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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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Advocacy

US Congresswoman speaks out about how cannabis helped her depression

Nancy Mace spoke out about using cannabis to help her depression after experiencing a traumatic event as a teenager

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Image credit: Nancy Mace/Instagram

A Republican congresswoman who has proposed a federal bill to legalise cannabis has spoken out about her experience using cannabis to combat depression.

Nancy Mace, a republican politician from South Carolina appeared on Fox Business’s ‘Kennedy’ show to talk about the bill which would legalise cannabis but would also focus on veteran access.

It also includes expungement for non-violent cannabis crimes and imposes a revenue tax that would support reinvestment into communities hurt by the war on drugs.

Bill: A banner for always pure organics

The bill titled the States Reform Act would federally legalise and tax cannabis has been proposed ahead of competing Democrat proposed bills. While the bill was originally proposed in July, Mace shared her story after officially filing the State Reform Act in November.

At the end of the discussion, host, Lisa “Kennedy” Montgomery asked the congresswoman if she smoked cannabis.

Nancy replied: “When I was 16, I was raped. I was given prescription medication that made the feelings I had of depression worsen, and I stopped taking those prescription drugs and I turned to cannabis for a brief period of time in my life.”

She added that she believed her experience with cannabis made her more sympathetic to veterans who may use cannabis for conditions such as post-traumatic stress disorder (PTSD).

Bill protection for veterans

The congresswoman explained that the new bill is “particularity protective of veterans, ensuring they are protected, not discriminated against and that the US Department of Veteran Affairs can utilise cannabis for their PTSD.”

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She added: “When I talk to vets and I see that pain, it hurts because I felt that pain before in my life. Veteran suicide, we see every single day.”

One other provision in the bill is that cannabis would be under the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau (TTB) instead of the Food and Drug Administration (FDA). The FDA would have some involvement similar to its current control over the alcohol industry.

Bill history

Mace has already won an exception for rape and incest victims in a fatal fetal heartbeat bill. She mentioned her history when it came to proposing that bill in 2019.

She said: “I’ve had family that have overdosed from hardcore opiates and prescription drugs. And I’ve mentioned part of this in 2019, at the time I got the exception for rape and incest in the fetal-heartbeat bill I told my story about being raped when I was 16, but I’ve never said this part publicly before: I was prescribed antidepressants afterwards, and it made my feelings a lot worse. And so I started using cannabis for a brief moment, for a time in my life. It helped me. It cut down on my anxiety and helped me get through some dark periods.”

 

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Industry

Study: States with full legal access show fewer registered medical cannabis patients

“If true, this could have implications for public health and policy,” say researchers.

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Study shows U.S states where cannabis is legal for recreational purposes have experienced a decrease in patients registering for medical cannabis programmes.

The study on different US states, published in the International Drug Journal, revealed that numbers of registered and active medical cannabis consumers increased while it was not legal for recreational use.

Researchers in Arizona took data from the medical cannabis registry from two dozen states between 2013 and 2020.  These are mandatory registries that record the number of medical cannabis patients. They analysed the data to see if there were any changes around the times that recreational legalisation was introduced.

There are currently 19 states in the US that have legalised recreational cannabis including New Jersey, Vermont, Arizona and New York. However, more states have medical cannabis programs although some are still not operational. Some states such as Colorado have had recreational access since 2012, the year before the study was started.

Medical cannabis patients

The results confirmed that medical cannabis cardholders increased during times when recreational use was not legal. It then subsequently decreased when it became legal.

It also revealed an increase of 380 patients per 100,000 people per year when just medical cannabis was legal. This corresponded to a decrease of 100 patients per 100,000 after recreational cannabis was allowed. The researchers noted that active registered active male patients decreased faster than women. In states where only medical cannabis was legal, the older age groups (35 or older), increased faster.

They also found that in three states with medical-only use, the results showed significant increases in enrollment from 2016 to 2020 across white, African-American and Hispanic patients.

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The researchers wrote: “There is speculation that enrollment in U.S. state medical cannabis programs differs depending on whether adult recreational cannabis use is legal. If true, this could have implications for public health and policy.”

“Findings suggest that recreational cannabis legalisation is associated with decreasing enrollment in medical cannabis programs, particularly for males.”

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Fibromyalgia

Fibromyalgia and medical cannabis: “I find my pain is completely gone”

Natalie began experiencing fibromyalgia pain when she was a teenager but wasn’t diagnosed until her 20s.

