CBD Isolates Are Becoming a Controlled Substance

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Why CBD Isolates are slowly becoming a controlled substance and what exactly constitutes the CBD as a novel food situation? Let’s take a look and get to the bottom of it.

In an attempt to clear the misunderstanding surrounding the whole controlled substance / novel food crisis, we have received a clarification from the UK CTA (Cannabis Trade Association) that points to the path of future regulations. While the CTA only gave us clarification that Novel Food will only apply for CBD products using isolates, we dare to take the subject one step further and based on what we saw happening lately, all over the world, predict that CBD isolates are on their way to become a controlled substance.

As similar regulations attempts exist in the US, we also believe that following the UK and the EU, the US will see a rise of local forces trying to make CBD isolates a controlled substance. Unlike the situation in Europe the US CBD industry has more power, and CBD isolates are practically everywhere, so it’s too early to call who will have the upper hand in this conflict.

Only CBD Isolates are Novel Food – Will they become a Controlled Substance?

As we have mentioned before, we believe that the future will divide CBD products between Pharma and non-pharma, where CBD isolates, currently used by everyone, will end up under the complete control of pharmaceutical companies, leaving ‘regular’ CBD suppliers, to use hemp-extract products. While enforcement actions are still far from taking place, all CBD companies should understand that these future regulations are not limited to UK and EU companies, but they will find their way to the US CBD market sooner than later.

In fact, some states have already been playing with enforcing new CBD regulations, as we saw happening in New York, Maine and California. The important thing to understand is that, while these actions are directed at the CBD edibles markets which is currently under fire, future regulations will most-likely look at CBD isolates as controlled substance and prevent non-pharmaceutical companies from using CBD isolates at all. Therefore, if your CBD business is based on isolates, take the necessary actions today and switch them to hemp extract ones.

Beside making CBD isolates a controlled substance, there are other future regulations that you should be aware of, starting with the changes in the way we look at the maximum THC level. The current way of looking at 0.3% (or 0.2% if you come from the EU) is not the accurate way, but instead, you should calculate the maximum amount of THC in the product, since this is where regulation is pushing. We will discuss it in length in future articles, so make sure to subscribe to our weekly newsletter:

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Read the full announcement from the CTA below:

The UK CTA (Cannabis Trade Association) believes only CBD isolates should be considered as a Novel Food. As a result, will CBD isolates become a controlled substance?
The UK CTA (Cannabis Trade Association) believes only CBD isolates should be considered as a Novel Food.

The Foods Standards Agency (FSA) and the UK Cannabis Trades Association (CTA) have met to discuss the status of Cannabidiol (CBD), the increasingly popular compound found in Cannabis, after a recent EU recommendation to change its status to ‘novel’ when added to food.

As the largest industry organisation of its kind, the CTA met with the FSA to dispute the recommendation of CBD as a Novel Food, which is defined as ‘food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel food came into force’.

In January 2018, the CTA agreed with the FSA that CBD in its purest form, known as isolate, was to be added to the Novel Foods Catalogue. However, the recent change to the catalogue implies that CBD in all forms, along with all other cannabinoids found in Cannabis sativa L. (the hemp plant), are to be declared Novel Foods. The CTA firmly disputes this.

Meeting with Alison Asquith and Karen Todd from the FSA’s Novel Foods team were CTA chairman Mike Harlington, director Tom Whettam and legal representative Robert Jappie from Mackrell Turner Garett.

In the wake of the meeting, the CTA released the following statement from its board of directors to its members:

“The CTA feel it’s fair to say that the FSA seem to be quite misinformed around standard industry practices and accept that they are not conversant with how members’ products are manufactured. The general impression is that the production of CBD oil is achieved through the addition of CBD isolate to a carrier oil. It was not previously understood that CBD oil is created using a full plant extract that is diluted.”

“It was not contested by the CTA that isolated individual cannabinoids should be novel. It was also confirmed by the FSA that it was not the extraction process that was considered novel. What was agreed by both parties is that there is a significant amount of doubt by the FSA as to what constitutes a product containing CBD that would fall within the scope of Novel Foods.”

“In principle it can be assumed that based on the FSA’s understanding, it would only be products that are enriched with isolated CBD that would be novel. Which is the position the CTA has presented for almost two years now.”

“The CTA also agreed that the threat of enforcement was not conducive to business in general and that the FSA were required to give an official statement. The FSA was also informed that the CTA, as stakeholders, is required to be consulted on that statement.”

“It was agreed that any action would be proportionate and not hinder the economic activity of the industry but would address their primary remit of protection of consumers. When asked for information on any concerns the FSA have, or had been reported to them, about CBD products currently on the market, there were none. As such it can be assumed that in the absence of any direct concerns and in line with a proportional approach to enforcement, that any enforcement action would be unlikely.”

“The FSA have not as yet released any statement no matter what any other organisation states, any suggestion that there would be an 18-month grace period where enforcement would not take place was not confirmed as accurate.”

“The CTA is concerned that this almost new team in Novel Foods haven’t referenced the material evidence presented to them by the CTA almost 2 years ago, and further to that have reneged on the agreement reached in January 2018 regarding the issues of isolates in foods, which has already been classified as ‘novel’ under EU guidelines.”

“While it is appreciated that the FSA has a difficult job to do, it is also required to provide a legal definition on its decision and it could not do so. The FSA has just as much duty to provide that information to the industry as the CTA has to it.”

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