FDA Proposes New Claims for Calcium

The FDA said that the action is part of its 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.

08/01/07 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.

"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."

The FDA said that the action is part of its 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 Coca-Cola Company makes Minute Maid orange juice products fortified with calcium and vitamin D.

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.

Pepsi division Tropicana said it applauds the Food and Drug Administration's proposed changes to its calcium health claim including adding vitamin D for bone health throughout life.  Tropicana has believed vitamin D is critical for bone health and, when combined with calcium, works to help reduce the risk of osteoporosis. Tropicana Calcium and Vitamin D orange juice contains calcium citrate malate (CCM), known as FruitCal, which is an ideal calcium source for fortifying fruit juices since it is very soluble and does not affect the juice's natural taste.  This highly absorbable form of calcium has been clinically tested and shown to help build strong bones in children and adolescents and help maintain bone mass in adult women.  In addition to its excellent solubility, CCM is better absorbed by the body than calcium carbonate supplements (the most popular calcium supplements). Vitamin D further enhances the body's ability to absorb calcium.

Tropicana, through a partnership with the Osteoporosis Research Center at Creighton University, a leading center for bone health, has provided a brochure to educate consumers about the recommended intake of these essential nutrients.

Last week, Tropicana introduced Tropicana Healthy Heart with Omega-3s, the first national orange juice with omega-3 fatty acids.