Tag: CBD

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European CBD Novel Food Evaluations Put On Hold

Written by Frank Schuler on June 13, 2022. Posted in Policy, Science.

Cannabidiol (CBD) products are extremely popular around the world, with consumers and patients buying them every day around the globe from brick and mortar stores, online, and virtually every other way that people buy any other type of product.

A vast majority of those products are either under-regulated or completely unregulated. That is not to say that every product is unsafe, however, what percentage of products are unsafe is nearly impossible to know right now.

Governments around the world are scrambling to try to implement rules and regulations for the emerging CBD industry, with many of them experiencing setbacks.

The latest example of that is in Europe, where the European Food Safety Authority announced this week that it will be putting a pause on processing CBD novel food applications. Below is more information about it via a news release from the European Food Safety Authority:

EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens (NDA) has received 19 applications for CBD as a novel food, with more in the pipeline.

Chair of the NDA Panel, Prof. Dominique Turck said: “We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead. It is important to stress at this point that we have not concluded that CBD is unsafe as food.”

There is insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being.

Studies in animals show significant adverse effects especially in relation to reproduction. It is important to determine if these effects are also seen in humans.

This latest delay is definitely disappointing, and will likely be pointed to by cannabis opponents as ‘justification’ to abandon the CBD industry entirely.

It’s not as if there is a lack of research on this subject. A quick search on PubMed.gov, which houses peer-reviewed study results from around the globe, lists 4,881 returns for a ‘cannabidiol’ search query. A search for ‘CBD’ returns 9,727 study results.

By comparison, a search for the common sleep aid ‘Lunesta’ returns only 314 results. Obviously, it’s not an apples-to-apples comparison, but it does provide context regarding the level of research that CBD has already been subjected to.

Hopefully the European Food Safety Authority gets the data that they think they need and can get back to processing applications sooner rather than later.

In addition to the growing body of peer-reviewed research, there are literally millions of people around the globe that now regularly use CBD products and the sky has yet to fall. It’s anecdotal but still worth noting.

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Researchers Find CBD To Be An Effective Form Of Oral Care Treatment

Written by Frank Schuler on June 4, 2022. Posted in Science.

Having a wound in your mouth can be very uncomfortable, and in some cases, can lead to serious health issues. Developing a wound in your mouth can happen due to a number of factors, and regardless of the reason, it’s something that needs to be taken seriously.

Failing to properly care for a mouth wound can lead to infections in some cases, and at the very least, it will make the problem last longer if it goes untreated.

Researchers in Thailand recently examined the ability of cannabidiol (CBD) to treat oral inflammation, gingival wounds, and ulcers by using a scratch test assay and evaluating cytotoxicity.

“The hemp extract and CBD significantly decreased TNF-α release by up to 91.05 ± 2.91% and 50.78 ± 7.21% of LPS activity, respectively, in a dose-dependent manner, compared to 10 µg/mL hydrocortisone (61.67 ± 3.79%). The hemp extract and CBD also significantly decreased IL-1β release, also in dose-dependent response, up to 78.03 ± 3.34% and 85.87 ± 1.11% of LPS activity, respectively, compared to 5 µg/mL hydrocortisone (80.81 ± 3.55%).” the researchers stated.

“The mean percentage of closure of the wound area was 27.92 ± 1.21% when exposed to 5 µg/mL hemp extract and 33.49 ± 1.67% when exposed to 0.5 µg/mL CBD, compared to 24.34 ± 2.29% for non-treated control.” the researchers went on to say.

“Our study demonstrates that both hemp extract and CBD can inhibit TNF-α and IL-1β production in LPS-induced RAW 264.7 cells and promote wound healing in HGF-1 cells. This is the first to show that short-term exposure to hemp extract and CBD promoted gingival fibroblast wound healing, demonstrating that hemp extract and CBD have potential benefits in the treatment of oral inflammation and ulcers.” the researchers concluded.

