Calcium, vitamin D osteoporosis health claim.

What 21 CFR 101.72 covers

Section 101.72 is one of the FDA's authorized health claims. It lets a food label state a relationship between adequate calcium (or calcium with vitamin D) and a reduced risk of osteoporosis, as long as the food and the wording meet the section. Paragraphs (a) and (b) contain the regulation's own summary of the science, and paragraph (c) contains the requirements. The text here is the eCFR version current through October 29, 2026; its history line reads 73 FR 56486, September 29, 2008. This page reports the printed rule and says nothing about whether the underlying science or the claim has changed since.

The general rule and 101.14: paragraph (c)(1)

Paragraph (c)(1) says "all requirements set forth in 101.14 shall be met." Section 101.14 is the general health claims rule, and it is not reproduced on this page. A label writer therefore needs both sections: 101.72 for the specifics and 101.14 for the general conditions that sit underneath every authorized claim.

Nature of the claim: paragraph (c)(2)(i)

• The claim must make clear the importance of adequate calcium intake, or calcium and vitamin D intake when appropriate, throughout life and in a healthful diet, as essential to reducing osteoporosis risk.
• It must not imply that adequate calcium (or calcium and vitamin D) is the only recognized risk factor.
• It must not attribute any degree of reduction in osteoporosis risk to maintaining adequate intake.

Nature of the food: paragraph (c)(2)(ii)

• (A) The food must meet or exceed the "high" level of calcium defined in 101.54(b). Section 101.54(b)(1) sets that at 20 percent or more of the RDI or DRV per reference amount customarily consumed.
• (B) The calcium content must be assimilable.
• (C) Dietary supplements must meet United States Pharmacopeia standards for disintegration and dissolution that apply to their calcium salts; where no USP standard exists, the supplement must show appropriate assimilability under the label's stated conditions of use.
• (D) A food, or the total daily recommended supplement intake, must not contain more phosphorus than calcium on a weight per weight basis.

Optional information: paragraph (d)

The claim may name vitamin D only if the food reaches the "high" level for vitamin D in 101.54(b). It may add the physiology from paragraphs (a) and (b), refer to physical activity, and give current counts of people in the United States with osteoporosis or low bone density, provided the source is identified and is current information from the National Center for Health Statistics, the National Institutes of Health, or the National Osteoporosis Foundation. It may say that adequate calcium (or calcium and vitamin D) works through optimizing peak bone mass in adolescence and early adulthood, and the phrase "build and maintain good bone health" may express that idea; it may also refer to slowing bone loss for people with a family history, post-menopausal women, and elderly men and women.

The model claims: paragraphs (e) and (f)

The section prints model wording that may be used. For calcium: "Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis," and "Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life." For calcium and vitamin D the same two sentences appear with "calcium and vitamin D." Notice the verb "may": the claim is framed as a possible reduction in risk, never a degree of reduction.

Worked example

A product has 25 percent of the Daily Value for calcium per reference amount, which is at or above the 20 percent "high" level, and 300 mg calcium against 200 mg phosphorus per serving, so phosphorus does not exceed calcium. On those food-side numbers the product clears (c)(2)(ii)(A) and (D). If its vitamin D is 10 percent of the Daily Value, the claim could not mention vitamin D under (d)(1), because vitamin D is below the 20 percent "high" level; it could still use the calcium-only model claims. The assimilability tests in (B) and (C) need lab or supplier evidence that a calculator cannot supply.

Limits of this page

The checker covers two numeric food tests and the vitamin D wording gate. It does not test assimilability, USP compliance, the general 101.14 conditions, disqualifying levels of other nutrients, or label formatting. It is not a determination that a product may carry the claim.

Sources

Sources opened and read November 2, 2026.

• eCFR: 21 CFR 101.72, Health claims: calcium, vitamin D, and osteoporosis (current through October 29, 2026) (read November 2, 2026)
• eCFR: 21 CFR 101.54, Nutrient content claims for "good source," "high," "more," and "high potency" (read November 2, 2026)