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HHS/FDA RIN: 0910-AI13 Publication ID: Fall 2023 
Title: Nutrient Content Claims, Definition of Term: Healthy 

The rule would update the definition for the implied nutrient content claim "healthy" to be consistent with current nutrition science and federal dietary guidelines. The rule would revise the requirements for when the claim "healthy" can be voluntarily used in the labeling of human food products to indicate that a food, because of its nutrient content, may be useful in achieving a total diet that conforms to current dietary recommendations and helps consumers maintain healthy dietary practices.

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: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 10 CFR 101.65 (revision)   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 343    21 U.S.C. 371   
Legal Deadline:  None

Statement of Need:

This rule would update the "healthy" claim to make it more consistent with advances in nutrition science and public health recommendations, including those captured in recent changes to the Nutrition Facts label. The existing definition of "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 and now emphasize healthy dietary patterns, which include getting enough of certain foods from food groups such as fruits, vegetables, low-fat dairy, and whole grains. Diet is a contributing factor to chronic diseases, such as heart disease, cancer, and stroke, which are the leading causes of death and disability in the United States. Claims on food packages such as "healthy" can provide quick signals to busy consumers about the healthfulness of a food or beverage.

FDA is updating the existing definition of the "healthy" claim based on the food groups recommended by the Dietary Guidelines for Americans by requiring that food products bearing the claim contain a certain amount of food from such food groups or subgroups. The rule would also require a food product to be limited in saturated fat, sodium, and added sugar. These updates would ensure that foods bearing the claim are ones that are part of a healthy dietary pattern and are recommended by current dietary guidelines. The rule is also part of FDA’s ongoing effort to empower consumers with information to help them improve their nutrition and dietary patterns and reduce their risk of diet-related chronic disease.

Summary of the Legal Basis:

FDA is issuing this 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 rule would update the existing definition to be consistent with current nutrition science and federal dietary guidance.


Alternative 1: Codify the alternative criteria 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 alternative criteria in this guidance rather than the proposed update to the definition.  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 compliance date on the rule updating the definition of healthy 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, an extended compliance date runs the risk of not being helpful to consumers because they may not know whether a packaged food product labeled "healthy" follows the existing 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. Quantified costs to manufacturers include labeling, reformulating, and recordkeeping. Discounted at seven percent over 20 years, the mean present value of costs of the rule is $237 million, with a lower bound of $110 million and an upper bound of $434 million.

Updating the definition of "healthy" to align with current dietary recommendations can provide information to help consumers build more healthful diets to help reduce their risk of diet-related chronic diseases. Discounted at seven percent over 20 years, the mean present value of benefits of the rule is $290 million, with a lower bound estimate of $9 million and an upper bound estimate of $857 million.



Action Date FR Cite
NPRM  09/29/2022  87 FR 59168   
NPRM Comment Period End  12/28/2022 
NPRM Comment Period Extended  11/29/2022  87 FR 73267   
NPRM Comment Period Extended End  02/16/2023 
Final Action  04/00/2024 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
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