A quick look at the infant formula space shows a huge focus on immunity and cognitive function and development. But Eric Chappuis, director of European consulting and clinical trials firm Naturalpha, said these were difficult and costly topics to address.
“The issue we have is that most of the claims which are accepted are based on very well-defined outcomes, generally from the cardiometabolic field, like glycemic management for example. However, when moving into the immune system, what’s very hard is at the end there is no clear-cut answer to one trial,” Chappuis told DairyReporter.com.
Immunity and cognitive health, he said, were areas facing “big scientific challenges”. “…We still need to develop more robust ways of analyzing results and be more confident on them.”
Another challenge, he said, was cost because trials in infants were expensive and required lots of precautionary measures.
Asked if collaboration with pharmaceutical majors would help funding and progress in trials, he said: “I’m not sure teaming up with pharma will bring [infant formula makers] additional strength because with research and development in infant formula companies, you already have strong teams which are very organized – you generally have clinical teams already.”
Infant formula companies had the most organized R&D model in the nutra space, he said, much more in line with pharma than food.
Essential nutrients
What infant formula manufacturers should consider instead, Chappuis said, were general claims around vitamins and minerals.
“Short to mid-term, most of the opportunities are in vitamin and mineral claims that are very simple claims that do not rely necessarily on randomized, controlled trials,” he said.
The science behind these nutrients was also strong and industry already had a thorough understanding on how they worked in the body, he added. “For vitamins and minerals, we know they’re ingested, absorbed and go into the organs – it’s clear how they work.”
Claims around vitamins and minerals in Europe, he said, would go through Article 14 of EFSA’s health claim regulations.
“What we see most of the claims for are essential nutrients, not for specialty ingredients like plant extracts and fibers. Most opportunities are in this area of essential nutrients,” he explained.
EFSA published an opinion earlier this year on what were 'essential' infant formula compositions following a period of public consultation. They said, for example, that fluoride was not an essential nutrient and omega-3 form DHA (docosahexaenoic acid) had "no scientific evidence" for the long term benefits or effects of its inclusion in formula.
Evaluating risk
For infant formula makers wanting to make health claims, Chappius said it was a matter of risk evaluation.
“They have to think about why they’re doing it – is it really for developing the science or only for a claim? And they should be evaluating the risk of doing it now and trying to focus on the least risky option if they want to go for a health claim,” he said.