FDA Strikes Down Antioxidant/Cancer Health Claim

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FDA Strikes Down Antioxidant/Cancer Health Claim

WASHINGTON--After almost six months of dragging its feet, the Food and Drug Administration (FDA) struck down a health claim for the relationship between antioxidants and cancer. In a May 4 letter to the plaintiffs who petitioned for the claim, the director of the Office of Nutritional Products, Labeling and Dietary Supplements, Christine Lewis, stated that there was a lack of scientific agreement among qualified experts in regard to the relationship between the intake of antioxidant vitamins, such as vitamins C and E, and a decreased risk for certain kinds of cancer. This is the last of four claims FDA has reviewed under the Pearson v. Shalala decision.

According to FDA, it reviewed scientific evidence for the claims by conducting a literature search and publishing two notices in the Federal Register soliciting comments. It then reviewed the validity of these health claims by applying the "significant scientific agreement" standard and evaluating whether evidence for the claim outweighed the evidence against the claim. FDA found that the scientific evidence against vitamins E and C, both alone and in combination, far outweighed the evidence that supported the antioxidants' benefits for cancer. Due to the lack of scientific evidence, the agency reported that it thoroughly evaluated the safety of vitamin C and E supplements, although the letter did cite two studies where these vitamins possibly increased the risk for cancer. "Should the scientific evidence change in the future ... FDA would consider these potential safety concerns at that time," wrote Lewis.

Some believe there is more than enough evidence suggesting that antioxidants offer health benefits. "The more information we can get to the public through health claims, the healthier the country will be," said Susan Carlson, co-founder of Arlington Heights, Ill.-based J.R. Carlson Laboratories Inc. "Any way that we can get information to the public is to everyone's advantage." Carlson Labs produces a wide range of supplements, including vitamin E and other antioxidants.

Though not every type of cancer may be impacted by antioxidants, that does not mean certain vitamins cannot benefit certain cancers. "Of all of the claims [under Pearson v. Shalala], I don't consider this one to be the strongest," said Annette Dickinson, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN). "But I'm not willing to say that one or more of these cancers [may not benefit from antioxidant intake]." She added that one drawback in reviewing health claims is knowing where to draw the line as to how much scientific evidence is needed to support a claim.

Although the agency decided to withhold a qualified health claim, FDA could have come back with a disclaimer--something FDA failed to evaluate, according to Jonathan Emord of Emord & Associates P.C., the law firm that received FDA's letter and which represents the Pearson v. Shalala plaintiffs. "This was a less restrictive alternative to outright suppression [of the claim]."

Emord said he believed politics rather than science drove FDA to make this decision. "There is no question that the process of reducing free radicals reduces cancer risk," he said. "The agency's analysis looks at the wrong matter [in some cases]--they've demanded evidence that antioxidant vitamins actually mitigate ... polyps and elevated PSA. Our claim has nothing to do with treatment [but with risk]."

Emord said that one possible action taken by the plaintiffs might be to seek a court order directing FDA and certain FDA officers to comply with the order under threat of contempt and personal liability.

To read the FDA letter, visit www.emord.com.

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