If you are experiencing any of the conditions mentioned in this article make sure to contact a medical professional as soon as possible before trying any new treatments.

Does CBD Cause Physical Dependency?

Written by Johnny Green on May 9, 2022. Posted in Archives, Science.

Cannabidiol (CBD) is arguably the most popular cannabinoid on the planet right now. As evidence of that, consider the fact that ‘CBD’ is Google’d more often than ‘THC’, and that has been the case for multiple years now.

Interest in CBD has spiked partially because of increased availability thanks to recent policy reforms around the globe, as well as partially because it is effectively helping suffering patients treat their conditions.

CBD is just one of the dozens of cannabinoids found within the cannabis plant. It does not cause intoxication and can be infused into a number of products.

A team of researchers in the United Kingdom and the United States recently collaborated on a study to try to determine if CBD causes physical dependency and/or withdrawal symptoms in rats.

“Cannabidiol (CBD) is a constituent of the cannabis plant with a diverse array of pharmacological activities as well as potential therapeutic uses. An oral formulation of CBD (Epidiolex^® in the US; Epidyolex^® in Europe) is approved for treating seizures associated with rare and severe forms of epilepsy. These studies, which supported the approval of the medication, investigated abuse-related effects of CBD in rats and nonhuman primates (NHPs) using drug self-administration, drug discrimination, and physical dependence procedures and characterized its pharmacokinetics.” the researchers stated in their study abstract.

“In NHPs (n=5) that self-administered midazolam (0.01 or 0.032 mg/kg/infusion), CBD (0.1-3.2 mg/kg/infusion) failed to maintain responding above vehicle levels. CBD maintained very modest levels of self-administration in rats (n=7-8) that self-administered heroin (0.015 mg/kg/infusion) and did not increase drug-lever responding, up to a dose of 150 mg/kg (p.o.), in rats (n=6) trained to discriminate 0.5 mg/kg (i.p.) midazolam. In juvenile (5-6 weeks old) and adult (10-11 weeks old) male and female rats, discontinuation of chronic treatment (twice daily for 20 days) with an oral formulation of CBD (20 or 100 mg/kg, p.o.) did not reliably produce signs of withdrawal.” the researchers went on to say.

“Pharmacokinetic studies confirmed that the dosing regimens used in these studies resulted in therapeutically relevant plasma levels. Taken together, the lack of reliable self-administration, the failure to increase drug-lever responding in rats trained to discriminate midazolam, and the absence of withdrawal signs upon discontinuation of chronic treatment indicate that CBD has very low abuse potential and is unlikely to produce physical dependence.” the researchers concluded.

Obviously, this study involved lab rats and not humans, so the results need to be kept in perspective. With that being said, with so many humans now using CBD around the globe, and no reports of dependency or withdrawal, the results of this study seem to be in line with what we are seeing among the global human population in real-time.

Does CBD Help Reduce Methamphetamine Withdrawal Issues?

Written by Johnny Green on March 2, 2022. Posted in Science.

Stigmatizing drug use and treating drug addiction as a crime are both wrong. Drug addiction should be treated as a serious public health issue and not as a criminal justice issue.

Part of battling drug addiction issues is implementing meaningful strategies for mitigating harm and helping people that are addicted to harmful substances work through withdrawal issues as they quit.

Methamphetamine is a substance that is considerably more harmful compared to cannabis. Meth is very addictive and can wreak havoc on a person’s life. Meth is often combined with other harmful substances and the use of it can lead to death.

CBD Study

Researchers in Iran recently conducted a study in which they explored the potential for cannabidiol (CBD) to help people that are trying to quit using methamphetamine.

“In this review article, we focus on the effects of CBD in the treatment of addiction in a preclinical investigation concerning the pharmaceutic effectiveness and the underlying mechanisms of action on drug abuse specially METH.” the researchers stated.

“Through multiple-mechanisms, there is a belief that CBD modulates brain dopamine responding to METH, resulting in a reduction of METH-seeking behaviors.” the researchers went on to say.

