The specific wording of the claim states: “Vitamin D reduces the risk of falling. Falling is a risk factor for fractures.”
Men and women over 60 are the target group with DSM’s QualiD formulation at the core of the submission that contains, “several QualiD-specific, peer-reviewed, human clinical studies”, according to senior vice president in nutrition science and advocacy, Dr Manfred Eggersdorfer.
“We have the human studies that are required by EFSA,” he told NutraIngredients this morning.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) has already passed in a positive article 13.1 opinion linking vitamin D and muscle function, but DSM sought something more specific – in both claim and formulation.
“The existing claim is general and will be able to be used by everybody [if approved at European Commission level at the beginning of 2012],” he said. “This is much more specific and can have more impact on-market as well as being specific to QualiD.”
DSM’s submission notes that, “vitamin D has a role in preventing falls in the elderly”.
“This effect may be mediated via muscle function. The relationship between vitamin D and muscle function has been previously recognised [by EFSA]. An additional intake of 700-1000IU/day is required to benefit from fall risk reduction.”
Eggersdorfer said the article 13 opinion was likely to feature in the NDA’s assessment of its dossier but no feedback had yet been received from the NDA.
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The NDA has already found that vitamin D is important for normal bone and teeth, absorption and utilisation of calcium and phosphorus and normal blood calcium concentrations, normal cell division, normal functioning of the immune system, healthy inflammatory response and maintenance of normal muscle function.
The US Institute of Medicine recently recommended new vitamin D levels of 600IU/day for adults and 800IU for those over 70.