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BENEFIT CHOLESTEROL-REDUCING CEREAL WITH PSYLLIUM: FDA

Executive Summary

BENEFIT CHOLESTEROL-REDUCING CEREAL WITH PSYLLIUM: FDA is readying a letter discussing the use of psyllium as a cholesterol-lowering fiber source in General Mills' new Benefit cold cereal. The Center for Food Safety and Applied Nutrition (CFSAN) Division of Regulatory Guidance will be replying shortly to a 1989 letter from a representative of the cereal maker. General Mills is in the process of launching Benefit, which contains beet fiber, wheat and oat bran and rice, in addition to psyllium -- the main ingredient in some bulk laxatives such as Metamucil. An earlier CFSAN letter on psyllium sets forth the agency's position on the grain's use as a food ingredient and appears to telegraph the likelihood that FDA will ask General Mills to submit a GRAS petition for the product. A June 19, 1985 letter notes that psyllium has not been affirmed as generally recognized as safe (GRAS) as a food ingredient. "Since this substance has been used in drug preparations for laxative purposes, we are assuming that your proposed use would be as a source of fiber," FDA said, adding: "In order to legally market food containing psyllium . . . you will need to submit a petition under 21 CFR, 170.35 or 171.1." The letter anticipates and opposes a proposed designation of psyllium as a food supplement. "Since psyllium is neither a vitamin, mineral or protein, nor a significant source of either, it is not a supplement." Beet fiber also is not considered a supplement, and its use in Benefit will be discussed in the forthcoming letter, an agency spokesperson said. Psyllium seed husk is used in laxatives and does hold prior sanction status as an optional food ingredient -- but only in ice cream, ice milk and sherbet at a level no more than 0.5% of the finished product's weight. Benefit is made with whole-grain psyllium. With Benefit, General Mills may be facing a situation similar to Procter & Gamble's Olestra (sucrose polyester) and Nutrasweet's Simplesse fat substitutes: foods with medicinal or preventive claims that have substantial drug-style clinical study backgrounds. P&G took one route to FDA approval when it submitted a food additive petition for Olestra in May 1987. Nutrasweet opted to file for GRAS status for its naturally derived fat substitute following a meeting with FDA Commissioner Young ("The Pink Sheet" Feb. 1, 1988, T&G-3). Young had asserted that a press conference for Simplesse generated major media coverage without prior substantive consultation with the agency. A spokesperson said CFSAN was unaware of General Mills' planned launch until more than two weeks after the cereal was introduced to the media. Benefit's claims are based on a 14-week dietary study of 38 men, aged 24-70, with high cholesterol levels. Conducted at the University of Minnesota Heart Disease Prevention Clinic, the study found that subjects who ate two ounces of Benefit daily for six weeks as part of a low-fat diet showed an average 5.9% decrease in blood cholesterol levels. Those same subjects decreased their blood cholesterol by 3.3% following the American Heart Association's fat-modifying diet for the first eight weeks of the study. Benefit contains 3 grams of soluble fiber and 2 grams of insoluble fiber from oat bran, psyllium and beet fiber, which is "twice the soluble fiber of any other cold cereal," according to General Mills. Press materials for Benefit echo some of the caveats of psyllium laxative labeling. For example, General Mills recommends adding Benefit "to the diet gradually" to avoid gastrointestinal discomfort. The company further recommends that the product not be given to children under two years old, "because most children at that age have difficulty eating cereal flakes and raisins," and that children over two not eat "more than one standard serving of cereal in a single day." Packaging for Benefit Flakes and Flakes with Raisins features a banner on the front of the box stating; "Soluble Fiber when part of a low-fat diet Can Help Reduce Cholesterol." The front of the package also states prominently: "The High Soluble Fiber Cereal Shown to Reduce Cholesterol When Part of a Low-Fat Diet. . . ." The ready-to-eat cereal is being introduced first in Wisconsin and Minnesota. By July, the product is expected to be available in about one-third of the country, General Mills said, with national roll-out dependent on demand.
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