Solae first submitted its petition for a claim on the link between soy and cancer prevention in March 2004. As is the case with a number of other submissions, a decision has been delayed on a number of occasions.
But despite the industry's frustration over such delays, Solae's withdrawal is not a sign of total disillusionment with the process. Dr Greg Paul, director of health and nutrition at The Solae Company, told NutraIngredients-USA.com that the FDA does the best it can, given the volume of petitions it receives and its limited resources.
Rather, Solae has signaled that it will be making some improvements to its submission, after having studied the nature of other recent petitions and approvals. This, it believes, will give it a better chance of success.
In particular, Dr Paul said, there are some similarities between the soy/cancer reduction claim and the claim for green tea and cancer risk reduction. In this instance, the FDA chose to look specifically at studies with validated food frequency questionnaires - a process that did not gain use in population-based studies until 2000. "Our decision has nothing to do with our confidence in the science," said Dr Paul. "We have an improved understanding of the process and have decided to withdraw the petition and re-structure it so it will be in-line with the FDA's current qualified health claim process."
He explained that Solae began working on the claim four years prior to its evenutal submission, basing it on regulations that were in place under the 1990 Nutritional Labelling and Education Act. When qualified health claims were introduced, there were no initial guidelines but these have evolved as each claim is reviewed along the way.
No specific time-line has been set for the resubmission, but Solae has said that the 60-study strong body of evidence supporting the link between soy consumption and a reduced risk of developing several types of cancer continues to grow.
Most recently, the current issue of the Journal of the American Medical Association contains a University of Texas study indicating that eating foods containing phytoestrogens, including soya products, reduces the risk of developing lung cancer even in smokers.
"The company's objective in filing this petition was to enable research-based health information to be made more readily available to consumers," said the company in a statement.
Dr Paul said that, as far as he is aware, only one other health claim exists for soy in the US - the 1999 unqualified health claim for soy protein and coronary heart disease. This has also been approved in the UK, Korea, Brazil, Japan, the Philippines and South Africa, is under review in France and Malaysia, and is soon to be submitted in Canada.
Dr Paul was not able to speculate on any future claims the company may make, but said that it is constantly evaluating the science on soy.
As for EU-wide health claims, he said that Solae "will certainly review the process" when it is finalised.
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