Editing Lycopene (section)

===Regulatory status in Europe and the United States===

In a review of literature on lycopene and its potential benefit in the diet, the [[European Food Safety Authority]] concluded there was insufficient evidence for lycopene having antioxidant effects in humans, particularly in skin, heart function, or vision protection from [[ultraviolet light]].<ref name="efsa">{{cite journal|journal=EFSA Journal|volume=9|issue=4|year=2011|title=Scientific Opinion on the substantiation of health claims related to lycopene and protection of DNA, proteins and lipids from oxidative damage (ID 1608, 1609, 1611, 1662, 1663, 1664, 1899, 1942, 2081, 2082, 2142, 2374), protection of the skin from UV-induced (including photo-oxidative) damage (ID 1259, 1607, 1665, 2143, 2262, 2373), contribution to normal cardiac function (ID 1610, 2372), and maintenance of normal vision (ID 1827) pursuant to Article 13(1) of Regulation (EC) No 1924/2006|doi=10.2903/j.efsa.2011.2031 |page=2031|doi-access=free}}</ref>

Although lycopene from tomatoes has been tested in humans for cardiovascular diseases and prostate cancer, no effect on any disease was found.<ref name="ReferenceA">{{cite web|title=Qualified Health Claims: Letter Regarding Tomatoes and Prostate Cancer (Lycopene Health Claim Coalition) (Docket No. 2004Q-0201) (Updated 9 July 2015)|publisher=US Food and Drug Administration|url=https://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm072767.htm|date=8 November 2005|access-date=16 December 2019|archive-url=https://web.archive.org/web/20170722101944/https://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm072767.htm|archive-date=22 July 2017|url-status=dead}}</ref> The US [[Food and Drug Administration]], in rejecting manufacturers' requests in 2005 to allow "qualified labeling" for lycopene and the reduction of various cancer risks, provided a conclusion that remains in effect {{Asof|2015|lc=y}}:
{{blockquote |text=no studies provided information about whether lycopene intake may reduce the risk of any of the specific forms of cancer. Based on the above, FDA concludes that there is no credible evidence supporting a relationship between lycopene consumption, either as a food ingredient, a component of food, or as a dietary supplement, and any of these cancers.<ref name=ReferenceA/>}}

In a review of research through 2024, the US [[National Cancer Institute]] concluded that the FDA has not approved the use of lycopene as effective for treating any medical condition, including various types of cancer.<ref name="nci">{{cite web |title=Lycopene |url=https://www.cancer.gov/about-cancer/treatment/cam/hp/prostate-supplements-pdq#_16 |publisher=US National Cancer Institute |access-date=14 September 2024 |date=5 April 2024}}</ref>