The article 14 children’s health opinion – published by EFSA yesterday – found insufficient evidence linking consumption of Danone’s Immunofortis prebiotic formula and a claim to, “naturally strengthen the baby’s immune system”.
The opinion for babies up to 12 months of age found Danone’s 30-trial strong dossier wanting for containing limited, inconsistent and irrelevant trial data. It can be found here.
A failure to communicate
Danone Baby Nutrition vice president of global quality and public affairs, Phillip Pratt, said while Danone remained a supporter of the regulation, EFSA’s failure to communicate with applicants was compromising the working of a system that remained a “learning experience” for all concerned.
He said published guidelines and EFSA’s assessment procedures and criteria were not in alliance, with the agency, “seeming to follow a different approach in reviewing our science than we had expected”.
“This opinion raises questions about the procedure applicants are obliged to follow,” Pratt told NutraIngredients.com.
“There clearly remains a discrepancy between the dossier submission requirements and EFSA assessment. As previously highlighted by stakeholders, this again focuses attention on the urgent need for direct scientific dialogue, which is currently lacking in the process between EFSA and applicants.”
He said Danone would take advantage of the 30-day response period to engage with EFSA on its opinion. “There is a lot that can happen.”
Added Pratt: “Key for us is the full body of evidence but EFSA has discounted animal data, composition of microbiota, stool pH, SCFA profile, faecal sIgA and anti-immunoglobulin profile. EFSA does not appear to have appreciated the relevance of all other studies.”
EFSA says no
In rejecting Danone’s submission that included 25 human and five non-human trials, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) highlighted a 2005 ‘gold standard’, double-blind, randomised controlled trial employing dietary prebiotic oligosaccharides (Moro et al (2005).
The trial was conducted on 259 infants (128 males) with a history of atopic dermatitis and other infections. It showed significant reductions in atopic dermatitis among the intervention group fed the Immunofortis 9:1 mixture of short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS).
After two years, atopic dermatitis (13.6% v 27.9%), recurrent wheeze (8% v 21%), allergic urticaria (1.5% v 10%) were significantly lower among those on the formula for the 134 infants who completed the trial.
But the NDA pointed out several weaknesses that led it to discount the trial findings. These included:
- a failure to assess the allergic nature of dermatitis, wheezing and urticaria
- a lack of clarity about how the infections were diagnosed
- unclear criteria used by paediatricians to prescribe antiobiotics
- failure to correct for multiple endpoints
Pratt said: “The Panel concluded that the weaknesses of this study only ‘limits’ its value. So therefore we consider the study is still relevant as substantiation for the submitted consumer claim.”
He said other studies in the area were underway, “using the translational research approach which is as recommended by the WHO and PASSCLAIM.”
The NDA also discounted animal studies for irrelevance to human populations; other clinical trials for inappropriate outcomes or inconsistent or unconvincing evidence.
“It is increasingly evident that EFSA requires an unprecedented level of scientific evidence in this emerging field, linking nutrition and immunity,” Pratt said.
Danone employs the claim on products such as Aptamel and Nutrilon in the 14 European Union countries in which it sells follow-on formulas that are designed for infants over the age of six months. (Infant formulas are designed for babies under six months and are prohibited from making such marketing slogans under European Union law.)
Pratt said that while the company “stood by its science” it acknowledged the opinion “does have an impact” on its existing follow-on formula claim-making.
“There are packaging implications so we will sit down and look at what we have to do,” he said, noting that even though the opinion was not yet law; nor certain to become law in its current shape; the marketing of follow-on formulas with long shelves needed to be considered now.
If and when the opinion is adopted into the European Union legislature, companies have six months to comply with it.
The issues confronted by Danone and others seeking to make health claims in the EU, the US and Canada, will be discussed at a Cantox-hosted conference in Brussels on February 23.
For more information on that event, please click here .