Lycopene: What the Research Actually Says (Including the FDA Review)

By the ProstateFoods editorial team · Last updated October 13, 2026 Short answer: Lycopene is a red pigment found mostly in tomatoes and tomato products. Many observational studies have looked at tomatoes, lycopene and prostate cancer, but when the FDA reviewed the evidence in 2005 it found no credible evidence for lycopene itself and called the evidence for tomatoes "very limited and preliminary." Eating tomatoes is a reasonable part of a vegetable-rich diet. Expecting them, or a lycopene pill, to protect your prostate is not supported.

What lycopene is

Lycopene is a carotenoid, a family of plant pigments that also includes beta-carotene. Unlike beta-carotene, the body does not turn lycopene into vitamin A, and it is not an essential nutrient. It is fat-soluble, so it is absorbed better when eaten with some fat [3].

The richest everyday sources are tomato paste, tomato purée, tomato sauce, tomato juice, watermelon, pink grapefruit, guava and papaya. See our per-serving lycopene table.

What the FDA concluded

In 2004 a petitioner asked the FDA to allow health claims linking lycopene and tomatoes to lower cancer risk. The agency's scientists reviewed the studies and published their reasoning [4]:

• Lycopene (as a food ingredient or supplement) and prostate cancer: the FDA found no credible evidence and denied the claim [1].
• Tomatoes and tomato sauce and prostate cancer: the FDA allowed only a heavily qualified statement under "enforcement discretion." Its required wording calls the research "very limited and preliminary" and ends: "FDA concludes that there is little scientific evidence supporting this claim" [2].
• Claims for several other cancers were also denied or limited [1][4].

That qualified wording is how a food label would have to describe the evidence, if it mentioned it at all. We hold this site to the same standard.

Why observational studies aren't enough

Most of the tomato research compares groups of men who report eating more or less tomato products. Men who eat more tomato sauce may also differ in many other ways: overall diet, weight, exercise, smoking and access to screening. Those studies can suggest questions. They can't show that tomatoes caused any difference [4]. The National Cancer Institute's prevention summary also does not list lycopene or tomatoes as proven ways to lower prostate cancer risk [5].

Lycopene supplements

Supplements are a separate question from food. The FDA's 2005 review found no credible evidence for lycopene supplements and prostate cancer [1]. If you are considering any supplement, talk to your doctor or pharmacist first, especially if you take medication. A separate large trial, SELECT, is a useful reminder that nutrient pills can surprise researchers: vitamin E supplements were linked to a higher rate of prostate cancer in that trial [6].

How to eat tomatoes well anyway

Tomatoes are a low-calorie vegetable that fits the vegetable-rich eating patterns in the Dietary Guidelines for Americans [7]. Easy options:

• Stir a tablespoon of tomato paste into soups, beans and chili.
• Make a pot of simple tomato sauce with olive oil.
• Pick "no salt added" canned tomatoes to keep sodium down. Colavita no-salt-added crushed tomatoes are one option.

Sources

1. U.S. Food and Drug Administration. Qualified Health Claims: Letters of Denial (includes lycopene and prostate cancer, 2005). https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/qualified-health-claims-letters-denial
2. U.S. Food and Drug Administration. Qualified Health Claims: Letters of Enforcement Discretion (includes tomatoes and prostate cancer, 2005). https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/qualified-health-claims-letters-enforcement-discretion
3. Gärtner C, Stahl W, Sies H. Lycopene is more bioavailable from tomato paste than from fresh tomatoes. Am J Clin Nutr. 1997;66(1):116-22. https://pubmed.ncbi.nlm.nih.gov/9209178/
4. Kavanaugh CJ, Trumbo PR, Ellwood KC. The U.S. Food and Drug Administration's evidence-based review for qualified health claims: tomatoes, lycopene, and cancer. J Natl Cancer Inst. 2007;99(14):1074-85. https://pubmed.ncbi.nlm.nih.gov/17623802/
5. National Cancer Institute. Prostate Cancer Prevention (PDQ®), Patient Version. https://www.cancer.gov/types/prostate/patient/prostate-prevention-pdq
6. Klein EA, Thompson IM Jr, Tangen CM, et al. Vitamin E and the risk of prostate cancer: SELECT. JAMA. 2011;306(14):1549-56. https://pubmed.ncbi.nlm.nih.gov/21990298/
7. U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans. https://www.dietaryguidelines.gov/

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ProstateFoods writes about food, not treatment. Nothing here is medical advice or a claim that any food treats, cures or prevents a disease. Talk to your doctor before changing how you eat, especially if you take medication or have a health condition. See our medical disclaimer. Photo: Watermelon slices (8481636501).jpg) by fitri agung from Pekanbaru, Riau, Indonesia, Indonesia, CC BY 2.0, via Wikimedia Commons.