FDA rejects claims that lycopene reduces cancer risks
FDA rejects claims that lycopene reduces cancer risks
WASHINGTON -- Tomatoes and/or tomato sauces may reduce the risk of certain cancers, but the Food & Drug Administration has flatly rejected health claims linking lycopene as having any cancer-prevention qualities.
After a two-year review and several delays, FDA ruled on two petitions that asked regulators to allow a wide variety of new health claims regarding eating tomatoes and processed tomato products.
In the "partial denial" letters, FDA allowed only limited health claims linking tomatoes and tomato sauces with reducing the risk of ovarian, prostate, gastric and pancreatic cancers, and rejected evidence that lycopene as part of a food or as a dietary supplement reduces the risk of cancer.
One of the petitioners, H.J. Heinz Co., hailed FDA's new ruling for recognizing a growing body of scientific evidence that linked consumption of tomatoes and tomato products with reducing the risk of prostate cancer.
"We're delighted with the FDA's announcement, reinforcing what Heinz has long believed about the health benefits of tomatoes," said F. Kerr Dow, vice president and chief technical officer for Heinz.
But it is far from a strong endorsement. FDA found that the "very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer." The agency concluded that there is "a very low level of comfort that a relationship exists between tomatoes and/or tomato sauce and prostate cancer."
FDA warned food companies that since there is "very limited credible evidence" for qualified health claims for tomatoes and/or tomato sauce and prostate, gastric, ovarian and pancreatic cancers, that the labels should be worded carefully:
-- Prostate cancer: "Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim."
-- Gastric cancer: "Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer."
-- Ovarian cancer: "One study suggests that consumption of tomato sauce two times per week may reduce the risk of ovarian cancer; while this same study shows that consumption of tomatoes or tomato juice had no effect on ovarian cancer risk. FDA concludes that it is highly uncertain that tomato sauce reduces the risk of ovarian cancer."
-- Pancreatic cancer: "One study suggests that consuming tomatoes does not reduce the risk of pancreatic cancer, but one weaker, more limited study suggests that consuming tomatoes may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that tomatoes reduce the risk of pancreatic cancer."
"We would have liked to have seen a stronger statement, but the fact that more people are hearing about the health benefits of tomatoes is a good thing," said Nancy Freese of the Morning Star Co., a large tomato processor for Heinz and a co-petitioner.
The Produce for Better Health Foundation said FDA's latest action illustrates how high the bar is set for regulators to approve health claims for individual foods. Of the 177 supporting documents submitted with the qualified health claims petition, there were only 13 human observational studies that had scientific significance related to the petitioned claim, said Linda Brugler, the group's nutrition manager. Although of high quality, the 13 studies did not show consistent results and this resulted in the "weak" qualified claim granted to tomatoes and/or tomato sauce, she said.
While marketers are eager to sell products to health- conscious consumers, "health claims must have a solid base of high-quality supporting evidence, specific to the product for which the claim is being made in order to comply with federal health claim regulations," said Ms. Brugler. "This requires time and a good deal of resources, significant barriers to obtaining future fruit- or vegetable-specific health claims."
In the meantime, the foundation said that savvy health marketers can safely feature approved nutrient content claims for tomatoes, such as these products are high in vitamins A and C, and messages such as, "Tomatoes, together with a diet rich in fruits and vegetables, may reduce the risk of some types of cancer and other chronic diseases."
While Heinz hailed FDA's decision, a dietary supplement maker vowed to sue the agency for rejecting the lycopene health claim. In a Nov. 8 letter, FDA said there was "no credible evidence supporting a relationship between consumption of lycopene, either as a food ingredient, a component of food or as a dietary supplement, and reduced risk of any of the cancers specified in the petition."
Expert opinions revealed that lycopene and not tomatoes is the source of the cancer risk-reducing effect, said American Longevity Inc., the California dietary supplement maker that petitioned FDA to label their products with the health claim.
"The FDA decision greatly misleads the American consumer," said Steve Wallach, general manager of American Longevity, who added that the FDA decision fails to credit lycopenes as anti-cancer agents except in the context of tomato sauce and tomatoes themselves.
For the past few years, researchers have been publishing studies suggesting that lycopene, the antioxidant that gives tomatoes their red hue, may prevent certain cancers and other diseases. A big source of lycopene comes from processed tomato products. According to Heinz, tomatoes and tomato products are among the top food sources for vitamins C, A, E, potassium, fiber and lycopene.
