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“The industry doesn’t need to be divided”: Negotiating novel foods as a small CBD brand

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Applications for novel foods need to be submitted by March 31st

Amelia Baerlein, co-founder and CEO of Apothem Labs shares her experience of navigating the novel food process as a small business and why she feels positive about the future of the sector.

With the novel food deadline looming at the end of the month the future of the CBD industry can seem uncertain.

Some smaller, independent companies have reported feeling “cornered” by the Food Standards Authority (FSA) guidance, which announced early last year requires any brand on the market before February 2020 to submit a novel food application by 31 March.

Only those with a submitted application will be permitted on the market after this date and some have complained of feeling pushed out of the market completely. 

But despite it being challenging at times to understand what’s actually required, Amelia Baerlein, co-founder of Apothem Labs, a small CBD lifestyle brand launched in 2019, believes that ultimately the introduction of novel food regulation is a positive move for the sector. 

Amelia Baerlein – co-founder of Apothem Labs

“It has been quite frustrating at times, I do think there has been some misinformation in industry and we had our own concerns when it was announced in 2020 and we didn’t know what we didn’t know,” she says, speaking to Cannabis Health.

“The novel food application is a much needed shakeup, but it’s a really positive thing for the industry, for the companies themselves, as well as customers and retailers. Just having the knowledge and peace of mind that you are fully compliant is a big reassurance.”

Apothem entered a Primary Authority partnership with Trading Standards in November last year to help them negotiate the novel food process. 

The legally recognised partnership allows the local authority to deliver guidance and advice in order to support the company to be 100 percent compliant. 

The partnership has been a huge help for the team over the last few months, says Amelia and is “extremely accessible” for smaller brands in terms of fees. 

“Taking the relationship with Trading Standards was a brave decision, but one that has been really helpful for us through this process as they are in direct contact with the FSA,” she continues.

“Opening the door to Trading Standards was a big decision in such an emerging category and to me one that shows our commitment as a brand to being fully compliant 

“We’re going through all of our claims and messaging, not just from a novel food point of view, but complete compliance, making sure we’re not saying or doing anything that is misleading.

“It’s been quite labour intensive in that respect but it’s been a really good learning curve and it has taken away some of the stress of the novel foods process.”

Apothem Labs sells a range of oils, topicals and personal care products, made from CBD isolate.

As only selective extracts of the hemp plant are considered ‘novel’ food supplements, it is thought that after the March, only isolates will be permitted to legally remain on the market. 

Indeed, some suppliers have not submitted applications for full spectrum products at all, due to the fact they contain trace levels of THC and other cannabinoids. 

While from a personal perspective, Amelia supports the role of whole-plant products in cannabinoid therapy, she and her co-founder made the decision to stick to CBD isolate when they launched two years ago.

“The whole plant has a number of great properties and I really believe in it, but when we launched there was a lot of misinformation out there that any products with less than 0.2 percent THC were legal,” Amelia explains.

“When you look at the market, people have been buying products for a long time that contain controlled cannabinoids, so from a consumer and compliance point of view I don’t think they should have been on the UK market.

“As a consumer you can look at something with a pretty label and a beautiful brand and be seduced by that, which is why an industry like CBD needs to be regulated.”

The FSA is now said to be compiling a “positive CBD list” of all the companies who are covered by a valid novel food application. 

Although this doesn’t mean excluded brands will not be allowed on the market, if approached they will likely have to provide proof of a supporting application along with their product dossiers, including the details of how they test everything from the raw ingredients to the finished product.

No new brands will be allowed to enter the market without one.

Apothem sees this as an exciting opportunity for all brands –  big or small – who are compliant, with demand expected to grow exponentially.

“From a business point of view, it’s great news because it means that we have a level playing field with no brands able to assume a financial advantage when it comes to regulation as long as you are doing things compliantly,” says Amelia.

“This means that the brands in our space have a real opportunity now to bed into the UK market as no brands on sale after February 2020 will be able to launch for the best part of two years.”

She continues: “The growth potential of the CBD category is massive, off the back of COVID people are thinking more about their health and their wellbeing and the wellness space as a whole is really exciting.”

And there’s room for everyone, Amelia adds, believing that Apothem is proof that small businesses can still achieve success under the regulation.

“It shouldn’t feel like this industry is divided. It wasn’t designed to be an us and them situation and we’re proof of that, alongside other small brands,” she says.

