Will the FDA Regulate CBD?

Will the FDA regulate CBD? It’s a question on many minds as the FDA commissioner is to appear before the U.S. House Oversight Committee. Chairman of the Committee, James Comer, wants details on CBD. He said: “It’s not just their lack of action with respect to CBD and other types of hemp. It’s their inaction regarding a lot of areas of their jurisdiction … We’ve got an agency here that has a big budget, they have a lot of employees, […]

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Is Delta-8 THC Dangerous? 

Is Delta-8 THC dangerous? What is it, and why does it have a bad reputation? Delta-8 THC is a psychoactive compound found in cannabis. As a minor cannabinoid, it is one of the many natural compounds found in cannabis that interact with our body’s endocannabinoid system. Delta-8 THC is similar to delta-9 THC, the primary psychoactive compound in cannabis. Like delta-9, delta-8 THC has medicinal and therapeutic benefits, from reducing anxiety and stress to improving appetite and nausea.  Thanks to […]

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Can Cannabis Help Glaucoma Patients?

In 1976, a glaucoma patient named Robert Randall became the first person in the US to be granted legal status as a medical marijuana patient. As a teenager, Randall had been diagnosed with glaucoma and was told by doctors he would likely lose his eyesight before his 30th birthday. After learning of research that indicated THC could be an effective treatment for the disease, he began smoking marijuana. He was subsequently arrested for marijuana cultivation in Washington, D.C., but wasn’t convicted of the charges based on a defense of medical necessity. Thus, the cannabis and glaucoma debate began.

Randall then petitioned the Food and Drug Administration to provide marijuana to treat his disease. In 1976 the FDA approved the petition, later launching the Compassionate Investigational New Drug (IND) program to provide unapproved but promising drugs including cannabis to Randall and patients like him. After receiving shipments of joints from the federal government for 25 years to treat the disease, Randal died at the age of 53 in 2001. During that time, he never lost his eyesight.

What is Glaucoma?

Glaucoma is a group of related diseases of the eyes characterized by a buildup of fluid in the eye resulting in an increase in interocular pressure (IOP). The condition causes pressure on the optic nerve leading from the eye to the brain, leading to a slow loss of vision that can culminate in blindness. Traditional treatments for glaucoma include eye drops, oral medications and surgery. Glaucoma is the leading cause of blindness among people older than 60, according to the Mayo Clinic.

Some research has shown that THC, the cannabinoid largely associated with the classic marijuana “high,” can temporarily reduce IOP, thereby reducing the pressure on the optic nerve. A review of research into cannabis and glaucoma published in 2019 found that five randomized clinical trials found evidence that cannabis could lower interocular pressure. However, the researchers noted that the studies reviewed had design flaws including a small sample size and inadequate controls. But the glaucoma and marijuana studies also failed to compare the effects of cannabis on glaucoma to traditional treatments. The study concluded that randomized clinical trials (RCTs) showing the efficacy of cannabis as a treatment for the disease were necessary before its use could be recommended.

“The studies that were reviewed were highly variable in their methods and patient population selected, and therefore no current evidence supports the use of any form of cannabis to replace existing,” the authors of the review wrote in their conclusion. “Until further research in the form of RCTs with more evidence to support the use of cannabis for lowering IOP, it should not be recommended at this time.”

Noting that the effect that THC has on IOP is short-lived, the authors also added that if patients decide to use cannabis to treat the disease, “they would require frequent dosing, which has the potential to reduce patient adherence and increase side effects of the medication.”

Other research that supports cannabis as a treatment for glaucoma include animal studies that suggested cannabis might improve blood flow to the eyes and promote healing. Animal research also suggests that cannabis may have neuroprotective effects that might prevent damage to the optic nerve.

What About CBD?

However, not all forms of cannabis and glaucoma are effective and shouldn’t be used as a treatment for the disease. A study published in 2006 found that while THC reduced interocular pressure, CBD actually increased IOP. The educational website Glaucoma Today notes that cannabis varietals “with higher THC content can be expected to lower IOP, whereas strains with higher CBD content can be expected to increase IOP. It is therefore important that eye care providers caution patients who are interested in treating their glaucoma with medical cannabis that products with a high CBD content may have a detrimental effect on their disease process.” Patients who choose to treat their glaucoma with cannabis should choose products with negligible amounts of CBD.

Proponents of medical cannabis as a treatment for glaucoma argue that it’s a natural medication with few side effects. Advocates for the glaucoma and marijuana marriage also believe that cannabis can help the pain often associated with glaucoma and reduce the need for surgery. However, the American Academy of Ophthalmology (AAO) maintains that cannabis is not a practical treatment for glaucoma, primarily because of the temporary nature of its effect. The AAO notes that to effectively reduce IOP, patients would have to ingest 18 mg to 20 mg of THC six to eight times daily. The AAO also cites evidence that cannabis might have the opposite effect than intended, increasing IOP and causing additional damage to optic nerve. As a result, the professional group does not recommend the use of cannabis to treat glaucoma.

