SMALL ENTITY COMPLIANCE GUIDE

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 YogurtNOVEMBER 2023

Download the Final Small Entity Compliance Guide Read the Federal Register Notice

Final

• Share
•  Post
• Linkedin
• Email
• Print

Docket Number:FDA-2023-D-4722Issued by:

Center for Food Safety and Applied Nutrition, Office of Nutrition and Food Labeling

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.  

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28).  This guidance document is intended to help small entities comply with 21 CFR parts 130 and 131 concerning the standard of identity for yogurt and revoking the standards of identity for lowfat yogurt and nonfat yogurt.  

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

In the remainder of this guidance, “you” refers to yogurt manufacturers whose products are subject to 21 CFR parts 130 and 131.  Many answers in this guidance are followed by citations to show where a specific requirement can be found in either the Federal Food, Drug, and Cosmetic Act (FD&C Act) and/or Title 21 of the Code of Federal Regulations.

Download the Guidance

Related Information

• Labeling & Nutrition Guidance Documents & Regulatory Information
• Constituent Update: FDA Releases Small Entity Compliance Guide on Final Rule To Revoke the SOIs for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt (November 27, 2023)
• Constituent Update: FDA Amends Standard of Identity for Yogurt (April 13, 2023) 

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-4722.