Title 21: Food and Drugs
PART 101—FOOD LABELING
Subpart E—Specific Requirements for Health Claims
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§ 101.72 Health claims: calcium and osteoporosis.
Link to an amendment published at 73 FR 56486, Sept. 29, 2008.
(a) Relationship between calcium and osteoporosis. An inadequate calcium intake contributes to low peak bone mass and 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. An adequate intake of calcium 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 an adequate calcium intake 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 an adequate intake of calcium 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.
(b) Significance of calcium. Calcium intake is not the only recognized risk factor in the development of osteoporosis, a multifactorial bone disease. Other factors including a person's sex, race, hormonal status, family history, body stature, level of exercise, general diet, and specific life style choices such as smoking and excess alcohol consumption affect the risk of osteoporosis.
(1) Heredity and being female are two key factors identifying those individuals at risk for the development of osteoporosis. Hereditary risk factors include race: Notably, Caucasians and Asians are characterized by low peak bone mass at maturity. Caucasian women, particularly those of northern European ancestry, experience the highest incidence of osteoporosis-related bone fracture. American women of African heritage are characterized by the highest peak bone mass and lowest incidence of osteoporotic fracture, despite the fact that they have low calcium intake.
(2) Maintenance of an adequate intake of calcium throughout life is particularly important for a subpopulation of individuals at greatest risk of developing osteoporosis and for whom adequate dietary calcium intake may have the most important beneficial effects on bone health. This target subpopulation includes adolescent and young adult Caucasian and Asian American women.
(c) Requirements. (1) All requirements set forth in §101.14 shall be met.
(2) Specific requirements —(i) Nature of the claim. A health claim associating calcium with a reduced risk of osteoporosis may be made on the label or labeling of a food described in paragraph (c)(2)(ii) of this section, provided that:
(A) The claim makes clear that adequate calcium intake throughout life is not the only recognized risk factor in this multifactorial bone disease by listing specific factors, including sex, race, and age that place persons at risk of developing osteoporosis and stating that an adequate level of exercise and a healthful diet are also needed;
(B) The claim does not state or imply that the risk of osteoporosis is equally applicable to the general United States population. The claim shall identify the populations at particular risk for the development of osteoporosis. These populations include white (or the term “Caucasian”) women and Asian women in their bone forming years (approximately 11 to 35 years of age or the phrase “during teen or early adult years” may be used). The claim may also identify menopausal (or the term “middle-aged”) women, persons with a family history of the disease, and elderly (or “older”) men and women as being at risk;
(C) The claim states that adequate calcium 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. When reference is made to persons with a family history of the disease, menopausal women, and elderly men and women, the claim may also state that adequate calcium intake is linked to reduced risk of osteoporosis through the mechanism of slowing the rate of bone loss;
(D) The claim does not attribute any degree of reduction in risk of osteoporosis to maintaining an adequate calcium intake throughout life; and
(E) The claim states that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further known benefit to bone health. This requirement does not apply to foods that contain less than 40 percent of the recommended daily intake of 1,000 mg of calcium per day or 400 mg of calcium per reference amount customarily consumed as defined in §101.12 (b) or per total daily recommended supplement intake.
(ii) Nature of the food. (A) The food shall meet or exceed the requirements for a “high” level of calcium as defined in §101.54(b);
(B) The calcium content of the product shall be assimilable;
(C) Dietary supplements shall meet the United States Pharmacopeia (U.S.P.) standards for disintegration and dissolution applicable to their component calcium salts, except that dietary supplements for which no U.S.P. standards exist shall exhibit appropriate assimilability under the conditions of use stated on the product label;
(D) A food or total daily recommended supplement intake shall not contain more phosphorus than calcium on a weight per weight basis.
(d) Optional information. (1) The claim may include information from paragraphs (a) and (b) of this section.
(2) The claim may include information on the number of people in the United States who have osteoporosis. 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 “Dietary Guidelines for Americans.”
(e) Model health claim. The following model health claims may be used in food labeling to describe the relationship between calcium and osteoporosis:
Model Health Claim Appropriate for Most Conventional Foods:
Regular exercise and a healthy diet with enough calcium helps teen and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life.
Model Health Claim Appropriate for Foods Exceptionally High in Calcium and Most Calcium Supplements:
Regular exercise and a healthy diet with enough calcium helps teen and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life. Adequate calcium intake is important, but daily intakes above about 2,000 mg are not likely to provide any additional benefit.
[58 FR 2676, Jan. 6, 1993; 58 FR 17101, Apr. 1, 1993; 62 FR 15342, Mar. 31, 1997]
