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HHS/FDA

RIN: 0910-AF23

Publication ID: Fall 2013

Title: Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs
Abstract: FDA is proposing to amend its labeling regulations for foods to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. If finalized, this rule would provide consumers with nutrition information based on the amount of food that is customarily consumed, which would assist consumers in maintaining healthy dietary practices. In addition to updating certain RACCs, FDA is also considering amending the definition of single-serving containers; amending the definition of serving size for breath mints; and providing for dual-column labeling, which would provide nutrition information per serving and per container, for certain containers.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Yes	Unfunded Mandates: Private Sector
CFR Citation: 21 CFR 101.9 21 CFR 101.12
Legal Authority: 21 USC 321 21 USC 343 21 USC 371

Legal Deadline: None

Statement of Need: The regulations for serving sizes for nutrition labeling of foods have not been amended since mandatory nutrition labeling was first required in 1993. New scientific evidence, consumption data, and consumer research has become available in the last 18 years that can be used to update the serving size information on Nutrition Facts labels to reflect the amount of food customarily consumed. This will allow consumers to use the serving size information more effectively to select foods that will promote maintenance of healthy dietary practices.

Summary of the Legal Basis: FDA's legal basis derived from sections 201, 403 and 701 (a) of the Federal Food, Drug and Cosmetic Act.

Alternatives: The Agency will consider different options for the amount of time that manufacturers have to come into compliance with the requirements of this regulation, if finalized, so that the economic burden to industry can be minimized. The Agency also intends to publish this regulation simultaneously with other regulations requiring changes to Nutrition Fact labels to ease economic burden on manufacturers.

Anticipated Costs and Benefits: If finalized, this rule will affect most foods that are currently required to bear nutrition labeling. It will have a significant cost to industry because food labels on all affected foods will have to be updated. Much of the information currently provided on the Nutrition Facts labels is based on old reference values and scientific information. The proposed changes would provide more current information to assist consumers in constructing a healthful diet.

Risks: If serving size information on the Nutrition Facts label is not updated, reference amounts customarily consumed that serve as the basis for serving sizes will continue to be based on old consumption data. Proposed updates to the serving size listed on the Nutrition Facts label will be based on current nationwide consumption data. Without these updates, consumers will not have current information to assist them in constructing a healthy diet.

Timetable:

Action	Date	FR Cite
ANPRM	04/04/2005	70 FR 17010
ANPRM Comment Period End	06/20/2005
NPRM	12/00/2013

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Federal, State
Small Entities Affected: Businesses	Federalism: Yes
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: Cherisa Henderson Nutritionist Department of Health and Human Services Food and Drug Administration HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740 Phone:240 402-5429 Fax:301 436-1191 Email: nutritionprogramstaff@fda.hhs.gov