Vitamin D Added to FDA Osteoporosis Risk-Reduction Health Claim

PRNewswire/ -- As a result of a 2004 petition from the Beverage Institute for Health & Wellness (hereafter the Institute) of The Coca-Cola Company (NYSE:KO) , the US Food and Drug Administration (FDA) announced today that it 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 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 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."

"Osteoporosis is a growing public health crisis, and all Americans, men and women alike, will benefit from knowing that vitamin D along with calcium can help delay or prevent the onset of this disease," said Robert P. Heaney MD, FACP, John A. Creighton University Professor and Professor of Medicine at Creighton University in Omaha, Nebraska. "Along with weight-bearing exercise, the most valuable intervention for maintaining bone health is an overall healthful diet that supplies adequate amounts of all nutrients such as vitamin D."

The US 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. These numbers are expected to continue climbing. To help address this significant public health issue, the 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.

Increasing Awareness and Consumption of Vitamin D

"We initiated this petition because we believe consumers will benefit from efforts to increase awareness of the link between calcium and vitamin D and bone health," said Dr. Rhona Applebaum, Vice President and Chief Scientific and Regulatory Officer for The Coca-Cola Company. "Revising the osteoporosis risk reduction health claim to include both vitamin D and calcium will help the food industry communicate the importance of these nutrients to consumers."

According to Carolyn E. Moore, PhD, RD, Principal Scientist with The Coca- Cola Company's Institute, studies sponsored by the Institute at the Boston University Medical Center and ENVIRON Health Sciences, demonstrated that many consumers are not getting enough Vitamin D from food and dietary supplements. The groups at greatest risk in the US include teenage girls, women, the elderly, and African-American and Mexican-American adults.

It was The Coca-Cola Company who sought approval to add vitamin D to calcium-fortified juices and juice drinks from the FDA, through research the Company sponsored at the Vitamin D and Bone Health Research Laboratory at Boston University Medical School. Results from this research demonstrated that vitamin D is readily absorbed by the body when added to skim milk and

orange juice. The FDA approved the addition of vitamin D to calcium-fortified juices in 2003.

The Importance of Vitamin D for Strong Bones

Vitamin D requirements of all age groups can be met under conditions of adequate exposure to sunlight. However, several factors can reduce the production of vitamin D from the skin including the use of sunscreens, increased skin pigmentation, normal aging, and insufficient exposure to sunlight.

The primary function of Vitamin D is to aid in the body's absorption of calcium, helping to form and maintain strong bones. Without Vitamin D, the body absorbs 10 - 15 percent of calcium consumed in the diet. With Vitamin D, the absorption level increases to 30 - 50 percent.

Emerging Research on Vitamin D

Vitamin D has been the subject of extensive basic and clinical research in the past several years, which has generated valuable insights about this vital nutrient.

-- In a recent study supported in part by the Institute, researchers from Boston University School of Medicine found that vitamin D2 (found naturally in plants) is equally as effective as vitamin D3 (produced as a result of sun exposure and found in some food sources such as cod liver oil and oily fish) in maintaining circulating blood levels of vitamin D.

-- With support from the National Institutes of Health and the Institute, the United States Department of Agriculture's Nutrient Data Laboratory is in the process of conducting an updated analysis of vitamin D content in a wide range of whole and processed foods, including, for the first time, specific forms of vitamin D, i.e., D2 and D3.

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