The proposed rule would amend one of the first health claims authorized in 1993 through the Nutrition Labeling and Education Act for the relationship between calcium intake and the disease characterized by low bone mass and deterioration of bone tissue, osteoporosis.
Health claims for ingredients are both highly sought after and hard to come by in the supplement industry, partly because they require a significant body of scientific literature to back them up and in turn can give credibility and authority to supplement and food marketing, but also because of the increased awareness they generate amongst consumers.
The proposal is likely to be welcomed by the vitamin industry - at both supply and finished product levels - since it communicates the importance of vitamin D. Moreover, it does not restrict the advice to just some demographics, which could help marketers target new sectors of the market more effectively. Compared to some rather verbose claims, the existing calcium/osteroporosis claim allowed by the FDA is relatively straightforward:
"Regular exercise and a healthy diet with enough calcium helps teens and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life."
FDA has proposed to change this claim by adding vitamin D into the equation, with calcium, for a reduced risk of osteoporosis.
FDA said its proposed amendment is based on the agency's review of scientific evidence including the 2004 Surgeon General's Report on Bone Health and Osteoporosis and the 2000 National Institutes of Health (NIH) Consensus Statement on Osteoporosis, Prevention, Diagnosis and Therapy.
In addition, FDA proposes to shorten the claim by dropping references to sex, race, and age because it said the benefits apply to both sexes at all ages and race categories.
The agency also said it proposes to get rid of requiring labels to identify the mechanism by which calcium reduces the risk of osteoporosis, which currently outlined as: "mechanism relating calcium to osteoporosis: optimizes peak bone mass."
FDA proposes to drop the requirement that the claim state there are limits to benefit of calcium intakes above 200 percent of the Daily Value. This reads: "Foods or supplements containing more than 400 mg calcium must state that total intakes of greater than 2,000 mg calcium provide no added benefit to bone health."
"Osteoporosis is a significant public health problem, especially for women," said Kathleen Uhl, assistant commissioner of FDA's Office of Women's Health.
"This new labeling should assist consumers to select foods - and women especially since women do the majority of food shopping in the US - that provide adequate calcium and vitamin D intake and hopefully prevent the occurrence of osteoporosis in themselves and their family members."
According to the National Osteoporosis Foundation, ten million Americans have osteoporosis and almost 34 million more are estimated to have low bone mass, placing them at risk for the disease. Of the ten million with osteoporosis, eight million are women and two million are men.
FDA is calling for comments on the proposed amendment.