FDA Allows Only Qualified Health Claims for Lycopene

WASHINGTON--Following two years and six delayed decisions, 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 infringement suit against FDA.

FDA decided there was not enough scientific evidence linking tomatoes, tomato-based products and the antioxidant carotenoid lycopene to a reduced risk of cancer. Even in approving several qualified health claims, the agency excluded tomato-based products and lycopene supplements, while indicating tomatoes and tomato sauce had limited scientific evidence of risk reduction for various cancers. The approved qualified claims included:

The lycopene petitions were field by American Longevity and a group of lycopene-based product companies, including Heinz and LycoRed, called the Lycopene Health Claim Coalition. In response to the FDA decision on lycopene claims, the companies 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 amend 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 on approving or denying a claim petition to 100 days, the agency’s right to waive conflicts of interest on its ruling board, and its control 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 symptom, 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 addition 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 censoring health information to the detriment of Americans and their families. “FDA prohibited the claim that folic acid reduces the risk of neural tube defects for four years, while the Centers for Disease Control and Prevention recommended every woman of childbearing age take that supplement,” said the Coalition, in a statement. “Thus, the FDA contributed to an estimated 10,000 preventable neural 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 Amendment.

American Longevity expressed great disappointment in the scope of FDA’s decision on lycopene and has promised additional action against FDA. The company said it will file a lawsuit within 30 days, charging FDA with violating its free-speech right to make such claims for lycopene and cancer. “The FDA decision greatly misleads the American consumer,” said Steve Wallach, general manager of American Longevity. "The American public is entitled to the whole truth and we will do all we can to prevent the FDA from keeping this scientific information from the American people.”