FDA’s Proposed Label Change Clarifies Benefits for Bones

By Maureen Williams, ND

Healthnotes Newswire (February 8, 2007)—The US Food and Drug Administration (FDA) has proposed changes to an existing rule that allows a health claim for foods and supplements that contain calcium. The changes will simplify the language of the health claim, and allow a special claim for foods and supplements with both calcium and vitamin D.

The current health claim was authorized in 1993 and was one of the first of its kind to be issued under the Nutrition Labeling and Education Act. It allows packaging on foods and supplements that contain calcium to carry the claim that they might help prevent osteoporosis.

The FDA’s new proposal would allow the claim to state that scientific evidence supports a link between calcium and vitamin D intake and reduced risk of osteoporosis.

Approximately 10 million Americans—80% of whom are women—have osteoporosis, a condition characterized by low bone density and increased risk of fracture.

“Osteoporosis is a significant public health problem, especially for women,” said Kathleen Uhl, MD, assistant commissioner of the 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.”

The decision to amend the existing health claim was based on the agency’s 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.

The new claim, if approved, will simplify the language of the old claim by eliminating several aspects. The current claim reads: “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.” The proposed change will drop the reference to gender, age, and race because the benefits apply to both sexes and all ages and race categories.

Under the new proposal, the claim would no longer have to state that calcium intake above 200% of the Daily Value has no added benefit to bone health.

Lastly, the proposed claim would not identify the mechanism by which calcium prevents osteoporosis. The claim currently reads: “Mechanism relating calcium to osteoporosis: optimizes peak bone mass.”

The FDA has suggested these simplifications in order to make the claim more accessible to consumers. Revising the claim is part of FDA’s continued effort to help the public make informed and healthy food choices.

“This is important information for all citizens,” said Robert E. Brackett, PhD, director of the FDA’s Center for Food Safety and Nutrition. “All persons lose bone with age, and the loss can influence an individual’s risk of developing osteoporosis. Maintenance of an adequate intake of calcium and vitamin D in all stages of life can help lower one’s risk.”

Maureen Williams, ND, received her bachelor’s degree from the University of Pennsylvania and her Doctorate of Naturopathic Medicine from Bastyr University in Seattle, WA. She has a private practice in Quechee, VT, and does extensive work with traditional herbal medicine in Guatemala and Honduras. Dr. Williams is a regular contributor to Healthnotes Newswire.

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