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 last of four claims FDA has reviewed under the Pearson v. Shalala decision.

Last November, the agency allowed a qualified claim for vitamin B6, B12 and folic acid reducing the risk of heart disease and a modified claim for omega 3's role in reducing cardiovascular disease. As of early April, FDA was battling with the courts to have its disclaimer accompany the health claim for folic acid decreasing the risk for neural tube defects. [For the latest on this court decision on this health claim, see www.naturalproductsinsider.com/hotnews/15h11151114.html.]

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 whether evidence for the claim outweighed the evidence against the claim. FDA found that the science evidence against vitamin 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 did thoroughly evaluate 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 that there is more than enough evidence that suggests 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 antioxidant products.

And even though not every type of cancer may benefit from 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 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.

"The FDA was not acting out of hand by denying this claim at the present time," said David Seckman, executive director and chief executive officer of the National Nutritional Foods Association (NNFA). "Cancer is a complex disease and although there have been studies that correlate the use of antioxidants with reduced cancer risk, the claim is simply a little ahead of the science." He added that within a few years' time, more substantive studies will give this claim legs.

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, elevated PSA . and actual reduction in cancer. Our claim has nothing to do with treatment [but with risk]."

Emord added that the plaintiffs still have to review the 77-page letter and 15 pages of notes. He said that one possible action taken by the plaintiffs may 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.