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FDA Confuses Consumers by Allowing Dubious Health Claims on Foods, FDA Study Finds

September 29, 2005

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The Food and Drug Administration’s (FDA) policy of allowing preliminary health claims on food labels misleads consumers and has "failed the key communications test," according to a previously undisclosed FDA study obtained by the Center for Science in the Public Interest (CSPI).

In 2002, the Bush administration reversed a decade-old policy requiring that health claims be based on sound science. Under the new policy, which the food industry helped craft, health claims are generally permitted regardless of the state of scientific evidence as long as companies include a disclaimer such as the scientific evidence supporting a claim is “limited and inconclusive.”

For instance, the FDA authorized a label claim that green tea may reduce the risk of breast and prostate cancer, as long as the label also states that the agency believes it is “highly unlikely” green tea has such an effect.

“The new FDA study clearly demonstrates that preliminary health claims lead to deception,” said CSPI director of legal affairs Bruce Silverglade. “The FDA should immediately cease authorizing preliminary health claims and withdraw approval for those that it has allowed.”

Those claims are permitted so long as they are qualified by terms like “scientific evidence suggests but does not prove,” or state that the claim is based on “supportive but not conclusive research.” The FDA study found that those qualifying statements don’t “reliably convey the intended level of scientific support for a health claim,” and that people in the study “attributed more certainty to claims with disclaimers than those without disclaimers.”

Among the preliminary health claims sanctioned under the policy are claims that nuts, olive oil, and foods containing omega-3 fatty acids can reduce the risk of heart disease. Under consideration are claims that whey protein in infant formula may reduce the risk of food allergies in infants, lycopene may reduce the risk of cancer, and that lutein may reduce the risk of cataracts and macular degeneration.

The food industry has long pressured the FDA to authorize claims without waiting for scientific agreement.

A 1990 law requires the FDA to only authorize health claims for foods that are supported by “significant scientific agreement.” The industry argued that the FDA should instead follow a 1999 U.S. Court of Appeals decision that dietary supplement manufacturers had a First Amendment right to make preliminary health claims so long as disclaimers prevented consumer deception. However, the court said that the FDA did not have to authorize preliminary health claims if the agency had evidence demonstrating that consumers would be “bewildered” and that the disclaimers “would fail to correct for deceptiveness.”

“The FDA’s current policy allows companies to dupe consumers into thinking that this food or that food is the key to reducing the risk of cancer and heart disease,” Silverglade said. “The courts have made it clear that the First Amendment is not a license to practice quackery, but that is exactly what the Bush FDA policy sanctions.”

CSPI obtained the study by filing a request under the Freedom of Information Act, which the FDA had initially declined. FDA had even declined to make the report available to several members of Congress. Shortly after turning over the study to CSPI the FDA put the study, Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims, on its web site at http://www.fda.gov/OHRMS/dockets/dockets/03N0496/03N-0496-rpt0001.pdf.

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