The science to substantiate health claims should bring together all studies, and putting too much emphasis on clinical trials is “not practical”.
“It is scientific dogma to state that health claims should be based primarily on well designed human intervention studies,” said Professor David Richardson, scientific adviser to the UK Council for Responsible Nutrition (CRN) and IADSA.
“Much of what is already known about human health cannot be validated using ‘gold standard’ clinical trials. These studies are, of course, important, but they provide only one source of information. All sources of scientific data have inherent limitations, hence the need to focus on the totality of the available data and weighing of the evidence.”
Codex agreed at the end of 2007 that its draft rules on health claims needs further work following concerns over what evidence should be required for scientific substantiation.
And the calls for a wider consideration of the overall science by IADSA will keep up the pressure on Codex ahead of a review and redraft by a France-led working group, which will present its conclusions at the next Codex Nutrition Committee meeting in November 2008.
Although Codex is not a regulatory body, its decisions are used as a benchmark of discussion should trade disputes arise in the future, and while Codex does not have the same force of law as an EU directive or national legislation, it is used as a reference point for countries that are looking at revising or creating legislation.
In Europe, the EU has already unveiled its own health claims regulation - which says claims about foods and drinks should be supported by science - and has caused uncertainty for the industry since coming into force in July because parts of the law have not yet been finalised.
These EU rules would be bolted-on to the Codex regulation as an annex, but any wider implications for Europe are not yet known at this stage.
The text, as it currently stands, states that short-term human intervention studies in healthy subjects should be the prime source of evidence in claims substantiation.
However, this approach was described by IADSA as “medicine-based, aimed at deciding whether a drug can prevent, cure or alleviate a disease or medical condition in the treatment of well-defined groups of people at high risk of disease or already with a disease”.
“The scientific evidence to support the diet and health relationships for dietary guidelines and health claims for fruits and vegetables, and for whole grain cereals, are based mainly on human observational studies, not clinical interventions,” said Richardson.
Sources of scientific evidence can include generally accepted authoritative information that has been verified and validated over time; human intervention studies; human observational or epidemiological studies; animal and in vitro studies, and traditional knowledge and experience of use.
The scientific data that will be accepted for a health claim for botanical problems in EU law has also caused some concern. Lobbyists have called for the traditional use of a botanical to be acceptable as evidence and are opposed to clinical trials.