GRS News

On 12^th October 2023 – the Food Standards Agency [FSA] issued new precautionary advice on CBD, recommending healthy adults should limit their consumption of CBD from food to 10mg per day, which is about 4-5 drops of 5% CBD oil.

 

This change has been brought about by new evidence which has been assessed by two independent safety committees

• Advisory Committee on Novel Foods and Processes (ACNFP)
• Committee on Toxicity (COT)

 

Based on industry reaction and our discussions with peers, it is clear that this new precautionary advice is potentially quite alarming for the UK CBD Industry. Before we dive deeper into understanding the impact on manufacturers and ongoing novel food applications, let us explore the key points from this new precautionary advice:

 

• This announcement is ‘Consumer Advice’. The FSA are highlighting a possible safety issue if consumers decide to ingest more than 10mg of CBD per day over their lifetime. 
• Based on scientific advice from two independent safety committees, the FSA has concluded that a healthy adult should not consume more than 10mg of CBD per day.
• If a consumer chooses to ingest higher levels of CBD over a short period of time, the FSA has determined that there is no acute safety risk.
• The FSA is encouraging consumers to monitor their daily consumption of CBD and to make an informed decision on how much CBD they are willing to ingest when considering possible long-term side effects.

 

What does the ‘new precautionary advice’ mean for CBD manufacturers?

• The FSA has confirmed that they have briefed retailers to reassure them that they can continue to sell CBD products which have a higher content of CBD than 10mg, as long as those products are still listed on the CBD Public List.
• As a contingency, companies may wish to consider reformulating their current products so that a 10mg version can be made available if, or when, needed. 
• It is noted that new precautionary advice from the FSA includes an additional ‘vulnerable group’ i.e. “parents trying to conceive”. 

 

What does the ‘new precautionary advice’ mean for CBD Novel Food Applications?

In support of the UK CBD Industry, GRS specialist representatives have spoken with the FSA and

• have been informed by the FSA that even though this new precautionary advice has been published today, which greatly reduces the safe level for daily consumption of CBD, all CBD Novel Food Applications will be considered on their own merit.
• As long as a company, and its CBD products, are listed on the CBD Public List (on the FSA’s website), these products can remain on the market until the applicable submission is either authorised or denied.
• The FSA has confirmed that they have briefed retailers to reassure them that they can continue to sell CBD products which have a higher content of CBD than 10mg, as long as those products are still listed on the CBD Public List.

 

What action does the ‘new precautionary advice’ require CBD manufacturers to take?

The following opinion is from the specialists at GRS. We have shared the same opinion with our clients and are sharing the same for the wider CBD industry. We aim to support all manufacturers and industry members in staying compliant with regulatory requirements and promoting high standards for patient/consumer safety.

Currently, specialists at GRS are recommending that companies should not take any immediate action with respect to reformulating products since:

1. current products (cited on the CBD Public List) are still allowed to be sold onto the market;
2. retailers have been assured by the FSA that they can continue to sell CBD Products whilst Novel Food Applications are ongoing, and the product(s) is listed on the CBD Public List; and
3. over the coming months, the FSA will be providing further advice including the reformulating of product to be in line with the new precautionary advice of 10mg per day.

 

For the safety of consumers, and as a result of today’s [12/10/2023] announcement, specialists at GRS recommend at least one change to the text on the product label because the FSA had included an additional ‘vulnerable group’:

“parents trying to conceive”. 

 

For the next packaging run, GRS advises that manufacturers should update their product labelling to include this new vulnerable group.  For example:

Electronic materials, such as websites, can easily be updated with this new information.

 

Manufacturers may also want to consider making a further change to the labelling text to include the following statement (or similar) to product labels and/or package leaflets:

Based on our client feedback, we understand that these statements could be a bit ‘wordy’ and that some product packaging is too small to include all this text.

 

If manufacturers are unable to include the text ‘on pack’ then they might want to consider adding it to

• a package leaflet (if there is one) or
• including the text on your website and other promotional material.

 

Apart from the above points, GRS recommends that CBD product Manufacturers continue ‘as is’ until further guidance from the FSA is issued.

 

Experts at GRS are relentlessly working towards Driving innovation to market success™.

Feel free to get in touch by sending an email on – grs@globalregulatoryservices.com or by

visiting this link - https://globalregulatoryservices.com/global-regulatory-services-contact-details

 

GRS can support you with

• FSA Novel Food Application Process
• Performing ongoing Post Market Vigilance requirements
• Ad-hoc Regulatory Support
• Establishing Good Manufacturing Process [GMP]
• Creation of Technical Documents and Consumer information leaflets
• Bespoke Regulatory and Quality Compliance Support
• and … much, much more!

 

Feel free to get in touch by sending an email on – grs@globalregulatoryservices.com or by

visiting this link - https://globalregulatoryservices.com/global-regulatory-services-contact-details