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FDA Approves Qualified Health Claim on Tomatoes and Tomato Sauces

Clinically researched LycoMato® provides daily dose
of all tomato nutrients to help reduce prostate cancer risk

The Food & Drug Administration has issued a qualified health claim on tomatoes and tomato sauces indicating that ½ 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 mgs of whole tomato complex, such as LycoMato®.

LycoRed Natural Products, Ltd. supports continued research on the relationship between tomatoes and prostate cancer. The FDA’s finding on the relationship between tomatoes and reduced risk of prostate cancer is very promising. LycoMato®, a whole tomato extract, provides not only tomato lycopene but the whole complex of phytonutrients found in the tomato that research is suggesting will reduce the risk of prostate cancer.

LycoRed President and CEO Morris Zelkha said, “There are two human clinical trials under way 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.”

LycoRed Natural Products Industries, Ltd. was the only manufacturer of both food and dietary supplement natural, whole tomato complex ingredients participating with a consortium of 3 other companies in the preparation of the petition to FDA requesting this qualified health claim. A key piece of research submitted for FDA review as part of the petitioning process was a placebo controlled, double blind human clinical trial conducted using LycoRed’s LycoMato® -- the only all-natural tomato complex.

“Prostate cancer is the second leading cause of cancer-related deaths for adult males in the United States,” explains Omer Kucuk, MD, FACN, Medical Oncologist at the Barbara Ann Karmanos Cancer Institute in Detroit. “There is comprehensive scientific evidence that tomato lycopene has potent antioxidant properties that may reduce the risk of prostate cancer. For those men who are not consuming whole tomatoes or tomato sauce, men can supplement their dietary intake with the clinically researched LycoMato® natural, whole tomato complex that contains all of the tomato’s phyonutrients.”

Dr. Kucuk is one of the leading researchers in the area of tomato lycopene and cancer. He recently evaluated the effect of LycoMato®, a natural lycopene complex, on patients with existing prostate cancer. The study, published in Cancer Epidemiology Biomarkers and Prevention, an official journal of the American Association for Cancer Research, found after treatment, those treated with the tomato lycopene complex containing lycopene and other tomato phytonutrients had smaller tumors, and these tumors were more likely to be confined to the prostate.

“This clinical trial showed the efficacy of a compound containing several tomato phytonutrients which may be effective in the prevention and treatment of prostate cancer,” Dr. Kucuk said.

“We appreciate the FDA’s work on this matter, which we feel will lead to better understanding by consumers of the benefits of consuming an adequate amount of tomato lycopene daily,” said Zelkha. “Half of Americans are reported to consume an average of 1.86 mg. or less of lycopene daily. The data suggest we need to raise those levels because a healthy diet that includes tomato lycopene is consistent with a lower risk of prostate cancer and other chronic diseases.”

LycoMato® is the only all-natural tomato complex rich in lycopene, phytoene, phytofluene, tocopherols, phytosterols and beta carotene. LycoMato is extracted from non-GMO, specially selected, lycopene-rich tomatoes, containing four times the lycopene content of ordinary supermarket varieties. Supplements containing 15 mg. lycopene from LycoMato® contain the power of five tomatoes in one pill – including all of the other antioxidant compounds found naturally in the tomato. LycoMatoÒ, in powder form, is favored by food manufacturers as an additive to a variety of food products from cereals to soy burgers. LycoMatoÒ adds to foods a standardized level of lycopene per serving along with a powerful health benefit.


Dr. Omer Kucuk is a graduate of Hacettepe University Medical School in Ankara, Turkey. He completed his medical residency at St. Francis Hospital in Evanston, Illinois, then completed a fellowship in Hematology-Oncology at Northwestern University Medical School in Chicago. Currently, he is a professor in the Department of Internal Medicine, Division of Hematology and Oncology, at Wayne State University in Detroit where he is also a member of the graduate faculty in the Cancer Biology program. Dr. Kucuk leads the Prevention Program at the Barbara Ann Karmanos Cancer Institute, a National Cancer Institute designated Comprehensive Cancer Center. Additionally, he is an attending staff physician in the Harper and Detroit Receiving Hospitals at the Detroit Medical Center. He is a fellow of American College of Nutrition, and member of the American Society of Clinical Oncology, the American Association for Cancer Research, the American Society of Preventive Oncology, the American Society for Nutritional Sciences, the American Society for Clinical Nutrition, and the International Society for Nutrition Research.

As a leading cancer prevention researcher, Dr. Kucuk has received grant support from agencies including NIH, NCI, and the Department of Defense to study the effects of nutrients such as zinc, soy isoflavones and tomato lycopene on human carcinogenesis. He has investigated the effects of nutritional interventions on lung, head and neck, prostate, colon and breast cancers.

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