03.01.07
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 eliminate certain other information. This announcement came in response to a health claim petition submitted by the Beverage Institute for Health and Wellness, which is part of The Coca-Cola Company. FDA’s decision to amend the existing health claim also comes in response to 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.
The proposed rule would amend one of the first health claims authorized in 1993 through the Nutrition Labeling and Education Act (NLEA) of 1990 for the relationship between calcium intake and osteoporosis.
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.
The proposed rule would amend one of the first health claims authorized in 1993 through the Nutrition Labeling and Education Act (NLEA) of 1990 for the relationship between calcium intake and osteoporosis.
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.