Solae withdraws soy/cancer health claim petition (FDA)
By Jess
Halliday
10/3/2005 -
FDA’s record on qualified health claims approvals is causing
companies to re-think their petitions. In the light of recent decisions
the FDA has handed down, The Solae Company has decided to temporarily
withdraw its soy/cancer prevention claim.
A
spokesperson for Solae told NutraIngredients-USA.com that the company
first submitted its petition for a claim on the link between soy and
cancer prevention in April 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. Rather, it 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.
"Our
decision has nothing to do with our confidence in the science," said Dr
Greg Paul, director of health and nutrition for The Solae Company. "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."
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.
In an
interview with NutraIngredients-USA.com in June, Kathy Ellwood,
director of nutrition programs and labeling at the FDA's Center for
Food Safety and Applied Nutrition, said that the approval delays are
the result of “very limited resources”.
http://www.fda.gov/ohrms/dockets/dockets/04q0151/04Q-0151-emc0002-vol4.doc
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