CBD Novel Foods deadline fast approaching as firms embrace regulatory challenges
Nutraingredients spoke to Andy Duckworth (AD), founder and CEO of NatureCan, an online retailer of hemp derived CBD, as well as other health related products such as vitamins and minerals.
Also trying to make sense of the current challenge is Filipp Korentsvit (FK), managing director of the Austrian CBD company WeedWorks.
Thanks for talking to NutraIngredients. Firstly, what are your thoughts and feelings as to the new updated legislation by the FSA?
AD: “We are delighted with the clarity the deadline has given the CBD industry. We are excited to benefit from this barrier to entry which will inevitably lead to market consolidation and the survival of the fittest and compliant companies.”
FK: “We welcome this important initiative that will improve and homogenise the quality of CBD consumer product in the short term and promises to aid wider adoption of CBD products by raising quality standards and thereby improving end-user confidence in the products and how they are made, which is so crucially important in this developing market.”
The FSA confirms that all finished products need a Novel Foods application. These products may fall within the scope of a single application. What are the complexities in adhering to this requirement?
AD: “Our CBD range is already unrivalled, and our suppliers are chosen with extreme care. We’re fussy about who we do business with and we know our valued customers feel the same way!
“The safety of our customers is always at the forefront of our minds, so Naturecan positively embraces the FSA Novel Food legislation.
“We are currently collaborating with the Association for the Cannabinoid Industry (ACI), engaged with qualified Nutritionist and Regulatory specialists, to compile a robust dossier of data for submission to the FSA by 31/12/20. This will allow our application to be validated by 31/03/21, so that the Naturecan CBD range can legally remain on sale.”
FK: “This requirement stipulates the need to submit multiple applications for the foods containing the same ‘active’ ingredient with same dose per product and same delivery mechanism.
“This will result in the increased admin and operational costs where significant economies could have been reached. In addition, longer time to market is to be expected for every new end product that is to be added to the product line.
“All in all, this is likely to reduce the variety of products offered by each company and limit the development of innovative secondary products.
“We do understand the need for separate applications where the dose per product is higher, or the ‘active’ ingredient is different (e.g. broad-spectrum vs full spectrum) or when the delivery mechanisms are different (oral vs transdermal) but not when the products are sufficiently similar.”
Could you comment on the expense involved in meeting the requirements of the FSA both financially and timewise? Would you outsourcing this task or tackle it yourself?
AD: “Considerable – in terms of time, organisation and expenditure itself. We are compiling the dossier with the help of Nutritional Supplement Industry specialist, Moyra Cosgrove (BSc Hons, MSc Nutrition) working closely with Paul and Andy. This is so important, so we are giving it our full priority and focus.”
FK: “The costs and complexities of any new significant regulation being adopted, such as the newly adopted legislation by the FSA, are typically very significant and it is not any different in this case.
“In order to appropriately address this new regulation, especially in light of our firm belief in its importance for the further strengthening and development of the CBD market, we have started building out our in-house scientific and laboratory teams with a view of strengthening them over the coming months.
“We will also be looking to outsource a significant part of specialised testing to certified and reputable laboratories, whilst also working to expand in-house laboratory testing capabilities.
“Our membership of the ACI plays a key role in helping us identify any gaps and ensure we meet all regulatory and compliance requirements defined by the FSA.”
The FSA confirms that firms need to compile information of individual formulations, which then require submitting a separate Novel Foods application or in addition to a Novel Foods application of their CBD ingredient supplier.
How are you able to address this requirement, which would surely require you to risk assess your finished product formulation if it was different from the CBD supplier?
AD: “We are heavily intertwined with our supply chain and only use one, high quality oil source, so again we are well positioned to deal with the challenge and welcome the fact that regulation is set to govern the market.”
FK: “We are looking to submit a separate application for our current line of primary products complete with the risk assessment. We expect to be able to work with a selected test services provider on all our product formulations.”
Do you think the delays or mixed messages regarding CBD regulation has caused firms to hold back and not take the deadline as seriously? How is your firm approaching the situation at the moment?
AD: “We are not in any way concerned with what other firms do, we only focus on our own application and have unerring focus to hit all requirements and are fully on course to have our dossier validated within the timeframe set out by the FSA.”
FK: “We understand that it would be in our advantage to submit the application to EFSA before the 31 Dec 2020 deadline to avoid submitting a separate FSA application, which we expect to be a less robust and effective process in comparison with the EFSA one.”
Finally, how does Brexit affect your timelines in getting a Novel Food application? Is the prospect of getting approval by the European Commission and complying with new legislation a real possibility?
AD: “It is indeed more than a possibility, and one we look forward to delivering, for both the UK and our valued partners and customers in the EU.”
FK: “We are pressured for time and are actively looking for the ways to accelerate the testing and reporting timelines that will allow us to get the application though before the Brexit deadline. We do not expect any problems in getting the approval by the EC provided all supplementary data is obtained in good time.”