“Several current, effective treatments for glaucoma are more reliable and safer than marijuana,” the AAO wrote in 2021.

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Medical Cannabis Bill in Wisconsin Likely Already Dead

A measure that would legalize medical cannabis in Wisconsin has apparently reached the end of the line. 

Republican lawmakers, who hold the majority in the state legislature, “allowed a Capitol debate on legislation that would legalize marijuana use, but the step forward for proponents won’t result in a new cannabis law in Wisconsin anytime soon,” the Milwaukee Journal Sentinel reported.

According to the newspaper, a medical cannabis bill got a hearing at the state capitol in Madison on Wednesday that was “scheduled weeks after GOP leaders concluded the Legislature’s work for the year—prompting some Democrats who have long supported legalization to accuse Republican bill authors of using the hearing as a ‘political ploy’ in an election year.”

The bill was authored by a GOP state senator who also leads the committee whose medical cannabis advocacy stems from her experience with breast cancer.

“All of those drugs have severe side effects, some that I realize yet today, which is fine. I mean, I’m alive. But if there was a way that a natural product could have helped me with that?” the senator, Mary Felzkowski, said at Wednesday’s hearing, as quoted by the Milwaukee Journal Sentinel.

“When you have a prescription drug that has a horrific side effect, then you’re taking a drug to counteract the side effect … it was unreal. I mean, it’s almost like I went through six months of a fog,” she added.

But the bill was seemingly dead on arrival, with the Journal Sentinel reporting that it “has little support in the state Senate and virtually no chance of advancing, where the GOP leader has said he won’t support such legislation unless the Food and Drug Administration approves it as a prescription drug.”

Cannabis policy has become a divisive issue in the Wisconsin legislature this year. In February, the state’s Democratic governor Tony Evers vetoed a Republican-backed bill that would have imposed stricter and distinct penalties for manufacturing and distributing cannabis or resin by butane extraction.

Evers, who has been vocal in his calls to legalize cannabis for all adults, said the bill was “another step in the wrong direction.”

“I am vetoing this bill in its entirety because I object to creating additional criminal offenses or penalties related to marijuana use,” Evers, who is up for re-election this year, said in his veto statement at the time. 

“State across our country—both Democrat and Republican-controlled alike—have and are taking meaningful steps to address increased incarceration rates and reduce racial disparities by investing in substance use treatment, community reentry programming, alternatives to incarceration, rehabilitation, and other data-driven, evidence-based practices we know are essential solutions to reforming our justice system,” the governor added. “The data and the science are clear on this issue, and I welcome the legislature to start having meaningful conversations around justice reform in Wisconsin.”

Neither medicinal nor recreational pot is legal in Wisconsin.

For now, with Republicans controlling the legislature, outright legalization appears unlikely. But in a moment of candor, one top GOP lawmaker in the Badger State recently suggested that such reform might be inevitable.

“Recreational marijuana, I think, has a much tougher path to get through the legislature and eventually signed into law, but I do think we’re heading in that direction,” Jim Steineke, the majority leader in the state assembly, said last month. 

But last year, Steineke’s counterpart in the state Senate, Majority Leader Devin LeMathieu, said that legalization is a nonstarter in the GOP-controlled legislature.

“We don’t have support from the caucus. That’s pretty clear, that we don’t have 17 votes in the caucus for medicinal purposes or recreational purposes [to] legalize it,” LeMathieu said then.

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Proposed Hemp Bill Aims to Federally Regulate CBD Products

A bipartisan group of lawmakers wants to establish federal standards for the CBD market that has blossomed in recent years.

U.S. House Reps. Kathleen Rice (D-NY), Morgan Griffith (R-VA), Angie Craig (D-MN) and Dan Crenshaw (R-TX) introduced a bill last week that they say will help set standards for CBD-based food and beverage products “to protect consumers and provide marketplace stability for farmers, producers and retailers.”

The bill, called the “CBD Product Safety and Standardization Act of 2021,” “will establish the clear regulatory framework needed to provide stability for business and ensure unsafe products stay off the shelves,” Rice said in a statement.

The legislation “would allow [the Food and Drug Administration] to regulate CBD as it would any other food ingredient and subject these products to enforceable safeguards to ensure Accountability,” a press release explained, while also charging the agency “with establishing CBD content limits and packaging and labeling requirements and determining in which categories of food CBD is appropriate for use.”

“This bill will help distinguish responsible players from bad actors that ignore federal requirements for quality, manufacturing, labeling and claims, and it will bring safety and clarity to the market,” the press release said. 

