Qualified Health Claim Rulings Leave Little Leeway for Label Language

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After 18 months of delays, the U.S. Food and Drug Administration announced in separate rulings that limited evidence supports labeling tomato products and green tea as reducing the risk of prostate cancer and prostate and breast cancers, respectively. However, the agency rejected much broader claims requested by the H.J. Heinz Company (for tomato products) and Fleminger Inc. (for green tea). It also rejected a request from American Longevity to allow the tomato extract lycopene to be labeled as a cancer risk reducer. The agency also concluded that there is “limited scientific evidence” to support the claim that calcium supplements may reduce the risk of colorectal cancer or colorectal polyps.

The rulings clear the way for tomato product makers to include a qualified statement on their packaging: “Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce once a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim.”