Qualified health claim rulings leave little leeway for label language.

نویسنده

  • Brian Vastag
چکیده

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 scien tifi c 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 qualifi ed statement on their packaging: " Very limited and preliminary scientifi c 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 sci-entifi c evidence supporting this claim. " For green tea, the agency approved even more qualifi ed language: " Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer. " Approved wording for the green tea and calcium claims is similar. fi led a request to modify the FDA-approved language. On the basis of the two studies the FDA found most convincing, he requested labeling reading , " Drinking green tea equivalent to that consumed by Asian Americans may reduce the risk of breast cancer in women, " and " Drinking green tea equivalent to that consumed by residents living in Hangzhou, China, may reduce the risk of prostate cancer. " The request is pending. chief technical offi cer for Heinz, said that the company would probably not include the FDA-approved language on any of its labels. " It's kind of confusing for the consumer , " he said. However, he maintained that the ruling is good news for his company , which may use the ruling to tout the health benefi ts of tomatoes in its marketing campaigns. After these rulings, the fi rst of their kind, the Solae Company withdrew …

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عنوان ژورنال:
  • Journal of the National Cancer Institute

دوره 98 1  شماره 

صفحات  -

تاریخ انتشار 2006