It may look like a regular wellness product but the UK’s food law, toxicology, and regulatory evidence will determine its sale. Understanding How CBD Novel Foods Work It is less important to decode a label than it is to follow the chain of responsible parties behind it, from the extract manufacturer and dossier owner through retailer, regulator and consumers.
Commercially, CBD is a sector where the distinction is important. The Food Standards Agency may have received an application for a product that has been widely advertised and stocked in established retail outlets. These are two very different regulatory positions.
Why CBD is regarded as a novel foods
In general, a novel food is a food that was not consumed significantly in the UK and EU prior to 15 May 1997. CBD extracts are considered novel foods if they’re sold to humans, and this includes oils, capsules or gummies as well as drinks, and other edible forms.
It is not the case that CBD is inherently unsafe. To be approved for use, novel food regulations require that businesses demonstrate the safety of a product under its proposed conditions. This assessment is relevant in particular for CBD products, as they can vary materially with respect to purity, cannabinoid composition, extraction method and contaminants.
The regime is not to be confused with the regulation of medicines. CBD food products cannot make medical claims, such as the treatment of anxiety, pain or seizures, unless they are authorised as medicines. Even though a product is in the food category it can cause compliance problems elsewhere due to its marketing and formulation.
From application to approval, how CBD novel foods are approved
Food Standards Scotland plays a similar role in Scotland. The rules are part and parcel of the novel foods framework that is retained in Great Britain. They should be considered as a regulatory process which evolves, rather than a simple paperwork exercise.
A dossier is often submitted by a manufacturer, supplier, or another responsible business to submit a novel food application. The dossier should explain what the ingredient actually is, and why it is safe to consume at the suggested dosage. It usually addresses the source material and production process, chemical makeup, specifications, stability as well as nutrition, food safety, and toxicology.
CBD regulators will examine CBD-related questions, such as the amount CBD per serving, THC content, residual solvents, heavy materials, pesticides, microbiological risks, etc. The regulators also look at whether the safety tests used are relevant to the product being sold. The evidence for a CBD isolate with a high purity, for example does not settle the case for safety for a broad-spectrum CBD extract that has a different chemical composition.
Validation, not approval is the milestone.
Validation is required before a complete scientific assessment. The regulator has decided that the dossier is complete enough to begin the assessment process. It does not mean a product has been approved or found to be safe.
This distinction was especially important following the March 2021 FSA deadline for CBD companies to submit novel food application. The agency created a list of products that were linked to applications which had been processed by the agency. This was to assist local authorities, retailers and customers in identifying these products. In terms of the market, this provided an interim route for CBD products as assessments continued.
It is not a bad thing to have a public list, but many people misunderstand it. The inclusion of a brand does not mean that the entire product range is endorsed. Listings can be linked to an applicant, extract or product format. Retailers must check that the products they sell are correctly associated with the application, and meet the applicable specifications.
After the FSA has completed the scientific review, it can recommend to the ministers whether or not to approve the novel food. It will also specify the conditions of approval. A food authorisation can set out specifications, maximum amounts, labelling requirements, or other restrictions. The application may be withdrawn, delayed or refused if the evidence is not sufficient or raises safety concerns.
The CBD Public List has Commercial Weight
Operators are concerned about the food safety issue, but also market access. Without a credible regulatory pathway, products may face removal requests by local authorities, retailers delisting them or disruptions to distribution agreements. This exposure does not only affect the company who manufactured the extract.
All parties involved in the supply chain, including brands, white-label providers, importers, and online retailers, need to know who is responsible for the application. It is common to believe that the general statement of a supplier that they are “FSA-compliant” will suffice. Compliance is dependent on aligning the CBD ingredient, formulation and dose of the product with the dossier or authorized specification.
Due diligence is different for investors and buyers. Brand value is more than just social media followings or shelf presence. Data ownership, exclusivity and manufacturing control, as well as regulatory continuity, can all affect whether a CBD product will remain on the market when enforcement is tightened.
Evidence of safety is still being developed
CBD has generated a lot of interest among consumers, but the science behind its long-term use and high-dose consumption is still incomplete. Regulators have raised concerns over potential liver effects, interactions with medications and reproductive health. This does not mean that all CBD foods are equally risky. Safety cannot be determined by popularity or the fact that it is a plant-derived product.
The FSA has released precautionary consumer guidance around CBD. It includes a recommended daily maximum intake for healthy adults, and a warning to certain groups that they should avoid CBD products. The exact recommendations can change over time as new evidence and risk assessments are developed. Therefore, businesses should not rely solely on marketing copy or claims made at trade shows.
Quality of the product is also important. CBD concentrations can vary from batch to batch, and the term “full spectrum” does not describe the exact level of each cannabinoid. Certificates of Analysis can be valuable if they’re recent, batch specific, produced by an experienced laboratory, and clearly linked to the finished product, rather than a generic sample.
THC presents a unique challenge to compliance
In law, CBD and cannabinoids controlled by the FDA are not interchangeable. Hemp-derived extracts can contain trace amounts of THC, but businesses are required to ensure that their products meet the relevant food and controlled drug legislation. The novelty of a food product does not exempt it from these rules.
One reason for the fact that a product’s position on regulatory issues cannot be reduced into a simple tick box is because of this. A compliant CBD food strategy requires alignment across novel foods law, food labelling, advertising standards, product safety controls and controlled-substances obligations.
What consumers and retailers should check
Retailers should always ask questions to ensure that they are getting the most out of their supplier’s statement. Is the product accompanied by a valid application? Who is the company that submitted the application? Does the extracted ingredient match the listed one? Does the CBD daily intake fall within the safety parameters of the product? Are there batch records or test results available?
Consumers have a much simpler, yet still important, task. You should look for a company that has been identified as a responsible one, the CBD content and serving sizes, and packaging which avoids making unsubstantiated health claims. Be especially careful when a seller says CBD can be used to replace prescribed medication, if dosage information or lab testing are vague, and if the seller makes unsubstantiated health claims.
The UK CBD market has moved away from a time when any hemp extract was able to be packaged and sold under a wellness label. Businesses that invest in traceability, evidence and accurate labelling can benefit from the novel foods framework. The safest step for everyone else is to check the actual product and the regulatory route that supports it, rather than making a louder claim of compliance.