Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis

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The Food and Drug Administration (FDA) is proposing to amend the 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 claims for calcium and osteoporosis, additional claims can be made for calcium and vitamin D and osteoporosis; eliminate the requirement in Sec. 101.72(c)(2)(i)(A) (21 CFR 101.72(c)(2)(i)(A)) that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; eliminate the requirement in Sec. 101.72(c)(2)(i)(B) 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; eliminate the requirement in Sec. 101.72(c)(2)(i)(C) that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; and eliminate the requirement in Sec. 101.72(c)(2)(i)(E) that the claim include a statement that reflects the limit of the benefits derived from dietary calcium intake, when the level of calcium in the food exceeds a set threshold level. FD