While questioning the validity of such an approach, Andrew Shao, PhD, the senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition, believes a crucial difference exists in the way the two agencies go about applying that criteria.
“EFSA does not appear to be taking into account the nature of the claim,” Dr Shao tells Shane Starling. “The reason they say no is because they are looking for proof of a therapeutic claim that a drug treats a disease...”
“What EFSA is trying to do is provide a black and white answer to something that is a grey continuum and it doesn’t fit.”
While the FDA employs similar ‘gold standard’ scientific criteria, it is more sympathetic to the fact that – in claim-making as in claim-backing – an element of grey exists.
The FDA is also more transparent, Shao says, which yields greater understanding of its criteria by all stakeholders.
“If [EFSA] is willing to have an open dialogue with the industry, it’s possible that the approach could be modified in a way that takes into account the fact that nutrients are not like drugs – and neither are bioactives – and that science is an evolving process, that this is a continuum, and it is not simply a black and white situation,” Shao concluded.