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Health claim for lycopene?

16-Jun-2003

Natural health products supplier American Longevity has filed a health claim petition with the Food and Drug Administration (FDA) for the use of certain dietary supplement health claims for lycopene, tomatoes, tomato-based products, and cancer.

The proposed claims include: 'Lycopene may reduce the risk of certain forms of cancer', 'Lycopene may reduce the risk of prostate cancer', 'Lycopene may reduce the risk of lung cancer', 'Tomatoes and tomato-based products may reduce the risk of certain forms of cancer', 'Tomatoes and tomato-based products may reduce the risk of prostate cancer', and 'Tomatoes and tomato-based products may reduce the risk of lung cancer'.

 

The petition presented to FDA, through Virginia-based law firm Emord & Associates, presents an evaluation of the scientific studies and clinical trials concerning lycopene's effect on reduction in the risk of certain cancers, prostate cancer and lung cancer.

 

The average daily intake of lycopene, a carotenoid responsible for the red color of tomatoes, watermelon, papaya, and pink grapefruit, is approximately 25 milligrams, with 50 per cent of this in the form of processed tomato products. It is known to have antioxidant and anticarcinogenic activity. American Longevity compiled scientific studies demonstrating that consumption of tomatoes, tomato-based products, and lycopene supplementation may reduce the incidence of prostate, lung, and stomach cancers.

 

The petition states : 'The scientific evidence justifies permitting the proposed health claims linking consumption of lycopene to a reduction in the risk of certain kinds of cancers; to reduction in the risk of prostate cancer; and to reduction in the risk of lung cancer.' It also notes that the proposed health claims 'respond to a major public health concern in the United States: cancer'. Cancer is the second leading cause of death in the United States with around 1,334,100 new cancer cases expected to be diagnosed this year alone.

 

The petition also claims to 'further national and DHHS policies by identifying a low cost means to help reduce the risk of certain cancers'.

 

In the event that the science provided does not satisfy FDA requirements, the company is asking that the claims are permitted, along with a suitable disclaimer.

 

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