21 CFR 101.72 - Health claims: calcium, vitamin D, and osteoporosis.
(a) Relationship between calcium, vitamin D, and osteoporosis. An inadequate intake of calcium or calcium and vitamin D contributes to low peak bone mass, which has been identified as one of many risk factors in the development of osteoporosis. Peak bone mass is the total quantity of bone present at maturity, and experts believe that it has the greatest bearing on whether a person will be at risk of developing osteoporosis and related bone fractures later in life. Another factor that influences total bone mass and susceptibility to osteoporosis is the rate of bone loss after skeletal maturity. Vitamin D is required for normal absorption of calcium and to prevent the occurrence of high serum parathyroid hormone (PTH) concentration, which stimulates mobilization of calcium from the skeleton and can lower bone mass. Calcium, along with vitamin D and several other nutrients, is required for normal bone mineralization. While vitamin D is required for optimal bone mineralization, it is more effective when calcium intake is adequate. An adequate intake of calcium and vitamin D is thought to exert a positive effect during adolescence and early adulthood in optimizing the amount of bone that is laid down. However, the upper limit of peak bone mass is genetically determined. The mechanism through which adequate intakes of calcium and vitamin D and optimal peak bone mass reduce the risk of osteoporosis is thought to be as follows. All persons lose bone with age. Hence, those with higher bone mass at maturity take longer to reach the critically reduced mass at which bones can fracture easily. The rate of bone loss after skeletal maturity also influences the amount of bone present at old age and can influence an individual's risk of developing osteoporosis. Maintenance of adequate intakes of calcium and vitamin D later in life is thought to be important in reducing the rate of bone loss particularly in the elderly and in women during the first decade following menopause, but a significant protective effect is also seen among men and younger women.
(b) Significance of calcium or calcium and vitamin D. Adequate calcium intake, or adequate calcium and vitamin D intake, is not the only recognized risk factor in the development of osteoporosis, which is a multifactorial bone disease. Maintenance of adequate calcium and vitamin D intakes throughout life is necessary to achieve optimal peak bone mass and to reduce the risk of osteoporosis in later life. However, vitamin D is most effective in this regard when calcium intake is adequate. Increasing intake of calcium has been shown to have beneficial effects on bone health independent of dietary vitamin D.
(1) All requirements set forth in § 101.14 shall be met.
(2) Specific requirements -
(i) Nature of the claim. A health claim associating calcium or, when appropriate, calcium and vitamin D with a reduced risk of osteoporosis may be made on the label or labeling of a food described in paragraphs (c)(2)(ii) and (d)(1) of this section, provided that:
(A) The claim makes clear the importance of adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, throughout life, in a healthful diet, are essential to reduce osteoporosis risk. The claim does not imply that adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, is the only recognized risk factor for the development of osteoporosis;
(B) The claim does not attribute any degree of reduction in risk of osteoporosis to maintaining an adequate dietary calcium intake, or when appropriate, an adequate dietary calcium and vitamin D intake, throughout life.
(ii) Nature of the food.
(B) The calcium content of the product shall be assimilable;
(C) Dietary supplements shall meet the United States Pharmacopeia (USP) standards for disintegration and dissolution applicable to their component calcium salts, except that dietary supplements for which no USP standards exist shall exhibit appropriate assimilability under the conditions of use stated on the product label;
(d) Optional information.
(1) The claim may include the term “vitamin D” if the food meets or exceeds the requirements for a “high” level of vitamin D as defined in § 101.54(b);
(2) The claim may include information from paragraphs (a) and (b) of this section.
(3) The claim may make reference to physical activity.
(4) The claim may include information on the number of people in the United States, including the number of people in certain subpopulations in the United States, who have osteoporosis or low bone density. The sources of this information must be identified, and it must be current information from the National Center for Health Statistics, the National Institutes of Health, or the National Osteoporosis Foundation.
(5) The claim may state that the role of adequate calcium intake, or when appropriate, the role of adequate calcium and vitamin D intake, throughout life is linked to reduced risk of osteoporosis through the mechanism of optimizing peak bone mass during adolescence and early adulthood. The phrase “build and maintain good bone health” may be used to convey the concept of optimizing peak bone mass. The claim may also state that adequate intake of calcium, or when appropriate, adequate intake of calcium and vitamin D, is linked to reduced risk of osteoporosis through the mechanism of slowing the rate of bone loss for persons with a family history of the disease, post-menopausal women, and elderly men and women.
(e) Model health claims. The following model health claims may be used in food labeling to describe the relationship between calcium and osteoporosis:
(f) Model additional health claims for calcium and vitamin D. The following model health claims may be used in food labeling to describe the relationship between calcium, vitamin D, and osteoporosis:
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 101 after this date.