FDA approves lycopene claim

After waiting nearly 18 months for a decision on whether tomatoes and lycopene can have a qualified health claim about prostate cancer reduction, the industry has a qualified answer: yes, sort of.

The Food and Drug Administration responded in November to the petition that American Longevity Inc and H J Heinz Co submitted in May 2004. The FDA stated that there was sufficient scientific evidence to award a qualified health claim for consumption of tomatoes and/or tomato sauce, but not of products containing lycopene.

The claim states: "Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim."

To explain why lycopene-containing products were excluded, the FDA stated that lycopene in isolation from other nutritional factors was limited and the research inadequate.

Lycopene supplements manufacturer LycoRed viewed the news positively. "It's a step," said Lizz Stendera with Israel-based LycoRed, maker of Lyc-OMato. "They're all stepping stones to get to the point where we can say, with the FDA backing us … that (lycopene) can shrink tumour size."

San Diego supplements maker American Longevity was less bullish. On its website, the company said it intends to sue the FDA for misleading the public and keeping scientific information out of view.

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