FDA Proposes Health Claim for Psyllium.

Washington, D.C.- According to the May 22 Federal Register, the FDA proposed a rule that would amend the regulation permitting food labeling bearing a health claim on soluble fiber from whole oats and a lower risk of coronary heart disease to include soluble fiber from psyllium husks. The qualifying level of psyllium fiber is proposed to be 10.2g per total daily intake. This proposal is a result of Kellogg Co. Filling a petition in June 1996 requesting that foods that contain a certain amount of psyllium become eligible for the reduced coronary heart disease risk claim. The cereal manufacturer’s petition contained data from 57 clinical studies on psyllium’s effects on lowering cholesterol and the risk of coronary heart disease dated from 1965-1996.
Psyllium, a harvestable grain mostly grown in France, Spain and India, according to Health Daily News, is cultivated in small amounts in southwestern United States. The FDA is not certain that it will consider psyllium husk in grain based food applications as generally recognized as safe (GRAS), which Kellogg requested. According to the FDA, ” a preliminary review of the GRAS affirmation petition reveals that it contains significant evidence supporting the safety of the use of this substance at the levels necessary to justify a health claim”. The FDA refers to a report from the Federation of American Societies for Experimental Biology’s Life Sciences Research Office determining that psyllium is at safe levels of up to 25 g per day.

However, the FDA expressed concern about psyllium’s long tern risk, in which high levels of psyllium husk “may enhance epithelial cell proliferation in the gastrointestinal tract,” or cause allergies in some people. Two other companies, Proctor and Gamble and Ciba-Geigy have tried to receive FDA approval for a Cholesterol-lowering claim on their psyllium-based laxatives, Metamucil and Perdiem, respectively, but have not received it. (as taken from the Federal Register, Health Daily News and Health Supplement Retailer).