Description
This guidance is intended to identify for manufacturers specific, additional isolated or synthetic non-digestible carbohydrates that we intend to propose adding to the list of those that meet our regulatory definition of "dietary fiber" (21 CFR 101.9(c)(6)(i)).
Scope & Applicability
Product Classes
1The category of non-digestible carbohydrates being declared on labels.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
1The energy contribution of allulose, determined to be 0.4 kcal/g.; Scientific Review of the Evidence on the Caloric Value of Allulose
Related CFR Sections (4)
- 21CFR101.9§ 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.Read full regulation →
- 21CFR101.81§ 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD).
(a) Relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods and the risk of CHD.Read full regulation →
- 21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- Guidance for Industry: Guide for Developing and Using Data Bases for Nutrition Labeling (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels (Status: Final)
- Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals (Status: Final)
- Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- CPG Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG 7133.21) (Status: Final)
- Guidance for Industry: Seafood HACCP Transition Guidance (Status: Final)