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This article was originally published in The Tan Sheet

Executive Summary

FDA FOOD ADVISORY COMMITTEE SPLITS ON GENERAL CONCEPT OF HEALTH CLAIMS for food products and dietary supplements at an Oct. 14 meeting of the Food Advisory Committee and its Folic Acid Subcommittee. When asked by Subcommittee Chairperson Edward Brandt, MD/PhD, University of Oklahoma, if the joint committee supported health claims on food labels "generally, irrespective of the folic acid [health] claim," the joint committee responded with an 8-8 vote (with five abstentions). Many committee members appeared uncomfortable with the concept of health claims on food and dietary supplement labels, suggesting, instead, that a general promotion of healthy foods would be more beneficial. Food Advisory Committee member Marion Nestle, PhD, New York University, was concerned with "singling out one vitamin [in foods] for a particular health claim" when "there are many other reasons to consume fruits and vegetables." Joan Dye Gussow, Columbia University, asserted that "general health claims on foods are a bad idea because they focus on single nutrients" when "combinations of foods are much healthier." Folic Acid Subcommittee member Irwin Rosenberg, MD, Tufts University, commented, however, that although many experts in the scientific community are wary of health claims, they can "no longer avoid the issue." "Congress has said there will be health claims," Rosenberg observed, "[and] I have a responsibility here . . . to look at this health claim in the context of what has been determined to be national policy." He stressed that health claims will continue to be approved and that the committee must focus on "this mechanism" of education so as not to mislead the public. David Lineback, PhD, University of Idaho, underscored Rosenberg's point when he emphasized that the existence of health claims is not in question; rather, it is the issue of whether "the evidence that we have meets the guidelines of what a health claim should have." FDA convened the joint meeting of the Food Advisory Committee and the Folic Acid Subcommittee in order to gather comments on the proposed rules allowing a folic acid health claim and fortification of grain products with folic acid. Although announced on Oct. 7, the proposed rules did not appear in the Federal Register until Oct. 14 ("The Tan Sheet Oct. 11, p. 4). In comments to the advisory committees, FDA's Center for Food Safety and Applied Nutrition Director Fred Shank said that "FDA has . . . proposed that there be a health claim" for folic acid and that it is the agency's "judgment that . . . there will be one." However, Shank also stressed to the committee the importance of their comments to FDA on how the claim should be constructed. "We're asking you all to help out to make sure that we get the best label statements that we can," he said. Nevertheless, Folic Acid Subcommittee member Jane Zones, PhD, University of California, expressed to the committee her "mixed feelings" for the health claim. "I do agree that there is good evidence for a dietary claim [that] increased folate . . . reduces neural tube defects," she declared. "I think what I'm concerned about are the unknowns regarding safety." Zones also emphasized the need for more research on the safety and efficacy of different levels of folic acid. Food Advisory Committee member Marsha Cohen, Hastings College of Law, also suggested that the increase in dietary folate to help a small target population may not be worth the dangers that excess folate could pose to a larger at-risk population. Unlike other health claims that deal with "the prevention of chronic, long developing conditions" such as osteoporosis and cancer, the folic acid health claim, Cohen noted, "is directed to a very narrow target population . . . and may have a down-side risk if the wrong [people] take too much." Rosenberg suggested to the committee that a health claim with "specific recommendations" would most benefit the public and be "very useful from a nutrition education point of view." A more specific claim could also warn the specific at-risk population, Rosenberg stated, with a clarification similar to that in the Public Health Service's recommendation: "effects of high intakes [of folate] are not well known but include complication of the diagnosis of vitamin B[12] deficiency." Other committee members disagreed with Rosenberg, stating that a lengthy health claim would only confuse consumers. Subcommittee member Lynn Bailey, PhD, University of Florida, reminded the committee that they should consider the level of consumer understanding when composing the label. "We should keep in mind," she continued, "the group who would most benefit -- the less educated and lower socioeconomic groups." Subcommittee member Barbara Alving, MD, Walter Reed Army Research Center, suggested making the label "consumer usable" and questioned whether many consumers will understand terms like "folic acid"' and "neural tube defects." Hoffmann-La Roche Senior Clinical Research Coordinator Adrienne Bendich, PhD, in a presentation to the joint committee, advised that a simply stated health claim -- such as "may reduce the risk of some serious birth defects" -- would be the best way to communicate the benefits of the nutrient. A label with a "myriad of caveats," she contended, would deter women who have been protected by the supplements from taking them. Speaking for the Council for Responsible Nutrition, Pharmavite Regulatory Affairs Director Paul Bolar added that "the label can't do the whole job. Many of these ancillary claims should be considered optional . . . and could be communicated by other educational means." Despite being divided over a folic acid health claim, the joint committee overwhelmingly supported the idea of a nutritional education program. Brandt noted that "this group, on at least two occasions" has endorsed a public education program. Zones restated her opposition to a folic acid health claim and fortification but strongly supported, instead, a "mass education of women" as well as supplement use during childbearing years. National Cancer Institute Division of Cancer Prevention and Control Director Peter Greenwald, MD, indicated he supported the health claim "with some minor refinements" in the context of a broader research agenda that would "include attention to the effects on children, the safety . . . issue and the potential benefits" of folate for diseases such as heart disease and cancer. The Food Advisory Committee and Folic Acid Subcommittee also heard from a panel of scientists representing three public health agencies -- the Centers for Disease Control, the National Institutes of Health, and the Health Resources and Services Administration -- regarding fortification of grain products with folic acid. CDC's Chronic Disease Control Division Director Marjorie Speers supported fortification, maintaining that the potential for preventing neural tube defects increases as the level of fortification goes up while the potential cases of adverse effects remain reasonably small. Representatives from NIH and HRSA voiced reservations on the fortification proposal, however. They asserted that the lack of information concerning the potential harmful effects of folic acid should not be ignored when considering fortification of foods that will reach the entire population.

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