Dietary Fiber - FDA-approved Health Claims

FDA-approved Health Claims

The FDA allows producers of foods containing 1.7g per serving of psyllium husk soluble fiber or 0.75g of oat or barley soluble fiber as beta-glucans to claim that reduced risk of heart disease can result from their regular consumption.

The FDA statement template for making this claim is: Soluble fiber from foods such as, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of supplies __ grams of the soluble fiber from necessary per day to have this effect.

Eligible sources of soluble fiber providing beta-glucan include:

1. Oat bran
2. Rolled oats
3. Whole oat flour
4. Oatrim
5. Whole grain barley and dry milled barley
6. Soluble fiber from psyllium husk with purity of no less than 95%

The allowed label may state that diets low in saturated fat and cholesterol and that include soluble fiber from certain of the above foods "may" or "might" reduce the risk of heart disease.

As discussed in FDA regulation 21 CFR 101.81, the daily dietary intake levels of soluble fiber from sources listed above associated with reduced risk of coronary heart disease are:

• 3g or more per day of beta-glucan soluble fiber from either whole oats or barley, or a combination of whole oats and barley
• 7g or more per day of soluble fiber from psyllium seed husk.

Soluble fiber from consuming grains is included in other allowed health claims for lowering risk of some types of cancer and heart disease by consuming fruit and vegetables (21 CFR 101.76, 101.77, and 101.78).