“Regulation shouldn’t be a swear word. It’s a positive thing for retailers and consumers who really believe in the category and don’t deserve to get caught up in the confusion.”

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New studies examine effects of THC and CBD on stroke

New data suggests both positive and negative effects of cannabis in stroke patients

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A new study has shown that pre-treatment CBD may have a neuroprotective effect in stroke patients.

The study aimed to investigate the effect of CBD on oxidative stress and cell death which occurs in ischemic stroke patients.

It revealed that the cannabinoid may reduce the destructive effects of cell damage associated with stroke.

Ischemic strokes are the most common type of stroke. They occur when a blood clot blocks a flow of oxygen or blood to the brain. This takes place in arteries that have been narrowed or blocked over time by fatty deposits (plaques). The most common symptoms of a stroke include facial drooping on one side, not being able to lift your arms and slurred speech.

If this occurs, it is vital that a person be taken to the emergency room immediately.

The National Institute of Health Care and Excellence (NICE) estimate that there are around 100,000 strokes every year in the UK. It is also thought that 1.3 million people live with the effects of a stroke.

Stroke recovery and CBD results

The Study showed that CBD reduced the amount of infarction in those samples which had been given the cannabinoid. Infarction refers to the death of tissue as a result of a lack of blood supply and is commonly due to a blood vessel being obstructed or narrowed.

There were also differences in malondialdehyde level (MDA) – a common marker of oxidative stress – between the brains of the CBD group and the vehicle group.

It also revealed that CBD may help to protect tissue by preventing further damage.

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THC and stroke risk

Another recent study examined the effect that tetrahydrocannabinol (THC) could have on strokes. It found that it may increase the risk of a certain type of stroke among cannabis consumers.

According to findings, cannabis consumers who experience a stroke known as an aneurysmal subarachnoid haemorrhage (aSAH), are twice as likely to develop further complications.

An aSAH occurs when a weakened blood vessel bursts on the surface of the brain leading to bleeding between the brain and tissue that covers it. It can result in neurological disabilities, long-term slurred speech or even death. It is estimated that aSAH affects around eight people per 100,000 of the population each year, accounting for six per cent of first strokes.

The study by the American Stroke Association suggested there is twice the risk of developing delayed cerebral ischemia for cannabis consumers. The researchers analysed data from 1,000 patients who had received treatment for bleeding over a 12 year period. In the group of participants, 36 per cent developed cerebral ischemia and 50 per cent had moderate to severe disabilities.

When comparing the results of patients who tested positive for THC with those who did not, they found cannabis consumers were 2.7 times more likely to develop cerebral ischemia. They were also 2.8 times more likely to develop long-term moderate to severe physical disabilities.

However, compared to those who tested negative for THC, the cannabis group did not have larger aneurysms, higher blood pressures or worse stroke symptoms when admitted to the hospital. They did not have any higher cardiovascular risk factors than the negative group.

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Researchers are now conducting further studies in which they hope to better understand if THC can impact aneurysm formation and rupture.

Stroke: A banner advert for cannabis health news sign ups

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New study shows CBD may prevent Covid-19 infection

Researchers are calling for more trials to determine if CBD could be a preventative or early treatment for the virus.

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Covid: A covid infection

Researchers are recommending clinical trials to examine if CBD could help to prevent Covid infection after more positive findings have been published.

Researchers from the University of Chicago have reported that CBD may stop the infection of Covid-19 by blocking its ability to replicate in the lungs.

A number of cannabinoids including CBD and THC were tested along with 7-Hydroxycannabidiol (7-OH-CBD) which is thought to be produced when cannabidiol is processed by the body.

The study found that CBD showed a significant negative association with SARS-CoV-2 positive tests in a national sample of patients who were taking  high doses of CBD, prescribed for epilepsy.

As a result of their findings, researchers are calling for more clinical trials to determine whether CBD could eventually be used as a preventative or early treatment for the virus.

Covid- Covid infection

Covid and CBD study

Researchers treated human lung cells with a non-toxic dose of CBD for two hours before exposing the cells to SARS-CoV-2 and monitoring them for the virus and the viral spike protein.

They found that, above a certain threshold concentration, CBD inhibited the virus’ ability to replicate.

Further investigation found that CBD had the same effect in two other types of cells and for three variants of SARS-CoV-2 in addition to the original strain.

