The disease-reduction claim application, made under article 14 of the European Union’s nutrition and health claims regulation, was submitted by Abtei Pharma Vertriebs, a GlaxoSmithKline company.
The dossier claimed that chewing tablets with calcium and vitamin D improves bone density in women over the age of 50, and may reduce the risk of osteoporotic fractures and hip fractures. The proposed dosages were 1000mg calcium and 800 IU vitamin D3.
EFSA agreed that submitted evidence demonstrated a cause and effect relationship between the supplementation with calcium alone or calcium and vitamin D with a reduction in the loss of bone mineral density (BMD) and the reduction in the risk of bone fractures in post-menopausal women.
However, it proposed a re-wording of the health claim, and also said that the information provided was insufficient to establish conditions of use for the claims.
The current opinion would apply to any calcium or vitamin D product with a similar composition, said EFSA.
Health relationship acknowledged
EFSA reviewed 53 publications cited by Abtei, including 43 randomized controlled trials (RCT) in humans and 10 meta-analyses of RCTs in which calcium, vitamin D or calcium in combination with vitamin D were used to prevent bone fracture and osteoporotic bone loss.
Trials that studied calcium and vitamin D naturally present in the diet were excluded.
The meta-analyses “consistently” supported the benefits of calcium and vitamin D for bone health, said EFSA, but proposed new wording to better reflect the science. This reads:
“Calcium may reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor in the development of osteoporotic bone fractures” and “Calcium and vitamin D may reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor in the development of osteoporotic bone fractures”.
Dosage levels uncertain
However, EFSA’s Panel on Dietetic Products, Nutrition and Allergies said there was insufficient information provided to establish conditions of use for the claims.
“In the meta-analyses of the studies on the effect of calcium, alone supplementation with calcium was in the range of 500-1600 mg/d in addition to diet, while in the meta-analyses of the studies on the effect of calcium and vitamin D, combined supplementation with calcium and vitamin D was in the range of 200-1200 mg/d and 200 - 800 IU/d, respectively, in addition to diet,” it said.
“The Panel notes that in the evidence provided there is limited information about the dose-response relationship of calcium and vitamin D and BMD or osteoporotic fractures.”
EFSA said its opinion applies to all forms of calcium and vitamin D naturally occurring in foods and those forms authorised for addition to foods and for use in food supplements from all sources with appropriate bioavailability. EFSA’s opinion now passes to the EC.
To view the full opinion, click here.