FDA Adds “Calcium and Vitamin D” Health Claim for Osteoporosis Risk Reduction

FDA recently published a final rule to expand and streamline authorized health claims related to osteoporosis risk reduction. Effective January 1, 2010, companies may use the newly simplified health claims for calcium and vitamin D products, and calcium products in relation to osteoporosis risk reduction. In addition to adding a “calcium and vitamin D” health claim to FDA’s regulations, the Agency shortened and simplified the language of approved claims in an effort to promote wider use of the claims on product labeling.

The final rule:

• Adds a claim for calcium and vitamin D combination products to reduce osteoporosis risk;
• Eliminates current mandated references to age, sex and race as specific risk factors  and makes optional mention of the prevalence of osteoporosis in U.S. population (and/or subpopulations);
• Eliminates the requirement that the claim include a statement that total dietary intake greater than 200 percent of the recommended daily intake has no further benefit to bone health;
• Makes optional the currently required explanation of the mechanism through which calcium (and calcium and vitamin D) reduces osteoporosis risk; and
• Makes optional a reference to the need for physical activity in reducing risk.

FDA's examination of calcium and vitamin D health claims for osteoporosis originated in response to a 2004 citizen petition submitted by the Beverage Institute for Health and Wellness, a Coca Cola research company. Relying heavily on the 2000 National Institutes of Health “Consensus Statement on Osteoporosis, Prevention and Therapy” and the 2004 Surgeon General’s report, “Bone Health and Osteoporosis,” FDA proposed these changes to the previously allowable health claims to increase the use of osteoporosis risk health claims for calcium and vitamin D in an effort to “improve the U.S. population’s consumption of these nutrients.”

In its final rule, FDA acknowledges that the cumbersome nature of the old format for these claims and their limited scope is the likely reason that so few eligible products use the claim on their labels. These claims were long and difficult to include on labels where space already is precious. A 2001 Food Label and Package Survey report showed the health claims being used in only one of 87 shelf-stable juices and none of the ten milk products in the survey.

The current revisions make the osteoporosis health claim language shorter and more flexible and thus more appealing to put on labels. FDA hopes the simplification of calcium claims and the addition of vitamin D claims will increase their use.

Some model claims under the new regulations include:

• Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.
• Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.
• Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis later in life.
• Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis later in life.

FDA presents some sobering numbers in support of its effort. According to the final rule osteoporosis “affects more than 10 million individuals and causes approximately 1.5 million fractures annually. Every year, these lead to more than 2.6 million physician office visits, over 800,000 emergency room visits, and more than 500,000 hospitalizations. . . .  The direct care expenditures for osteoporotic fractures along range from 12 to 18 billion dollars each year (measured in 2002 dollars).”

By Ricardo Carvajal & Colleen M. Brown

UPDATE:

• On October 13, 2008, the American Academy of Pediatrics issued a report recommending a doubling of vitamin D for children.