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HHS/FDA RIN: 0910-AI80 Publication ID: Fall 2023 
Title: Front-of-Package Nutrition Labeling 

This proposed rule would require the front of food labels to display certain nutrition information to help consumers, especially those with lower nutrition knowledge, make more informed dietary choices.  Front-of-package (FOP) nutrition labeling is intended to complement the Nutrition Facts label on packaged foods by giving consumers additional context to help them quickly and easily identify foods that can help them build a healthy eating pattern. A variety of FOP labeling systems have been adopted in countries world-wide and the experience in these countries suggests that FOP labeling may aid the ability to make healthier choices. FDA plays a key role within a broader, whole-of-government approach to help reduce the burden of chronic diseases and advance health equity by helping to improve dietary patterns in the U.S. This proposed rule is part of FDA’s nutrition efforts to empower consumers with nutrition information to help them more easily identify healthier choices and may result in industry innovation to produce healthier foods. FDA will conduct public outreach on this project. FDA has held, and will continue to hold, listening sessions with a wide range of stakeholders, including consumer groups, public health organizations, academia, health care groups, and industry. Additionally, the Reagan-Udall Foundation will host a public meeting in November in collaboration with FDA to hear input from a broad array of stakeholders, and we are launching a series of Tribal Listening Sessions to begin a conversation with federally recognized tribes on, among other things, our FOP initiative.

Agency: Department of Health and Human Services(HHS)  Priority: Section 3(f)(1) Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 101.6 (new)   
Legal Authority: Not Yet Determined   
Legal Deadline:  None

Statement of Need:

HHS implemented its first mandatory nutrition labeling 32 years ago. The resulting Nutrition Facts label is iconic and 87% of American consumers report using the label.  However, many consumers, particularly those with lower nutrition literacy, may find additional information on food packaging helpful in identifying foods that are part of constructing a healthy diet. This proposed rule, if finalized, could empower consumers with information to help them quickly identify foods that can help them build a healthy eating pattern.

Summary of the Legal Basis:

In general, our legal authority rests on the 1990 Nutrition Labeling and Education Act, which gave the Secretary the authority to require that certain nutrition information be conveyed to allow the public to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet.  (Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 2(b)(1)(A)).  Authority for certain aspects may also be found in section 403(q), 403(a)(1), and 201(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, section 701(a) of the FD&C Act authorizes the promulgation of regulations for the efficient enforcement of the FD&C Act.


FDA will consider different options so that we maximize benefits to consumers.

Anticipated Costs and Benefits:

The proposed rule, if finalized, is expected to generate compliance costs on affected entities, such as the cost to label packaged foods and the one-time costs to read and understand the rule. Estimated benefits to consumers TBD.




Action Date FR Cite
NPRM  06/00/2024 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Mark Kantor
Department of Health and Human Services
Food and Drug Administration
CPK1 RM 3D034, HFS-830, 5001 Campus Drive,
College Park, MD 20740
Phone:240 402-2082