The 2018 Farm Bill removed hemp and its derivatives from the list of federal controlled substances, clearing the way for states to pass their own laws governing its cultivation. In April, with Idaho’s passage of its own measure, all 50 states had legalized industrial hemp. Market research data released last week found that “industrial hemp accounted for USD 3.91 billion in 2020.”

The data from Brandessence Market Research found that the industry’s projections “are on a promising trajectory to grow at promising 16.27 percent CAGR during 2021-2027 period.”

“The legalization of marijuana in 18 states in the United States has increased the promise of already robust growth of the hemp market. At its peak, industrial hemp fetched $45 to $50 per pound in 2018,” Brandessence said in its report. 

“The COVID-19 crisis has had a negative impact on industrial hemp with a slowdown in demand. The United States Agriculture Department (USDA) estimates farmers can produce as much as two to 12 ton dry-stem yields per acre. Similar estimates are projected in Europe, where farmers produce 3.6 to 8.7 ton per acre. The USDA also estimated that the variable, fixed and operator cost accounted for $286 per acre for hemp fibre, $233 for certified seed and $196 for seed. While these estimates are age-old, the promising new growth due to legalization of marijuana in 18 states is a promising new driver for growth of the industrial hemp market.”

But despite the industry’s growth, and the ubiquity of CBD-based products, there remains “a lack of clear federal standards in the CBD industry [that] has left businesses guessing and customers at risk,” Craig, the Democrat from Minnesota, said in a statement.

“It’s clear that this growing industry needs regulatory clarity in order to continue selling their products safely and effectively,” said Craig. “I’m proud to join my colleagues in introducing this bipartisan legislation to create enforceable safeguards and ensure accountability in the industry.”

The press release from congressmembers said that the “discrepancy between the Controlled Substances Act and FDA law has created a regulatory gray area in which CBD is widely available but unregulated—and considered illegal—by FDA.”

Griffith, the Virginia Republican, said that “demand for CBD products has surged, but Food and Drug Administration regulations do not reflect this new reality.”

“As a result, adulterated or unsafe products are available that threaten consumer health, and businesses lack clarity,” Griffith said. “The CBD Product Safety and Standardization Act would require the FDA to address the issue and ensure more certainty in the CBD marketplace. I’m pleased to join this bipartisan effort.”

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US Menthol Ban – Benefit or Bad Move

As the US Food and Drug Administration takes steps to ban them, menthol cigarettes and flavored cigars might soon become a thing of the past. This action is being taken to try to prevent addiction and save lives, but why flavored tobacco, specifically menthol? The simple answer is that it’s much more addictive than non-flavored […]

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Former Head Of The FDA Says CBD Is ‘Not Safe’

The former head of the U.S. Food and Drug Administration (FDA)  has aimed a shot across the bows of the CBD industry by declaring it ‘not safe’.

While the FDA has yet to pronounce on the status of CBD, at a federal level, the industry will resolutely hope that Scott Gottlieb’s latest pronouncement is not indicative of his former employer’s position.

The former FDA commissioner, who stepped down from his post earlier this year, made his opinions clear in a series of tweets, reports The Motley Fool website. Stating that ‘CBD hype has outpaced science’ and that CBD is not safe’, he says the FDA needs to move quickly to oversee the ‘production, quality, and purity levels of CBD products’.

Still Waiting

And he goes on to say ‘all non-compliant producers, or those who fail to meet rigorous purity and quality standards, should be removed from the marketplace’, the report continued.

Following hearings in to the CBD phenomenon, in May this year, the FDA indicated it would be in a position to outline it guidelines for the CBD industry ‘by early fall’ – and with Christmas on the horizon the industry is still waiting.

The passing of last year’s Farm Bill boosted hemp production, supporting the boom in the U.S CBD industry. The Brightfield Group estimates U.S. CBD sales will grow from around $600 million in 2018 to $23.7 billion by 2023. 

But CBD, as a cannabinoid found in the cannabis plant, is still illegal at a federal level, and the industry is looking for regulatory clarity from the FDA. Meanwhile the U.S. The National Consumers League (NCL) has announced a new initiative; Consumers for Safe CBD.

Potential Harm

Consumers for Safe CBD say CBD is ‘a clear and present public health issue’ and is pressing for speedy FDA regulation. 

Sally Greenberg, Executive Director of NCL, said: “Consumers are being told these products will cure their chronic illnesses and help their anxious pets or children. Yet there is no scientific evidence behind the claims. What’s even more concerning is that without FDA’s stamp of approval, we do not know what is in these products…(which) may contain contaminants and ingredients that could harm consumers.”

She said Consumers for Safe CBD is calling for ‘gold standard testing of CBD by the FDA’.

A rapidly-growing database of clinical evidence, from trials and first-hand patient experience, demonstrate that CBD can help with a number of conditions including; inflammation, arthritis, pain management and anxiety.

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