Gut microbiome research could enhance our understanding of other body systems and give us the tools to tackle public health crises such as mental health – but regulatory hurdles around language restrict industry’s ability to communicate with consumers.
That was the message from an expert panel at last month’s Future Food Tech event in London, entitled “Replenishing the microbiome: Advancing personalised nutrition and probiotics”.
Richard Day, vice-president of medical affairs and clinical development at ADM, stressed the importance of the gut to distant body systems, such as the skin and brain.
He said: “It's interesting to talk about gut health and its impact on digestive outcomes. But there's so much more to the microbiome. And I think, for me, understanding how those distant physiological systems can be impacted by our microbiome is really the next frontier in microbiome research.”
George Hadjigeorgiou, co-founder and president of the personalised nutrition programme ZOE, agreed that the opportunities presented by microbiome research were “super exciting”, but warned it was still early days in terms of our knowledge.
He said: “Just to remind ourselves, a few years ago, we only knew about 50% of the microbes that exist. Now we know maybe 80%... That means that there are a number of unanswered questions...
“My belief is that microbiome can be a new way to measure health, a new way to understand where you are on the journey towards diseases before they arise. It’s not where it is today, but that’s where it can go.”
Caitlin Hall, head of clinical research at health tech startup Myota, agreed that understanding of “effects beyond the gut, particularly the gut-brain axis” was becoming a “key priority” for consumers, scientists, and industry alike. However, she warned this left the category vulnerable to unscrupulous vendors jumping too quickly to commercialise products.
She said: “What we see a lot of the time now is companies saying [a product is] ‘backed by science’ or ‘backed by over 100 clinical trials’, and when you dig in a little bit further, we can see that a lot of these trials are not done by that company or they're largely based in preclinical or animal model studies…
“I think the next five to 10 years are going to be massive for this area. We just need to be quite careful about how we approach this and not commercialising too quickly.”
One of the challenges with microbiome research is the fact that it occupies a space “between food and pharma”, said Day, meaning products can fall into a grey space that inhibits the audience they can reach.
He explained: “What we're often doing is investigating these products in a randomised, double-blind, placebo-controlled trial, which is the same as the gold standard for the pharmaceutical industry. But we're doing so with products that are regulated as foods. And this can create conflict with the regulator.”
He gave as an example the UK, where the regulator “can really insist that clinical endpoints are not part of the trial design for non-drug products”.
He said: “If we're going to bring effective, evidence-based products to the market, we need to have a regulatory system that is flexible enough to allow us to investigate these products in the way that is best suited to serve those end consumers.
“And at the moment, we're in a bit of a transition phase, where the regulator, I think, is still trying to catch up with what's happening with the science.”
Hadjigeorgiou struck a more positive note, saying: “I foresee a world where people are going to get many more predictive insights of what's going to happen to their health, and that will give them much more power… And as with every other technological innovation, the regulation will need to adapt and evolve.”
He added: “We will see also, with these new technology advancements, regulators becoming more advanced in terms of supporting that ecosystem.”
Hall highlighted the phrase “replenishing the microbiome” in the panel’s title as an example of language that is confusing for the consumer.
“I don't think that anyone actually knows what that means,” she said. “We don't exactly know what a healthy gut microbiome is or what an unhealthy gut microbiome is. So it's hard to say… what you can specifically do to replenish the microbiome.”
She added: “I think that's where the confusion comes for consumers, is that they're told ‘balance your gut microbiome’, ‘replenish your gut microbiome’ – these are things that we would never use in academia or in industry… It's very confusing for a customer to be able to navigate this world when they're told many conflicting things.”
Day put the blame on regulators, saying they needed to evolve and allow industry to move away from “these wishy-washy terms”.
He said: “This is all part of treading that delicate line with the regulator. We're not talking about drugs, we're not talking about therapeutics, so you can't use drug language. And then the compromise is we wind up with these words that don't really mean anything.”
Hall highlighted that the language allowed by EFSA was “very standardised” and not necessarily marketable.
“The ones that we use, for example, would be ‘maintains your cholesterol levels’ or ‘helps to improve transit time’. And these are not quite what we need,” she said. “If we were to put that on to a fibre bar… I have no faith that that is going to sell a single product.”
She added: “This common language is now becoming alienating to many people because it's often reduced down to something that's very safe and very conservative, which rightly so, it should be based on the evidence that we have, but… it's just very difficult and very restrictive to communicate the health benefits of our products.”
Day agreed there was a balance that needed to be struck.
“[Y]ou don't want unsubstantiated claims being made about products that have no evidence – that's completely unhelpful,” he said. “Are we maybe a little bit too far the other way at the moment, where it's too difficult to talk about good-quality microbiome evidence to the general public, to the end user? Maybe yes. And we need to find that right balance and, I guess, challenge.”