“As our studies indicate, CBD can decrease METH addiction-associated problems, for example, symptoms of withdrawal and craving.” the researchers concluded.

The Safer Choice

As stated previously, no one should ever be shamed for their drug use, whether that drug use involves methamphetamine or not. With that being said, people should also be helped when they are trying to curb addiction.

CBD is non-psychoactive and by all measures is a safe substance. It is widely available and is now infused in all types of products, from gummies to tinctures to beverages.

Talking to a friend or family member that is battling addiction is not an easy task, and it takes tact, compassion, and understanding. If you feel comfortable discussing the matter with someone you know, offer up CBD as an option for battling withdrawals.

In addition to this study, other studies have found that CBD may be helpful in battling other types of addictions as well, including addiction to cigarettes and alcohol – two substances that are also more harmful than cannabis.

British Food Standards Agency To Publish CBD Guidelines

Written by Marguerite Arnold on January 6, 2022. Posted in Politics.

The regulatory agency is about to release a guide of legal CBD products in the UK market

Sometime in the next few weeks, the British Food Standards Agency (FSA) will publish details about the CBD companies and products allowed to remain on sale in the UK market.

The move comes as 210 applications for CBD products are still in consideration. Late last year, the FSA claimed that the reason this document is almost 9 months late is because of the ‘quality of applications” was lower than expected.

It is now expected that the FSA will potentially issue several documents. One is a public list of validated products, the second is a list of applications for products likely to be approved.

While it is a frustrating process for all involved, it does create, at last, a formal regulatory and approvals infrastructure for CBD products specifically.

This puts the UK ahead of several other countries at least on a regulatory front. This includes Germany, where CBD is still technically regulated under the German Narcotics Act (although CBD products are on sale in the country). It also includes Italy and France, which just issued national guidelines for the cannabinoid on December 31.

What Next?

The decision by the FSA could be the regulatory peg that the developing industry in-country hangs its hat on. This will, for the first time, allow a conversation to proceed that well may become the first regulatory schemata for the entire British industry. This in turn may help other cannabinoids, like THC, become more accepted.

So far, tragically, on the THC front, the British government has put the brakes on including medical cannabis as a covered prescription under national healthcare. As a result, the only medical cannabis available in the country is imported and further, not accessible to anyone who cannot afford both the medication and the prescription costs.

The Future of The British Cannabis Industry

It is unlikely that moving events on the continent are going to pass the UK by. Germany has just announced its intention to move forward with full boat recreational cannabis. Luxembourg, Malta, and presumably Luxembourg will all move forward in this year. Beyond this, the French have finally begun to accept CBD as a legitimate cannabinoid.

It is unlikely the Brexited British will sit this one out entirely.

How fast further reform will come, however, is still very much in the air. The silver lining of this cloud, however, is that cannabis reform has moved another step forward in the UK.

Stay abreast of European cannabis industry developments by attending the International Cannabis Business Conference in Barcelona, Berlin, and Zurich this year.

Does CBD Impair Driving Ability?

Written by Johnny Green on December 22, 2021. Posted in Science.

Cannabidiol (CBD) is one of the several dozens of cannabinoids that are contained within the cannabis plant.

When it comes to popularity, not all cannabinoids are created equal, and that is particularly true when comparing CBD to other cannabinoids.

For many years the most popular and well-known cannabinoid was THC. However, in recent years THC’s popularity has lost ground to CBD, at least when it comes to Google searches.

CBD’s popularity has also risen dramatically when it comes to products due to its ability to treat various ailments. The rise in popularity is also due in large part to CBD policy reforms around the globe.

The ever-increasing rate at which consumers and patients are using CBD products is leading to concerns in some regulatory circles regarding if it causes too much impairment.

CBD And Driving

A team of researchers in Switzerland recently explored the relationship between the use of CBD products (cigarettes) and a consumer’s ability to safely operate a motor vehicle.

