In the upcoming days, European authorities are coming up with stringent policies regarding the production and supply of CBD products.
Unlike most of the European countries, the Food Standards Authority in the UK has accepted to clarify documentation regarding CBD novel food applications. In this article, we are going to take an overview of CBD and Novel Foods regulation in the UK.
The FSA has given the deadline for all the businesses related to CBD to apply before 31 March 2021. The local businessmen considered this news as a relief, as there was lots of confusion and uncertainty regarding the legal distribution of CBD in the country.
This was a much-needed step by the FSA, as it helps bring a certain level of transparency for the buyers. Before that, many CBD products contained either high amounts of THC or contained some percentage of toxic chemical solvents. Now, it would not be easy for fraudulent suppliers to get a medical claim, as the regulatory authorities would be strictly inspecting the production process and legal documents of the registered companies.
The FSA’s CBD inspection announcement is similar to that of the policy by the European Commission during the summer of 2020, which has currently brought the whole process to a halt under the suspicion that the cannabis extract might contain a drug under narcotics law. Once the Brexit transition period comes to an end, all the local businesses would have to legally register with the UK’s food regulation authority.
As a CBD retailer or supplier, you need to start assembling all the data and files to prove that your business complies with the standards imposed by the FSA.
What Is Meant By Novel Foods?
Novel foods refer to specific types of foods that have not been widely consumed by the people in the UK or EU before 15 May 1997. These food types either don’t have a well-studied history of consumption or are manufactured using contemporary methods that have the following potential effects on food:
- A variation in the food’s composition
- A decline or increase in the food’s nutritional value
- Unsafe or unknown ingredients in the food
- A variation in the way food is metabolized in the body
If a manufacturer intents to produce a novel food, they must comply with the following requirements:
- Food must be safe for consumption
- Food must be professionally labeled, without missing out on any ingredient or constituent
- It must provide the promised nutritional value to the consumers
When the novel food status of CBD was accepted in the UK in the year 2019, most of the local businesses started to submit documents to comply with all the legalities. However, the European Commission “paused” the approval process because it was unsure whether hemp extract would fall in the category of “food products”.
Despite the uncertainties in the European Union regarding the legalization of cannabidiol (CBD), the UK Home Office and other regulatory bodies were open for acceptance, as they did not find CBD as a potential narcotics drug. Until a uniform approach is carried out by the EU, things would remain unclear for the local CBD manufacturers.
Is CBD a Controlled Drug?
With the recent pharmacological activities revolved around CBD-based products, there is growing confusion regarding the legal status of this plant-extract.
In the US, health experts have developed some prescription drugs derived from cannabis that can be used to treat neurodegenerative diseases, such as epilepsy. Before this, the medications used to treat epileptic attacks had adverse effects on the physiological and psychological wellbeing of the patient. With these CBD-based medicines, epilepsy can be potentially treated in a minimally invasive manner.
The scientific data regarding the health benefits of CBD has allowed drug regulatory authorities in the UK to give it the status of a non-controlled drug, which means that patients would be able to purchase it from the local pharmacies and dispensaries.
There are still various complications regarding the legalization of CBD, as any CBD-based medicine that contains traces of THC can potentially be considered illegal for sale and distribution.
Can CBD-Based Products Be Considered Medicinal Products?
A product may fall in the category of medicinal products if it meets any or both of the following criteria:
- A substance used to treat a diseases or illness
- A substance that can potentially prevent a disease or illness by prior dosage
Once a product has the potential to be used as prescription medicine, the manufacturers would be required to file an application to the Medicines and Health Care products Regulatory Agency (MHRA) for approval.
Cannabis-based products that have already been mentioned in Schedule 1 can now be sold as prescription drugs by licensed health professionals in the UK. Also, the Department of Health and Social Care (DHSC) has now accepted the scientific data related to the health benefits of CBD.
Sativex, which is a CBD-derived medicine used to treat multiple sclerosis is now licensed for distribution in the UK – including 29 other countries.
Toxicology Tests Will Be Required
The FSA has indicated that it would require toxicology tests from CBD local manufacturers before it can deem them safe for public use.
Some health studies show that high doses of CBD can trigger liver problems in some individuals. Therefore, just like any other therapeutic medicine, it is required to take CBD in controlled amounts.
The onus is definitely on the FSA, as it needs to ensure that the alternative drug doesn’t possess toxic properties. So, the validation of your novel food dossier also depends on whether or not you have examined the toxicity of your CBD products.
There is still some grey regarding the toxicological data requirements by the FSA, which has put new entrants in the field in serious trouble. Newcomers should keep up with the latest policies regarding toxicological test criteria.
Many major CBD companies in the country are taking on a consortium approach regarding the novel foods regulation application, as that would help them cut down on costs related to individual laboratory tests and other related expenses.
The Cannabis Trades Associated is advising all of its current and prospective members to adhere to the policies imposed by the FSA, as that would help the individual stakeholders sustain their businesses. The group is also planning to come up with a collective full-spectrum ingredient application.
This potential approach will not only help the investors avoid future enforcement but also minimize the chances of missing the application deadline, as they would be able to meet the requirements by working together.
Article 4 Consultations
Businesses that want to double-check that they comply with the novel foods policy they can opt for article 4 consultation.
Many newbie CBD stakeholders have a misconception that submitting the related dossier for article 4 consultations would exempt them from listing their product in the novel foods list. Submission of the article 4 consultations indicates that you have not yet received any authorization for your CBD-based products/drugs.
You should also keep in mind that going through this consultation also doesn’t mean that you would no more be penalized for not applying to the novel foods legalization process.
Despite the apparent strictness regarding the approval process, the Novel Foods regulation would offer a win-win situation for the consumers and entrepreneurs.
The obvious benefit of going through this rigorous monitoring process is that you would not be asked to remove your CBD-based products from the shelves, and you would be able to continue serving your clients.
Previously, inexperienced consumers were duped into buying illegal or products that contained harmful amounts of THC. Now, with the stricter regulations, consumers have higher chances of ending up with products that would provide the desired healing and therapeutic benefits to them. Once the consumers’ confidence is retained, this would help CBD business grow gradually without facing any criticism.
With EU regulatory authority remains a quagmire for the current CBD stakeholders; the UK seems to take charge of the entire situation by providing a legal way for businesses to get approved. The approval system is designed in a way that would help businessmen regain the money invested in toxicity studies.
Once you fill out your novel foods regulation dossier, it can about a year for the approval of the application.
The quality of the CBD toxicity tests and other legal files can impact the overall approval time, as the regulatory authorities would be more inclined to give preference to professionally prepared documents over unclear dossiers. We hope you were able to get some insights regarding CBD and Novel Foods regulation in the UK.
We expect that the Novel Foods regulation process will bring a positive change to the currently unregulated CBD market in the UK and other European countries. During this monitoring process, many potentially unsafe CBD-based products would also be removed from the market.
As a CBD retailer, you need to focus on gathering robust data that would prove the safety and authenticity of your products. This way you would not have to worry about facing any hurdles while supplying your CBD products within the UK market.