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Journal of the National Cancer Institute Advance Access originally published online on July 10, 2007
JNCI Journal of the National Cancer Institute 2007 99(14):1074-1085; doi:10.1093/jnci/djm037
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Published by Oxford University Press 2007.

REVIEW

The U.S. Food and Drug Administration's Evidence-Based Review for Qualified Health Claims: Tomatoes, Lycopene, and Cancer

Claudine J. Kavanaugh, Paula R. Trumbo, Kathleen C. Ellwood

Affiliation of authors: Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, College Park, MD

Correspondence to: Claudine J. Kavanaugh, PhD, MPH, RD, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740 (e-mail: claudine.kavanaugh{at}fda.hhs.gov).

Several studies have reported an inverse association between tomato and/or lycopene intake and the risk of some types of cancer. In 2004, the U.S. Food and Drug Administration (FDA) received two petitions for qualified health claims regarding tomatoes, lycopene, and the risk reduction for some forms of cancer. Health claims that characterize the relationship between a food or food component and a disease or health-related condition require premarket approval by FDA to be included on the labels of conventional foods and dietary supplements. Here we describe FDA's review of the scientific data for tomato and/or lycopene intake with respect to risk reduction for certain forms of cancer. The FDA found no credible evidence to support an association between lycopene intake and a reduced risk of prostate, lung, colorectal, gastric, breast, ovarian, endometrial, or pancreatic cancer. The FDA also found no credible evidence for an assocaition between tomato consumption and a reduced risk of lung, colorectal, breast, cervical, or endometrial cancer. The FDA found very limited evidence to support an association between tomato consumption and reduced risks of prostate, ovarian, gastric, and pancreatic cancers.

Manuscript received December 28, 2006; revised May 2, 2007; accepted May 30, 2007.


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Editorials about this Article

Does Prostate-Specific Antigen Screening Influence the Results of Studies of Tomatoes, Lycopene, and Prostate Cancer Risk?
Edward Giovannucci
J Natl Cancer Inst 2007 99: 1060-1062. [Extract] [Full Text] [PDF]

Evidence-Based Reviews in Support of Health Policy Decisions
Paul M. Coates
J Natl Cancer Inst 2007 99: 1059. [Extract] [Full Text] [PDF]

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IN THIS ISSUE
J Natl Cancer Inst 2007 99: 1057. [Extract] [Full Text] [PDF]

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Liz Savage and Andrea Widener
J Natl Cancer Inst 2007 99: 1057. [Extract] [Full Text] [PDF]



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