FDA rejects health claims that tomatoes and lycopene reduce cancer risk

Posted by Kate Murphy on July 11th, 2007

The United States Food and Drug Administration has refused to allow health claims that tomatoes or lycopene reduce the risk of getting cancer.  For such claims to appear on the labels of food products or dietary supplements, the FDA must approve them before they are marketed. 

According to a review in the Journal of the National Cancer Institute, the FDA found

  • No credible evidence that there was an association between lycopene intake and a reduced risk of prostate, lung, colorectal, gastric, breast, ovarian, endometrial, or pancreatic cancer.
  • No credible evidence for an association between tomato consumption and a reduced risk of lung, colorectal, breast, cervical, or endometrial cancer
  • Very limited evidence to support an association between tomato consumption and reduced risks of prostate, ovarian, gastric, and pancreatic cancers.

In 2004 the FDA received two petitions for qualified health claims supporting the association between tomatoes, lycopene, and the risk of certain cancers.

In an accompanying editorial, Paul M. Coates from the Office of Dietary Supplements at the National Institutes of Health points out the difficulties of finding strong evidence to support tomato and lycopene claims.  Many studies were preclinical, small, or based on observation.  However, he defends the importance of clear and transparent evidence-based reviews and points out that such reviews can be updated if new information becomes available.

A second editorial writer, Edward Giovannucci, from the Department of Nutrition at the Harvard School of Public Health points out that studies supporting an association between tomato sauce, lycopene, and prostate cancer were done before PSA testing became common in the United States.  More recent studies don’t agree.  However, he believes that there may be a connection between more advanced prostate cancer and tomatoes that should be studied further, along with possible genetic associations and combinations of tomatoes, lycopene and other antioxidants.

More information is available in a JCNI press release.

SOURCE: Kavanaugh et. al, Journal of the National Cancer Institute, advance access, July 10, 2007.

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