The FDA has proposed a rule that would amend the regulation permitting food labeling bearing a health claim on soluble fiber for a lower risk of coronary heart disease (CHD) to include soluble fiber from psyllium husks (Plantago asiatica L., Plantaginaceae). The qualifying level of psyllium fiber is proposed to be 10.2 g per total daily intake (about 7 g of soluble fiber). This proposal, published in the May 22 Federal Register, is a result of Kellogg Co. filing a petition in June 1996 requesting that foods which contain a certain amount of psyllium become eligible for the reduced CHD risk claim. The cereal manufacturer's petition contained data from 57 clinical studies (1965-1996 -- including 21 human studies) on psyllium's effects in lowering cholesterol and the risk of coronary heart disease.

Psyllium, a harvestable grain mostly grown in France, Spain, and India, is cultivated in small amounts in the southwestern United States. The FDA is not certain whether 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 1993 report from the Federation of American Societies for Experimental Biology's (FASEB) Life Sciences Research Office determining that psyllium is safe at levels up to 25 g per day.

However, the FDA expressed "some concern" about psyllium's long-term risk, in which high levels of psyllium husk "may enhance epithelial cell proliferation in the gastrointestinal tract or cause allergies in some people. There is no agreement in the scientific community, however, whether such an increase in cell proliferation is related to an adverse health effect."

Psyllium husk can also cause allergic reactions in some people, FDA notes. Increasing the purity of the husk by mechanical sieving can reduce the allergy-causing substances; therefore, FDA is proposing specifications for purity of no less than 95 percent and requests comments on them. In addition, the notice asks, "Are other steps such as requiring that a psyllium-containing product that bears a health claim declare on its principal display panel that psyllium is present in the food, necessary?"

FDA is asking for comments on the subject. Two other companies, Procter & Gamble and Ciba-Geigy, have tried to receive FDA approval for a cholesterol-lowering claim on their psyllium-based laxatives, (Metamucil(R) and Perdiem(R), respectively), but have not received it.

[Health Supplement Retailer. 1997. p. 35. Federal Register 1997. May 22.

F-D-C Reports -- "The Tan Sheet." 1997. p. 15. May 26.]

Article copyright American Botanical Council.

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By Barbara A. Johnston