WASHINGTON - Following two years and six delayed descisions, the Food and Drug Administration (FDA) ruled against a health claim for lycopene and reduced risk of cancer, instead allowing a number of heavily-qualified health claims for lycopene and risk of gastric, prostate, ovarian and pancreatic cancers. Several petitioners for the health claim formed a coalition to support a new bill introduced into the House of Representatives that would loosen FDA''s restrictions and powers over such health claims. One petitioner, American Longevity, further vowed to file a First Amendment infingement suit against FDA.
FDA decided there was not enough scientific eveidence linking tomatoes, tomatoe-based products and the antioxidant carotenoid lycopene to a reduced risk of cancer. Even in approving several qualified health claims, the agency excluded tomatoe-based products and lycopene supplements, while indicating tomatoes and tomatoe sauce had limited scientific eveidence of risk reduction for various cancers.
The approved qualified claims included:
The lycopene petitions were filed by American Longevity and a group of lycopene-based companies, including Heinz and LycoRed, called the Lycopene Health Claim Coaliton. in response the FDA decision on lycopene claims, the compaines involved formed the Coalition to End FDA and FTC (Federal Trade Commission) Censorship, in support of a bill, the Health Freedom Protection 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.), Jeff Miller (R-Fla.) and Rob Bishop (R-Utah).
If enacted, the bill would ammend the health claim provisions of the Food, Drug and Cosmetic Act to allow truthful disease and treatment claims for foods and dietary supplements. The bill would also limit FDA''s use of disclaimers on health claims, the time spent approving or denying a claim petition to 100 days, the agency''s right to waive conflicts of interest on ruling it''s board, and it''s contol over consumer access to submitted scientific evidence. Further, the bill seeks to overturn the denial or restriction of previous claims- including omega-3s and heart disease/heart attacks, saw palmetto and benign prostatic hyperplasia, glucosamine-chondroitin and osteoarthritis, and calcium and bone loss - as well as lift restrictions against claims involving treatment of specific signs or sympton, as long as the disease is not mentioned.
The bill also targets FTC, seeking to exempt all publications from deceptive advertising regulation, including summaries of peer-reviewed research findings, in additon to mandating FTC prove an ad is misleading before bringing charges against advertisers.
The 50-company coalition initiated a grassroots campaign in support of the bill, accusing FDA of cencoring health information to the detriment of Americans and their families. "FDA prohibited the claim that folic acid reduces the risk of neural tubes defects for four years, while the Centers for Disease Control and Prevention recommended every woman of childbearng age take that supplement," said the Coalition, in a statement. "Thus, the FDA contributed to an estimated 10,000 preventable neaural tube defects." They further noted by passing the Dietary Supplement Health and Education Act (DSHEA), Congress authorized public access to scientific information on nutrients and disease, and four federal court orders have condemned FDA''s practice of censorship as a violation of the First Ammendment.
The FDA ruling can be found here.