WASHINGTON - The Food and Drug Administration (FDA) was correct in rejecting demands by dietary supplement companies to make health claims asserting a relationship between dietary fiber and colorectal cancer, according to the Center for Science in the Public Interest (CSPI). CSPI, a non-profit consumer advocacy group, agreed with the FDA’s conclusion that although fiber-rich foods such as fruits and vegetables are linked to a lower risk of colorectal cancer, fiber supplements have not been shown to reduce the risk of that disease.
CSPI said the FDA was also correct in permitting supplement labels to state that women who may become pregnant should consume 400 micrograms of folate daily “from supplements, fortified foods or both, in addition to consuming food folate from a varied diet.”
Supplement companies had sought permission to claim that folic acid supplements could prevent neural-tube birth defects more effectively than a diet rich in foods containing folate, as long as labels carried a disclaimer such as “The FDA believes the evidence in support of this claim is inconclusive.”
Bruce Silverglade, CSPI director of legal affairs, stated that “the FDA was right to prohibit disclaimers that confuse, rather than inform, consumers.”
The FDA actions were the result of a court case, Pearson v. Shalala, brought by supplement companies. The U.S. Court of Appeals concluded in 1999 that the FDA should consider allowing health claims that are not widely recognized as valid by the scientific community if the evidence supporting the claim outweighs the evidence against the claim, and if the claim could be qualified by a disclaimer to prevent consumers from being misled. The Court found that under the First Amendment’s protection of free speech, the FDA could not prohibit supplement companies from using a health claim based on weak evidence without first considering whether a disclaimer regarding the state of the scientific evidence could render the claim not misleading.
“We are pleased by the FDA’s initial decisions but remain concerned that this court-ordered policy ultimately will confuse consumers and weaken the credibility of well-supported claims for dietary supplements. This new policy could make it more difficult for consumers to sort the wheat from the chaff and to choose supplements that really work,” Silverglade said.
“Some supplement companies seem intent on turning the First Amendment into a license to practice quackery. This undermines public confidence—which is unfortunate because many supplements can complement conventional medical treatment,” he said.
The Court decision applies only to dietary supplement claims that specifically mention the name of a disease or symptoms associated with a particular disease. Supplement companies can already make more general claims regarding health conditions without FDA pre-market approval.