid for newly licensed businesses.

The Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau (TTB) would be the chief regulator for marijuana with respect to interstate commerce.

The Food and Drug Administration (FDA) would be limited in its regulatory authority, with the intent being that it would have no more control over cannabis than it does for alcohol except when it comes to medical cannabis.

The agency could prescribe serving sizes, certify designated state medical cannabis products and approve and regulate pharmaceuticals derived from marijuana, but could not ban the use of cannabis or its derivatives in non-drug applications, like in designated state medical cannabis products, dietary supplements, foods, beverages, non-drug topicals or cosmetics.

Raw cannabis would be considered an agricultural commodity regulated by the U.S. Department of Agriculture (USDA). The legislation would grandfather existing state-licensed cannabis operators into the federal scheme to ensure continued patient access and incentivize participation in the legal market.

Department of Agriculture (USDA)

As federal agencies work to promulgate rules, there would be safe harbor provisions to protect patients and marijuana businesses acting in compliance with existing state laws.

People with certain federal cannabis convictions that were non-violent would be eligible for expungements.

To prevent youth use, there would be a mandatory 21 age limit for recreational cannabis, and the bill also prescribes certain restrictions on things like advertising. SBA would need to treat marijuana businesses the same as other regulated markets, like it does for alcohol companies, for example.

The measure also stipulates veterans can’t face discrimination in federal hiring due to cannabis use, and doctors with the U.S. Department of Veterans Affairs (VA) would be specifically authorized to issue recommendations for medical cannabis for veterans.

Federal agencies could continue to drug test for marijuana.

The Bureau of Labor Statistics (BLS) would be required to issue a report to Congress on the marijuana industry.

Provisions are subject to change as the proposal is finalized ahead of its formal introduction in Congress.

What does this look like for investors in the cannabis sector?

Increased trading as the push for federal cannabis reform continues;

with upcoming healthy 4th quarter earnings; and cannabis listed as one of the top five crops in the U.S.

“As it stands, cannabis is already a multi-billion dollar industry and reports show that this number will only increase over time.”

With the market expected to grow to $51 billion by 2025, can one expect anything less?

Time is Running Out

Lucrative opportunities abound in the cannabis sector much like in the industrial hemp sector. Industrial hemp has nearly unlimited potential and the surface of that potential has only been scratched. With immense profits to be made, there is no doubt that companies in the industry, will benefit from it.

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President Joe Biden Announced Friday Intention To Nominate Dr Califf as Food and Drug Administration (FDA) Commissioner, Who Once Prescribed Marijuana

President Joe Biden announced on Friday that he intends to nominate a new Food and Drug Administration (FDA) commissioner who has acknowledged the potential medical benefits of marijuana and says he actually prescribed a cannabinoid drug as a doctor.

Dr. Robert Califf, who previously served a short stint as the FDA head under the Obama administration, hasn’t been especially vocal about marijuana issues.

But at a 2016 federally hosted research summit on cannabis, he recognized various therapeutic applications for the plant and its components and emphasized that the agency is interested in promoting research and development. “We understand that people have identified a number of possible uses of marijuana and marijuana-derived products. For example, AIDS wasting, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis, cancer and chemotherapy-induced nausea,” Dr. Califf said.

“And I had the chance to prescribe some of this in my cardiology practice in people with extreme heart failure who get a wasting cachectic syndrome.” Notably, he also said that while FDA had yet to find that botanical marijuana is “safe and effective for any indication,” that’s not to say there aren’t any good uses for it, and additional studies could shed light on the situation.

FDA’s position on cannabis is “not because we’ve had a ton of applications to look at,” he pointed out. “It’s because we haven’t gotten them into the pathway,” Califf said. “What this means is that no one has demonstrated to FDA that any such product is safe or effective for the treatment of any disease or condition. To change that we need studies conducted using marijuana to rigorously assess the safety and effectiveness of marijuana for medical use.”

“Then we need to get those studies submitted to FDA and a marketing application for review under the legal standard set out in the federal Drug and Cosmetic Act,” he said.

“This assures that the drug product meets the statutory standards for approval.” “This is what we really want and we actively encourage it and want to work with people to make this happen,” he added.

“To do this, we know we need to facilitate the work of companies interested in appropriately bringing safe, effective and quality products to market, including scientifically based research concerning these medicinal uses.”

“We believe this process, which includes collaboration with other federal and state agencies, researchers and manufacturers working on issues related to the use of cannabidiol and other constituents of marijuana in the U.S. remains the best way to identify new treatments that are safe and effective for patients and to protect patients from products that are not what they purport to be.”

At the summit, Califf also noted that FDA has approved synthetic cannabis products like Marinol for the treatment of anorexia associated with AIDS and nausea related to chemotherapy treatment.

The approval of these substances “supports the point I made earlier that our decisions on the approval of any medicine relies on the science to determine the safety and effectiveness of new medicines. And it’s also consistent with the approach we’ll continue to take going forward in this area,” he said.

Overall, the remarks suggest that, if confirmed, it doesn’t seem that Califf wouldn’t be hostile toward attempts to explore the therapeutic potential of cannabis. But he does seem to defer to statutory processes within FDA that favor pharmaceutical approaches to these medicines that have so far kept marijuana in a tightly regulated drug category.

Separately, some vaping stakeholders have raised concerns about the prospective nominee, pointing to a 2019 op-ed he authored that advocated for a ban on flavored vape products as a way to mitigate the risks of the e-cigarette or vaping use-associated lung injury (EVALI) crisis.

“I believe that we should move to enact strict regulation to limit the harm done by vaping products, augmented by an aggressive public education program that is particularly aimed at vulnerable young people, but not excluding adults,” Dr. Califf wrote at the time.

However, he acknowledged that an “outright prohibition of vaping products seems impracticable on several grounds,” adding that the “regime of legal prohibition also dissuades people from seeking help with addiction for fear of stigma that might negatively affect future employment and social mobility.”

If Califf does become commissioner, he’ll have his work cut out for him on the cannabis front.

For example, industry stakeholders are eagerly awaiting action by the FDA to allow CBD to be marketed as a food item or dietary supplement.

 The agency has said that it is exploring regulatory pathways to allow for such cannabidiol commerce, but bipartisan lawmakers have introduced legislation this session to force a change.

FDA was mandated under appropriations legislation enacted in 2019 to provide an update on its regulatory approach to CBD, and it did so in March of last year.

The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”

Another issue that FDA is focusing on concerns delta-8 THC products that are made through a synthetic process using hemp-derived CBD.

The agency issued warnings to consumers about the potential risks of the cannabinoid in September.

FDA also recently announced that it plans to use Reddit and other “novel” data sources to gain a better understanding of public health issues surrounding use of CBD and other “emerging” marijuana derivatives like delta-8 THC.

With respect to broader marijuana policy, FDA would play a critical role in any moves to reschedule or deschedule cannabis.

If a scheduling petition is accepted, the agency would need to assess the scientific, medical and public health implications before submitting that review to the Justice Department with its recommendations.

FDA Acting Commissioner Janet Woodcock, meanwhile, frustrated advocates earlier this year after dodging a congressman’s question about whether marijuana is more harmful than tobacco.  

 

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