FDA Approves Some Cancer Claims for Lycopene

Companies will now be able to say that eating tomatoes and tomato sauce is linked with a reduced risk of gastric, ovarian, pancreatic, and prostate cancers.

10/11/05 The US Food and Drug Administration (FDA) has allowed just a few of the many cancer-fighting claims being sought related to lycopene. Companies will now be able to say that eating tomatoes and tomato sauce is linked with a reduced risk of gastric, ovarian, pancreatic, and prostate cancers. That is wider than the prostate cancer claim a coalition led by H.J. Heinz Co. sought. The FDA approval also means any manufacturer, not just the original applicants to the agency, can promote the cancer-fighting abilities of tomatoes and tomato sauce. But the FDA rejected some of the claims that a California supplement company, American Longevity, wanted to make.

Heinz, which is the world's largest producer of processed tomato products, applauded the approval for the use of a Qualified Health Claim for raw, cooked, dried or canned tomatoes. Heinz said that the request for a Qualified Health Claim was submitted because of the growing body of scientific evidence that the consumption of tomato products may reduce the risk of prostate cancer, the second-leading cause of cancer-related deaths for adult males in the United States.

The petition was submitted by an H.J. Heinz Company-led consortium of the principal processed tomato organizations and a major health advocacy foundation. The consortium included Lyco Red Natural Products Industries, Ltd., Beer Sheva, Israel, the leading research and development company marketing natural products based on the phytonutrients in tomatoes; “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. "It validates Heinz's long-term support of tomato research and our ongoing education program. 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."

Dr. Dow noted: "Based on health claim guidance provided by the FDA, the risk of prostate cancer may be reduced by eating just 1/2 to 1 cup of tomatoes and /or tomato sauce - such as a single serving of Classico pasta sauce - per week."

But while the news was generally good for Heinz, American Longevity received a 44 page response from the FDA, which said that it had found “no credible evidence” linking lycopene when used as a supplement or component of food with reduced risk of nine cancers specified in the company's petition to the agency.