Novel Foods Confusion Leading to Innovation Graveyard, Expert Warns

An abundance of innovation in the grey space between food and supplements has led to a ‘graveyard’ of innovative companies ill-prepared for the hurdles they must jump, a regulatory expert has warned.

“From 2020 there have been a lot of startups launch which are not too dis-similar to those in the infancy of the CBD industry, in that they fall within the space between being a food and being an anecdotal heath product, and fall into the dual nets of novel foods and health claims,” according to Stephen Oliver, co-founder at MAST Consulting that runs both The Canna Consultants and Advanced Food Regulation.

“There’s a lot of hurdles to go through for novel foods approval and often these companies will only discover they don’t satisfy requirements at the eleventh hour – because they either believed that they did not need expert regulatory advice, or those from whom they sought advice were not experts at all”.

He noted innovative products which have run aground have included alternative proteins and botanicals, including ashwagandha, mushrooms and Brassica derivatives.

There are no specific regulations on the use of botanicals in the EU and no consolidated list of permitted herbs and plants and their allowable preparations and concentrations, meaning it remains the responsibility of food companies to demonstrate that the product is safe.

“There’s a graveyard of companies who have invested huge sums to create a fantastic product and engaged marketing consultants to get the product to the attention of B2B and then someone’s asked the question as to the Novel Food status of the product – which the company had never considered and their general food advisors had never raised with them.”, he asserted, adding that food focused consultants tend to focus on food labelling, product functionality and market access.

The intricacies of Novel Foods

Many companies don’t realise their product is novel, he explained, as they might start with a food stuff that has been consumed for millennia, but the process that they’ve applied to it is new, making the resulting ingredient novel for the purposes of Novel Food classification.

“We need to examine how the food is produced as well as the end product. Many companies fail to consider the process itself can be Novel with a prime example being UV baked bread – the same end product, but the different production mechanism means that the end result is Novel.”

Food supplements might contain a plant’s roots, leaves, flowers, fruit, or extracts. In the European Union (EU), a root infused extract of ashwagandha is not subject to the Novel Food Regulation because it was on the market as a food or food ingredient before May 1997, but extracts from the body of the plant and isolated elements are considered novel.

The use of nootropic mushrooms is very much “in vogue”, noted Oliver, but whilst the mushroom stem and fruiting body are not novel, the mycelium (the sub-root-like structure) are.

What’s more, a lack of harmonization across different member states makes these rules all-the-more confusing, with differing attitudes to botanicals, most notably ashwagandha​, and protein alternatives, from both a safety and marketing perspective.

Other routes to market

The consultant said this has caused several UK and European brands to look for alternative routes to market and GRAS approval in the US has proved a less cumbersome process.

“Creating a GRAS dossier is not as onerous as creating a novel foods dossier and this allows companies to get onto the market and start creating revenue, while they make their way through the novel foods process, which can take many years,” Oliver explained.

“Self-determination under the GRAS system allows a brand to launch with the correct regulatory support and a robust safety and analytical dossier on hand. Commercially the same opportunity exists because there’s a lot of influencer cross over across the Pond, this means a lot of the ingredients that are popular here, are also popular there.”

However, the GRAS process doesn’t come without its challenges, the consultant explained: “You may have a fantastic manufacturing facility outside of the USA but if you’re not registered with the FDA you can’t import products. You also need an agent within the states as a point of contact for the FDA and to make product notifications before each importation.”

“At MAST Consulting we have been providing services to companies in the emerging ingredient food space for several years, however, the prevalence of poor advice and misinformation within this ever-burgeoning area of the food world led us to want to establish a highly visible division within the MAST Group through the “Advanced Food Regulation” division, catering for these firms.”

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