FDA delays again on lycopene/cancer decision
American Longevity's health claim petition on the link between
lycopene and a reduced risk of developing certain types of cancer,
until 12 April.
Lycopene, the carotenoid that gives tomatoes, watermelon, papaya and pink grapefruit their red color, is a known antioxidant.
The natural health products company compiled scientific studies indicating that consumption of tomatoes, tomato-based products, and lycopene supplementation may reduce the incidence of prostate, lung, and stomach cancers and submitted these to the agency in 2003, along with its petition.
A decision was initially expected on 24 December 2004. However in mid-December the agency informed the company that the decision would be delayed by seven weeks until 11 February.
"Obviously, we are disappointed that there has been another delay in getting this important health information out to the general public," said Steve Wallach of American Longevity.
The reasons for the continuing delay were not given, but the company notes that that the FDA has attributed requests for extensions in its review of seven other qualified health claim petitions in recent months to lack of resources.
Wallach does not interpret the delay as a sign that the claim may be denied. "We look forward to getting approval on this lycopene/cancer health claim petition in April," he said.
Of the several health claim petitions submitted to the FDA by American Longevity, two have so far been authorized: the reduced risk of certain cancers by consuming the trace mineral selenium; and the reduced risk of cardiovascular heart disease by consuming fatty acids EPA and DHA.