“To investigate effects of smoking cannabidiol (CBD)-rich marijuana on driving ability and determine free CBD and Δ9-tetrahydrocannabinol (THC) concentrations in capillary blood samples, a randomised, double-blind, placebo-controlled, two-way crossover pilot study was conducted with 33 participants.” the researchers stated.

“Participants smoked a joint containing 500 mg of tobacco and either 500 mg of CBD-rich marijuana (16.6% total CBD; 0.9% total THC) or 500 mg of a placebo substance, then performed three different dimensions of the Vienna Test System TRAFFIC examining reaction time, behaviour under stress, and concentration performance. For further assessment of participants’ fitness to drive, three tests of balance and coordination were evaluated and vital signs (blood pressure and pulse) were measured.” the researchers went on to say.

“The results revealed no significant differences between the effects of smoking CBD-rich marijuana and placebo on reaction time, motor time, behaviour under stress, or concentration performance.” the researchers concluded.

Beware Per Se DUII Laws

Regulators around the globe are crafting cannabis policies specific to driving under the influence of intoxicants (DUII). It is one of many facets of public policy that gets reviewed when cannabis laws change.

DUII laws, for any intoxicating substance, fall into two ‘method of detection’ categories. One is detecting DUII via a comprehensive set of field sobriety tests.

The other category for the method of detection is relying on a per se limit. For instance, most jurisdictions have a per se limit for alcohol, such as .08 BAC in the United States.

Many regulators try to rely on a per se limit for THC, falsely believing that cannabis affects the human body the same as alcohol.

With that in mind, CBD consumers could in theory have THC built up in their bodily fluids, and if they have too much and get caught driving in a jurisdiction that has a per se law, it could result in some unfortunate consequences.

Is The FDA Going To Issue Commercial CBD Regulations Soon?

Written by Johnny Green on December 8, 2021. Posted in Politics.

Three years ago the United States Congress, via the 2018 Farm Bill, legalized hemp nationwide, and with it, cannabidiol (CBD) products derived from hemp. Given how long domestic hemp cultivation was previously illegal in the United States, it was a very big deal.

Since that time domestic CBD products have proliferated store shelves all across the United States, with products coming in all types and forms, from shampoo to drinks to toothpicks (literally).

However, comprehensive regulations for over-the-counter commercial CBD products have yet to be implemented, and from what it sounds like, no one should expect regulations any time soon. Below is more about it via our friends at NORML:

Washington, DC: Nearly three years following the passage of federal legislation legalizing hemp production, the US Food and Drug Administration (FDA) has yet to promulgate rules regulating the marketing and sale of commercial products containing hemp-derived CBD.

Speaking last month at the National Industrial Hemp Business Summit in Washington, DC, FDA representative Gail Sipes said that the agency cannot move forward with regulations without more data on the safety of CBD products. She reiterated the agency’s position that companies which market CBD-infused products as either food products or as dietary supplements are violating the Food, Drugs, and Cosmetics Act.

NORML and other groups have urged the FDA to provide regulatory guidelines overseeing the production, testing, labeling, and marketing of hemp-derived CBD products. Analyses conducted by the FDA and others have consistently reported that many over-the-counter (OTC) CBD products are of variable quality and potency, and that they may contain contaminants or elevated levels of heavy metals.

Survey data compiled last year by the National Consumers League reported that more than eight in ten US voters desire greater federal regulatory oversight over the labeling and marketing of commercially available CBD products.

In a report provided by the FDA to Congress in 2020, the agency said that regulating OTC CBD products presents unique challenges because the substance is already available as a FDA-approved medicine (Epidiolex).

Additional information is available from the NORML fact sheet, “FAQs About Cannabidiol (CBD).”

Lidl Supermarket Faces Issues Over CBD Products Across Europe

Written by Marguerite Arnold on September 15, 2021. Posted in Business.

