FDA Amends Labeling Regulations for Health Claims Pertaining to Calcium, Osteoporosis and Vitamin D

FDA has issued a final rule “amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis.” Effective January 1, 2010, the rule would also eliminate (i) “the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis”; (ii) “the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis”; (iii) “the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis
and instead make it optional”; and (iv) “the requirement that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further benefit to bone health when the food contains 400 mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake.” In addition, the rule would “allow reference for the need of physical activity in either of the health claims to be optional rather then required.”