FDA Does Not Authorize Two Health Claims

WASHINGTON--In a follow-up to its interim enforcement strategy for Pearson v. Shalala, the Food and Drug Administration (FDA) did not authorize two of four health claims to be used for dietary supplements. FDA determined that these health claims--for fiber and folic acid--could not be "appropriately qualified." However, FDA considered whether the claims could be reworded with appropriate qualifying language.

FDA found that the claim stating that dietary fiber may reduce the risk of colorectal cancer could not be authorized because studies about dietary fiber "consistently showed a lack of relationship between dietary fiber supplements and the risk of colorectal cancer," according to the agency's "Talk Paper." FDA also found evidence against the claim outweighed the evidence for it, one of the agency's prerequisites for establishing a health claim.

FDA did not authorize the second proposed claim--that 0.8 mg of folic acid in supplement form was more effective than lower amounts found in food reduced the risk of neural tube defects-because it said the claim could not be appropriately qualified without being misleading. However, FDA did provide examples of appropriate qualified claims.

FDA will decide on the two remaining claims--one for antioxidant vitamins and cancer, and the other for omega-3 fatty acids and coronary heart disease--no later than Oct. 24.

The National Nutritional Foods Association (NNFA) released a statement that FDA should be flexible on health claims for dietary supplements, but that adequate scientific standards should continue to be upheld. "My impression is that FDA relied on a thorough review of the science for their determination," said Phil Harvey, Ph.D., NNFA's director of science and quality assurance. "Although the outcome is not what some would have liked, the process was fair."

For additional information, visit www.cfsan.fda.gov/~lrd/tppearso.html.

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