In a decision on Tuesday, November 10th, the FDA authorized a limited, qualified health claim that says one-half to one cup of tomatoes or tomato sauce weekly may be beneficial in reducing the risk of prostate cancer. That amount of tomatoes is roughly equivalent to 10 milligrams of whole tomato complex.

LycoRed Natural Products, Ltd., Beer Sheva, Israel, along with companies like Heinz, Pittsburgh, PA, Morningstar Farms, Battle Creek, MI, and The Prostate Cancer Foundation, Santa Monica, CA, submitted a qualified claim petition over two years ago scientifically substantiating the relationship between lycopene and prostate cancer prevention. American Longevity, San Diego, CA, eventually submitted its own petition describing the relationship between lycopene in foods and supplements and the prevention of a variety of cancers. After six extensions, FDA finally came out with its ruling. The claim that manufacturers are permitted to use in the case of prostate cancer says: “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 evidence to support this claim.”

In response to FDA’s ruling, LycoRed president and CEO Morris Zelkha said, “There are two human clinical trials underway in the U.S. studying the relationship between prostate cancer and LycoMato whole tomato complex, which is available in supplement form. We hope that the results from these studies will help further refine research that has been conducted to date on whole tomato complex.” According to LycoRed, it will continue to push forward with its own clinical research for lycopene and eventually re-file a petition with FDA to obtain a stronger health claim, which includes supplements.