FDA Adds Vitamin D to Calcium/Osteoporosis Health Claim

WASHINGTONThe Food and Drug Administration (FDA) released a proposed rule Jan. 5 that would amend the calcium/osteoporosis health claim; the agency acted, in part, in response to a health claim petition submitted by The Beverage Institute for Health and Wellness LLC. The original health claim, released in January 1993, concerned calcium and a reduced risk of osteoporosis; in response to petitions, the agency has reopened the comment period about the claim several times since 1995.

In deciding to permit additional claims for calcium and vitamin D and a reduced risk of osteoporosis, FDA reviewed the effects of the nutrient combination on direct measures of bone status and bone mineral content. After reviewing intervention and observational studies, the agency determined there is sufficient evidence that a combination of calcium and vitamin D reduces the risk of osteoporosis. Foods can carry the claim if they meet existing requirements for the calcium/osteoporosis claim, meet or exceed requirements for a high level of vitamin D, and meet all general health claim requirements.

Beyond the inclusion of vitamin D, FDA proposed to eliminate certain restrictive labeling requirements in connection with the claim. FDA determined the claim no longer needs to list specific risk factors for the development of osteoporosis, including sex, race and age; however, references to a healthful diet, adequate physical activity and adequate calcium and/or calcium/vitamin D intake throughout life are still necessary.

Sample claims included in the Federal Register notice include:

Physical activity and adequate calcium intake throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.

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

Comments on the proposed rule (Docket No. 2004P-0464) are being taken through March 21; comments can be submitted electronically (www.regulations.gov or www.fda.gov/dockets/ecomments) or in written format via fax or mail.