One of the world’s largest grocery stores faces repeated problems over “cannabis” products in its European outlets

The going has not been easy for Lidl this summer on the cannabis front. The supermarket giant, with over 12,000 brick and mortar stores across Europe and the United States has now run into its second contretemps over “CBD” in a single month

Last month, in the middle of August, the supermarket chain faced considerable embarrassment after the Munich police raided a Lidl store in the city. By the end of the month, Lidl Ireland had also pulled two hemp products due to concerns over unduly high levels of THC. One of those products was for an organic hemp seed oil product and the other was for that good old standby, hemp tea. They also sent warnings of the recalls to their shops across the country.

Customers are being asked to refrain from consuming the products and to return them to the store of purchase for a full refund.

Even individually, the incidents are embarrassing to Lidl Corporate, an international German company with US headquarters in Arlington Virginia and150 storefronts across the country. In Europe, the chain has a footprint in almost every country.

Taken together, even the largest retailers are now facing the biggest issues that the entire cannabis industry from mom-and-pop hemp farmers to larger players, has struggled with now for the better part of five years – certainly on the CBD front.

Changing Cannabis Policy Globally

It is certainly easy to understand why a global grocery store has gotten it so wrong on cannabis. It is still easy to do. In the United States, CBD products are legit in state markets thanks to the 2018 Farm Bill. In Europe, CBD has been declared “not a narcotic” on the EU level by the European Commission. However, on a country-by-country basis, there is still a great deal of confusion. In Germany, for example, cannabis is still part of the German Narcotics Act, no matter that the government is now actively funding several CBD and hemp experiments.

There is no “global” standard – which makes corporate decision-making difficult to do – although other large corporations like Apple and Amazon are clearly moving in this direction also.

Ultimately, full and final cannabis reform is still a global goal – even as countries and regions begin to make headway.

The International Cannabis Business Conference is back! Make sure to check our website and social media for recordings of sessions and stay tuned!

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Spanish Court References European Decision On CBD

Written by Marguerite Arnold on July 14, 2021. Posted in Medical.

A Spanish lawsuit acquitting a CBD store owner in Spain becomes the first legal judgment in the country to reference the EU decision that the cannabinoid is not a narcotic.

Legal eagles are paying attention to an interesting Spanish case this month which is likely to be as influential in the country in terms of setting precedent for CBD sales as the French vape case.

According to legal counsel, Joan Bertomeu of the Brotsanbert law firm which defended the store, “This ruling is very important because, contrary to what the Anti-Drug Prosecutor’s Office and the Medicines Agency maintain, it is clear that the hemp flower, with low THC content and prevalence of CBD, cannot be considered a narcotic because it does not produce an effect and, therefore, cannot be considered criminally taxable.”

An overview of the case

Much like other CBD precedent cases around Europe, this saga began on August 14, 2018, after two Civil Guards inspected the Valencia-based store. While none of the product on sale violated European limits on THC in the plants and other products on sale to the public, there was hashish and marijuana in a private office that was for personal consumption. The defendant also purchased the for-sale products legally with invoices that were produced in court.

The judge recognized the recent judgment of November 19, 2020, in the Court of Justice of the European Union.

Other Precedents in Europe

The Brotansbert law firm, which is becoming known for activist cases in Spain (they also represented Albert Tio, the Spanish cannabis club activist) is clearly looking for these kinds of cases in the country, and even better, winning them. They are joining other law firms across the region in defending clients from conflicting regulations as the impact of the EU CBD case ripples through impactful court cases and thus precedent.

While this case is very much like the case in France where the sellers of CBD vapes imported from another EU country also were acquitted, there is one case which is not like this. The recent German hemp case is NOT like either the Spanish or French cases in that while the federal court did not convict, they remanded the case back to the lower court because the seller violated the rule on hemp levels in the EU.

In the meantime, it is very clear that the EU precedent on hemp is shaking through national legal systems at minimum via legal battles and victories if not national legislative action. That push must come from the industry.

Be sure to book your tickets now to the International Cannabis Business Conference when it returns to Berlin in August 2021.