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FDA Allows Only Qualified Health Claims for Lycopene 41081FDA Allows Only Qualified Health Claims for Lycopene

December 5, 2005

4 Min Read
FDA Allows Only Qualified Health Claims for Lycopene

FDA Allows Only Qualified Health Claims for Lycopene


Followingtwo years and six delayed decisions, the Food and Drug Administration (FDA)ruled against a health claim for lycopene and reduced risk of cancer, insteadallowing a number of heavily-qualified health claims for lycopene and risk ofgastric, prostate, ovarian and pancreatic cancers. Several petitioners for thehealth claim formed a coalition to support a new bill introduced into the Houseof Representatives that would loosen FDAs restrictions and powers over suchhealth claims. One petitioner, American Longevity (www.americanlongevity.net),further vowed to file a First Amendment infringement suit against FDA.

FDA decided there was not enough scientific evidence linkingtomatoes, tomato-based products and the antioxidant carotenoid lycopene to areduced risk of cancer.Even in approving several qualified health claims, theagency excluded tomato-based products and lycopene supplements, while indicatingtomatoes and tomato sauce had limited scientific evidence of risk reduction forvarious cancers. The approved qualified claims included:

One study suggests that consuming tomatoes does not reduce therisk of pancreatic cancer, but one weaker, more limited study suggests thatconsuming tomatoes may reduce this risk. Based on these studies, FDA concludesthat it is highly unlikely that tomatoes reduce the risk of pancreatic cancer.

One study suggests that consumption of tomato sauce two timesper week may reduce the risk of ovarian cancer; while this same study shows thatconsumption of tomatoes or tomato juice had no effect on ovarian cancer risk.FDAconcludes that it is highly uncertain that tomato sauce reduces the risk ofovarian cancer.

Very limited and preliminary scientific research suggests thateating one-half to one cup of tomatoes and/or tomato sauce a week may reduce therisk of prostate cancer. FDA concludes that there is little scientific evidencesupporting the claim.

Four studies did not show that tomato intake reduces the riskof gastric cancer, but three studies suggest that tomato intake may reduce thisrisk. Based on these studies, FDA concludes that it is unlikely that tomatoesreduce the risk of gastric cancer.

The lycopene petitions were field by American Longevity and agroup of lycopene-based product companies, including Heinz and LycoRed, calledthe Lycopene Health Claim Coalition. In response to the FDA decision on lycopeneclaims, the companies involved formed the Coalition to End FDA and FTC [FederalTrade Commission] Censorship, in support of a bill, the Health FreedomProtection Act (H.R. 4282), introduced Nov. 9 and backed by eight congressman,including Ron Paul (R-Texas), Walter Jones (R-N.C.), John Duncan (R-Tenn.),Peter DeFazio (D-Ore.), Roscoe Bartlett (R-Md.), Dan Burton (R-Ind.), JeffMiller (R-Fla.), and Rob Bishop (R-Utah).

If enacted, the bill would amend the health claim provisionsof the Food, Drug and Cosmetic Act to allow truthful disease and treatmentclaims for foods and dietary supplements. The bill would also limit FDAs useof disclaimers on health claims, the time spent on approving or denying a claimpetition to 100 days, the agencys right to waive conflicts of interest on itsruling board, and its control over consumer access to submitted scientificevidence. Further, the bill seeks to overturn the denial or restriction ofprevious claimsincluding omega-3s and heart disease/heart attacks, sawpalmetto and benign prostatic hyperplasia, glucosamine-chondroitin andosteoarthritis, and calcium and bone lossas well as lift restrictions againstclaims involving treatment of specific signs or symptom, as long as the diseaseis not mentioned.

The bill also targets FTC, seeking to exempt all publicationsfrom deceptive advertising regulation, including summaries of peer-reviewedresearch findings, in addition to mandating FTC prove an ad is misleading beforebringing charges against advertisers.

The 50-company coalition initiated a grassroots campaign insupport of the bill, accusing FDA of censoring health information to thedetriment of Americans and their families. FDA prohibited the claim thatfolic acid reduces the risk of neural tube defects for four years, while theCenters for Disease Control and Prevention recommended every woman ofchildbearing age take that supplement, said the Coalition, in a statement.Thus, the FDA contributed to an estimated 10,000 preventable neural tubedefects. They further noted by passing the Dietary Supplement Health andEducation Act (DSHEA), Congress authorized public access to scientificinformation on nutrients and disease, and four federal court orders havecondemned FDAs practice of censorship as a violation of the First Amendment.

American Longevity expressed great disappointment in the scopeof FDAs decision on lycopene and has promised additional action againstFDA.The company said it will file a lawsuit within 30 days, charging FDA withviolating its free-speech right to make such claims for lycopene and cancer. TheFDA decision greatly misleads the American consumer, said Steve Wallach, general manager of American Longevity. TheAmerican public is entitled to the whole truth and we will do all we can toprevent the FDA from keeping this scientific information from the Americanpeople.

The FDA ruling can be found atwww.cfsan.fda.gov/~dms/qhclyco2.html.

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