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PSYLLIUM FOOD ADDITIVE OR GRAS PETITIONS FOR BENEFIT, HEARTWISE

Executive Summary

PSYLLIUM FOOD ADDITIVE OR GRAS PETITIONS FOR BENEFIT, HEARTWISE cereals were requested by FDA in Sept. 29 letters from FDA Regulatory Affairs Acting Associate Commissioner Ronald Chesemore to General Mills counsel Stuart Pape (Patton, Boggs, & Blow) and Kellogg Senior-VP Science and Technology Daryl Schaller, PhD. Both companies "should submit a food additive or GRAS [generally recognized as safe] affirmation petition to demonstrate the safety of psyllium as a source of dietary fiber in cereal," Chesemore advised in the virtually identical letters. "On the basis of the data available to us, FDA is of the opinion that the use of psyllium husks in the [Heartwise/Benefit] . . . cereal has not been shown to be generally recognized as safe," FDA said. "Therefore," the agency added, "we intend to publish a Federal Register notice to propose to find that psyllium seed husks are not GRAS in cereals at the level found in [Heartwise/Benefit]." Chesemore pointed out that "although psyllium seed husks are prior-sanctioned as optional ingredients in frozen desserts, the sanction is limited to a level of not more than 0.5% of the weight of the finished product." The psyllium levels in the cereals, FDA maintained "would represent a very significant increase in exposure to psyllium from the prior-sanctioned food use." Citing possible safety considerations, FDA commented that "increasing the ratio of soluble to insoluble dietary fiber components by adding isolated polysaccharides to the diet has the potential for harmful intestinal effects including depletion of beneficial colonic bacteria, constipation, fecal impaction, or altered nutrient intake or absorption." "Dietary ratios of 75%-80% insoluble fractions of dietary fiber have a long history of safe use," FDA noted, adding: "We are unaware, however, of evidence that the deviations from these ratios that would result from the addition of large amounts of soluble fibers to breakfast cereals are safe." The agency remarked that General Mills even recognizes the potential for adverse effects by a statement on the Benefit package which advises the consumer to "gradually increase amount." FDA may propose "to find that psyllium at the levels in [Benefit/Heartwise] is a drug," the agency warned General Mills and Kellogg. "We are concerned that the potential levels of psyllium consumed by eating [Benefit/Heartwise] will result in a psyllium intake equivalent to the levels found in OTC drug products," the letters state. Thus, "the allegation could be made that [Benefit/Heartwise] is serving as a delivery vehicle for a drug," Chesemore pointed out. Proctor & Gamble sent FDA a letter in June urging the agency to remove Benefit from the market because it contained psyllium, an ingredient of its OTC laxative Metamucil, and therefore should be regulated as a drug product. Both P&G and Ciba-Geigy, the maker of psyllium-containing Fiberall, have petitioned the agency to allow cholesterol-lowering claims for psyllium in the OTC laxative monograph. However, the agency informed the companies in August 1988 that the existing clinical data was insufficient to support cholesterol-reduction claims. In the letters to the cereal makers, the agency does not address the health claims issue so much as the basic safety of the products. Although the agency is "concerned about the potential misleading nature of numerous claims made" for Benefit and Heartwise, FDA explained that not until "the GRAS/food additive issues are resolved, will [the agency] be willing to comment further on the specific food labeling concerns." FDA has been working on its policy regarding psyllium-containing food products that make cholesterol-reducing claims since General Mills rolled out Benefit cereal in May ("The Pink Sheet" May 15, T&G-7). Kellogg introduced Heartwise in August, with similar claims associating high soluble fiber content from psyllium with cholesterol-lowering attributes ("The Pink Sheet" Sept. 4, T&G-14). FDA is also preparing to develop guidelines on food labeling issues.
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