Description
This guidance is intended for conventional food and dietary supplement manufacturers. It will provide questions and answers on topics related primarily to two final rules: (1) “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”; and (2) “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.” This guidance also discusses formatting issues for dual-column labeling, products that have limited space for nutrition labeling, and additional issues dealing with compliance.
Scope & Applicability
Product Classes
10guidance is intended for conventional food and dietary supplement manufacturers
Packages where size renders full labeling impracticable
Retail food products containing multiple individually packaged items
guidance is intended for conventional food and dietary supplement manufacturers
A product that is packaged and sold individually and contains less than 200 percent of the applicable RACC.; A package that contains less than 200 percent of the RACC.
Products requiring specific technical considerations for RACC determination.
Defined in 21 CFR 101.13(l) with specific serving size rules.
Defined in 21 CFR 101.13(m) with specific serving size rules.
Foods like cheeses sold in varying weights where 'varied' may be declared for number of servings.
Individual items like muffins, sliced bread, or individually packaged products.
Stakeholders
1Entity 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.
Regulatory Context
Attributes
4The RACC for yogurt is 170 grams.
Reference Amount Customarily Consumed, which is 170 grams for yogurt
amount of food customarily consumed in one eating occasion; The amount of food customarily consumed, declared on the label.
Standardized serving size metric (RACC)
Related CFR Sections (6)
- 21CFR101.2§ 101.2 Information panel of package form food.
(a) The term information panel as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel with the following exceptions:Read full regulation →
- 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 →
- 21CFR101.1§ 101.1 Principal display panel of package form food.
The term principal display panel as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to acRead full regulation →
- 21CFR101.12§ 101.12 Reference amounts customarily consumed per eating occasion.
(a) The general principles and factors that the Food and Drug Administration (FDA) considered in arriving at the reference amounts customarily consumed per eating occasion (reference amounts) which are set forth in paragraph (b) of this section, are that:Read 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 →
- 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 →
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: Food Labeling Guide (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)
- Guidance for Industry: Labeling of Infant Formula (Status: Final)
- Guidance for Industry: Frequently Asked Questions About Medical Foods - Third Edition (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- 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)