Trumbo Paula R, Ellwood Kathleen C
Division of Nutrition Programs and Labeling, US Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, USA.
Nutr Rev. 2007 Feb;65(2):78-87. doi: 10.1111/j.1753-4887.2007.tb00284.x.
The labeling of health claims that meet the significant scientific agreement (SSA) standard (authorized health claims) and qualified health claims on conventional foods and dietary supplements requires premarket approval by the US Food and Drug Administration (FDA). FDA conducts an evidence-based review to determine whether there is sufficient evidence to support an authorized or qualified health claim. An evidence-based review was conducted on the human intervention and observational studies evaluating the role of supplemental calcium in reducing the risk of hypertension, pregnancy-induced hypertension, and preeclampsia. This review provides FDA's evaluation of the current scientific evidence on the role of supplemental calcium in reducing the risk of these three end points. Based on this evidence-based review, the agency concluded that the relationship between calcium and risk of hypertension is inconsistent and inconclusive, and the relationship between calcium and risk of pregnancy-induced hypertension and preeclampsia is highly unlikely.
