Description
This guidance is intended for conventional food and dietary supplement manufacturers. It provides questions and answers on topics related to compliance with our final rules issued on May 27, 2016, entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742; the “Nutrition Facts label final rule”) and “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000; the “serving size final rule”) (codified at title 21 of the Code of Federal Regulations, part 101 (21 CFR part 101)). This guidance also discusses labeling of added sugars, as well as formatting for lines (e.g. thickness of lines) and leading (e.g. space between lines) in the examples of graphics used by FDA on the Nutrition Facts label.
Scope & Applicability
Product Classes
8guidance is intended for conventional food and dietary supplement manufacturers
dairy products treated with lactase
beverages made from oats and rice
100 percent juice used as a baseline for sugar content
ingredient used in products requiring added sugar calculation
guidance is intended for conventional food and dietary supplement manufacturers
Subject to enforcement discretion regarding mandatory nutrition labeling.
Non-standardized products whose fruit component is excluded from added sugars.
Stakeholders
3Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Responsible for providing accurate nutrient information to manufacturers.
Entity responsible for submitting NDINs
Regulatory Context
Attributes
10Established for added sugars
Updated values used for calculating percent Daily Values; RDIs used in the declaration of the percent DV of nutrients; nutrition information for two different RDI groups
Refers to the degree of accuracy when rounding nutrients for declaration.
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
measure of the degree of polymerization in hydrolyzed ingredients
estimate for the sugar concentration in juice ingredients
used to convert volume-based serving size to weight-based sugar content
concentration levels in juice products
used to calculate labeled percentage of juice from concentrate
Related CFR Sections (10)
- 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 →
- 21CFR101.36§ 101.36 Nutrition labeling of dietary supplements.
(a) The label of a dietary supplement that is offered for sale shall bear nutrition labeling in accordance with this regulation unless an exemption is provided for the product in paragraph (h) of this section.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 →
- 21CFR168.122§ 168.122 Lactose.
(a) Lactose is the carbohydrate normally obtained from whey. It may be anhydrous or contain one molecule of water of crystallization or be a mixture of both forms.Read full regulation →
- 21CFR168.120§ 168.120 Glucose sirup.
(a) Glucose sirup is the purified, concentrated, aqueous solution of nutritive saccharides obtained from edible starch.Read full regulation →
- 21CFR184.1444§ 184.1444 Maltodextrin.
(a) Maltodextrin ((C 6 H 10 O 5 ) n , CAS Reg. No. 9050-36-6) is a nonsweet nutritive saccharide polymer that consists of D-glucose units linked primarily by α-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is prepared as a white powder or concentrated solution by partial hyRead full regulation →
- 21CFR101.30§ 101.30 Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.
(a) This section applies to any food that purports to be a beverage that contains any fruit or vegetable juice (i.e., the product's advertising, label, or labeling bears the name of, or variation on the name of, or makes any other direct or indirect representation with respect to, any fruit or vegetRead full regulation →
- 21CFR102.33§ 102.33 Beverages that contain fruit or vegetable juice.
(a) For a carbonated or noncarbonated beverage that contains less than 100 percent and more than 0 percent fruit or vegetable juice, the common or usual name shall be a descriptive name that meets the requirements of § 102.5(a) and, if the common or usual name uses the word “juice,” shall include a Read full regulation →
- 21CFR150.140§ 150.140 Fruit jelly.
(a) The jellies for which definitions and standards of identity are prescribed by this section are the jelled foods each of which is made from a mixture of one or a permitted combination of the fruit juice ingredients specified in paragraph (b) of this section and one or any combination of the optioRead full regulation →
- 21CFR150.160§ 150.160 Fruit preserves and jams.
(a) The preserves or jams for which definitions and standards of identity are prescribed by this section are the viscous or semi-solid foods, each of which is made from a mixture composed of one or a permitted combination of the fruit ingredients specified in paragraph (b) of this section and one orRead full regulation →
Related Warning Letters (10)
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Valentine Enterprises, Inc.
- 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
- 2024-11-05
CGMP/Dietary Supplement/Adulterated
Top Health Manufacturing, 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
- 2024-07-23
New Drugs/Dietary Supplements/Food Labeling/Misbranded
Formulation Technology, Inc.
See Also (8)
- Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration (Status: Final)
- Guidance for Industry: Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity (Status: Final)
- Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling (Status: Final)
- Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels (Status: Final)
- Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics (Status: Final)
- Guidance for Industry: Proper Labeling of Honey and Honey Products (Status: Final)
- Guidance for Industry: Reference Amounts Customarily Consumed (List of Products for Each Product Category) (Status: Final)
- Small Entity Compliance Guide: Calorie Labeling of Articles of Food in Vending Machines (Status: Final)