title: Qualified health claims for calcium and colorectal, breast, and prostate cancers: The U.S. Food and Drug Administration's evidence-based review.
abstract: In 2003, the United States Food and Drug Administration (FDA) received a health claim petition for calcium supplements and reduced risk of colorectal, breast, and prostate cancers. Health claims characterize the relationship between a substance (food or food component) and disease (e.g., cancer or cardiovascular disease) or health-related condition (e.g., hypertension) and require premarket approval for the labeling of conventional foods and dietary supplements by the FDA. This review describes how the FDA used the evidence-based review system to evaluate the scientific evidence for these proposed health claims. FDA found no credible evidence to support health claims for calcium and a reduced risk of breast and prostate cancers. The agency did find limited evidence for the relationship between calcium intake and colorectal cancer risk.
authors.affiliation: Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, USA. claudine.kavanaugh@fda.hhs.gov
authors.forename: Claudine J
authors.initials: CJ
authors.lastname: Kavanaugh
authors.forename: Paula R
authors.initials: PR
authors.lastname: Trumbo
authors.forename: Kathleen C
authors.initials: KC
authors.lastname: Ellwood
mesh_terms: D001943:Breast Neoplasms / Q000517:prevention & control*; D002136:Calcium, Dietary / Q000008:administration & dosage*; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000517:prevention & control*; D019587:Dietary Supplements; D019317:Evidence-Based Medicine; D005260:Female; D006293:Health Promotion; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D002136:Calcium, Dietary