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Fibromyalgia: An illustration of a woman in pain holding an umbrella

Natalie talks to Cannabis Health about living with fibromyalgia and how cannabis has helped her with pain relief.

Fibromyalgia can be a debilitating condition leaving patients with chronic pain, fatigue and increased sensitivity. Other side effects can include poor sleep, cognitive issues and headaches. It is thought to affect around 1.5-2 million people in the UK.

Natalie was diagnosed with fibromyalgia when she was in her first year of teaching. She had been experiencing some of the symptoms since she was in her early teens but doctors told her it was growing pains.

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“Since I was about 12, I had a lot of pain that came and went with a lot of fatigue,” she explains.

“The doctor’s put it down to growing pains. When I was I was in my first year of teaching, one day I woke up and couldn’t do anything. I was incredibly tired and in so much pain.

“I felt that way for months and I was really struggling. I got my formal diagnosis from a rheumatologist. I had a lot of blood and strength tests to make sure I didn’t have arthritis or lupus because of the similar symptoms.”

Life with fibromyalgia

Once Natalie had her diagnosis, her life began to change. She quit her teaching job as it became too much to cope with when her symptoms were bad. She took on jobs where she could choose her own hours or work part-time.

“I ended up working as a children’s entertainer because it was good money,” she says.

“I could do it over a few days a week and make an acceptable amount of money to cover my bills. I did retail work alongside it.”

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When it came to socialising, to stop herself from feeling isolated, Natalie turned to online communities to meet people and make friends.

“I’m not amazing at socialising, so I’ve always found it a struggle. I didn’t stay in touch with a lot of people from university or school because I also have mental health problems that held me back. This isolated me a lot so I did turn to online communities where I met a few people who I’m still friends with now,” says Natalie.

It wasn’t until she joined online fibromyalgia communities that someone suggested that cannabis may have benefits.

“I never really knew about its benefits, although I knew it would relax you,” she admits.

“People in my fibromyalgia groups said they used medical cannabis and found it helpful. It’s only really been the last few years where I’ve used it properly as a medicine.”

Fibromyalgia: An illustration of a woman using a laptop

Fibromyalgia pain

Cannabis may help with the pain experienced by fibromyalgia patients. A recent study on patients diagnosed with fibromyalgia and other inflammatory rheumatic diseases reported a reduction in pain levels following medical cannabis use. The study surveyed 319 patients about their use of medical cannabis products. Those with fibromyalgia reported a mean pain level reduction of 77 per cent while 78 per cent also reported sleep quality improvement.

Although Natalie has family members who use medical cannabis in legal states in the US, she hadn’t considered using it herself. Despite being open to the idea of a prescription, she says there was very little mentioned to her about pursuing it by her doctors.

“It’s weird because it’s almost like a whisper network. I would never have known about the private medical thing because it’s not really mentioned and the health sector doesn’t talk about it. They don’t actively tell you about prescriptions,” she says.

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Natalie has found that cannabis helps her most with the pain.

“A lot of the time, I get shoulder or lower back pain. If other people knew my pain level, they would have a different idea of what pain is, but I guess I’m used to it,” she says.

““Due to the way I work, I don’t use it until the evening. At the end of the day, I’ll use cannabis and I find my pain is completely gone. Sometimes, if I’m struggling then I’ll have a nice bath, have my cannabis and that’s the perfect combination.”

Cannabis Stigma

Natalie is guarded about her cannabis use because of the stigma but also due to her job. She is open with some of her friends but not her family. She chose to use only her first name to avoid being identified.

“My parents are from a different generation and they are quite conservative too. It’s very different for them so they don’t understand how it would help. My clients obviously don’t know, as some wouldn’t like it. [But] I have clients in the Netherlands who don’t drink but will go for a joint but it’s different for me,” she says.

“People still struggle to admit to taking medication because of the attitude. I’ve tried Tramadol, Xanax and all sorts of things that have more impact on how you feel, physically and mentally compared to cannabis. But that’s  acceptable because it’s prescribed by a big pharmaceutical company.”

Natalie feels that there is a lot to be changed in terms of education, so that people know the benefit of cannabis when it comes to conditions like fibromyalgia. She also highlighted that there should be more awareness of the options out there when it comes to accessing a prescription.

READ MORE  How CBD can improve quality of life for fibromyalgia patients

“More people should be aware of the benefits of what it can do, rather than it being a niche internet topic or having a weird stigma around it,” she adds.

“Medical professionals need to be more aware of how it can help and the different avenues that people can go down to get prescriptions.”

 

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