ISABGOL

FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

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T98-7                           Print Media:         202-205-4144 February 17, 1998                                                Consumer Inquiries:  800-532-4440  

FDA ALLOWS FOODS CONTAINING PSYLLIUM
TO MAKE HEALTH CLAIM ON REDUCING RISK OF HEART DISEASE

FDA today ruled that labels on certain foods containing soluble fiber from psyllium seed husk (PSH), such as certain breakfast cereals, may claim that these foods, as part of a diet low in saturated fat and cholesterol, may reduce the risk of coronary heart disease (CHD).

The following may be used to answer questions.

FDA authorizes health claims on food labels under provisions of the Nutrition Labeling and Education Act of 1990 to ensure that claims are accurate and not misleading to consumers. Health claims are authorized only if, based on the totality of publicly available scientific evidence, there is significant scientific agreement that the claim is true.

The psyllium health claim is an amendment to the FDA regulation published on January 23, 1997, which allows a health claim on the association between soluble fiber from whole oats and a reduced risk of coronary heart disease. In allowing the whole oats-CHD health claim, FDA acknowledged the likelihood that soluble fiber from sources other than whole oats could affect blood lipid levels and thus lower the risk of heart disease. However, since soluble dietary fibers are a family of very heterogeneous substances that vary greatly in their effect on risk of CHD, a case-by-case approach is necessary to evaluate petitions for health claims for soluble fiber. The new amendment adds PSH to the sources of soluble fiber allowed to carry the claim for the nutrient-disease relationship of soluble fiber and CHD.

During this rulemaking, FDA evaluated placebo-controlled studies that tested an intake of 10.2 grams of PSH (about 7 grams of soluble fiber) per day as part of a diet low in saturated fat and cholesterol. These studies showed consistently significant blood total- and LDL-cholesterol lowering effects. Foods carrying the health claim must provide at least 1.7 grams of soluble fiber from PSH per reference amount customarily consumed of the product. This single-serving size, multiplied by 4 eating occasions per day, totals the 7-gram per day intake of the controlled studies.

The soluble fiber of psyllium comes from the dried husk of the psyllium seed. Psyllium, primarily cultivated in India, is known as blond or Indian psyllium. Currently it is used in Kellogg's Bran Buds and in a variety of dietary supplement products promoted for increased fiber intake and as aids for weight loss.

Because some foods containing PSH can be difficult to swallow, foods carrying the PSH health claim must also have a label statement advising of the need to consume the food with adequate amounts of liquid and to avoid eating the food if one has difficulty swallowing. Certain foods that do not pose such a choking risk may be exempt from this requirement.

An example of how the newly allowed health claim may be used is:

• "The soluble fiber from psyllium seed husk in this product, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease."

The new health claim responds to a petition submitted by the Kellogg Company and will be published February 18, 1998 in the Federal Register to become effective immediately.

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