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HHS/FDA RIN: 0910-AI13 Publication ID: Fall 2018 
Title: ●Nutrient Content Claims, Definition of Term: Healthy 

The proposed rule would update the definition for the implied nutrient content claim "healthy" to be consistent with current nutrition science and federal dietary guidelines. The proposed rule would revise the requirements for when the claim "healthy" can be voluntarily used in the labeling of human food products so that the claim reflects current science and dietary guidelines and help consumers maintain healthy dietary practices.



Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
CFR Citation: 10 CFR 101.65 (revision)   
Legal Authority: 21 U.S.C. 321, 331, 343, and 371   
Legal Deadline:  None

Statement of Need:

FDA is proposing to redefine healthy to make it more consistent with current public health recommendations, including those captured in recent changes to the Nutrition Facts label.  The existing definition for healthy is based on nutrition recommendations regarding intake of fat, saturated fat, and cholesterol, and specific nutrients Americans were not getting enough of in the early 1990s.  Nutrition recommendations have evolved since that time; recommended diets now focus on dietary patterns, which includes getting enough of certain food groups such as fruits, vegetables, low-fat dairy, and whole grains.  Chronic diseases, such as heart disease, cancer, and stroke, are the leading causes of death and disability in the United States and diet is a contributing factor to these diseases.  Claims on food packages such as healthy can provide quick signals to consumers about the healthfulness of a food or beverage, thereby making it easier for busy consumers to make healthy choices. 

FDA is proposing to update the existing nutrient content claim definition of Healthy based on the food groups recommended by the Dietary Guidelines for Americans and also include nutrients to limit to ensure that foods bearing the claim can help consumers build more healthful diets to reduce their risk of diet-related chronic diseases.

Summary of the Legal Basis:

FDA is issuing this proposed rule under sections 201(n), 301(a), 403(a), 403(r), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(n), 331(a), 343(a), 343(r), and 371(a)). These sections authorize the agency to adopt regulations that prohibit labeling that bears claims that characterize the level of a nutrient which is of a type required to be declared in nutrition labeling unless the claim is made in accordance with a regulatory definition established by FDA. Pursuant to this authority, FDA issued a regulation defining the healthy implied nutrient content claim, which is codified at 21 CFR 101.65.  This proposed rule would update the existing definition to be consistent with current federal dietary guidance.


Alternative 1: Codify the policy in the current enforcement discretion guidance.

In 2016, FDA published Use of the Term ‘Healthy’ in the Labeling of Human Food Products: Guidance for Industry.  This guidance was intended to advise food manufacturers of FDA’s intent to exercise enforcement discretion relative to foods that use the implied nutrient content claim healthy on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

One alternative is to codify the policy in the current enforcement discretion.  Although guidance is non-binding, we assume that most packaged food manufacturers are aware of the guidance and, over the past 2 years, have already made any adjustments to their products or product packaging.  Therefore, we assume that this alternative would have no costs to industry and no benefits to consumers.


Alternative 2: Extend the compliance date by 1 year.

Extending the anticipated proposed compliance date on the rule updating the definition by 1 year would reduce costs to industry as they would have more time to change products that may be affected by the rule or potentially coordinate label changes with already scheduled label changes.  On the other hand, a longer compliance date runs the risk of confusing consumers that may not understand whether a packaged food product labeled healthy follows the old definition or the updated one.

Anticipated Costs and Benefits:

Food products bearing the healthy claim currently make up a small percentage (5%) of total packaged foods.  Relabeling and reformulating costs can range from about $2,000/UPC to relabel, $800,000/formula to reformulate.  We currently anticipate that total cost to industry will be about $15 million, annualized at 7% in perpetuity.

Updating the definition of healthy to align with current dietary recommendations help consumers build more healthful diets to reduce their risk of diet-related chronic diseases.  We currently anticipate the monetized benefits to be around $100 million, annualized at 7% in perpetuity.

There are no cost savings.


Action Date FR Cite
NPRM  03/00/2019 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Vincent De Jesus
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:240 402-1774
Fax:301 436-1191