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Vitamin D Added to Osteoporosis Claim

FDA has amended its osteoporosis risk reduction health claim to reflect the importance of vitamin D, in combination with calcium, in promoting long-term bone health.

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By: Sean Moloughney

Editor, Nutraceuticals World

FDA has amended its osteoporosis risk reduction health claim to reflect the importance of vitamin D, in combination with calcium, in promoting long-term bone health.

The amended labeling regulation explains that vitamin D is required for the normal absorption of calcium, and authorizes the health claim: “Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.”

The amended rule also includes a broader definition of the populations that could benefit from consuming calcium and vitamin D to include both men and women of all ages and races. The agency’s action comes as a result of a 2004 petition from the Beverage Institute for Health & Wellness of The Coca-Cola Company.

The U.S. National Osteoporosis Foundation predicts that by 2010, about 12 million people over the age of 50 will have osteoporosis, and another 40 million will have low bone mass. To help address this public health issue, FDA developed this health claim for manufacturers to include on labels of appropriate foods and dietary supplements. The new labeling can help consumers identify products with adequate calcium and vitamin D that can help to reduce their risk of osteoporosis.

The Coca-Cola Company sought approval to add vitamin D to calcium-fortified juices and juice drinks from FDA through research it sponsored at the Vitamin D and Bone Health Research Laboratory at Boston University Medical School. Results indicated that vitamin D is readily absorbed by the body when added to skim milk and orange juice. FDA approved the addition of vitamin D to calcium-fortified juices in 2003.

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