Psyllium seed husk/heart disease health claim for food approved.

PSYLLIUM SEED HUSK/HEART DISEASE CLAIM FOR FOOD APPROVED by FDA in a final rule published in the Federal Register Feb. 18 and effective immediately. The agency is amending current food labeling regulations to allow foods containing soluble fiber from psyllium seed husk, when included as part of a diet low in saturated fat and cholesterol, to bear labeling claiming a link to a reduction of the risk of coronary heart disease (CHD). Soluble fiber from psyllium seed husk has been shown in studies to lower blood total and LDL ("bad") cholesterol.

Psyllium husk currently is used in only one food -- Kellogg's Bran Buds breakfast cereal -- as well as in OTC bulk laxatives such as Metamucil (Procter & Gamble) and Perdiem (Novartis) and in a number of dietary supplement products intended for weight loss and increased fiber intake. FDA believes food manufacturers, inspired by the health claim, will add psyllium seed husk to other foods such as snack bars, fruit drinks, peanut butter, cookies, muffins, bread, pasta and toaster pastries.

The Kellogg Company petitioned FDA for the health claim in June 1996 ("The Tan Sheet" Sept. 30, 1996, p. 7). FDA published a proposed rule in May 1997 ("The Tan Sheet" May 26, 1997, p. 15).

Despite attempts by OTC laxative makers to convince FDA to broaden the health claim for use on psyllium husk-containing laxatives, the final rule applies to foods only.

P&G, in Aug. 4, 1997 comments, urges the agency not to restrict the types or classes of products that may bear the health claim ("The Tan Sheet" Aug. 18, 1997, p. 11). P&G and Ciba-Geigy (now Novartis) attempted to gain FDA approval of a cholesterol-lowering claim for psyllium seed husks in 1995 but did not succeed ("The Tan Sheet" Jan. 9, 1995, p. 8).

In a Feb. 19 response to the final rule, P&G said it is "pleased" by FDA's decision, pointing out that the firm had conducted several of the studies on Metamucil reviewed by FDA during the rulemaking process. FDA says in the final rule the laxative studies were "appropriate in the evaluation of this nutrient/disease relationship," answering a question the agency had posed in the proposed rule.

FDA is requiring foods bearing the health claim to provide at least 1.7 g soluble fiber from psyllium seed husks per reference amount usually consumed, which, multiplied by four eating occasions per day, totals 7 g intake per day (from 10.2 g of psyllium seed husks).

P&G's Metamucil, taken one to three times daily, provides 3.4 g psyllium husk fiber per dose, up to 10.2 g total per day. Several Metamucil formulations contain psyllium hydrophilic mucilloid instead of the husk fiber. Novartis' Perdiem Fiber contains 4 g psyllium per teaspoon and Perdiem with sennosides contains slightly less, 3.3 g per teaspoon. Users are directed to take 1-2 teaspoonfuls in the evening and/or before breakfast, resulting in a maximum daily intake of 16 g.

FDA concludes that Kellogg has provided evidence supporting the safety of consumption up to 25 g per day of psyllium husk, giving final approval to the company's GRAS (generally recognized as safe) affirmation petition.

Foods containing dry or incompletely hydrated psyllium husk bearing the health claim also must carry a label statement informing consumers they need to ingest the food with adequate amounts of liquid and avoid eating the food if they have an impaired ability to swallow (e.g., "NOTICE: This food should be eaten with at least a full glass of liquid. Eating this product without enough liquid may cause choking. Do not eat this product if you have difficulty in swallowing"). Foods that do not pose a choking risk may be exempt from the warning requirement. OTC drugs containing water soluble gums such as psyllium husk and in a dry or partially hydrated form are required to bear similar warning and direction statements.

"The agency recognizes that there are inherent differences between foods in conventional food form, which contain other food ingredients such as salt, sugar and flour in addition to psyllium husk, and OTC drug products that would influence the likelihood of esophageal obstruction occurring from the ingestion of psyllium husk-containing foods," the final rule says. "For example, drug products are formulated in tablets, capsules and powders that are usually intended to be ingested and swallowed in a single bolus, whereas a serving of food is not swallowed as a single bolus, but eaten in several bites, chewed and swallowed over a period of time," FDA states. In addition, the psyllium husk in a conventional food is dispersed within a larger volume of other food components, the rule notes.

Psyllium husk-containing OTC laxatives also bear a warning regarding the chance of allergic reaction to psyllium in people who have ingested or inhaled the product, which is frequently in the form of a powder. However, FDA is not requiring an allergy warning for food, explaining that the majority of the allergic reactions reported involved ingestion of a product made with psyllium husk of less than 95% purity. Accordingly, the final rule specifies the psyllium husk used in food must be no less than 95% pure, as determined by the U.S. Pharmacopeia.

The psyllium seed husk health claim augments FDA's January 1997 reg allowing a health claim for soluble fiber from whole oats and a reduced risk of CHD ("The Tan Sheet" Jan. 27, 1997, In Brief). At the time, FDA acknowledged that other sources of soluble fiber likely could affect blood lipid levels, thus lowering the chance of heart disease. However, because the substances are so different from one another, the agency decided to approach them on a case-by-case basis.