Despite the fact that a number of studies have been reported that show an association between tomato and/or lycopene intake and a reduced risk of some types of cancer, the FDA has seen a different picture.
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.) Since then, the agency has been investigating the matter further.
The FDA has 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 association between tomato consumption and a reduced risk of lung, colorectal, breast, cervical, or endometrial cancer. Because the FDA found "very limited evidence" to support the reduced risk of cancer claim, those seeking functional food status for their lycopene containing products will not be getting their wish.