[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.72]

[Page 125-127]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--CONTINUED
 
PART 101--FOOD LABELING--Table of Contents
 
           Subpart E--Specific Requirements for Health Claims
 
Sec. 101.72  Health claims: calcium and osteoporosis.

    (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

[[Page 126]]

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 Sec. 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 
Sec. 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 
Sec. 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.''

[[Page 127]]

    (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]