Petitioner American Longevity plans to file a lawsuit against the government agency, claiming that the decision infringes its first amendment rights.
The approval means that tomato and tomato sauce products may make heavily qualified health claims on their packaging about their ability to reduce the risk of prostate, gastric, ovarian and pancreatic cancers - and these are couched in very negative terms, "unlikely", "highly uncertain", and "highly unlikely".
This falls way short of American Longevity's hopes. It had asked the agency to consider evidence that the risk reduction could be attributed to lycopene, the antioxidant carotenoid that gives tomatoes their color. This would have meant that tomato-based products and dietary supplements containing lycopene could also make the claims.
According to general manager Steve Wallach, it costs as much as $100,000 to make a health claim petition.
"The FDA decision greatly misleads the American consumer," he said. "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."
American Longevity has been deeply involved in a campaign to relax the rules on health claims, as it holds that restricting companies' communication of the benefits of certain ingredients for health constitutes an infringement of the right to free speech.
It has been waiting a decision on its claim for two years, and the FDA has delayed its decision on six occasions. The San Deigo-based company has said it will file a lawsuit against the government agency in the next 30 days.
Other petitioners over tomato and lycopene and cancer include Israel's LycoRed, and The Heinz Group. However not all the petitioners were as disappointed with the outcome of the FDA's deliberations. The Heinz Group has even said it applauds the decision on tomatoes and prostate cancer - despite its conclusion that there is "very little scientific evidence" to support the risk reduction.
"It validates Heinz's long-term support of tomato research and our ongoing education program," said F Kerr Dow, vice president and chief technical officer for Heinz. "As the FDA confirmed, research findings are still limited and scientific studies must continue on tomatoes and their link to preventing disease and enhancing well-being."
The claim on pancreatic cancer reads: "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."
The wording of the other three qualified claims reads: "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;"
"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," and;
"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."