"These nutrients work in combination to offer health benefits which we are just now beginning to understand," said Dr. Ida Laquatra, director of nutrition for Heinz.
After a two-year review and several delays, FDA ruled on two petitions that asked regulators to allow a wide variety of new health claims regarding eating tomatoes and processed tomato products.
In the "partial denial" letters, FDA allowed only limited health claims linking tomatoes and tomato sauces with reducing the risk of ovarian, prostate, gastric and pancreatic cancers, and rejected evidence that lycopene as part of a food or as a dietary supplement reduces the risk of cancer.
One of the petitioners, H.J. Heinz Co., hailed FDA's new ruling for recognizing a growing body of scientific evidence that linked consumption of tomatoes and tomato products with reducing the risk of prostate cancer.
"We're delighted with the FDA's announcement, reinforcing what Heinz has long believed about the health benefits of tomatoes," said F. Kerr Dow, vice president and chief technical officer for Heinz.
But it is far from a strong endorsement. FDA found that the "very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer." The agency concluded that there is "a very low level of comfort that a relationship exists between tomatoes and/or tomato sauce and prostate cancer."
FDA warned food companies that since there is "very limited credible evidence" for qualified health claims for tomatoes and/or tomato sauce and prostate, gastric, ovarian and pancreatic cancers, that the labels should be worded carefully:
-- Prostate cancer: "Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim."
-- Gastric cancer: "Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer."
-- Ovarian cancer: "One study suggests that consumption of tomato sauce two times per week may reduce the risk of ovarian cancer; while this same study shows that consumption of tomatoes or tomato juice had no effect on ovarian cancer risk. FDA concludes that it is highly uncertain that tomato sauce reduces the risk of ovarian cancer."
-- Pancreatic cancer: "One study suggests that consuming tomatoes does not reduce the risk of pancreatic cancer, but one weaker, more limited study suggests that consuming tomatoes may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that tomatoes reduce the risk of pancreatic cancer."
"We would have liked to have seen a stronger statement, but the fact that more people are hearing about the health benefits of tomatoes is a good thing," said Nancy Freese of the Morning Star Co., a large tomato processor for Heinz and a co-petitioner.
The Produce for Better Health Foundation said FDA's latest action illustrates how high the bar is set for regulators to approve health claims for individual foods. Of the 177 supporting documents submitted with the qualified health claims petition, there were only 13 human observational studies that had scientific significance related to the petitioned claim, said Linda Brugler, the group's nutrition manager. Although of high quality, the 13 studies did not show consistent results and this resulted in the "weak" qualified claim granted to tomatoes and/or tomato sauce, she said.
While marketers are eager to sell products to health- conscious consumers, "health claims must have a solid base of high-quality supporting evidence, specific to the product for which the claim is being made in order to comply with federal health claim regulations," said Ms. Brugler. "This requires time and a good deal of resources, significant barriers to obtaining future fruit- or vegetable-specific health claims."
In the meantime, the foundation said that savvy health marketers can safely feature approved nutrient content claims for tomatoes, such as these products are high in vitamins A and C, and messages such as, "Tomatoes, together with a diet rich in fruits and vegetables, may reduce the risk of some types of cancer and other chronic diseases."
While Heinz hailed FDA's decision, a dietary supplement maker vowed to sue the agency for rejecting the lycopene health claim. In a Nov. 8 letter, FDA said there was "no credible evidence supporting a relationship between consumption of lycopene, either as a food ingredient, a component of food or as a dietary supplement, and reduced risk of any of the cancers specified in the petition."
Expert opinions revealed that lycopene and not tomatoes is the source of the cancer risk-reducing effect, said American Longevity Inc., the California dietary supplement maker that petitioned FDA to label their products with the health claim.
"The FDA decision greatly misleads the American consumer," said Steve Wallach, general manager of American Longevity, who added that the FDA decision fails to credit lycopenes as anti-cancer agents except in the context of tomato sauce and tomatoes themselves.
For the past few years, researchers have been publishing studies suggesting that lycopene, the antioxidant that gives tomatoes their red hue, may prevent certain cancers and other diseases. A big source of lycopene comes from processed tomato products. According to Heinz, tomatoes and tomato products are among the top food sources for vitamins C, A, E, potassium, fiber and lycopene.
"These nutrients work in combination to offer health benefits which we are just now beginning to understand," said Dr. Ida Laquatra, director of nutrition for Heinz.
