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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P07-02
January 5, 2007

Media Inquiries:
Mike Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Updates Health Claim for Calcium and Osteoporosis
Proposal Would Give Consumers More Information to Make Healthy Food Choices

The Food and Drug Administration (FDA) is proposing to allow new claims on foods and dietary supplements containing calcium and Vitamin D to show their potential to reduce the risk of osteoporosis. The proposed rule would allow manufacturers to include new information on their food and supplement labeling and to eliminate certain other information, described below.

"This is important information for all citizens," said Robert E. Brackett, Ph.D., director of 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."

Today's action is part of FDA's continued commitment to helping consumers make informed and healthy food choices, and responds to a health claim petition submitted by the Beverage Institute for Health and Wellness, The Coca-Cola Company.

The proposed rule would amend one of the first health claims authorized in 1993 through the Nutrition Labeling and Education Act of 1990 for the relationship between calcium intake and osteoporosis. The proposal would amend this existing health claim by allowing for claims of a reduced risk of osteoporosis with the consumption of both calcium and vitamin D.

The proposed rule also would eliminate certain requirements that were a part of the required claim language in the existing calcium and osteoporosis health claim. However, FDA is not changing its conclusion that there is still significant scientific agreement to support claims for calcium intake and reduced risk of osteoporosis.

"Osteoporosis is a significant public health problem, especially for women," said Kathleen Uhl, MD, 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."

FDA's decision to amend the existing health claim is based on the agency's review of the publicly available scientific evidence, which included the 2004 Surgeon General's report on Bone Health and Osteoporosis and the 2000 NIH Consensus Statement on Osteoporosis, Prevention, Diagnosis and Therapy.

Specifically, FDA is proposing to change the calcium and osteoporosis health claim to:

  • Add a claim for calcium and vitamin D together and a reduced risk of osteoporosis.

Shorten the claim language by:

  • Dropping the reference to sex, race, and age since the benefits apply to both sexes at all ages and race categories.
  • Dropping the need to identify the mechanism by which calcium reduces the risk of osteoporosis.
  • Dropping the requirement that the claim state that there are limits to benefit of calcium intakes above 200% of the Daily Value.

Comments may be submitted electronically to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA (click on the Docket Search link on the left side and put in the docket number 2004P-0464) or in writing to the Division of Dockets Management, 5630 Fishers Lane, room 1061, Rockville, MD 20852. Please reference the docket number when submitting comments.

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