Last September the FSA published its final rule amending the claim associating calcium with reduced risk of osteoporosis, so that a claim could also be made for calcium and vitamin D.
Vitamin D has a role in aiding calcium absorption. Without sufficient vitamin D, bones can become thin, brittle or misshapen.
Other amendments eliminated certain qualifications, such as listing of sex, race and age as risk factors and identification of populations most at risk. It also made optional the previous requirement that physical activity be listed as a risk factor, and made it optional to give calcium’s mechanism of action.
Manufacturers could start using the new claim as of last September, although the final rule is effective as of January 1 2010.
The FDA’s new guidance document is intended to present the rule in plain, easy to understand language – although it makes clear that it is the law itself, rather than the guidance document, that establishes the legally enforceable responsibilities.
The guidance is presented in the form of a Q&A. It explains specific requirements that must be met to make a claim on the label or labeling of food, and the characteristics that the food or dietary supplement must have in order to be eligible.
It also explains the option information that can now be included on a label making a health claim, and gives some examples of health claims that can now be used.
For example, a claim on calcium and osteoporosis may read: “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis" or “Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.”
A claim on calcium, vitamin D, and osteoporosis may read: “Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis” or "Adequate calcium and vitamin D throughout life, along with physical activity, may reduce the risk of osteoporosis in later life."
The guidance document is available online