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FDA Proposes New Calcium and Vitamin D Claims for Osteoporosis

Foods, beverages and dietary supplements containing both calcium and vitamin D may soon carry labels saying they help reduce the risk of osteoporosis, according to a U.S. government proposal made on Friday.

The U.S. Food and Drug Administration's proposal came in response to a petition from Coca-Cola Co., which makes Minute Maid orange juice products fortified with calcium and vitamin D.

"Osteoporosis is a significant public health problem, especially for women," Dr. Kathleen Uhl, assistant commissioner of FDA's Office of Women's Health, said. "This new labeling should assist consumers to select foods ... that provide adequate calcium and vitamin D intake and hopefully prevent the occurrence of osteoporosis in themselves and their family members," she said.

In a search of the National Library of Medicine and National Institutes of Health database called PubMed, there are 3,131 published articles on osteoporosis, calcium and vitamin D as of December 2006. Whereas, some newly approved pharmaceutical drugs approved by the FDA may have as few as 2 studies.

The proposal would amend a 1993 regulation by allowing foodmakers to claim a reduced risk of osteoporosis with the consumption of both calcium and vitamin D. It would also let companies drop a requirement that their labels state there are limits to the benefits of taking more than 200 percent of the recommended daily intake.

Osteoporosis is a decrease in bone density that makes bones brittle and more prone to fracture. Studies show that vitamin D helps the body absorb calcium. The FDA recommends adults consume 1.0 gram of calcium and 400 international units of vitamin D each day for a healthy diet. New studies suggest 1,000 to 2000 IU Vitamin D is a more health-promoting daily dose.


Press release - unknown source Jan 2007

Key concepts: calcium, osteoporosis, drug