FDA Denies Lycopene Supplement Health Claims

Agency says there's little proof to substantiate cancer-prevention assertions

WEDNESDAY, Nov. 9, 2005 (HealthDay News) -- The U.S. Food and Drug Administration has determined that the antioxidant lycopene is not likely to reduce the risk of cancer.

Supplement maker American Longevity had sought FDA approval to make cancer-fighting claims for its lycopene supplements. But the agency concluded that "there is no credible evidence to support qualified health claims for lycopene, as a food ingredient, component of food, or as a dietary supplement, and reduced risk of any of the cancers in the petition."

The malignancies that are supposedly inhibited by lycopene -- an antioxidant found in red fruits such as tomatoes and watermelon -- include prostate, gastric, ovarian and pancreatic cancer. However, for each of these cancers, the FDA said a review of studies found there was "uncertain" or "little scientific evidence" that lycopene conferred any benefits.

Several years ago, the H.J. Heinz Co. took out full-page ads proclaiming the health benefits of lycopene, and ketchup sales rose 4 percent. The FDA ordered the company to stop the ads because such claims required the agency's approval, according to the Boston Globe.

The FDA's ability to regulate dietary supplements is limited. The agency can take action against any unsafe dietary supplement after it reaches the market. Manufacturers do not need to register their products with the FDA, or get FDA approval before producing or selling dietary supplements. However, manufacturers must make sure that product labels are "truthful and not misleading."

The FDA announced its decision on lycopene in a Nov. 8 letter to American Longevity.

In response, the San Diego-based company said it would sue the agency within 30 days. "It's a violation of the First Amendment. We have all the evidence to back up our claim, and we should be able to tell the public," said American Longevity spokeswoman Brooke Holve.

American Longevity fought a similar battle over the cancer-prevention claims made for the mineral selenium. The company's effort got the FDA to change its position in 2003, and it is hoping that the lawsuit will do the same for lycopene, Holve said.

Holve said the FDA now allows selenium supplements to say on the label that they "may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce certain forms of cancer." The label must also say: "The FDA has determined that this evidence is limited and not conclusive."

Dr. Michael Thun, vice president for epidemiology and surveillance research at the American Cancer Society, thinks that the position taken by the FDA on lycopene is well reasoned.

"The FDA is beset by companies hoping to make health claims," Thun said. "The FDA's reasoning for the decision was clearly laid out."

Thun said he also wonders whether the health claims made for lycopene truly come from lycopene. "Foods are complex mixtures, and it is a leap of faith to say that one substance in isolation is the reason for the benefit. In addition, things that come in the context of a complex food are different from things that come in isolation at a different dose," he said.

The FDA must ensure that health claims, either direct or implied, are adequately supported by evidence, Thun said. "The FDA clearly put a lot of work into this review," he said.

More information

The National Cancer Institute can tell you more about antioxidants and cancer.

SOURCES: Brooke Holve, spokeswoman, American Longevity, San Diego, Calif.; Michael Thun, M.D., vice president, Epidemiology and Surveillance Research, American Cancer Society, Atlanta
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