Companies will be able to suggest a limited link between tomatoes and a lowered risk of prostate cancer, the agency said.
In response to proposals from industry and other groups, the FDA said it will allow only a few limited health claims to appear on packages of tomatoes and tomato sauce. It also rejected proposals to advertise lycopene alone, available in supplements, as having cancer-related benefits.
The rulings were in response to petitions from American Longevity, which makes supplements and other health products, and the Lycopene Health Claim Coalition, a group that includes ketchup manufacturer H.J. Heinz Co.
American Longevity contends the lycopene in tomatoes reduces the risk of a number of cancers, including prostate, colon and breast cancer. The company offered a number of published studies that it said supported its assertion.
Heinz, meanwhile, only sought a connection between tomatoes and prostate cancer, company officials said. The FDA authorized the following for use on product labels: "Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting the claim."
"It sounds horrible," said Kerr Dow, chief technical officer for Heinz. "It's actually really good news."
He said it is unlikely Heinz would include the claim on its products, but it could use the language to promote further research into a link between tomatoes and reduced prostate cancer risk.
About 232,000 U.S. men will be diagnosed with prostate cancer this year, and 30,000 will die, the American Cancer Society estimates.
In its response to American Longevity's petition, the FDA questioned many of the studies, saying they were not conclusive.
American Longevity contends it has a free-speech right to make the statements, which are governed under two-year-old regulations allowing qualified health claims on some products where the science is less than universally accepted.
"The FDA decision greatly misleads the American consumer," said Steve Wallach, general manager of American Longevity, in a statement. "The American public is entitled to the whole truth and we will do all we can to prevent FDA from keeping this scientific information from the American people."
Still, the agency authorized three more tomato-related claims to be used on product labels, saying there was "very limited credible evidence" they provide a health benefit. Like the prostate language, the authorized claims must be heavily qualified:
Gastric cancer: "Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer."
Ovarian cancer: "One study suggests that consumption of tomato sauce 2 times per week may reduce the risk of ovarian cancer; while this same study shows that consumption of tomatoes or tomato juice had no effect on ovarian cancer risk. FDA concludes that it is highly uncertain that tomato sauce reduces the risk of ovarian cancer."
Pancreatic cancer: "One study suggests that consuming tomatoes does not reduce the risk of pancreatic cancer, but one weaker, more limited study suggests that consuming tomatoes may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that tomatoes reduce the risk of pancreatic cancer."