validated methods
ISO
Expedited tracked shipping worldwide
A multi award winning company

United States FDA Health Claims

The four approved health claims for fiber containing products are outlined in detail below:

1) Fiber-containing foods and cancer

Grain products, fruits or vegetables that are a naturally “good” source of fiber, may state that a low fat diet containing grain, fruit or vegetable sources of dietary fiber can reduce the risk of “some types of cancer.” No claim is permitted for “dietary fiber and cancer.”

The US Food and Drug Administration has provided the following Model Health Claims for fiber-containing foods and cancer:

  • “Low fat diets rich in fiber-containing grain products, fruits and vegetables may reduce the risk of some types of cancer, a disease associated with many factors.”
  • “Development of cancer depends on many factors. Eating a diet low in fat and high in grain products, fruits and vegeta­bles that contain dietary fiber may reduce your risk of some cancers.”

Specific requirements for this health claim are:

  • The food must be, or contain, a grain product, fruit, or vegetable.
  • The food must qualify as “low fat” (i.e., generally 3 g or less total fat per reference amount).
  • The food must qualify, without fortifica­tion, as a “good source” of dietary fiber (i.e. generally 2.5 g or more dietary fiber per reference amount).

For more information please see 21 CFR 101.76

2) Fiber-containing foods and coronary heart disease

Grain products, fruits or vegetables, that qualify as “low saturated fat”, “low cholesterol” and “low-fat” and contain, without fortification, at least 0.6 g soluble fiber per reference amount may state that diets low in saturated fat and cholesterol may reduce the risk of coronary heart disease.

The US Food and Drug Administration has provided the following Model Health Claims for fiber-containing foods and coronary heart disease:

  • “Diets low in saturated fat and cholesterol and rich in fruits, vegetables and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors.”
  • “Development of heart disease depends on many factors. Eating a diet low in sat­urated fat and cholesterol and high in fruits, vegetables and grain products that contain fiber may lower blood cholesterol levels and reduce your risk of heart disease.”

Specific requirements for this health claim are:

  • The food must be, or contain, a fruit, vegetable, or grain product.
  • The food must qualify as “low saturated fat” (i.e. generally l g or less saturated fat per reference amount and no more than 15% of calories from saturated fat).
  • The food must qualify as “low cholesterol” (i.e. generally 20 mg or less cholesterol and 2 g or less saturated fat per reference amount).
  • The food must qualify as “low fat” (i.e. generally 3 g or less total fat per reference amount).
  • The food must contain, without fortifica­tion, at least 0.6 g of soluble fiber.
  • Soluble fiber content must be declared in nutrition labeling.

For more information please see 21 CFR 101.77 

3) Fruits and Vegetables and Cancer

A food that is, or contains, fruit or vegetables, is “low fat” and a naturally “good” source of Vitamins A or C or fiber may state that diets low in fat and high in fruit or vegetables that can contain Vitamins A or C or fiber “may” reduce the risk of some cancers. If the fruit or vegetable is an ingredient, it must be identified along with its relevant qualifying constituents.

No claim may be made for “antioxidant vitamins and cancer.”

The US Food and Drug Administration has provided the following Model Health Claims for Fruits and Vegetables and Cancer

  • “Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, Vitamin A, and Vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. [Broccoli] is high in Vitamins A and C, and it is a good source of dietary fiber.”
  • “Development of cancer depends on many factors. Eating a diet low in fat and high in fruits and vegetables, foods that are low in fat and may contain Vitamin A, Vitamin C and dietary fiber, may reduce your risk of some cancers. [Oranges], a food low in fat, are a good source of fiber and Vitamin C.”

Specific requirements for this health claim are:

  • The food must be or contain a fruit or vegetable.
  • The food must qualify as “low fat” (i.e. generally 3 g or less total fat per reference amount).
  • The food must qualify, without fortifica­tion, as a “good source” of at least one of the following: Vitamin A, Vitamin C, or dietary fiber (i.e. generally at least 500 IU or more Vitamin A, 6 mg or more Vitamin C, or 2.5 g or more per dietary reference amount).

For more information please see 21 CFR 101.78

4) Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease

A food containing at least 0.75 g of soluble fiber from certain whole oat or barley foods per reference amount or at least 1.7 g of soluble fiber per reference amount from psyllium or at least 0.75 g beta-glucan soluble fiber from oatrim and meeting the requirements for a “low saturated fat”, “low cholesterol” and “low fat” food may state that diets low in saturated fat and cholesterol that include soluble fiber from eligible sources may reduce the risk of coronary heart disease.

The food must contain oat bran (providing at least 5.5% beta-glucan on a dry weight basis and total dietary fiber content of 16% of which one-third is soluble fiber,) or rolled oats (providing at least 4% of beta-glucan and a total dietary fiber of at least 10%) or whole oat flour (providing at least 4% of beta-glucan soluble fiber and a total dietary fiber content of at least 10%) or psyllium husk which meets certain specifications or the soluble fraction of alpha-amylase hydrolysed oat bran or whole wheat flour, also known as oatrim providing up to 10% (dwb) and not less than that of the starting material (dwb) of beta-glucan soluble fiber or whole grain barley with a beta-glucan soluble fiber content of at least 4% (dwb) and a total dietary fiber content of at least 10% (dwb). The amount of soluble fiber must be declared in the nutrition label.

The US Food and Drug Administration has provided the following Model Health Claims for Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease.

  • Soluble fiber from foods such as [name soluble fiber source specified in the regulation and, if desired, name of food product], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.  A serving of [name of food] supplies ____ grams of the [specify soluble fiber listed in the regulation] soluble fiber from [specify the soluble fiber source from those listed in the regulation] necessary per day to have this effect.
  • Diets low in saturated fat and cholesterol that include ____ grams of soluble fiber [from a source specified in the regulation] per day from [name of soluble fiber source specified in the regulation and, if desired, the name of the food product] may reduce the risk of heart disease.  One serving of [name of food] provides ____ grams of this soluble fiber.

Specific requirements for this health claim are:

  • The amount of soluble fiber must be declared in the Nutrition Facts Panel.
  • The food shall meet the nutrient content requirements for a “low saturated fat”, “low cholesterol”, and “low fat” food.
  • Foods containing psyllium husk must bear a label statement that the appropriate use of such foods requires adequate consumption of fluids to prevent swallowing difficulties. (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.”)  However, a product in conventional food form may be exempt from this requirement if a viscous adhesive mass is not formed when the food is exposed to fluids. 

For more information please see 21 CFR 101.81

To return to the section on regulation, click
here