Description
This guidance provides our current view on the declaration of allulose on Nutrition and Supplement Facts labels, as well as on the caloric content of allulose. This guidance also advises manufacturers of our intent to exercise enforcement discretion for the exclusion of allulose from the amount of “Total Sugars” and “Added Sugars” declared on the label and the use of a general factor of 0.4 calories per gram (kcal/g)[2] for allulose when determining “Calories” on the Nutrition and Supplement Facts labels pending review of the issues in a rulemaking.
Scope & Applicability
Product Classes
1The declaration of allulose and calories on these labels
Regulatory Context
Attributes
5General factor for allulose when determining Calories
Labeling element on Nutrition Facts; A nutrient declaration category on food labels.
Labeling element on Nutrition Facts; A subset of Total Sugars required on labels.; declared on Nutrition and Supplement Facts labels
Labeling element on Nutrition Facts; A mandatory nutrient declaration on food labels.
The 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 (3)
- 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 →
- 21CFR101.80§ 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.
(a) Relationship between dietary carbohydrates and dental caries.Read full regulation →
- 21CFR101.4§ 101.4 Food; designation of ingredients.
Related Warning Letters (10)
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-06-24
Food Labeling/Misbranded
Revolution Foods, PBC
- 2025-06-03
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
One Roof LLC
- 2024-12-03
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Mena Food Group, LLC
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2024-10-15
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Alfred Louie, Inc.
- 2024-10-01
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
NRS Enterprises, Inc. d/b/a Sunflour Bakery
- 2024-06-25
Food Labeling/Misbranded/False and Misleading
Bimbo Bakeries USA, Inc.
- 2024-06-11
Acidified Foods/Prepared Packed or Held Under Insanitary Conditions
Midwest Foods, LLC
- 2024-05-14
Food Labeling/Misbranded
California Bread Co.
See Also (8)
- Guidance for Industry: FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels (Status: Final)
- Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements (Status: Final)
- Small Entity Compliance Guide: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (Status: Final)
- Small Entity Compliance Guide: Nutrient Content Claims Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (Status: Final)
- Small Entity Compliance Guide: Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and Osteoporosis (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages (Status: Final)
- Small Entity Compliance Guide: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Status: Final)