A vitamin D qualified health claim will soon be submitted to the Food and Drug Administration even as concerns grow about the recent vitamin D scientific update issued by the Institute of Medicine (IOM).
The Alliance for Natural Health-USA (ANH-USA) announced this week that it was on the verge of submitting a dossier under the qualified health claims system.
It has enlisted Jonathan Emord, the attorney the group worked with in a 2010 court case that saw qualified selenium health claims altered, and who has been involved in several other cases including Pearson v Shalala in 1999 which was influential in the qualified health claims system being established in the first place.
The claims are likely to link vitamin D consumption with reduced rates of certain types of cancer, and reference more than 6000 studies that appear in the scientific literature.
“Alliance for Natural Health is having scientific experts evaluate the evidence, presently,” Emord told NutraIngredients-USA.com.
“If the scientists deem the evidence credible in support of Vitamin D/Cancer risk reductions, then appropriate claims will be created and a petition will be filed. Based on some 6,000 published peer reviewed articles on the association, we fully expect that the scientific evaluation will find a credible basis for one or more Vitamin D site specific cancer risk reduction claims.”
IOM on vitamin D
But in making its announcement the ANH-USA pointed to issues it has with the recent IOM report on Vitamin D, which it said had set, “ridiculously low daily vitamin D allowances for most people.”
The group publicized comments made by Dr Walt Willett, along with Professor Heike A. Bischoff-Ferrari, the director of the Centre on Aging and Mobility at the University of Zurich, which were also critical of the IOM’s recommendations.
The comments, which can be found here , were published by the Harvard School of Public Health, and highlight incongruity between the vitamin D levels in the randomized controlled trials (RCTs) studied by the IOM and the body’s final recommendations.
"With the IOM recommendation of 600 to 800IU of vitamin D, most healthy adults will reach 50nmol/l (20ng/ml) 25(OH)D but not optimal bone health with respect to hip bone density or fracture reduction," the two academics wrote.
But they acknowledged that, “In support of a greater safety margin in research and supplementation strategies, the IOM doubled the safe upper limit from 2000IU to 4000IU of vitamin D per day, which is appropriate.”
The ANH-USA agreed the IOM vitamin D daily dosage was too low to prevent the risk of bone fractures.
“The IOM’s report was based almost solely on the effect of vitamin D on bone health; other health benefits were largely ignored. Now Dr Willett says they didn’t even get the bone science right.”
In 2008, vitamin D was added to the calcium-osteoporosis unqualified health claim.