The Food and Drug Administration on Friday announced its
proposal to allow new health claims on foods and dietary supplements containing
calcium and vitamin D to indicate that these nutrients have the potential to
help reduce risk of osteoporosis.
The proposed rule allows food and beverage manufacturers to
include new information on the label and in the meantime eliminate some other
information which is no longer justified.
The claim on calcium for its preventative role in
osteoporosis was authorized in 1993, according to the FDA. The new rule amends
the existing health claim by allowing claims on both calcium and vitamin D for
their potential preventative effect against osteoporosis.
In addition, the proposed rule shortens the existing claim
language by eliminating the reference to sex, race, and age as the benefits
apply to both sexes, at all ages and race categories.
Also the new role would drop "the need to identify the
mechanism by which calcium reduces the risk of osteoporosis and the requirement
that the claim state that there are limits to benefit of calcium intakes above
200% of the Daily value," the FDA states in its announcement on Friday.
The proposal is a response to a health claim petition
submitted by the Beverage Institute for Health and Wellness, the Coca-Cola
The FDA bases its decision on
its review of the publicly available scientific evidence including the 2004
Surgeon General's report on Bone Health and Osteoporosis and the 2000 NIH
Consensus Statement on Osteoporosis, Prevention, Diagnosis and Therapy.
While calcium and vitamin D play an important role in
maintaining bone health in adults, a few issues need to be addressed, said a
scientist affiliated with foodconsumer.org. For instance, supplementation of
calcium and vitamin D may not be as important in children as in adults.
Healthy children who eat a healthy diet and follow
a healthy lifestyle rarely need supplements of vitamin D and calcium although supplementation
and fortification of calcium and vitamin D may help certain children, according
to a review article.
Calcium and vitamin D supplements do
not benefit all the adults.
study published in 2005 in the Lancet finds
that supplementation of vitamin D, calcium, or both, does not lower the risk of
secondary bone fracture from osteoporosis in the elderly who have had one
incident of bone fracture.
Elderly people who are frail and at risk for bone
fractures may be helped somewhat by giving them both vitamin D and calcium. But the
benefits may be marginal and appear only to help those who live in nursing
homes or other institutions, according to Alison Avenell, M.D., of the
University of Aberdeen, Scotland, and her colleagues who published their review
of 38 randomized or quasi-randomized trials in the July 2005 issue of issue of
The Cochrane Library.
Potential problems exist for uncontrolled intake of calcium
and vitamin D.
Too much of calcium in
the blood (hypercalcemia) has been associated with use of calcium
supplementation. Mild hypercalcemia may not result in any symptom, or cause
loss of appetite, nausea, vomiting, constipation and dry mouth, thirst and frequent
A severe condition could
cause confusion, delirium, coma, and if not treated, death, according to the
Linus Pauling Institute.
High levels of vitamin D in the blood (hypervitaminosis D)
are also toxic as it induces abnormally high serum calcium levels
To prevent osteoporosis, two things may be equally important,
One is to obtain the peak
bone mass during childhood and young adulthood and the other is to maintain the
bone health later in life by following a healthy diet and lifestyle.
For children, doing lots of physical exercise, particularly
those weight bearing activities such as jumping, and getting exposed to lots of
sunshine, and using a well-balanced diet with limited amounts of meat and dairy
and unlimited fruits and vegetables may be the best recipe to obtain the best
peak bone mass.
Similarly for adults, doing routine physical exercise and eating
a diet that can keep the body pH normal would likely prevent loss of bone
minerals such as calcium.
Taking calcium and vitamin D supplements alone may not work
as well as expected to help prevent osteoporosis.
Other dietary elements have proved important
For instance, high protein
intake may cause calcium loss and raise risk of osteoporosis.
Americans consume an average amount of
protein that is equivalent to 15% of their daily energy intake - 5 % more than
the recommended amount.
On the other hand, use of potassium citrate or similar salts
can help protect bone health, according to a study published a study published
in the November issue of The Journal of The American Society of
Vitamin 12 seems to be also
helpful, according to the Framingham Osteoporosis Study. This is particularly
important to those who do not eat meat and dairy as the vitamin does not exist
in plant foods.