Description
The purpose of this guidance is to provide examples of products that belong in each of the product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion established in 21 CFR 101.12(b).
Scope & Applicability
Product Classes
10Includes dry mixes and prepared forms
Product category including tomato sauce and puree
Product category including tomato paste
Product category for single or mixed vegetable juices
Product category including jalapeno and hot peppers
Product category including pimento and parsley
Product category listed in the RACC table
dried tomatoes, mushrooms, seaweed
cane, corn, maple, and fruit syrups
aspartame, maltodextrin, sucralose, stevia
Stakeholders
2Entity responsible for submitting NDINs
Responsible for declaring acceptable market names on labels.
Regulatory Context
Attributes
10The amount of food used as the basis for nutrient and food group statements.
The form of the product to which reference amounts typically apply
Reference amount for nuts and seeds
Reference amount for mixed dishes not measurable with cup
Reference amount for mini mixed dishes
Reference amount for milk and fruit juice concentrates
Reference amount basis for dietary supplements
Criteria for dried fish and meat substitutes (less than 2:1)
Reference amount for pastries
Reference amount for beverages; Reference amount for other drink mixes
Related CFR Sections (3)
- 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 →
- 21CFR101.9§ 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 →
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: Guidelines for Determining Metric Equivalents of Household Measures (Status: Final)
- Guidance for Industry: Guide for Developing and Using Data Bases for Nutrition Labeling (Status: Final)
- Small Entity Compliance Guide: Serving Sizes Reference Amount for Baking Powder, Baking Soda, and Pectin (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: 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 (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)
- Small Entity Compliance Guide: Milk and Cream Products and Yogurt Products; Final Rule to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt (Status: Final)
- Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration (Status: Final)