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CBD: A Cowboy Industry No More

CBD: A Cowboy Industry No More

CBD: A Cowboy Industry No More

Why we‘re lobbying for higher production standards and more transparency in the cannabinoids industry

Daye Wave Divider

Illustrations by

Sabrina Bezerra

Date

2nd June 2021

As more of us are continuously exposed to ever-increasing levels of stress and anxiety, the search for a cure-all has led many brands to add CBD to their products.

What started as a niche treatment for child epilepsy and psychosis has found its way into bath bombs, chocolate, skincare and even dog food. 

Thanks to a perfect blend of increasing consumer interest and lax regulations, the CBD market is expected to hit the £1 billion mark by 2025 in the UK alone. But as demand for CBD-infused products increases, unfortunately the same can’t be said for its manufacturing standards. 

Is CBD legal? 

A major reason why CBD is still so novel (much like its regulations) is down to the fact that it was legalised fairly recently. 

CBD was illegal until 2016 in Europe, and until 2018 on a federal level in the US – including for research purposes. The substance’s prohibition made it notoriously difficult to study, and as its medicinal use only became legal a few years ago, there’s still a shortage of qualified CBD chemists and researchers.

Having evolved from a botanical novelty to a burgeoning £400-million-a-year market in just a few years, CBD’s popularity has outpaced regulation. 

In the UK, most of the current CBD regulations revolve around the cultivation of specific cannabis plant (industrial hemp) and the levels of THC in CBD products (it legally has to be lower than 0.2%), but there is a dearth of guidelines when it comes to both manufacturing and marketing. 

The Medicine and Healthcare products Regulatory Agency (MHRA) has made it clear that any product containing CBD can’t be sold as a medicine or make any medical claims, but UK retailers can label their CBD products as food supplements, which gives them a sort of marketing loophole.

CBD: science or science fiction? 

Although the research on CBD is still young, this positioning of CBD as a type of snake oil has done the industry more harm than good. 

Like with most health trends, the boom in CBD may have over-saturated the market, but there’s a limited number of scientifically justified uses for CBD. 

The only CBD-derived medication approved by the FDA is Epidiolex, an oral solution made from a purified CBD extract for the treatment of seizures in child epilepsy. 

Epidolex was approved in 2018 after three randomised, double-blind and placebo-controlled clinical, considered the gold standard of medical studies. There is evidence to suggest that CBD could help insomnia patients fall and stay asleep, as well as modulating our body’s response to pain, but more research still needs to be done. 

The medical community is also still trying to understand the role of cannabinoids in pain management. Evidence from both animal and human studies shows that CBD modulates our response by interacting with the endocannabinoid, inflammatory and pain systems, but researchers still don’t really know how that happens. 

CBD & Daye

At Daye we recognise the potential cannabinoids have in advancing human health, so we’ve been working alongside regulators from the start and pushing for more stringent manufacturing guidelines.

When our team first had the idea for Daye’s CBD tampon in 2017, we realised the concept sounded like the epitome of millennial health fads. We anticipated facing rightful scrutiny and wanted to ensure we had solid answers to every possible consumer safety and product efficacy question, so before undergoing clinical validation we sought out the highest quality possible CBD. 

Our exclusive supplier, PBG Global, is one of the few CBD suppliers to have a closed supply chain, which means they grow their own hemp and conduct extraction and bottling in house, applying the highest quality controls along the way. 

PBG produces their quality extract through the implementation of a rigorous tracking and analysis system, which covers their entire operation – from seed to final product. They’re committed to raising the standards in cannabinoids research and production, something that is sorely lacking in the industry. 

“We achieve that by applying a system of rigorous tracking, analysis and triple-checks,” says Ervin Ivanov, MD, Founder of PBG.

“That’s the only way we can guarantee quality on every step of the closed production cycle – from sowing the right seed until shipment of the end product. Our production meets the prestigious and globally recognised standards for quality control and traceability, ISO9001 and GMP.”

“On top of the high quality control requirements set in these standards, we at PBG GLOBAL further test each batch for over 400 types of pesticides, heavy metals, mycotoxins, microbiological contamination, THC traces, peroxide and acid numbers.”

On top of our pharmaceutical-grade CBD, we conducted single-blind, multicenter, randomised control trials on the safety and efficacy of Daye’s CBD tampons with over 200 study participants. Currently, we’re also conducting a US trial with 90 people and a UK trial with 60 people, and we’re in the process of publishing our research. 

The self-regulation standards we have adopted at Daye are what prompted the FDA to select us as a speaker during their cannabinoids public hearing in May 2019, where we had the opportunity to present our research and safety standards to date. That same year we were also invited to present our research to the European Parliament. 

We also spent a lot of time developing our in-house CBD coating process to figure out not only how much CBD is needed on each tampon to make it bioavailable in the body (it’s 30% potency, in case you were wondering), but also how to coat them as efficiently as possible. Since tampons are meant to absorb liquid, you can’t just add a few drops of low-concentration CBD oil to them and expect that to work – despite what you may have read on the internet!

CBD is without a doubt still a cowboy industry, and the lack of regulation means poor quality products and misleading claims have become the market standard. 

In fact, a report from the Centre for Medicinal Cannabis in 2019 found that 62% of the UK high street products studied didn’t contain the CBD content promised on the label.

This isn’t to say CBD’s cowboy status is intentionally malicious – these are merely growing pains for a budding (pun intended) industry. 

At Daye we hope to set a precedent for more rigorous and transparent standards for what could be a game-changer in advancing gynae health. 

Daye tampons are manufactured in accordance with medical device standards, including ISO13485 and GMP. In order for a diagnosis to be confirmed, test results from the Diagnostic Tampon should be considered by a licensed healthcare provider alongside a patient's symptoms and medical history. Like every other diagnostic test, lab results are not sufficient for a diagnosis. Daye offers customers the option to connect with independent CQC-regulated healthcare providers virtually and in-person for a confirmed diagnosis. All prescriptions and treatments provided through the Daye platform are issued by third-party, independent pharmacists, who are also regulated under CQC and GPhC.