After waiting nearly 18 months for a decision on whether tomatoes and lycopene can make a qualified health claim about prostate cancer reduction, the industry has a qualified answer: yes, sort of.
The U.S. Food and Drug Administration responded last week to the petition that American Longevity Inc. and H.J. Heinz Co. submitted in May 2004. The letter from FDA states that there is sufficient scientific evidence to award a qualified health claim "related to consumption of tomatoes and/or tomato sauce, and a reduced risk of prostate cancer," but not to products containing lycopene.
Highlighting its uneasiness with the approved claim, the letter stated, "FDA finds that there is very limited credible evidence for a qualified health claim. FDA concludes that there is a very low level of comfort that a relationship exists between tomatoes and/or tomato sauce and prostate cancer."
The approved claim will allow the following language: "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 this claim."
FDA did not award even that much of a claim to lycopene or products containing lycopene, the antioxidant pigment in tomatoes that is usually seen as the food's source of cancer-prevention activity. "We concluded that neither a disclaimer nor qualifying language would suffice to prevent consumer deception in these instances, where there is no credible evidence to support the claims," FDA's letter said.
FDA cited numerous factors in reaching this decision; foremost was that existing research about lycopene in isolation from other nutritional factors was limited, and the research that was available was inadequate. FDA also noted that in past studies, nutrients have shown positive effects when consumed in food, but later were shown to be detrimental when taken as a dietary supplement.
While the claim for tomatoes may seem watered-down, many in the industry are encouraged. "We're delighted with the FDA's announcement, reinforcing what Heinz has long believed about the health benefits of tomatoes," said F. Kerr Dow, Ph.D., vice president and chief technical officer for Heinz.
Even lycopene supplements manufacturer LycoRed sees it as a positive development. "This is not a bad decision for us," said Lizz Stendera, a media specialist working with Israel-based LycoRed, which manufactures the Lyc-O-Mato supplement. "It's a step. They're all stepping stones to get to the point where we can say, with the FDA backing us … that [lycopene] can shrink tumor size."
American Longevity Inc., a San Diego manufacturer of dietary supplements, was less philosophical. The company noted in a statement on its Web site that it intends to sue FDA. "The FDA decision greatly misleads the American consumer," said Steve Wallach, general manager of American Longevity. "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."
LycoRed may be more optimistic because of the nature of its product. "[FDA is] giving their seal of approval to the sauces and the tomatoes," Stendera said. "That essentially is what the Lyc-O-Mato supplement is. If you take out all the water and the sugar in the tomato, that's what Lyc-O-Mato is." Nonetheless, LycoRed does not intend to change the labeling on its products, she said.
Stendera noted that because other supplements don't have the same science, their manufacturers may not see the FDA decision as an opportunity to educate the public, as LycoRed does. "The studies on single-molecule lycopene are not going to be great because it's synthetic, it's not natural. When you study the whole tomato complex you're going to have much better results because it comes from Mother Nature."