Moving into Review Phase: EIHA Novel Food Consortium Passes FSA Administrative Check

The EIHA Novel Food Consortium applications have passed FSA administrative check, the EIHA announced on Tuesday, 23rd of March. This means that both regular/full-spectrum and natural isolate products of EIHA consortium partners can remain for sale in the UK market, providing the products are compliant with UK controlled substances regulation.

As they point out in EIHA, the pending official registration will be granted only upon results of the undergoing toxicological studies on both CBD and THC, expected in the forthcoming months.

In their press release, the EIHA says they are delighted to announce that both regular/full-spectrum and natural isolate products of EIHA consortium partners can remain for sale on the UK market, following both applications passing the key administrative check by the UK FSA. The FSA has confirmed to EIHA that both applications were considered to be compliant with the administrative requirements.

By granting the pre-validation status, the Food Standards Agency recognizes and supports the strong will of the hemp sector, and particularly of the EIHA Consortium, to evaluate and determine the safety levels of its novel food products, the EIHA says.

“Having had the honor to represent EIHA and the hemp sector’s interest in meeting with the FSA for several years, I feel gratitude and relief that our voice has been heard and thank the FSA for their progressive stance to offer a path to regulatory compliance.”, says Ms. Catherine Wilson, EIHA Vice President.

“By way of background, after nearly 60 years, the UN set out to review the status of cannabis and the World Health Organisation (WHO) submitted their opinion to the UN for cannabis preparations in 2019.

For Cannabidiol preparations the WHO expert committee recommended that pure CBD should not be scheduled within the International Drug Control Conventions by adding a footnote to the entry for cannabis and cannabis resin in Schedule I of the Single Convention on Narcotic Drugs (1961) to read ‘Preparations containing predominantly cannabidiol and not more than 0.2% of delta9-tetrahydrocannabinol (THC) are not under international control.’

Whilst this recommendation has not yet been adopted by the UN, further consultation has been requested. We hope that the outcome of the world-leading EIHA clinical study on THC will be widely reviewed and that decisions will be based on scientific evidence.”, Wilson says.

EIHA’s THC study

EIHA’s THC study on human beings, carried out by ChemSafe in GLP laboratories, will start this summer. The outcome of the clinical study for THC will enable the FSA to determine and establish safe consumption levels of naturally occurring traces of THC in hemp foods and supplements. This study is the biggest ever undertaken and everyone is anticipating a positive outcome based on the many years of safe consumption of hemp foods and supplements.

“This is truly excellent news for the industry, and I would like to thank the FSA for the many constructive and positive discussions we have had together over the years. We are now on the path to building a regulatory framework that will facilitate investment and the expansion of our industry throughout the UK and Europe with the considerable employment and economic benefits this represents.”, says Mr. Tony Reeves, Member of the Advisory Committee and UK Representative.

“Most importantly, this development has within it the potential to preserve consumer choice by maintaining access to a range of CBD product forms, whilst ensuring safety and compliance is the priority of all members of the CBD supply chain. EIHA’s decision to build a joint application under the umbrella of a consortium was not taken lightly. Our approach was unprecedented and represented considerable financial investment and allocation of resources. However, the news from the FSA goes a long way to vindicate our decision and our strategy to deliver a credible solution for the industry.”, he said.

The review phase

This confirms that the product now moves into a review phase. The validation will be confirmed when the FSA publishes the list of validated products, which is expected next month. So far, about 33% (about 250) of all the applicants have passed this stage.

Earlier in March, due to a large number of received applications, the FSA decided to modify the criteria of products to remain on sale in the UK after the 1st of April. Previously, only products which were on sale at the time of the FSA’s announcement (13 February 2020) and were linked to an application that had been validated by 31 March 2021 were to be included. To maximize the opportunity to pass validation, this now includes all products on sale on 13 February 2020 and linked to an application submitted before 31 March 2021 that is subsequently validated.

”Applying for novel food authorization is the only way CBD products can remain on sale here. For the past year, we’ve been encouraging all businesses to submit good quality applications as a matter of urgency.”, said Emily Miles, Chief Executive of the Food Standards Agency.

As FSA published in their press release earlier in March, the applications are subject to an 8-day admin check, and it can then take up to 30 working days for an application to be validated. These validated applications will then continue through an authorization process that undertakes checks on safety to determine whether products can be authorized for sale.

A list of products linked to validated applications will be published on the FSA’s website in April and regularly updated.

The FSA will also publish a list of products associated with applications that have not yet fully met the legal requirements to be validated but have set out sufficiently robust plans to prove they are fully committed to delivering the remaining information required. This will include evidence of plans to complete the risk assessment process, with a clear deadline for submission of the outstanding information.

Validation is not the same as authorization, and there is no guarantee that a validated application will eventually be authorized – each application must follow the comprehensive risk analysis process.

“Ilesol Pharmaceuticals welcomes the news about Novel Food Consortium’s successful passing of the FSA administrative check. We are grateful for the EIHA’s thorough work in the process of novel food authorization, and we are convinced that it will prove to be fruitful. We are excited about the FSA validation list and look forward to seeing the highest safety standards fulfilled in the UK market.”, says Sasha Bajilo, founder of Ilesol Pharmaceuticals.

Reviewed by Sasha Bajilo, founder of ILESOL Pharmaceuticals, an industrial scale producer of CBD products and formulations. Expert on Hemp/Cannabis policy, member of the Croatian Ministry of Health regulatory commission for medical cannabis.