|View EO 12866 Meetings||Printer-Friendly Version Download RIN Data in XML|
|HHS/FDA||RIN: 0910-AF22||Publication ID: Fall 2015|
|Title: Food Labeling: Revision of the Nutrition and Supplement Facts Labels|
FDA is amending the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The rule would modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. On July 27, 2015, FDA issued a supplemental notice of proposed rulemaking accepting comments on limited additional provisions until October 13, 2015. Also on July 27, 2015, FDA reopened the comment period on the proposed rule as to specific documents until September 25, 2015.
|Agency: Department of Health and Human Services(HHS)||Priority: Economically Significant|
|RIN Status: Previously published in the Unified Agenda||Agenda Stage of Rulemaking: Final Rule Stage|
|Major: Yes||Unfunded Mandates: Private Sector|
|CFR Citation: 21 CFR 101.9 21 CFR 101.36|
|Legal Authority: 21 U.S.C. 321 21 U.S.C. 343 21 U.S.C. 371|
Statement of Need:
Almost all of the regulations for the nutrition labeling of foods and dietary supplements have not been amended since mandatory nutrition labeling was first required in 1993. New scientific evidence and consumer research has become available since 1993 that can be used to update the content and appearance of information on the Nutrition Facts and Supplement Facts labels. Consumers can use the updated information to select foods that will assist them to maintain healthy dietary practices.
Summary of the Legal Basis:
FDA's legal basis derives from sections 201, 403, and 701(a) of the Federal Food, Drug, and Cosmetic Act.
The Agency will consider different options for the amount of time that manufacturers have to come into compliance with the requirements of this regulation, when finalized, so that the economic burden to industry can be minimized.
Anticipated Costs and Benefits:
This rule will affect all foods that are currently required to bear nutrition labeling. It will have a significant cost to industry because all food labels will have to be updated. Much of the information currently provided on the Nutrition Facts and Supplement Facts labels is based on old reference values and scientific information. The changes would provide more current information to assist consumers in constructing a healthful diet. The potential economic benefit from the final rule stems from the improvement in diet among the U.S. population. Diet is a significant factor in the reduction in risk of chronic diseases such as coronary heart disease, certain types of cancer, stroke, diabetes, and obesity.
If information on the Nutrition Facts and Supplement Facts label is not updated, reference values that serve as the basis for the percent daily value will continue to be based on old scientific evidence, and consumers could believe that they are consuming an appropriate amount of nutrients when, in fact, they are not. In addition, consumers would not be able to determine the amount of specific nutrients in a food product because mandatory declaration of those nutrients is not currently required. Furthermore, consumers may overlook information on the label because it is not displayed prominently on the label. Changes to the reference values, nutrients declared on the label, and changes to the format and appearance of the label would reduce the risk of consumers not having information necessary to assist them in maintaining healthy dietary practices.
|Additional Information: Includes Retrospective Review under E.O. 13563.|
|Regulatory Flexibility Analysis Required: Yes||Government Levels Affected: Federal, Local|
|Small Entities Affected: Businesses, Governmental Jurisdictions||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|
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, HFS-830, 5100 Paint Branch Parkway,
College Park, MD 20740