CBD did not affect the ability of SARS-CoV-2 to enter the cell. Instead, CBD was effective at blocking replication early in the infection cycle and six hours after the virus had already infected the cell.

Like all viruses, SARS-CoV-2 affects the host cell by hijacking its gene expression machinery to produce more copies of itself and its viral proteins. This effect can be observed by tracking virus-induced changes in cellular RNAs. High concentrations of CBD almost completely eradicated the expression of viral RNAs.

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When it came to the other cannabinoids, CBD was found to be the only potentially potent agent. There was no or limited antiviral activity noted by the similar cannabinoids including THC, CBDA, CBDV, CBC or even CBG.

Marsha Rosner, PhD, professor and senior author of the study said it was a completely unexpected result, she commented: “CBD has anti-inflammatory effects, so we thought that maybe it would stop the second phase of COVID infection involving the immune system, the so-called ‘cytokine storm.’ Surprisingly, it directly inhibited viral replication in lung cells.

She added: “We just wanted to know if CBD would affect the immune system. No one in their right mind would have ever thought that it blocked viral replication, but that’s what it did.”

The researchers do caution that this is not possible with commercially available CBD. The CBD tested was high-purity and also medical grade.

However, Rosner cautioned:  “Going to your corner bakery and buying some CBD muffins or gummy bears probably won’t do anything. The commercially available CBD powder we looked at, which was off the shelf and something you could order online, was sometimes surprisingly of high purity but also of inconsistent quality. It is also hard to get into an oral solution that can be absorbed without the special, FDA-approved formulation.”

CBD and Covid studies

This is the second study to be released showing the potential for cannabinoids in Covid management and prevention.

A study by Oregon State University has revealed that the compounds cannabigerolic acid (CBGA) and cannabidiolic acid (CBDA), may have the ability to prevent the virus that causes Covid-19 from entering human cells.

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Researchers and scientists, led by Richard van Breedan, found that a pair of cannabinoid acids bind to the SARS-CoV-2 spike protein, blocking a step in the process the virus takes for infection.

Targeting compounds that block the virus-receptor interaction has been helpful for patients with other viral infections such as HIV-1 and hepatitis.

The researchers and scientists identified the two cannabinoid acids through a screening technique, developed previously in van Breeman’s laboratory. The team also screened different botanicals such as red clover, hops, wild yam and three types of liquorice.

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Partner of Irish politician “six years seizure free” faces charges over medical cannabis use

John Montaine uses medical cannabis to manage his epilepsy – and is said to be six years seizure free.

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Irish government medical cannabis
John Montaine, is the partner of Clare Sinn Fein TD Violet Ann Wynne.

The partner of a sitting Irish TD is contesting charges of cannabis possession, saying he uses it medicinally to manage his epilepsy.

John Montaine, who is the partner of Clare Sinn Fein TD Violet Ann Wynne, was charged with the alleged illegal possession of cannabis on February 11, 2021, at his family home, the Irish Independent reported.

Mr Montaine contests the charges and his partner Deputy Wynne has previously spoken publicly about how he uses cannabis medicinally to manage his epilepsy.

Speaking after the initial court hearing in November, Deputy Wynne said in March her partner would be “six years seizure free”.

She went on to say that it has improved his quality of life “100 per cent, without a doubt”.

“There was always some kind of issue – say John having a number of fits within the one month or losing teeth or suffering with severe migraine, but since John has been using the medicinal cannabis, he has had a better quality of life,” Deputy Wynne told the Independent.

She added: “It has also freed myself up. John would have been on disability allowance and I would have had to have been his carer but since using the medicinal cannabis, he doesn’t suffer from any of those issues any longer.”

Medical cannabis is legal in Ireland, but access to a prescription is limited.

Last year Ryan Gorman, a 26-year-old man, from Dublin, who also suffers from epilepsy, became the first patient to receive a cannabis-based medicine through the Medical Cannabis Access Programme.

Despite legislation being signed off in 2019, Ireland’s Health minister Stephen Donnelly only announced funding for it in January 2021, with the programme only becoming fully operational in November.

Four cannabis-based medicines are expected to be available through the MCAP, to people living with one of three qualifying conditions. These include intractable nausea and vomiting associated with chemotherapy, severe treatment-resistant epilepsy and spasticity associated with multiple sclerosis (MS). 

Mr Montaine’s solicitor appeared in Kilrush District Court on behalf of his client this week, where his case was adjourned until 15 March.

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