Responding to an article 14 nutrition and health claim regulation (NHCR) submission from DSM Nutritional Products, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said five randomised clinical trials referenced in DSM’s dossier “consistently showed” a positive effect, although others were discounted for varying reasons.
“DSM is pleased the EFSA opinion was in agreement with the findings of our lead science and regulatory teams,” said Will Black, global director of marketing at DSM Nutritional Products.
“The recommended dosage levels are consistent with our application and with recommendations of the US Institute of Medicine (IOM) for the elderly.”
Black said the claim was significantly differentiated from the general function, article 13 vitamin D-osteoporosis claim that had already won a positive opinion from the NDA.
“This claim stresses the importance of vitamin D, specifically in the elderly, not only with regard to osteoporosis but also with regard to the risk of falling – one of the main causes of fractures.”
Feeling of security
Black highlighted how the claim could help do more than just prevent physical injury in the elderly.
“Falling, aside from increasing the risk for bone fractures, also encompasses a strong psychological element with regard to the overall well-being and feeling of security by the elderly.”
“The potential loss of confidence from falling, regardless of whether it leads to fracture, may serve to deter otherwise capable elderly citizens from pursuing the physical activity that helps lead to healthier bones, strengthened muscle function and postural stability.”
In assessing the data, the NDA found, “Daily vitamin D supplementation (800-1000 I.U.; 20-25 μg) in combination with calcium, when compared to calcium alone, significantly reduced the risk of falling…”
The Panel agreed that vitamin D supplementation, when combined with calcium, could benefit, “body sway, muscle function and strength, or both, together with a significant reduction in the risk of falling.”
However calcium did not feature in its suggested claim: “Vitamin D may reduce the risk of falling. Falling is a risk factor for bone fractures.”
This was very close to DSM’s proposed claim wording: “Vitamin D reduces the risk of falling. Falling is a risk factor for fractures.”
The NDA opinion can be found here.