Description
The U.S. Food and Drug Administration (“FDA” or “we”) is issuing this Small Entity Compliance guide to help explain the actions that a small entity must take to comply with 21 CFR parts 130 and 131, “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” after recent changes made in 2021 and 2022.
Scope & Applicability
Product Classes
6Standard of identity for yogurt products; Food produced by culturing basic dairy ingredients with a characterizing bacterial culture.; Amend the Standard for Yogurt
Small Entity Compliance Guide regarding Yogurt Products
Small Entity Compliance Guide regarding Milk and Cream Products
Standards revoked by the final rule; Product class previously under 21 CFR 131.203, now under 21 CFR 130.10; Final Rule to Revoke the Standards for Lowfat Yogurt
Standards revoked by the final rule; Product class previously under 21 CFR 131.206, now under 21 CFR 130.10; Final Rule to Revoke the Standards for Nonfat Yogurt
Yogurt product containing at least 25 percent less milkfat than yogurt
Stakeholders
4Entities subject to 21 CFR parts 130 and 131
Responsible for declaring acceptable market names on labels.
Target audience for the compliance guide
Entities encouraged to reduce sodium in foods; Primary industry members encouraged to reformulate products
Regulatory Context
Attributes
4Option eliminated by the 2023 final order
Compliance date for products labeled on or after January 1, 2024
The RACC for yogurt is 170 grams.
Reference Amount Customarily Consumed, which is 170 grams for yogurt
Related CFR Sections (7)
- 21CFR131.200§ 131.200 Yogurt.
(a) Description. Yogurt is the food produced by culturing one or more of the basic dairy ingredients specified in paragraph (b) of this section and any of the optional dairy ingredients specified in paragraph (c) of this section with a characterizing bacterial culture that contains the lactic acid-pRead full regulation →
- 21CFR130.10§ 130.10 Requirements for foods named by use of a nutrient content claim and a standardized term.
(a) Description. The foods prescribed by this general definition and standard of identity are those foods that substitute (see § 101.13(d) of this chapter ) for a standardized food defined in parts 131 through 169 of this chapter and that use the name of that standardized food in their statement of Read full regulation →
- 21CFR114.90§ 114.90 Methodology.
Methods that may be used to determine pH or acidity for acidified foods include, but are not limited to, the following:Read 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 →
- 21CFR101.62§ 101.62 Nutrient content claims for fat, fatty acid, and cholesterol content of foods.
(a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a food may only be made on the label or in the labeling of foods if:Read full regulation →
- 21CFR101.60§ 101.60 Nutrient content claims for the calorie content of foods.
(a) General requirements. A claim about the calorie or sugar content of a food may only be made on the label or in the labeling of a food if: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 →
Related Warning Letters (5)
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2022-08-30
Food Labeling/Misbranded
National Food Industries LLC
- 2022-02-01
Food Labeling/Misbranded
Picket Fence Creamery LLC
- 2021-12-07
New Drug/Misbranded
Synaptent, LLC
- 2021-07-28
Unapproved New Drugs/Misbranded
Nutrishus Brands, Inc.
See Also (8)
- Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Status: Final)
- 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: Reference Amounts Customarily Consumed (List of Products for Each Product Category) (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)