The company is now requesting that the FDA - under the recent health claim rules - allow the use of dietary supplement health claims for lycopene, tomatoes, lycopene-containing tomato-based products, and cancer.
As in June, they propose the following claims : 'Lycopene may reduce the risk of cancer', 'Lycopene may reduce the risk of prostate cancer', 'Lycopene may reduce the risk of lung cancer' and 'Tomatoes and tomato-based products may reduce the risk of lung cancer'.
Acting through the law firm Emord & Associates, the company has this week added a string of new health claims to the proposed list to include : 'Lycopene may reduce the risk of gastric cancer', 'Lycopene may reduce the risk of colorectal cancer', 'Lycopene may reduce the risk of breast cancer', 'Lycopene may reduce the risk of cervical cancer', 'Lycopene may reduce the risk of endometrial cancer', 'Lycopene may reduce the risk of ovarian cancer', 'Lycopene may reduce the risk of pancreatic cancer', 'Tomatoes may reduce the risk of cancer'.
In addition :'Tomatoes may reduce the risk of prostate cancer', 'Tomatoes may reduce the risk of lung cancer', 'Tomatoes may reduce the risk of gastric cancer', 'Tomatoes may reduce the risk of colorectal cancer,' 'Tomatoes may reduce the risk of breast cancer,' 'Tomatoes may reduce the risk of cervical cancer', 'Tomatoes may reduce the risk of endometrial cancer', 'Tomatoes may reduce the risk of ovarian cancer', 'Tomatoes may reduce the risk of pancreatic cancer', 'Lycopene-containing tomato-based foods may reduce the risk of cancer', 'Lycopene-containing tomato-based foods may reduce the risk of prostate 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.
In February 2003, the FDA gave the green light for the use of two health claims, with cancer risk reduction and anticarcinogenic effect claims, proposed by Wellness Lifestyles - a subsidiary of American Longevity - for the labeling of dietary supplements containing selenium in daily dose amounts of 400 micrograms or less.
Health claims are subject to preapproval by the FDA and must meet a "weight of the evidence" standard. The FDA will respond to health claim petitions in one of three ways. If the claim meets the "significant scientific agreement" standard, FDA will authorize the claim and consider expediting publication to permit faster use in the market.
If the claim does not meet the "significant scientific agreement" standard but does meet a "weight of the evidence" standard, under which supporting evidence outweighs negative evidence, FDA will exercise "enforcement discretion," allowing companies to use the claim with an appropriate qualifier. If the claim does not meet either standard, the FDA will deny the petition.