Did you know that many CBD oils, snacks and drinks could be banned and removed from the shelves from April 2021 because of new legislation introduced by the Foods Standards Agency (FSA)?
CBD products are now classified as Novel Foods
The majority of CBD representative bodies agree that the legislation is needed in the industry, but there is considerable consternation about the current ruling whereby, following on from recent EU legislation, the FSA has classified CBD products as Novel Foods. These are foods which have not been widely consumed by people in the EU before May 1997. This includes, but is not limited to:
CBD oils, capsules & oral sprays
CBD gummies, mints & other sweets
CBD infused tea, coffee, beer and soft drinks
CBD snacks including energy bars
None of these products currently have Novel Foods approval!
These products must now have a pre-market safety assessment and application for approval under the Novel Foods Regulations by April 2021 or the products could be removed from the shelves.
Novel Foods approval process is costly
It should be noted that the Novel Foods approval process is complex, costly and time-consuming, thus making it outside the financial capacity of most small producers to comply. And yet, of course, this is not likely to present a problem for big business!
The majority of people who produce and sell CBD products are passionate about the potential benefits and provide quality products, properly labelled and honestly marketed. However, the exponential growth rate of the CBD industry has inevitably attracted interest from businesses whose primary concern is the bottom line.
Is Big Business exerting pressure?
And therefore, one must ask, is this an example of Big Business exerting pressure on Government bodies to ensure they scoop up maximum benefit from the ever-growing CBD market?
If the rhetoric of the various CBD trades bodies is anything to go by, it certainly seems this may be the case.
The Food Standards Agency (FSA) says the legislation is being introduced because of concerns about public safety. In tests, they have discovered:
- CBD products that contain unlisted and potentially hazardous ingredients,
- CBD products that contain illegal levels of tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis.
- CBD products that contain little or none of the CBD extract, contrary to their marketing claims and high prices.
Clearly, this growing market does need some legislation, but it should be appropriate. It is clear that in general terms, CBD products are safe and many thousands of people are benefitting from their use.
CBD has a good safety profile
Indeed, towards the end of 2017, the World Health Organization (WHO) said:
CBD is generally well tolerated with a good safety profile. Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications.”
The WHO also stated that there’s no known addiction potential associated with CBD. Similarly, studies on CBD dependence conducted on mice showed that while there was evidence of THC dependency, there was no evidence that suggests the same for CBD. (THC is the addictive component tetrahydrocannabinol which, apart from a minuscule allowed percentage, is removed from CBD products)
Compare this with the acknowledged addiction problem caused by the oversubscribing of opioids by GPs. The opioid issue is almost at a crisis level in the UK and while the NHS is trying hard to address the problem, GPs are still prescribing addictive substances against medical protocols.
How can one even begin to comprehend the huge irony that overprescribing of opioids continues in the NHS and yet the availability of a natural product that hasn’t been shown to be addictive and has many positive benefits including, according to many users, extremely effective pain relief, may be diminished because of restrictive legislation?
The FSA has stated concerns about the effects of CBD products on pregnant women and potential drug interactions by users taking other prescription medications. These are concerns that are common to almost every supplement and over-the-counter medication. Appropriate warnings should be clearly detailed on packaging. But does this warrant the level of legislation that is now required?
There is no consensus on the FSA ruling
The respective CBD Trades Associations agree that a level of legislation is necessary to protect not only the public but also their members from a minority of charlatans who are jumping on the CBD bandwagon and are more concerned with making easy money than providing quality products that benefit people’s health. But there is no consensus on the FSA ruling that all extracts of hemp and derived products containing cannabinoids, including CBD, should be classified as Novel Foods.
Peter Reynolds, Director of CannaPro, strongly believes the mainstream of the industry which, he says, is ethical, responsible and committed to quality, has been a model of self-regulation. He refers to this new FSA legislation as ‘The Novel Foods Scam.’ He continues to fight vociferously against this legislation. He argues:
Make no mistake, the attempt to seize control of the burgeoning CBD market under the guise of the EU Novel Foods Regulation is a hijack by bureaucrats and big business.
This new market has exploded from zero to £300 million per annum in just the last few years. It now exceeds the combined market for vitamin C and D. It is a sensation, created by consumer demand for legal access to the medicinal benefits of cannabis and built by a group of small, entrepreneurial businesses, deeply passionate and engaged in delivering honest value-for-money.”
As Peter Reynolds has noted, because of the stigma around cannabis, Big Business – the established supplement and health food companies – weren’t interested in the early years of CBD introduction into the UK marketplace. But attitudes have changed. The WHO has given CBD a clean bill of health. And Big Business is out to get their pound of flesh from a market that has grown exponentially. And, it seems clear, they are quite happy to do so at the expense of those entrepreneurial individuals and small companies who built the demand in the first place
The Cannabis Trades Association (CTA) has been in communication with the FSA for many months and has consistently argued that natural CBD products (not isolates or synthetic forms) should be treated as supplements and not Novel Foods. The CTA says it supports regulation which will ensure consumer safety and, whilst they do not agree in full with the regulations being proposed, believe the current stance is a positive step forward.
