FDA postpones decision on cancer health claim of lycopene

18/08/05 The FDA has requested a fifth extension on giving a decision on American Longevity's health claim petition on the link between lycopene and a reduced risk of developing certain types of cancer until October 10, 2005.

American Longevity has 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 December 24, 2004. However in mid-December the agency informed American Longevity that the decision would be delayed until February 11, 2005, again until April 12, 2005, again until June 12, 2005, yet again until August 12, 2005 and finally they have requested an additional 60 day extension. In recent months the agency has asked for extensions in its review of seven other pending qualified health claim petitions citing a lack of agency resources.

In a letter dated July 7, 2005, U.S. Senators Tom Harkin and Orrin Hatch wrote Dr. Lester Crawford, the commissioner of the Food and Drug Administration ( FDA ) expressing their concern about the length of time it takes to get an approval for Qualified Health Claim Petitions. The letter specifically asked how many petitions the FDA currently had, the length of time it has taken to approve each one, how many full-time equivalents ( FTEs ) are devoted to review them and the grade levels of the reviewers. The senators offered the disposal of their staffs to meet with the FDA to solve the problem.

American Longevity has submitted several Health Claim Petitions to the FDA and is responsible for the authorized Health Claim Petition for Selenium and its relationship to Cancer Risk Reduction. American Longevity has helped to defend the Health Claim Petition process through the courts and has submitted many official comments to the FDA on behalf of the nutrition industry, all in an effort to help consumers have more access to truthful information in order to base a more informed decision regarding their own health and wellness.