And yet, Tom Whettem, CEO of BRITISH CANNABIS® (the largest producer, manufacturer and distributor of legal cannabis-derived products in the UK.) and Director of Regulatory Compliance for the Cannabis Trades Association said:
BRITISH CANNABIS® today welcomes the clarity that has been provided by the Food Standards Agency (FSA). We are of the opinion that it provides a route towards protecting CBD companies from enforcement and steering a direction for a compliant industry moving forwards.
Today’s update by the FSA should provide great assurance to our consumers, the CBD industry and CBD retailers, as for the first time, it provides clarification of a possible exemption from enforcement.”
This statement does not appear to be aligned with the following press release issued by the CTA, and leaves one to question if there is a conflict of interest with Mr Whettem’s two roles:
CTA Press Release
On the 13th of February 2020, the FSA released a public statement for the first time, concerning the debate about the legislation of CBD extracts and products. Although the Cannabis Trades Association (CTA) duly welcome a Route to Compliance for the industry and its members, we are still of the opinion that natural (not isolates or synthetic forms) CBD products do not fall under the scope of the Novel Food schedule.
The CTA fully supports regulation as it ensures consumer safety and gives clarity to the processes required for its members’ products to remain in stores across the country. We are continuing a full review process including legal aspects and avenues into the current and proposed regulations for CBD in the UK, whilst maintaining close relationships with relevant authorities and stakeholders. In reality, not all members will be affected by the proposed legislative changes.
Further to the highlighted safety concerns, the CTA agree that CBD as a food supplement should not be administered in high daily doses (above 200mg), and consumers should always seek approved medical guidance if taking other medications or during pregnancy. We also maintain our position that CTA members’ products are compliant and continue to pose no safety concerns to those consuming within the set guidelines.
In summary, although we do not agree in full with all that is being proposed, we believe it is a positive step towards ensuring consumer safety and that CBD will be on the shelves for many years to come. As an association, we will continue to work tirelessly to maintain relationships with all the official agencies to ensure our members, their products and the entire industry maintain a Route to Compliance and will issue further statements and guidance outlining the steps the CTA are undertaking.”
At the end of this month, the Hemp & CBD Trade Expo will be held at the National Exhibition Centre. CBD compliance and regulation will be very high on the agenda.
Robert Sidebottom, Director of the Hemp and CBD Expo said:
The statement today from the FSA and the novel status of CBD has been a long-time coming, regardless of your views on CBD and ‘Novel Foods’ it is consumer safety that is paramount. It should act as a clarion call to the sector to work together towards complaint products which are not only safe but the best they can be for the consumer. Now more than ever is education and direction critical for those working in the cannabis space. I encourage everyone to attend our event at the end of this month and engage with the leading legal, trade and medical practitioners who are presenting. The future of the cannabis industry is in our opinion very positive”.
A new CBD Trades Association, the Association for the Cannabinoid Industry, has recently been launched. It welcomed the new legislation stating:
We believe it establishes a clear trajectory towards the development of a safe and legally compliant CBD industry in the UK. Today’s update will be welcomed by consumers, the industry, and retailers alike. It will generate significant levels of industry investment in research and product quality which will place the sector on a sustainable path.
Over the past five years the UK CBD market has grown rapidly; today over 1.6 million people consider themselves to be regular consumers. The sector employs thousands of people in hundreds of businesses all across the country. Until now, it had grown in the shadows of the necessary regulation any such industry requires, perpetuating a lack of consumer confidence and business confusion.”
While one would certainly expect all the CBD trade associations to provide advice and assistance to their respective members regarding this new legislation, it is interesting that ACI has taken this a step further and have partnered with Global Regulatory Services, ‘an award-winning life-science consultancy firm, to assist their members in the application process.’ Is it too cynical to consider that this arrangement could be potentially very lucrative, especially if their membership recruitment is focused on larger organisations?
But most importantly, what does this mean for the CBD consumer? Will you still have access to the products you love in just over a year’s time? And if you do, will price be inflated by a new breed of business ’taking over’ the market?
The ACI says the legislation will build consumer confidence and reduce business confusion. I suspect it may be the reverse. Such stringent legislation and a war cry about removing products from the shelves is far more likely to reduce consumer confidence. After all, the CBD marketplace in its current format could not possibly have grown to the extent it has without consumer confidence. And there’s plenty of anecdotal evidence of the effectiveness of the products from millions of users.
And reduce business confusion? Yes, of course, for BIG BUSINESS. The legislation is paving the way for big business to make its mark on the industry. But what about those thousands of entrepreneurs who have developed businesses based on providing good CBD products to an appreciative marketplace? They are left in total confusion as to how they will be able to comply with this legislation and maintain the business they have built.
We’ll aim to keep you updated but we aren’t the specialists. We are just the messenger. We would love to hear from you if you are a supplier or customer. We would love to know what you think about the new legislation.